cyrilzakka/clinical-trials huggingface dataset:
Clinical and Microbiological Evaluation Of The Efficacy Of Herbal Mouthwashes in Gingivitis

Plaque-induced gingivitis is a clinical condition that appears to cause persistent inflammation in gingiva. It is a preliminary cause to periodontitis but it can be inverted to address the risk of periodontitis development. This randomize controlled clinical trial (RCT) aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non-surgical periodontal therapy (NSPT) in patients with gingivitis. A total of 52 patients diagnosed with gingivitis were incorporated into the RCT and categorized into four groups as follows: Tea tree oil (Tebodont®), thyme hydrosol (Arifoglu®), essential oil (Listerine®), and placebo. The patients were advised to wash with15 ml of prescribed mouthwash twice a day for a period of 3rd months after NSPT. Clinical periodontal measurements; including plaque index (PI), gingival index (GI) and probing pocket depth (PPD) and microbiological sampling, were performed before enrollment and in 3rd months. Plaque samples were examined by quantitative polymerase chain reaction(qPCR).

This randomize controlled clinical trial aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non- surgical periodontal therapy in patients with gingivitis.

Eligibility Criteria:
Inclusion Criteria:

* According to EFP in 2017, gingivitis patients with a PPD ≤3 mm, BOP in the whole mouth ≥ % 10 and no radiological bone loss
* Having ≥ 20 teeth
* Male or female ≥ 18 years old
* Systemically healthy patients

Exclusion Criteria:

* Using of any antioxidant or antimicrobial agent in the last 6 months

  •. Smoking
* Pregnancy
* Alcoholism
Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
* Age of at least 18 years and 75 years or less
* Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l

Exclusion Criteria:

* Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
* Uncontrolled cardiac arrhythmias
* Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
* History of unstable or severe peripheral artery disease within 3 months of study entry
* Uncontrolled hypertension at study entry
* Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
* Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
* Active or chronic hepatic and hepatobiliary disease
* Disorders that would limit study evaluation or participation
ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of pathologically confirmed, advanced NSCLC (with known histology).
* Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).
* Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.
* Adequate renal, hematologic, liver function.
* ECOG PS of 0-2.
* Radiologically measurable disease.

Exclusion Criteria:

* Small cell histology.
* Symptomatic brain mets or known leptomeningeal mets.
* Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.
* Uncontrolled medical disorders.
Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)

Patients (homozygous MFN2 \[gene that provides instructions to produce the Mitofusin 2 protein\] R707W) will be treated with Metreleptin, and effects on body composition, metabolic parameters and safety will be assessed over a 6 month intervention period. Additional safety will be assessed for 1 more year (up to 1.5 years total) in which adverse event data will be collected.

In 2024, the IRB granted an amendment that allowed for continued data collection, including adverse events, up to 5 years per participant.

Eligibility Criteria:
Inclusion Criteria:

* Have the clinical diagnosis of MSL and being followed at University of Michigan (cohort to be studied in this proof-of-concept study is already available at Michigan).
* Willing and able to tolerate the study procedures.
* Willing and able to tolerate blood sampling.
* Having no condition that may impede successful data collection or interfere with testing parameters.
* \<60 years of age.
* If female of childbearing potential:

  * Not breastfeeding.
  * Negative pregnancy test (human chorionic gonadotropin, beta subunit) at baseline.
* Can read, understand and sign approved informed consent form, communicate with study physician, and study team, and understand and comply with protocol requirements.

Exclusion Criteria:

* Presence of advanced liver disease (abnormal synthetic function, prothrombin time \[PT\], or albumin) in medical records
* Evidence of other etiologies of viral hepatitis in medical records
* Presence of active hematologic, bone marrow or other abnormalities that may increase risk of bleeding in medical records.
* Presence of HIV infection in medical records.
* Presence of End-stage renal disease (ESRD), active cancer, or \>class 2 congestive heart failure based on medical history and physical examination.
* Active chronic infection (e.g., known chronic osteomyelitis or Tuberculosis \[TB\]). May have transient infections but must be free of active infection for two weeks prior to study visits.
* Unable to ambulate or tolerate trips to the University of Michigan Clinical Research Unit.
* Clinically relevant Coronary artery disease (CAD): history of stent or Coronary artery bypass graft surgery (CABG) with cardiologist confirmed angina.
* Presence of autoimmune disease.
* Hypersensitivity to metreleptin.
* General obesity not associated with congenital leptin deficiency.
* Any other condition that, in our opinion, may impede successful data collection.
An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data

Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.

A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included:

monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Women with established causes of infertility and indications for the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
* Infertility due to female and/or male factor.
* Presence of ovaries accessible for aspiration of follicles.
* Anatomical and functional capability of uterus to bear pregnancy.

Exclusion Criteria:

* Women with established contraindications to the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
* Presence of pregnancy
* Hypersensitivity to follitropin alfa or excipients.
* Ovarian cysts (not associated with polycystic ovarian syndrome), uterine hemorrhage of unclear etiology
* Premature ovarian failure
* Presence of clinically significant systemic disease
* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
* Neoplasia
* Narcomania, alcoholism
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.


