cyrilzakka/clinical-trials huggingface dataset:
Periodontal Outcomes After Sanative Therapy

Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. Absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. This study will determine if patients with dry mouth have different periodontal health than patients without dry mouth. Additionally, this study will examine if patients who have their periodontal maintenance appointments solely at a periodontal speciality clinic have different periodontal health than patients who alternate their appointments between a specialty office and their general dental office.

Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects the function and flow rate of saliva. Low saliva rates can range from mild self-reported symptoms and discomfort to significant oral diseases. Saliva is essential in preventing irritation and friction of mucosal surfaces. Progressively dry mouth can cause oral and bodily conditions that can affect an individuals quality of life and daily tasks, such as eating and avoiding social situations. Specifically, dry mouth is a risk factor for periodontal disease, a chronic oral inflammation of tissues and ligaments that support the tooth's structure and if untreated, will ultimately lead to tooth loss. In Canada, the first line of defense against periodontal disease is non-surgical sanative therapy (ST). Participants in this study have been attending a periodontal specialty clinic for routine periodontal maintenance appointments for at least 1 to 5 years following their initial scaling and root planing. Salivary flow rate will be measured to determine the level of dry mouth. At the regular maintenance appointment, clinical measures will be evaluated (probing depth, bleeding on probing, plaque index, gingival index, thickness of tissues, mobility, and furcations). Patients will also complete a dry mouth questionnaire to determine if dry mouth influences the day to day life of a patient, and the patient's Registered Dental Hygienist will complete a short questionnaire outlining oral symptoms of dry mouth. Additionally, the investigators aim to see if a patient who has periodontal maintenance appointments at a specialty office has different clinical outcomes than a patient who alternates these appointments between a specialty office and a general dental office. Overall, the investigators will determine if thorough periodontal maintenance appointments are efficient in preventing periodontal disease in patients with dry mouth.

Eligibility Criteria:
Inclusion Criteria:

* have had sanative therapy at this clinic in the previous 1 to 5 years.

Exclusion Criteria:

* anyone who is unable to provide informed consent
Effect of Steady State Meloxicam on Low Dose Aspirin Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females

The objective of this study was to investigate the influence of meloxicam on low dose aspirin induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>=18 and \<= 60 years
* The Body Mass Index (BMI) ≥ 18.5 kg/m2 (square meters) and ≤ 29.9 kg/m2.
* Laboratory values within a clinical normal range

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial, in particular aspirin containing drugs(\< 14 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 1 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
* Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 grams (g)/day)
* Drug abuse
* Blood donation or loss \> 400 mL (\< 1 month prior to administration or during the trial)
* Excessive physical activities (\< 5 days prior to administration or during the trial)
* Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB \> 480 ms or QRS interval \> 110 ms
* History of any familial bleeding disorder
* History of haemorrhagic diatheses
* History of gastrointestinal ulcer, perforation or bleeding
* History of bronchial asthma
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (e.g. sterilisation, intrauterine device (IUP), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period

Ovarian hormone substitution and oral contraception have to be continued during the study
Iontophoresis With Potassium Iodide and Thyroid Function

The aim of the study: To assess the influence of iontophoresis treatment with 2% potassium iodide on the level of thyroid hormones (TSH, FT3, FT4) The study group: conducting 10 iontophoresis treatments with Potassium iodide; The control group: conducting 10 placebo treatments with iontophoresis with destilled water; Intervention: 10 iontophoresis treatments with 2% potassium iodide in healthy individuals.

Test the level of thyroid hormones before and after the 10 iontophoresis treatments; The study allows to assess the influence of iodine on the function of thuroid gland.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals with normal thyroid function

Exclusion Criteria:

* individuals with thyroid disorders,
* taking thyroid medication,
* using drugs, alcohol, cigaretttes
Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects without clinical signs or symptoms of cardiovascular disease

Exclusion Criteria:

* cardiovascular disease
* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* C-reactive protein \> 05 mg/dL
* malignant disease
* cranberry allergy/intolerance
* hypotension (≤100 / 60 mm Hg)
Study of Alfimeprase to Rapidly Dissolve Blood Clots in the Leg and Help Prevent the Need for Surgery on Leg Arteries

The purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (PAO) as measured by a 30 day open vascular free surgery rate.

