cyrilzakka/clinical-trials huggingface dataset:
Effect of Suturing Protocols on Coronally Advanced Flap for Root Coverage Outcomes

The purpose of this retrospective study is to investigate whether suturing protocols (suture removal timing) influence root coverage outcomes in recession defects treated with a coronally advanced flap (CAF) procedure.

The aim of this study is to assess whether the timing of suture removal may influence the number of sites exhibiting complete coverage (CRC) or the mean root coverage (MRC) obtained in single-tooth recession-type defects treated by coronally advanced flap (CAF).

Records from patients that underwent a coronally advanced flap (CAF) procedure for root coverage will be analyzed. This surgical procedure is aimed at the treatment of root recessions that may arise following periodontal disease or mechanical trauma. The procedure, after obtaining deep local anesthesia, involves a sulcular incision on the buccal side and extending the incision mesially and distally to the base of the adjacent papillae. Two vertical incisions are then made at the corner of the adjacent tooth line and extended into the alveolar mucosa. A mixed thickness flap is then elevated and coronally advanced by releasing incisions through the periosteum to allow for flap placement to cover the recession without tension. The papillae are de-epithelized to provide the bed of connective tissue for the adaptation of the flap which is then sutured with single stitches.

The records, complete with photographic documentation, of all patients who have undergone this procedure will be identified and will be divided into two groups: those in which the sutures were removed at 2 weeks and those in which the sutures were removed at 3 or more weeks.

CRC as present or absent (yes/no) and MRC (percentage of roof surface that has been successfully covered) six months after surgery will be assessed in these patients.

The presence of patient discomfort on the day of suture removal will be recorded as present / absent to assess whether the permanence of the sutures for longer or shorter influences the patient's perception of the surgery.

The results will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients not affected by active periodontitis
* Single recessions on non-restored non-molar teeth
* CAF protocols using vertical releasing incisions
* records of patients clearly reporting timing of suture removals and root coverage outcomes at 6 months

Exclusion Criteria:

* Adjacent recessions
* Recessions on molar teeth
* Coronally advanced flaps without releasing incisions
* Patients with active periodontitis
Social Forces to Improve Statin Adherence (Study A)

To assess the effectiveness of reporting statin adherence patterns to a Medication Adherence Partner (MAP) in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle.

Hypothesis: Subjects with a MAP receiving daily adherence feedback will have the highest statin adherence of any arm, as measured by pill bottle data.

We propose to complete a randomized controlled trial (RCT) of 200 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (\<70% medication possession ratio determined through pharmacy records; no combination meds). Study subjects will use an electronic pill bottle (GlowCap) to store their statin medication. Study subjects will identify potential Medication Adherence Partners (MAPs) who can receive information about their adherence patterns at enrollment. For the 90-day trial, subjects will be randomized to: 1) the subject's MAP receives daily notification about whether subject took statin; 2) the subject's MAP receives weekly about how often the subject took statin during previous week; 3) the subject's MAP receives notification if the subject missed \>2 consecutive daily doses of statin; and 4) usual care (GlowCaps without any notifications). The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps. The secondary outcome will be subjects' statin medication possession ratio (MPR) during the study.

Eligibility Criteria:
Inclusion Criteria:

* The subject is Humana insured
* The subject is an English speaking adult
* Age range ≥18 years
* The subject has diagnosis with diabetes for ≥12 months
* The subject has an MPR \<70% to a statin medication
* Subject denies side-effects to their statin medication
* The subject identified a person who agreed to serve as their MAP

Exclusion Criteria:

* The subject is \<18 years old
* The subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman)
* On statin combination medication
* The subject does not identify an individual who agrees to serve as their MAP
* The subject reports a clinically important side effect to the statin medication or active liver disease:
Demonstrating Efficacy of JOGO for the Treatment of Tremor

This research is being done to determine the effectiveness of a new treatment, called JOGO, for patients with functional tremor (FT). JOGO is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and Parkinson's disease (PD)-related tremor. JOGO provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. This information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of functional tremor diagnosed by a Mayo Clinic Florida movement disorders specialist.
* Must have access to reliable internet video.

