cyrilzakka/clinical-trials huggingface dataset:
Effects of Gum Disease Treatment on Host Defense Factors

Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.


Eligibility Criteria:
Inclusion Criteria:

* Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) ≤ 3mm e absence of bleeding on probing.
* Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD ≥ 4mm and clinical attachment level (CAL) ≥ 3mm.
* Compensated diabetic individuals: compensated type 2 diabetes mellitus
* Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c \>7%)

Exclusion Criteria:

* Past or actual systemic diseases other than diabetes type 2 in the diabetic groups
* Gingivitis
* Gingival overgrowth
* Necrotizing periodontal diseases
* Pregnant or lactating
* smokers or former-smokers
* medication that can influence periodontal status or host response to periodontal therapy
* periodontal therapy in the past 6 months from baseline
* use of systemic or local antibiotics or anti-inflammatory drugs within 3 months prior baseline
Pro Osteon Bone Void Filler Study

This study was designed to observe the outcomes of Pro Osteon according to its cleared indications for use.

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of Pro Osteon® as a Bone Void Filler. FDA has cleared this device via premarket notifications 510(k) K063346, K980817, and K990131. There will be no experimental or investigational devices used.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will be the same as the stated indications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These indications are stated below:

* PRO OSTEON® 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
* PRO OSTEON® 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e, the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
* Surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection.
* All patients must sign an IRB-approved Informed Consent to be enrolled into the study.

Exclusion Criteria:

Exclusion criteria will be the same as the stated contraindications stated in the summary of the FDA approved 510(k) K063346, K980817, and K990131 application. These contraindications are stated below:

* Pro Osteon® 500R Resorbable Bone Graft Substitute is contraindicated for fractures of the growth plate
* For segmental defects
* For indications which may be subjected to excessive impact or stresses
* When there is significant vascular impairment proximal to the graft site
* When there are metabolic or systemic bone disorders that affect bone or wound healing
* In infected sites
* When stabilization of the defect is not possible.
* The use of Pro Osteon® 500R is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible.
Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes

The study aimed to explore the impact of obesity on both body composition and ovarian Doppler parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome (PCOS). Additionally, the investigation seeked to establish correlations between these parameters and their prevalence concerning the clinical criteria of PCOS.

Polycystic ovarian syndrome (PCOS) is a complex and multifactorial condition characterized by endocrinological, reproductive, metabolic, and biochemical abnormalities, affecting 12% to 21% of reproductive-aged females. It has emerged as a significant global public health concern. However, variations in diagnostic criteria and patient selection have led to considerable discrepancies in the absolute prevalence of PCOS and its temporal trends. Previous studies have examined ovarian volume and blood flow indices in both obese and non-obese females with PCOS, albeit employing different criteria for obesity classification. Notably, none have compared these parameters across normal weight, overweight, and obese PCOS females. Therefore, the current study aims to explore the impact of obesity on body composition and ovarian Doppler parameters within distinct PCOS phenotypes. An additional objective is to assess correlations between anthropometric, body composition, and ovarian Doppler parameters and the prevalence of PCOS symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age ranged from 18 to 40 years old.
* Individuals with Polycystic Ovary Syndrome (PCOS) should exhibit at least two of the three features outlined in the Rotterdam criteria for diagnosis, encompassing oligo- or anovulation, clinical and/or biochemical indications of hyperandrogenism, and the presence of polycystic ovaries as identified through ultrasonography.

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Thyroid dysfunction
* Hyperprolactinemia
* Androgen-secreting tumors
* Cushing syndrome
* Undergoing any medical therapy for the treatment of PCOS or for weight loss.
Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load

The increased complexity of the dismounted combatant's equipment can result in a strain on the various senses (e.g., visual, auditory) that can exceed an individual's limited information processing abilities. The combatant may thus be cognitively overloaded in multi-tasking operational situations.

There has been a great deal of research conducted on cognitive load. A battery of multitasking tests has been developed in the field of aeronautics, but, to our knowledge, no measurement of cognitive load specifically dedicated to combatants has been conducted yet.