There is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion (PAO). Currently used plasminogen activators can result in increased circulating levels of plasmin that result in a systemic "lytic state" that does not distinguish between physiologic and pathologic thrombosis. In general, mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage. A direct thrombolytic agent like alfimeprase, with a rapid mechanism of action and a potentially safer bleeding risk profile, could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* Ages 18 or older
* Acute PAO of a lower extremity with onset of symptoms within 14 days prior to randomization
* Acute index limb ischemia classified as SVS/ISCVS Class I or IIA caused by occlusion of a native artery and/or bypass graft (vein or prosthetic)
* Need for open vascular surgical intervention in the event of unsuccessful thrombolysis
* Available for follow-up assessments

Exclusion Criteria:

* Contraindication to systemic anticoagulation
* History of endovascular procedure or open vascular surgery on the index limb within the last 30 days
* History of significant acute or chronic kidney disease that would preclude contrast angiography
* Known allergy to contrast agents
* History of heparin-induced thrombocytopenia (HIT)
* Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
* Any thrombolytic therapy within 30 days prior to randomization
* Past participation in any alfimeprase clinical trial
* History of hypersensitivity to aspirin
* Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
* Uncontrolled hypertension: systolic blood pressure (BP) \> 180 mmHg, or diastolic BP \> 110 mmHg at the time of baseline assessment
* Hematocrit \< 30%; subjects with a low hematocrit who are not actively bleeding can be entered into this study if after transfusion their hematocrit is \>= 30%
* Platelet count \<100 X 10(9)/L on baseline labs
* Investigator inability to advance guidewire through index occlusion
* Medically unable to withstand an open vascular surgical procedure
* Any other feature that, in the opinion of the investigator, should preclude study participation
Side of Embryo Biopsy Interfering Implantation Potential

Selection of side of embryo biopsy that will not interfering with implantation power of developed blastocyst embryo during biopsy procedure arranged for PGT.

During process of embryo biopsy, it was indicated to avoid contacting cells closer to inner cell mass as it can decrease the quality of embryo and its structural composition. However, recommendation for collection from the trophectoderm (TE) side is indicated.

Absence of differentiation during cleavage-stage or morula stage at day 3 and day 4 respectively, will present the needful to focus a specific location for embryo biopsy during pre-blastocyst stages for embryo going to do genetic testing before implantation or embryo transfer.

In articulation around the second polar body or the animal pole of embryo, collection of the cell from the vegetal pole in crospondence to avoide collection form the animal pole is to be compare the results of implantation for biopsy done using the animal pole side or the random non organized biosy procedure.

Eligibility Criteria:
Inclusion Criteria:

* grade 1 or 2 embryos at eight cell stage or 8-1/ 8-2 embryo quality.

Exclusion Criteria:

* grade 3 embryo at day 3, or 8-3 embryos.
Tendon Transfer Rotator Cuff Tear

This is a prospective randomized study on using muscle tendons to repair tears of the muscles on the shoulder. There are 3 muscles covering the shoulder joint- supraspinatus, infraspinatus and subscapularis. Large tears involving these muscles can be treated by using some muscle from another location of the body known as Tendon transfer techniques. These muscle tendons may be from the lower back (Latissimus Dorsi), upper pack (lower trapezius) or chest (pectoralis). There are currently no studies to show which tendon transfer technique has better outcomes.

This study comprises two trials and a total of 84 participants would be enrolled. Each trial comparing the patient reported outcomes between two tendon transfer techniques. Large tears involving the supraspinatus and infraspinatus would be repaired using either the Latissimus dorsi technique or Lower trapezius technique. 21 patients would be randomly assigned to either groups. The second trial would be comparing the Latissimus dorsi technique and pectoralis technique in large tears of the subscapularis muscle. Another 21 patients would be randomly assigned to either groups.

The investigators are studying to see if the Lower Trapezius and Pectoralis transfer techniques for muscle tear repairs would have better post-surgical outcomes compared with Latissimus Dorsi transfer technique.

For both trials, participants would be followed up for 2 years and post-surgical outcomes would be compared between treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have massive, irreparable tear of the posterior-superior rotator cuff
* Subjects between 18 years and 65 years (≥ 18 and ≤ 65 years of age).
* Diagnosis of no to minimal glenohumeral arthritis- Hamada 1 and 2
* Subject with irreparable subscapularis tendon tear (Arms 3 and 4 ONLY)

Exclusion Criteria:

* Subjects having severe glenohumeral arthritis
* History of prior tendon transfer
* Axillary nerve injury
* Deltoid deficiency
* Subjects with pseudo paralysis
* History of post-operative deep shoulder infection
* Non-English-speaking subjects.
* Subject has any condition, that in the opinion of the investigator, would prevent them from completing this study
* Subject with irreparable subscapularis tendon tear (Arms 1 and 2 ONLY)
Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents

This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to remotely track the physical activity of obese pediatric patients who are concurrently enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit devices and will be called weekly to review their average daily steps and heart rates. Patients will receive the Fitbit either at the beginning of classes or upon completion of classes. Patients will then be followed remotely and called weekly for 12 additional weeks after completing classes. The two groups will be compared to examine for differences.

