cyrilzakka/clinical-trials huggingface dataset:
Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis

Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.

Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study

Exclusion Criteria:

* Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women
Inflammatory Marker in Ibd and Peripheral Arthritis

The Objective Of This Study Is To Estimate The Correlation Between Disease Activity In IBD, Inflammatory Markers And Peripheral Arthritis After Exclusion Of Other Causes Arthritis

Inflammatory Bowel Diseases (IBD) Are Chronic Relapsing Inflammatory Disorder Of The Gastrointestinal Tract (GIT) , Which Represented Mainly By Ulcerative Colitis (UC) And Crohn's Disease .

IBD Is To Be Considered Systemic Disease Since They Are Often Associated With Extra intestinal Manifestation, Especially During Activity, Which Reflect A Pathogenic Mechanism As Arthritis ,Erythema Nodosum ,Pyoderma Gangrenosum , Apthous Ulceration ,Iritis And Uveitis.

Peripheral Arthritis (Pa) Is Observed Rather Than Frequently, The Arthritis Involves Predominantly The Joint Of The Lower Limb ,And In Most Cases It Accompanies The Activity Of The Intestinal Disease Pauciarticular, Asymmetric, Migratory And Non Deforming.

Predicting Relapse By Measuring Non Invasive Biomarkers Could Allow Early Treatment Adaptation .Several Studies Have Shown A Correlation Between Intestinal Inflammation And Serum C-Reactive Protein Or Fecal Calprotectin Levels .

Eligibility Criteria:
Inclusion Criteria:

* 1-Pt Above 18 Yrs. 2- IBD Pt. Confirmed By Colonoscopy 3- IBD Patient with Arthritis During Activity

Exclusion Criteria:

* 1-Age Below 18 Yrs. Old 2-Arthritis Of Other Causes Than IBD PT
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients

The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.

French multicenter double-blind controlled parallel-group randomized clinical trial Phase IV assessing whether a hydrocortisone replacement therapy could increase the success rate of GC withdrawal at one year, in patients with Rheumatoid Arthritis in low disease activity or remission, in comparison to progressive decrease of GC (GC tapering).

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old.
* Fulfilling the 2010 American College of Rheumatology (ACR)/EULAR criteria for RA.
* Treated with a stable dose of Synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARD) or Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for at least 3 months.
* Who have been treated with prednisone or prednisolone for at least 6 months.
* With a stable dose of prednisone or prednisolone of 5mg/day for at least 3 months.
* With a DAS28 ≤3.2 for at least 3 months.
* Patients with health insurance
* Patients who have signed a written informed consent form.

Exclusion Criteria:

* Any chronic condition that would need long term corticoid use (e.g. chronic lung diseases).
* Evidence of a flare within the last 3 months.
* Evidence of an allergy or intolerance to hydrocortisone or prednisone.
* Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
* GC joint injections within the last 3 months or scheduled in the next 3 months.
* Any GC intake expected more than \>5mg/day within the next 12 months.
* Association with sultopride and with live vaccines
* Significant trauma or major surgery within the 3 months prior to the baseline visit.
* Scheduled surgery in the next 12 months.
* Fibromyalgia.
* Foreseeable poor compliance with the strategy.
* Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
* Alcohol and/or drug misuse as determined by the investigator.
* Pregnancy or breastfeeding.
* Patient is not willing to sign the informed consent.
* Juridical Protection
* DAS28\>3.2 after one month of a stable dose of prednisone 5 mg/day.
French National Cohort of Children With Port Wine Stain

Port Wine Stain on a limb can be either isolated or associated with complications (venous or orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes (Klippel-Trenaunay syndrome,Parkes-Weber syndrome).

Little is known about epidemiology of port wine stains: their evolution during the growth of the child, the frequency of complications, genetic data, and prognostic factors.

This prospective french national cohort will help for : description of the evolution of port wine stain and possible complications; prognostic factors for complications ; association with mutations of RASA1 gene; quality of life of these children. It will also help for global appreciation of the management of this disease in France.