Eligibility Criteria:
Inclusion Criteria:

1. Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial.
2. Have plans for future visits at the site for continued management of IBD.

Exclusion Criteria:

1. Inability to provide written informed consent/assent.
2. Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries).
3. Prior total abdominal colectomy for UC or IBDU.
Opiate Craving Reduction Study Using Post-detox Patients on Suboxone and Use of TEAS as Adjunctive Treatment

Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6 weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality of life and decrease drug cravings ultimately while facing everyday life stressors.

* this crossover study will involve participants who will be randomized into two treatment groups,A\&B. TEAS treatments will be given for 30 minutes,X2/week,for 6 weeks(12total sessions). Group A will receive 2 weeks(4 sessions) of active treatment followed by 4 weeks of sham treatment(8 sessions). Group B will receive 2 weeks(4 sessions) of sham treatment,2 weeks (4 sessions)of real treatment,and finally 2 weeks (4 sessions) of sham treatment.
* parameters to be measured include vital signs and questionnaires weeks 1,3,5,6 to assess self-reported past 14-day substance use,alcohol and drug craving,withdrawal symptoms,sleep,mood,pain and overall quality of life.
* goals include better lives for post-detox opiate addicts as they incorporate this treatment into their lives,saving themselves and loved ones more horror,and their communities resources.

Eligibility Criteria:
Inclusion Criteria:

* 18-59 years old
* early recovery(0-3months of abstinence
* not currently detoxing
* maintained on buprenorphine-naloxone under the care of qualified MD
* proficient in the English language

Exclusion Criteria:

* having acute,psychiatric symptoms which would pose safety concerns,or an adherence to treatment barrier(active suicidality/psychosis/mania)
* severe cognitive disorders\*not competent to give informed consent
* active cardiac disease or EKG abnormalities or with cardiac pacemaker
* currently detoxing from alcohol or illicit drugs
* inability or non-intention to attend all treatment sessions\*history of seizures\*pregnancy or breast feeding.
The Omeza Protocol for Chronic Ulcers

This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.

This is a randomized, multi-center, open-label study comparing the Omeza® Products Bundle versus standard of care treatments for 2 different types of chronic ulcers (venous leg ulcers and diabetic foot ulcers). The treatment period will be 12 weeks, with subjects coming into the study site weekly for evaluations, photography and formal measurements of the target wound, and dressing changes. There will be a total of 13 study site visits. The Screening Visit (Day 0) will occur 1 week prior to randomization and will include routine labs and vascular assessment to determine inclusion/exclusion of the potential subject from the study; followed by weekly treatment visits (Week 1 through Week 11); randomization will occur at Treatment Visit Week 1; the Treatment Visit Week 12/End of Study Visit will include end of study labs. Target wounds will be photographed and measured, and vascular assessment will be done at each of the 13 visits.

If the wound closes before Week 12, the subject will continue to come in for all the remaining study visits until study completion. If the wound does not close by Week 12, the subject will be immediately exited from the study and no further follow-up will occur as part of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 21-80 years of age
2. Participated in the informed consent process and signed study specific informed consent document
3. Willing and able to comply with study procedures, including study visits and study dressing regimens
4. Confirmation of venous disease by non-invasive venous studies with either Doppler- confirmed venous reflux or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema). Biopsy done to exclude other skin conditions e.g. cancer on ulcers ≥ 6 months
5. HbA1c of ≤ 10%
6. Have a venous ulcer between the knee and ankle, at or above the malleolus
7. For VLU's: Target wound size ≥ 4 cm2 to ≤ 150 cm2 in area without exposed tendon, muscle or bone For DFU's: Target wound size ≥ 0.25 cm2 to ≤ 150 cm2 post debridement at Screening Visit and Treatment Visit Week 1/Randomization
8. Target wound duration of at least 3 months and less than or equal to 12 months as of the date the subject signs consent for study
9. Containing yellow/white slough with or without fibrous/scar tissue and/or non- viable tissue
10. Be willing and able (or have family member/friend willing and able) to apply required dressing changes as well as the ability of the subject to tolerate limb compression bandage
11. Ankle-Branchial Index (ABI) less than 0.80 or greater than 1.3

Exclusion Criteria:

1. Subjects with a BMI ≥ 65
2. Subject is medically unable to consent (due to head trauma, coma, etc.) or cognitively impaired (due to being mentally challenged, having Alzheimer
Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease

The purpose of this study is to establish safety for CEP-1347 and to determine an efficacious dose in the treatment of Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

Patients will be included in the study if all of the following criteria are met:

* Willing and able to give informed consent
* Age 30 years or older at time of diagnosis of Parkinson's disease
* Have idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia, or rigidity
* Modified Hoehn and Yahr stage less than or equal to 2.5
* Must have had screening procedures for cancer appropriate for the patient's age and gender, within the last 12 months; or be willing to obtain such screening before randomization
* Women: are not breastfeeding
* Women: nonchildbearing potential (ie, postmenopausal or surgically sterile) or must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Women must be given a pregnancy test unless they are at least 2 years postmenopausal or surgically sterile.