Eligibility Criteria:
Inclusion Criteria:

* be a group leader in an infantry regiment,
* be over 18 years old.

Exclusion Criteria:

* be a woman,
* have a heart condition,
* have a visual disease not corrected by glasses or contact lenses,
* have a hearing score ≥ 2 on the SIGYCOP,
* have a psychiatric disorder, a progressive neurological or organic disease requiring drug treatment,
* take psychotropic drugs,
* take more than 28 units of alcohol per week.
The Efficacy of Cyanoacrylate Adhesive (PeriAcryl®90 HV) in Periodontal Wound Healing

Periodontal disease is a gum infection caused by plaque on teeth containing both bacteria and calculus (hard) deposits. These need to be removed on a regular basis to maintain gum health and to prevent teeth weakening. A routine cleaning procedure, scaling/root planing, is accompanied with post-operative soft tissue tenderness and teeth sensitivity making oral hygiene maintenance difficult during wound healing. The need for novel therapeutic approaches, such as cyanoacrylate adhesives, has been identified. It has been hypothesized that its application may provide comfort and assist patients with their daily oral self-care procedures following teeth cleaning.

Hypothesis: The supra-gingival marginal application of cyanoacrylate adhesive will promote periodontal wound healing and prevent the increase of sensitivity of hard (teeth) and soft (gingiva) tissues following non-surgical periodontal therapy (NSPT).

This pilot study involves a small number of participants, and while it is not designed to prove causation, it will evaluate safety and efficacy. If clinical results are positive, these data may be used to determine sample and power needs for larger studies.

With enhanced post-operative comfort, the patient's ability to disrupt biofilm and maintain optimal daily oral self-care can be achieved. Biofilm disruption is paramount to achieving periodontal health. Specifically, the adjunctive placement of an adhesive dressing may reduce biofilm accumulation that is associated with periodontal inflammation. This novel application could improve the patient's oral and thus overall health.

The present pilot trial aims to explore the therapeutic effectiveness of a cyanoacrylate adhesive (PeriAcryl®90 HV) in reducing patient-reported outcomes related to discomfort and sensitivity post NSPT, examine their potential positive effects on periodontal wound healing as well as recording any potential side-effects that may have been experienced by the patients.

Eligibility Criteria:
Inclusion Criteria:

The potential subjects must:

* Be capable of giving informed consent and 19 years of age or older
* Have a minimum of 18 teeth and at least 4 measurement sites with pocket depth at least 5.0 mm with bleeding on probing in at least 2 different quadrants
* Be able to understand and communicate in English, as the study cannot fund a certified interpreter
* Be willing and able to return for treatment and evaluation throughout the course of this study.

Exclusion Criteria:

Potential subjects must not:

* Have had any antibiotics in the last month
* Be pregnant, nursing or plan to become pregnant over the course of the trial
* Have an active smoking history (tobacco or otherwise)
* Have sites with overt abscess, active caries or crown/root fractures
* Have known adverse reactions or allergies to cyanoacrylates or formaldehyde
* Have any other significant disease or take medication(s) that, in the opinion of the investigator, may interfere with the evaluation of safety or efficacy of cyanoacrylate and overall compliance.
Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with type 2 diabetes currently treated with diet and exercise alone (HbA1c below 10%)
* Subjects with type 2 diabetes treated with sulphonylurea (HbA1c below 8.5%)
* Males or non-pregnant, non-lactating females
* Subjects should have normal renal function

Exclusion Criteria:

* Type 1 or other specific causes of diabetes
* Marked symptomatic diabetes
* Uncontrolled treated/untreated hypertension
* Known or suspected allergy to the trial products or related products
Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 65 years, inclusive.
2. Have had a diagnosis of Crohn's disease for at least 6 months.
3. Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
4. Have developed secondary resistance to anti-TNFα therapy.

Exclusion Criteria:

1. Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
2. History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
3. Treatment with immunosuppressive or immunomodulatory drugs
Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite, BMS-510849, following single and multiple oral doses of 5 mg saxagliptin in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women (not of childbearing potential) of Chinese ethnicity
* Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2
* Must have normal physical examination, laboratory values, ECG, pulse and blood pressure unless the investigator considers an abnormality to not be clinically significant.