Prospective national study, including 16 Pediatric and Dermatologic Departments.

Methods : each children with a port wine stain on a lower limb will be followed up for 5 years.

Collected data : demographic data, clinical features, alterations of RASA1 gene, vascular evaluation by ultrasonographic and orthopedic evaluation by X rays, quality of life with a questionnaire.

Inclusion period = 3 years Follow up period = 5 years Population = 150 children

Eligibility Criteria:
Inclusion Criteria:

* Child between 2 and 12 years old with a port wine stain on a lower limb ( or two lower limbs) with national health assurance with consent from one parent

Exclusion Criteria:

* child with orthopedic impairment with no link with the port wine stain
Study of the Impact of DPD Activity on the Efficacy of Capecitabine

This study evaluates the Impact of DihydroPyrimidine Dehydrogenase (DPD) activity on the efficacy of Capecitabine in patients with metastatic breast cancer. The DPD phenotype before the initiation of treatment will be assess and then the patient will be follow up during the treatment with Capecitabine up to 24 month.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18,
* Performance status 0 to 2,
* Patients with metastatic HER2 negative breast cancer,
* Patients eligible for capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days,
* Determination of Uracil level performed according to national recommendations,
* Patients with at least one lesion evaluable according to the RECIST criteria 1.1, or presenting at least 1 hypermetabolic lesion on PET-TDM according to PERCIST 1.0 criteria. In the case of single cutaneous metastasis (s), it is required to make photographs of lesions with a measure of the lesions using a ruler,
* Patients receiving social coverage.

Exclusion Criteria:

* Performance status\> 2,
* Contraindication to capecitabine monotherapy at a dose of 2000 mg / m² / day, 14 days every 21 days,
* Presence of untreated or uncontrolled symptomatic cerebral or leptomeningeal metastases (unstable corticosteroid requirements) and / or non-clinically stable in the 3 months prior to inclusion,
* History of cancer, with the exception of cancers in complete remission for more than 5 years, totally resected cutaneous basal cell carcinoma, in situ carcinoma or in situ cervical epithelioma treated,
* Vulnerable people
Kegg Fertility Study

Fertility Awareness Based Methods (FABMs), such as calendar tracking, basal body temperature (BBT), and monitoring cervical mucus, are widely used but may have limitations in accurately detecting the complete fertility window. Serum hormone measurements and transvaginal ultrasound are more accurate at determining time of ovulation and fertile window, but are costly and inconvenient. Urine-based luteinizing hormone (LH) tests offer improvement. However, LH surge typically occurs 24 to 36 hours prior to ovulation, only capturing the later portion of the fertile window.

A novel approach involves using electrical impedance to track compositional changes in cervical mucus, providing real-time, at-home data. The Kegg device (Lady Technologies Inc, San Francisco, CA, USA) is an intravaginal device that measures cervical mucus impedance to monitor fertility status. Previous studies show it has higher sensitivity, specificity, and accuracy compared to BBT alone in determining the ovulation window. This method offers a cost-effective and practical alternative for at-home fertility tracking.

The objectives of this study are to:

1. evaluate the association between Kegg electrical impedance readings and cervical mucus observations with regard to determining fertility status; and
2. compare the accuracy of Kegg electrical impedance readings with hormone urine strips in identifying the complete fertile window determined by cervical mucus observations.


Eligibility Criteria:
Inclusion Criteria:

1. Biological female
2. Age between 18-40 years old
3. Participant has provided signed informed consent
4. Completed cervical mucus observation training
5. Owns and uses daily a smart device meeting the following requirement: Apple iPad or iPhone running iOS 13 or newer, or Apple Watch running WatchOS 6.0 or newer, or Android operating system of 6.0 or newer
6. Has readily accessible internet
7. Legal residents of the continental United States, excluding Alaska and Hawaii.