Exclusion Criteria:

Patients will be excluded from participating in this study if 1 or more of the following criteria are met:

* Have atypical Parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases
* Have confirmed diagnosis of Parkinson's disease for more than 5 years
* Have a tremor score of 3 or more in any body part
* Have any other known medical or psychiatric condition that may compromise participation in the study
* Have a history of prior malignancy (excluding basal or squamous cell cancer of the skin) within the previous 5 years
* Have an unresolved abnormal cancer screening test result before randomization
* Have greater than trace amounts of glycosuria at screening, except for known diabetic patients
* Have estimated creatinine clearance less than 50 mL/min
* Have liver function tests (LFT) greater than 3 times the upper limit of normal (ULN)
* Have any other clinically significant ECG or laboratory finding
* Have any history of malignant melanoma
* Have history of seizures (except febrile) or posttraumatic epilepsy
* Have Mini-Mental State Exam (MMSE) score ≤ 26
* Have taken another investigational drug within 60 days before the baseline visit
* Have received prior treatment with CEP-1347
* Have received treatment with agents with potentially confounding anti-Parkinson's disease effects, with specified substrates for CYP3A4/5, or with inhibitors of CYP3A4/5
* Received treatment within 6 months before the baseline visit with agents that may induce Parkinson's disease
* Are expected, within the next 3 months, to reach a level of disability sufficient to require dopaminergic therapy
* Have BECK depression score ≥ 15
* Have known or suspected sensitivity to the investigational study drugs, including B-CIT
First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers

A first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of EDI048 administered orally in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
* At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the participant has rested for at least three (3) minutes, and again in the standing position. Supine vital signs should be within the following ranges:
* oral body temperature between 35.0-37.5 °C
* systolic blood pressure, 90-139 mmHg
* diastolic blood pressure, 50-89 mmHg
* pulse rate, 40-90 bpm

Exclusion Criteria:

* Participants who have received any IMP in a clinical research study within 90 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.
* History of multiple and recurring allergies or allergy or hypersensitivity to any of the study treatments, excipients or drugs of similar chemical classes. Hay fever is allowed unless it is active at time of screening or if there is a risk that it may become active during the study.
* Pregnant or nursing (lactating) women, assessed at screening and baseline.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 7 days after stopping the investigational drug.

Additional protocol-defined inclusion / exclusion criteria may apply.
Executive Functioning and Sleep Fragmentation in COVID-19 Patients

This project aims to investigate executive functioning abilities (primary outcome) and quality of sleep (secondary outcome) in patients with COVID-19 (while distinguishing between those with and without sleep fragmentation), compared with an age- and education matched control group of healthy individuals who did not experience contagion. Prefrontal electrical activity will be recorded with EEG in patients, and related to sleep and cognitive-executive metrics.

The main questions it aims to answer are:

* is executive functioning impaired in COVID-19 patients compared with individuals who were not infected?
* is there a relationship between altered sleep and impaired executive functioning in COVID-19 patients?
* is such relationship related to altered prefrontal brain activitity in COVID-19 patients?

While impaired executive functioning has been often reported in association with COVID-19 contagion, it is still unclear whether, and to what extent, executive deficits might be explained by an altered quality of sleep, that been also frequently reported in COVID-19 patients. On this basis, this project aims to investigate executive functioning abilities (primary outcome) in patients hospitalized for a COVID-19 contagion, while distinguishing between those with and without sleep fragmentation (quality of sleep; secondary outcome), compared with an age- and education matched control group of healthy individuals who did not experience contagion. To this purpose, 38 COVID-19 patients and 38 healthy controls will be administered questionnaires and cognitive tasks aimed to assess: a) executive functioning/inhibitory control (GoNogo task); b) quality of sleep (NOSAS; Insomnia Severity Index; Epworth sleepiness scale). Prefrontal electrical activity will be recorded with EEG in COVID-19 patients, and related to sleep and cognitive-executive metrics. Statistical analyses will be aimed to investigate: a) a possible decrease of executive skills in COVID-19 patients compared with healthy controls, and in COVID-19 patients with fragmented sleep compared with those with normal sleep; b) possible differences in the relationship between executive performance and quality of sleep across the three experimental groups; c) whether possible differences in such relationship relate to prefrontal brain activity in patients. The results of this study will provide novel insights into the consequences of COVID-19 at the cognitive level, thus informing about treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* For patients: current contagion from COVID-19
* For patients and controls:
* age\>18 years
* absence of clinical conditions, cognitive and sensory deficits, and severe psychiatric disorders that would impair participation in research identified through clinical history.

Exclusion Criteria:

* current or past neuro-psychiatric disorder
* current or past sleep disorder