Patients will be randomly assigned into one of two groups. In the first group, patients will undergo an already established multidisciplinary weight loss intervention program and will also wear Fitbit Charge HR devices. Their data will be regularly uploaded to their Fitbit Dashboard, and this information will be reviewed by the study team.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the Healthy Kids, Healthy Weight assessment and intervention program
* BMI greater than or equal to the 95th percentile

Exclusion Criteria:

* Compromising medical condition that prevents physical activity (sickle cell disease, severe asthma, fractures, etc)
* Severe intellectual disability
* History of smoking
* Current use of atypical antipsychotics, stimulants
Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient

Comparison of two techniques of renal pre-transplant infusion on the evolution of renal function in the recipient: multicentre randomized trial

Both machines differ in their operation: the LifePort® machine manufactured by the "Organ Recovery System (ORS)," says renal perfusion by maintaining a continuous perfusion pressure that is adjustable, while the Waves machine company "Medical Waters" assures infusion maintaining a controlled pulsatile flow.

Both machines are now available but the investigators currently have no study of whether an infusion type is superior to the other in terms of results on renal function recipients.

Study the impact of both types of infusion on renal function recipients evaluated in the early days of transplantation, at three months and one year after the transplant.

Eligibility Criteria:
RENAL Donors:

Inclusion Criteria:

* Deceased donor in brain-dead
* Donor presenting the expanded criteria of kidney removal (ECD criteria: elderly over 60 or aged 50 to 59 years and has two of the three following criteria: hypertension, stroke deaths, serum creatinine\> 1.5 mg / dL)
* Possibility of both kidneys perfused machines
* Sampling of both kidneys, for two distinct recipients

Exclusion Criteria:

* none

RENAL recipients:

The grafts are addressed to transplant centers in France according to the distribution rules of the National Center of Distribution of transplants . (Pôle National de Répartition des Greffons (PNRG).
Child HCAHPS: Automated Day of Discharge Survey

The goal of this study is to identify effective ways to assess the patient and family experience. Specifically, the study will examine automated administration of the Child Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey on the day of discharge through an electronic interactive patient care system. The will be a multisite study that will take place at Boston Children's Hospital (BCH) as well as at several other hospitals across the United States.

Preliminary research conducted by BCH on alternative administration methods of Child HCAHPS has proven promising. Specifically, a pilot of administration on the day of discharge using tablet computers increased response rates, especially among hard to reach groups.

To further explore modes of Child HCAHPS day of discharge administration, the Center of Excellence for Pediatric Quality Measurement (CEPQM) at BCH is collaborating with GetWellNetwork (GetWell), a company that provides interactive education material for patient televisions, to enable parents and guardians to complete Child HCAHPS on the day of discharge from the inpatient television. For this multisite study, parents of hospitalized children from BCH and participating sites will be randomized at the time of discharge to either receiving Child HCAHPS on the day of discharge on the inpatient television or standard Child HCAHPS administration via mail or email. The study will continue for up to six months at each participating site.

Eligibility Criteria:
Inclusion Criteria:

* Their child's hospitalization includes at least one overnight stay

Exclusion Criteria:

* Their child is aged 18 or older during the hospitalization
* Their child is hospitalized with a primary psychiatric diagnosis
* Their child dies during hospitalization
* Their child is in the hospital as a court/law enforcement patient
* Their child is a ward of the state
* Their child was admitted under DCF jurisdiction
* They are not fluent in English or Spanish
Tiotropium (Spiriva) Rehabilitation Study

The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.


Eligibility Criteria:
Inclusion Criteria:

History of COPD, FEV1 of less than or equal than 60% of predicted normal and less than or equal to 70% at Visit 1, Male or Female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from HandiHaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program.

Exclusion Criteria:

Patients with significant diseases other than COPD, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with SGOT greater than 80IU/L, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dL, recent history of MI (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active TB, history of CA or had treatment within the last 24 months, history of CF, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
Pilot Study Evaluating the Elasticity and Shear Wave Modulus (Stiffness) of the Median Nerve in Patients With Mild to Moderate Idiopathic Carpal Tunnel Syndrome Receiving OMT and Conservative Therapy

To evaluate and quantify changes in the elasticity and shear wave modulus (stiffness) of the median nerve in patients diagnosed with mild to moderate carpal tunnel syndrome following osteopathic manipulative therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral or bilateral mild to moderate carpal tunnel syndrome, based on recent EMG findings

Exclusion Criteria:

* History of undergoing recent physical therapy for treatment of carpal tunnel syndrome
* History of wrist trauma or surgery
* Hypothyroidism
* Severe CTS that has progressed to muscle atrophy
* Systemic disease or condition including but not limited to diabetes mellitus, thyroid disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or conditions in which peripheral neuropathies are common.
* Secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by US or MRI of the affected wrist.
* Bifid median nerve as shown by US or MRI of the affected wrist
* pregnant or recently postpartum