Exclusion Criteria:

1. Participant is unable to read and understand English
2. Postmenopausal women
3. Women with hysterectomy
4. Pregnancy
5. Hormonal or intrauterine contraceptives or other hormone use prior to start of study enrollment \[No oral hormonal contraceptives or other hormones for at least one month, no implantable contraceptives or hormonal or non-hormonal intrauterine device for at least two months (\~2 cycles), no injectable hormonal contraceptives or other hormones in past 9 months from the most recent injection and resumption of regular menstrual cycles
Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence

The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine . According to inclusion and exclusion criteria ,the investigators are expected to enroll 16000 participants who performed endotracheal intubation under general anesthesia. All enrolled participants must sign a written informed consent.In the preset studio,The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.Then,Statistical experts use quantitative software to quantify the data.The investigators will put all the data and images into a confidential database in order to build a large database of difficult airways.

Anesthesiologist will give every patient an endotracheal intubation as planned. After that the anesthesiologist will be asked to fill out the questionnaire immediately.This questionnaire allows obtaining a ground truth for the intubation difficulty.All data will be used for AI deep learning and intelligent analysis,Several of the most relevant landmarks will be selected to build an early warning model.The overall study did not involve any intervention in the process of anaesthesia and operation of the patients, only the three-dimensional facial images of the patients were obtained, without any trauma or injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients to be intubated under general anesthesia.

Exclusion Criteria:

* Patients with deaf-mutism or communication disorders.
* Patients with language deficiency or non-native language.
* Patients with mental or central nervous system disease.
* Patients with stupefaction or disturbance of consciousness.
* Patients with terrible injury.
* Patients cannot follow instructions to perform standard actions.
* Patients participated in other relevant clinical investigation in the past 3 months.
Easing Psychosocial Burden for Informal Caregivers

The overall goal of this study is to determine the best time to offer Meaning-Centered Psychotherapy (MCP), an intervention that has proven to be helpful in improving spiritual well-being and decreasing existential distress among patients with advanced cancer, to caregivers. (MCP has also been shown to be an appropriate method of attending to the palliative or comfort care needs of caregivers of patients with cancer. Studies show that the psychological burden associated with caring for a patient with advanced cancer is often greater than that experienced by the patients themselves.) The investigators would also like to find out about caregivers initial impressions of MCP-C, Meaning-Centered Psychotherapy for Cancer Caregivers, so that the intervention can be adjusted to meet the unique needs of caregivers of patients with Glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

Part I Focus group GBM informal caregivers (ICs):

* English-speaking as English proficiency screener and in the best judgment of the consenting professional. This is due to the focus groups being managed in English and the use of certain validated questionnaires only being available in English.
* Age \> 18
* IC to an MSKCC patient with GBM who died a year or more ago

Part II Randomized Intervention of GBM ICs:

* English-speaking as per English proficiency screener and in the best judgment of the consenting professional
* Current ICs to a patient with GBM
* Age ≥ 18
* Score of \> 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role per self-report

Exclusion Criteria:

* In the judgment of the consenting professional, clinician or PI and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information
* Another family member of caregiver to the same patients is currently enrolled in the study
* Ultimately, if interested, all caregivers who decline participation or are ineligible for the study for any reason, including because another caregiver of the patient is currently enrolled in the study, will be offered referrals to the MSKCC Counseling Center and to local mental health providers
Effect of Menstrual Cycle on Traumatic Systemic Response

It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.

89 female breast cancer patient who underwent modified radical mastectomy included into study. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. IL-1β and IL-6 levels, which are related to severeness of inflammation, were measured one day before and one day after surgery. Those are statistically analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal and premenopausal women during different phases of their menstrual cycles

Eligibility Criteria:
Inclusion Criteria:

* female patients
* who underwent modified radical mastectomy for breast cancer
* who signed informed consent forms

Exclusion Criteria:

* For premenopausal patients taking oral contraceptives
* for postmenopausal patients taking hormone replacement therapy.
Effects of SIMEOX on Static Hyperinflation in Patients With COPD

This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).