Exclusion Criteria:

* History of clinically significant hypoglycaemia (low blood sugar levels)
* Women who are pregnant or breastfeeding
Non-ablative Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Prospective Study on Efficacy, Safety, and Quality of Life and Sexuality Impact

The goal of this observational study is to evaluate the efficacy, safety, and impact on quality of life and sexuality of non-ablative dual-wavelength diode laser treatments in managing Genitourinary Syndrome of Menopause (GSM) in sexually active post-menopausal women who cannot use or have not benefited from local estrogen-based therapies. The main questions it aims to answer are:

Does non-ablative dual-wavelength diode laser therapy improve vaginal dryness, burning sensation, and dyspareunia in post-menopausal women? What is the impact of this therapy on the vaginal health index and sexual function? Researchers will compare the laser-treated group to their baseline measurements to see if non-ablative dual-wavelength diode laser therapy effectively treats GSM.

Participants will:

Undergo three monthly sessions of dual-wavelength diode laser therapy. Participate in follow-up evaluations at three and six months post-treatment. Complete self-assessments of GSM symptoms and questionnaires evaluating sexual function and quality of life at each follow-up.

This study aims to provide preliminary evidence that non-ablative dual-wavelength diode laser therapy is a safe and effective non-hormonal treatment for GSM, addressing a gap in existing treatments for women who cannot use or have not benefited from hormonal therapies.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women aged 45-73 years.
* Sexually active.
* Experiencing physiological amenorrhea for more than 12 months.
* Exhibiting at least one symptom of Genitourinary Syndrome of Menopause (GSM).
* Not using lubricants or hormonal therapy in the previous 6 months.
* Able to provide written informed consent.

Exclusion Criteria:

* Untreated uterine or vulvovaginal cancers.
* Pacemaker or other implanted electrode carriers.
* Severe multi-organ or neurological diseases.
* Active sexually transmitted infections.
* Moderate to severe uterine prolapse.
* Active urinary tract infections.
* Acute or chronic dermatological conditions in the vulvar or vaginal area.
* Active genital herpes.
* Active high-risk Human Papillomavirus (HPV).
* Ischemic tissues, unhealed wounds, sores, or undiagnosed mucosal or epithelial alterations.
* Recent unhealed invasive or ablative surgeries.
* Bleeding disorders or anticoagulant therapy.
* Immunodeficiencies.
* Uncontrolled diabetes.
PV Loop and Pulmonary Hypertension

The right ventricular (RV) systolic function is a key determinant of outcome in patients with pulmonary hypertension and elevated pulmonary vascular resistance. As the pulmonary artery pressure and vascular resistance increase (i.e. RV afterload) in these patients, so does the right ventricular contractility in an attempt to maintain cardiac output. This is response of a ventricle to its afterload is termed ventriculo-arterial (VA) coupling. However, there is a limit to this increase in contractility after which VA uncoupling occurs ultimately leading to decrease cardiac output and right ventricular failure. The accepted gold standard for measurement of VA coupling is the ratio of the end systolic ventricular elastance (Ees) to the end systolic arterial elastance (Ea) measured invasively via high fidelity conductance catheters during cardiac catheterization. In this study, the aim is to devise a non-invasive scoring system that can identify VA uncoupling in patients with elevated pulmonary vascular resistance using echocardiography, cardiac MRI, cardiopulmonary exercise testing and brain natriuretic peptide levels. The hypothesis is that a group of morphologic and functional variables obtained noninvasively can differentiate an RV with VA coupling from that with VA uncoupling.


Eligibility Criteria:
Inclusion Criteria:

* Children 1-21 years of age
* Patients referred for cardiac catheterization for hemodynamic evaluation due to concern for pulmonary hypertension
* Structurally normal heart

Exclusion Criteria:

* Pulmonary hypertension secondary to pulmonary venous hypertension defined as pulmonary capillary wedge pressure of more than or equal to 15mmHg
* Pulmonary hypertension secondary to mixed pulmonary arterial and venous hypertension
* Patient will be excluded from performing an MRI if they have:

claustrophobia, metal implants or allergy to contrast

* Patients will be excluded from performing a cardiopulmonary exercise test (CPET) if they are: 1) less than 8 years or 2) unable to follow instructions to run on a treadmill.
NUYou:mHealth Intervention to Preserve and Promote Ideal Cardiovascular Health

The purpose of the study is to investigate the preservation or promotion of health in students during the college years.