Exclusion Criteria:

* Cognitive impairment (Montreal Cognitive Assessment greater than 26).
* Currently taking any of the following medications to treat tremor: primidone, gabapentin, zonisamide, any non-selective beta blocker, any benzodiazepine.
* Exposure to tremorgenic drugs or drug with withdrawal states within 30 days prior to the study start.
* Direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor.
* Known history of other medical or neurological conditions that may cause or explain subject's tremor, including, but not limited to: Parkinson's disease, dystonia, cerebellar disease, traumatic brain injury, alcohol abuse or withdrawal, mercury poisoning, hyperthyroidism, pheochromocytoma, head trauma or cerebrovascular disease within 3 months prior to the onset of essential tremor, multiple sclerosis, polyneuropathy, family history of Fragile X syndrome.
* Prior MR-guided focused ultrasound or surgical intervention (e.g., deep brain stimulation, ablative thalamotomy or gamma knife thalamotomy).
* Botulinum toxin injection in the 6 months prior to screening.
* Use of medication(s) in the past month that might produce tremor or interfere with the evaluation of tremor, such as, but not limited to: CNS-stimulants, lithium, amiodarone, metoclopramide, theophylline, and valproate.
* Regular use of more than two units of alcohol per day.
* Sporadic use of a benzodiazepine, sleep medication or anxiolytic to improve sleep performance. Stable use at a consistent dose is allowed if tremor persists against the background of regular medication use.
* Current treatment with any investigational therapy for tremor.
Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol.

The primary objective of this randomized controlled trial is to examine the influence of a brief post-session battery, designed to foster patient self-monitoring and reflection on their emotional reactions toward their psychotherapist, on the quality of the therapeutic relationship and treatment outcomes.

The quality of the therapeutic relationship is critical in determining psychotherapy outcomes. However, facilitating patients' self-awareness and reflection on their affective responses to their therapist remains understudied as a potential tool for enhancing this relationship and subsequent treatment outcomes. The primary objective of this study is to examine the influence of a brief post-session battery, designed to foster patient self-monitoring and reflection on their emotional reactions toward their psychotherapist, on the quality of the therapeutic relationship and treatment outcomes. Using an observational randomized control trial design, participants will be allocated into intervention and control groups. Those in the intervention group will complete a postsession battery following each therapy session, while the control group will only undergo regular treatment. Data collection will be facilitated through the Qualtrics online survey software and span baseline, mid-trial (5th week), and end-of-trial (10th week) assessments.

Eligibility Criteria:
Inclusion Criteria:

* being aged 18 years or older,
* being fluent in English,
* being currently under individual psychotherapy with a minimum frequency of two sessions per month.

Exclusion Criteria:

* having a legal guardian.
The Effects of Sports Drinks on Urinary Lithogenicity

The effect of sports drinks on the tendency to form kidney stones has not been assessed. Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes in urine chemistry that may decrease the risk of forming stones.

Participants will drink 1 liter of water each day for one week in the control period, then 1 liter of sports drink each day for one week during the experimental period. Urine collections will be performed during both periods. Diet will be chosen by participants and a food diary will be kept so that participants can replicate diet during the urine collections.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years old
* men and women
* able to sign informed consent

Exclusion Criteria:

* history of kidney stones
* bone disease
* parathyroid disease
Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function.

The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2).

Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3).

It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy.

Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven epidermoid carcinoma of the anus
* Locally advanced tumour without metastases
* Stage T2\>3 cm or T3 or T4, irrespective of N
* Stage N1-N3 irrespective of T stage (T1 to T4)
* General condition WHO 0-1
* Life expectancy \> 3 months
* Signed informed consent form
* Age \> 18 years
* Effective contraception in female and/or male patients having reached sexual maturity during treatment and up to 6 months after the end of treatment
* CD4 \> 400 / mm3
* Measureable tumor on at least one of the following exams : MRI, endoscopic ultrasonography, clinical exam

Exclusion Criteria:

* Presence of metastases
* Previous anti-EGFR therapy
* Stage T1N0 or T2 \< 3 cm N0
* History of pelvic radiotherapy
* At least one of the following laboratory test results: Neutrophils \< 1500 /mm3, platelets \< 100 000 /mm3, Hb \< 9 g/dl, leukocytes \< 3000/mm3, blood bilirubin \> 1.5 times the upper limit of the normal range, transaminase (ASAT and ALAT) \> 2.5 times the upper limit of the normal range, creatinine clearance \< 50 mL/min (Cockcroft's formula Appendix x), Mg2+ \< the lower limit of the normal range, Ca2+ \< the lower limit of the normal range
* Significant coronary artery disease or myocardial infarction in the past year
* Follow-up not possible due to psychological or geographic reasons
* History of interstitial pneumonitis or pulmonary fibrosis
* History of malignant disease in the past five years apart from basocellular skin carcinoma or in situ cervical carcinoma having received adequate treatment
* Pregnant or breast-feeding women, women of child-bearing potential not having taken a pregnancy test.
Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants

* Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist
* Secondary objective of this study is to assess the safety and tolerability of CAIV-T compared to FluMist


Eligibility Criteria:
Inclusion Criteria:

* Age 5 through 49 years (not yet reached their 50th birthday);
* In general good health;
* Individual or parent/guardian available by telephone;
* Ability of the participant or parent/guardian to understand and comply with the requirements of the protocol; and
* Written informed consent and HIPAA authorization obtained from the participant's parent or legal guardian or written informed consent and HIPAA authorization obtained from the participant.

Exclusion Criteria:

* History of hypersensitivity to any component of FluMist or CAIV-T, including egg or egg products;
* History of hypersensitivity to gentamicin;
* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy;
* Household contact who is immunocompromised (participants should also avoid close contact with other immunocompromised individuals for at least 21 days);
* History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies;
* History of Guillain-Barré syndrome;
* History of asthma or reactive airways disease;
* For children age 5 through 8 years, receipt of prior influenza vaccination;
* Acute febrile (\>100.0°F oral) and/or respiratory illness within the 72 hours prior to enrollment;
* For participants under the age of 18, use of aspirin or aspirin containing products in the 30 days prior to enrollment or anticipated use during the study;
* Administration of any live vaccine within 30 days prior to enrollment or if receipt of another live vaccine is expected within 30 days of the vaccination in this study;
* Administration of any inactivated vaccine within two weeks prior to enrollment or if receipt of another inactivated vaccine is expected within two weeks of the vaccination in this study;
* Pregnancy or, in biologically capable women (e.g., menses within the last year), not willing to agree to acceptable birth control for 90 days after enrolling into the study (for those biologically capable, a urine pregnancy test must be performed on the day of vaccination with a negative result);
* Breastfeeding or lactating women;
* Participation in another investigational trial or administration of any investigational drug within 30 days prior to enrollment or during this study;
* Receipt of any blood product within 90 days prior to vaccination or expected receipt within the study duration;
* Employees of the research center, any individuals involved with the conduct of the study, or any family member of such individuals; and
* Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine.
A Thorough Corrected QT Interval Trial

The purpose of this study is to determine the effects of K-877 on ECG parameters with a focus on cardiac repolarization compared with placebo in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study specific evaluation is performed.
* Subject is a healthy adult male or female volunteer, of any race and ethnicity, between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a supine blood pressure after resting for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic.
* Subject has a supine Heart Rate (HR) (as measured at Screening or Check-in during collection of vital signs) after resting for at least 5 minutes that is outside the range of 40 to 90 beats per minute.
Study on Correlation Between Vascular ET-1 and Adiponectin in Pediatric Obesity