This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static hyperinflation in patients with COPD.

Patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP (depending of randomization).

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease,
* Forced expiratory volume in 1s (FEV1) \<80% of predicted value,
* Stable condition (no pulmonary exacerbation for more than 28 days).

Exclusion Criteria:

* Routine use of one of the two treatments - SIMEOX and/or PEP,
* Inability to understand or carry out the instructions,
* Severe cardiac comorbidity, neuromuscular disease,
* Severe scoliosis,
* Patient with a pacemaker.
Bispectral Index and Patient State Index During General Anesthesia With Remimazolam

The aim of this study is to compare the bispectral index (BIS) and patient state index (PSI) during general anesthesia using remimazolam. The infusion rate of remimazolam is 6-12mg/kg/h during induction of anesthesia and 1-2mg/kg/h during maintenance of anesthesia. To calculate the fraction, the sum of times when BIS\<60 and PSI \<50 will be divided by the time from the loss of consciousness during induction of anesthesia to fully awake during emergence. We will compare the fraction of BIS \<60 and the fraction of PSI \<50 to find if there is some difference between the two depth of anesthesia monitoring devices during remimazolam anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years need general anesthesia
* American Society of Anesthesiologists (ASA) Classification I, II
* Written informed consent

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) Classification III, IV, V
* BMI \> 40kg/m\^2
* Past medical history of anaphylactic reaction to remimazolam, remifentanil, or other benzodiazepines.
* Administration of anxiolytics, antipsychotics, rifampicin, succinylcholine, neostigmine, flumazenil, and cyclosporin within the past 24 hours
* Benzodiazepine user (e.g. for seizure control)
* Transfer to intensive care unit after surgery
Quantitative MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male

Infertility-the inability to conceive despite one year of properly timed unprotected intercourse-is a common problem. Of all types of male factor infertility, non-obstructive azoospermia may be the most difficult for couples. Importantly, patients with non-obstructive azoospermia are asked to make difficult decisions in terms of reproductive choice; surgical attempts at identifying sperm (microdissection testicular sperm extraction) are often offered to these patients without a guarantee of being able to identify sperm. New methodologies in terms of evaluation of azoospermic males PRIOR to the couple embarking upon IVF are needed urgently. The other potential benefit of non-invasive determination of testis function and spermatogenesis would be the potential targeting of sperm extraction procedures. We hypothesize that quantitative MRI employing advanced functional metrics will be sensitive to functional and metabolic differences between subsets of azoospermic cases and will improve upon current characterization of patients with this condition. Moreover, it is believed that these techniques will provide complementary information, such that they may be combined in a synergistic fashion for targeted extraction methodologies.

Of all types of male factor infertility, non-obstructive azoospermia may be the most difficult for couples. Azoospermia (both obstructive and non-obstructive) occurs in approximately 10-20% of all infertile males with non-obstructive azoospermia encompassing the majority of cases.

In this study, quantitative MRI will be investigated by employing advanced functional metrics for addressing these challenges. Specifically, diffusion-weighted imaging will be assessed, multi-echo T2 mapping, arterial-spin labeling, and spectroscopy. No intravenous contrast will be administered for purposes of this study. It is hypothesized that these techniques will be sensitive to functional and metabolic differences between subsets of azoospermic cases and will improve upon current characterization of patients with this condition. Moreover, it is believed that these techniques will provide complementary information, such that they may be combined in a synergistic fashion for targeted extraction methodologies.

The goal of this exploratory study is to investigate whether associations exist between quantitative MRI metrics and the previously noted features of testis architecture.

Eligibility Criteria:
Inclusion Criteria:

* Men with normospermia who are initiating testosterone replacement and are over 18 years of age will provide semen samples to NYU Fertility Center.

Exclusion Criteria:

* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study.
* All women are excluded as such patients do not have the relevant anatomy being considered in this study.