Freshman college students at Northwestern University will be cluster randomized to two groups based on their dorm. The intervention for one group will target smoking, physical activity, BMI and consumption of fruits and vegetables. The intervention in the second group will target traveling behavior, sexual risk behaviors, sunscreen use and hydration. Baseline health and lifestyle measures will be assessed for each participant prior to intervention. Health assessments will measure height, weight, fasting glucose, total cholesterol and carbon monoxide. The lifestyle measure will ask questions about physical activity, diet, alcohol and tobacco use, safe sex practices, driving habits, and sunscreen use. These same measures will be repeated during the fall of the students' sophomore and junior years.

Participants will be given a mobile application and encouraged to track some behaviors. In addition, participants will be asked to answer weekly questions regarding health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Freshman at Northwestern University in the fall of 2015
* Live on campus
* Read, write and speak English
* Own an Iphone or Android smart phone

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Established cardiovascular disease
* Unstable psychiatric or medical condition
Cosmetic Outcome of Leishmaniasis Scar After WR279396 Application

Primary Objectives:

Assess whether CL (caused by Leishmaniasis major) lesions treated with WR279396 improved the cosmetic outcome compared with no treatment (natural healing)

Secondary Objectives

1. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with no treatment (natural healing)
2. Evaluate the cosmetic outcome of CL lesions treated with "vehicle" compared with WR279396

   * To determine whether CL lesions treated with vehicle improves the cosmetic outcome (compared with natural healing)
   * To determine whether CL lesions treated with vehicle alone provides a cosmetic outcome similar to WR279396

Eligibility Criteria:
Inclusion Criteria:

* Included are volunteers who participated in WRAIR 813 (HSRRB Log # 9768.1) and those who participated in another CL study in/around the WRAIR 813 study site who had been assigned to a "no-treatment" (natural healing) arm. All volunteers will have had documented CL in the past that were treated with WR279396, vehicle, or no treatment (natural history), have signed informed consent, and are willing to comply with study assessments; age range: 5 to 75 years old.
* For study subjects who were enrolled in WRAIR 813 in 2004 (WR279396 or vehicle treated):

  * Written informed consent obtained from the subject or guardian
  * Willing to meet the requirements of the single clinic visit
  * Prior data in the clinical site data base documenting a diagnosis of CL
  * Each lesion for inclusion in this study conforms to WRAIR 813: ³ 1 cm in diameter and was primarily ulcerative (i.e., not verrucous or nodular)
  * The index lesion and others to be scored were proven parasitologically by Giemsa slide smear
  * CL scars documented to be \> 360 days old (clock starts at time of diagnosis)
  * No treatment of the lesions other than that received in the previous protocol
* Study subjects from the earlier studies to serve as "no treatment" controls:

  * Written informed consent obtained from the subject or guardian
  * Willing to meet the requirements of the single clinic visit
  * Same age range as WRAIR 813: 5-75 years old at time of diagnosis
  * Prior data in the clinical site data base documenting a diagnosis of CL, and that the volunteer was assigned to the "no treatment" group
  * Each lesion for inclusion in this study will conform to WRAIR 813: at the time of diagnosis, ≥1 cm in diameter and described as primarily ulcerative (i.e., not verrucous or nodular)
  * At least 1 lesion that was proven parasitologically by Giemsa slide smear for inclusion in the earlier study.
  * CL scars documented to be \> 360 days old (clock starts at time of diagnosis)
  * Never received any treatment of the lesions (natural healing) or applied any medication, such as herbal medication
  * Lesions present on the trunk or extremities, to match the WRAIR 813 study volunteers (no facial lesions were treated in the 2004 study)

Exclusion Criteria:

* Potential volunteers without a prior documented diagnosis of CL