The aim of this study is to explore whether and how high circulating levels of endothelin-1 (ET-1) in obese and overweight children may contribute to impair adiponectin (Ad) production, release and vascular activity


Eligibility Criteria:
Inclusion Criteria:

* Children will be enrolled into lean, overweight or obese groups based on Body mass index (BMI) calculated according to standard methods. International standards for sex-and age-specific BMI centiles for subjects aged 2-18 years will be used. The 95th centile of BMI reference is the cut off point for childhood obesity. Overweight and obese children are defined as those with a BMI higher than the centile curves.

Exclusion Criteria:

* presence of renal, liver and/or cardiovascular diseases;
* hypertension;
* metabolic and/or endocrine disorders;
* genetic syndromes;
* histories of chronic allergies, acute infectious or inflammatory diseases during the last 3 months preceding the study
Validation of Portable Monitoring Device for Diagnosing Sleep Apnea

portable monitoring device could diagnose sleep apnea in high risk patients.

This is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device.

Portable monitoring device is applied simultaneously with PSG to compare it's accuracy and validity.

Eligibility Criteria:
Inclusion Criteria:

* patients suspected of sleep apnea

Exclusion Criteria:

* patient refuse to participate
Efficacy of Automated Bolus Calculation in Type 2 Diabetes

The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes \> 1 year
* Age 18 years or older
* HbA1C \> 64 mmol/mol (8.0 %)
* Treatment with multiple daily insulin injections (basal and prandial insulin) ≥ 6 months
* GAD-antibody negative
* Naïve to bolus calculators

Exclusion Criteria:

* Pregnancy or breast feeding
* Gastroparesis
* Severe nephropathy (eGFR\<30 mL/min/1,73 m2)
* Use of sulfonylurea
Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult subjects following single ascending doses This is the first clinical study of PF-06946860.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
* Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
* Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.

Key Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
* History of allergic reactions to diagnostic or therapeutic protein or human albumin.
* History of recurrent infections or active infection within 28 days of screening.
* Exposure to live vaccines within 28 days of screening.
* History of regular alcohol consumption or positive drug test
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose
To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.

A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or severe renal impairment.

Study Design:

A phase I, open-label, nonrandomized study to determine safety and pharmacokinetics of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies and to determine the PK profiles in patients with renal impairment. Eligible patients will be assigned to 1 of 4 cohorts (A, B, C or D) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose A for normal or mild renal impairment, and dose B for moderate or severe renal impairment.

Enrollment into all cohorts will occur simultaneously rather than sequentially except in the following instance: Before any patient is enrolled in Cohort D, safety will be assessed for at least 1 patient in Cohort C through the end of Cycle 6. If the patient in Cohort C experiences a toxicity that is at least Grade 3 in severity, Cohort D will proceed at a reduced starting dose.

Belinostat will be administered via a 30-minute intravenous (IV) infusion once daily on Days 1 to 5 of a 21-day cycle (for up to 6 cycles). Clinical safety will be monitored in each patient, and up to two dose reductions from the starting dose (not less than 250mg/m\^2) is allowed based on pre-defined criteria.

If a patient cannot tolerate the reduced dose due to Grade 3 or 4 toxicity, belinostat administration must be discontinued. Dose escalation is not allowed. Blood samples for PK analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be collected from Day 1 to Day 4.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.
2. Patient must have received at least 1 prior therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.
3. Patient has either normal or impaired renal functions.
4. Patient has adequate hematological and hepatic functions.

Exclusion Criteria:

1. Patient has acute or progressive renal impairment related to disease or any other cause (eg, toxicity, obstructive uropathy due to retroperitoneal disease, proteinuria, nephrotic syndrome), or requires dialysis.
2. Patient has acute HBV or HCV
3. Patient has known human immunodeficiency virus (HIV) positive diagnosis.
4. Patient has had previous exposure to belinostat.