cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions

Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).

Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine);
* Miller class I and II gingival recession areas
* Non-abrasive, erosive, or carious root surfaces
* Unrotated, non-extruded, and non-movable teeth
* Systemically healthy patients without contraindication to periodontal surgical procedures

Exclusion Criteria:

* Smokers
* Pregnant women and infants
* Patients with a history of periodontal disease or recurrent abscess formation
* Patients previously submitted to surgical procedures for root coverage
* Patients taking anti-convulsant drugs
* Antihypertensives, contraceptives or immunosuppressors
* Patients with low oral hygiene (plaque and bleeding index over 20%)
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients

Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Kidney transplant received 1 year prior to randomization
* estimated glomerular filtration rate 30-90 ml/min/1.73m2
* Urine albumin to creatinine ratio (ACR) 30-5000 mg/g
* Pre-existing type 2 diabetes or post-transplant diabetes mellitus
* Blood pressure \<130/80 mm Hg prior to randomization
* Able to provide informed consent
* Stable immunosuppression for at least 3 months prior to baseline consisting of tacrolimus, mycophenolate mofetil/mycophenolic acid and prednisone
* Stable anti-hypertensive regimen for at least 1month prior to baseline
* Stable diabetes management for at least 3 months prior to baseline
* Stable angiotensin converting enzyme inhibitor/angiotensin receptor blocker use for at least 3 months prior to baseline (if applicable)
* Glucagon-like peptide-1 receptor agonist (GLP-1RA) for at least 3 months prior to baseline (if applicable)

Exclusion Criteria:

* Type 1 diabetes
* Anticipated life expectancy \<1 year
* Uncontrolled hypertension
* Hemoglobin A1c \>9%
* Body mass index \>40 kg/m2
* New York Heart Association Class 3 or 4 heart failure symptoms, an EF ≤30%, or hospitalization for heart failure in the past 3 months
* Pregnancy, plans to become pregnant, or breastfeeding
* Current use of sodium glucose cotransporter-2 (SGLT2) inhibitors
* Current urinary or urogenital infection
* Use of anticoagulants (contraindication to kidney biopsy)
* Magnetic resonance imaging (MRI) contraindications
* History of lower-limb amputation irrespective of etiology
* Known hypersensitivity to dapagliflozin
Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.

The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 18 to 75 years old;
* malignant Tumor of aerodigestive ways, in forgiveness;
* Treatment containing the external radiotherapy ended since \> 6 months
* Life expectancy \> 6 months;
* patient complaining from cervical spasms with functional disability;
* Negative Pregnancy test;
* Women under effective contraception;
* Patients benefiting from a national insurance scheme;
* Patient having given a written consent.

Exclusion Criteria:

* Cervico-facial Surgery with reconstruction by pedicled flap
* Implantable Chamber with catheter in the internal jugular vein near the spasm;
* Muscular, neurological Pathology or malformative pulling a disorder of perception of the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper limbs;
* Disorder generalized by the muscular activity (ex myasthenia);
* Cervical osseous or muscular Pathology pulling pains and disability before the beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the cervical radiography, the slipped disc);
* Previous cervical injection of botulinum toxin ;
* Local Infection at the level of one of the sites proposed for injection;
* Histories of epilepsy;
* Patients presenting a hypersensitivity to the botulinum neurotoxin A or in one of its excipients;
* Patients under anticoagulation therapy, Under antibiotic treatment by aminoglycosides or amino 4 quinoline, under myorelaxant treatment or that must undergo an intervention with curarisation;
* Patients for whom a surgical operation is planned in the zone interested in the treatment
* Pregnant or breast-feeding Women;
* Patients for whom questionnaires will not be assessable (handicaps of communication, patient not speaking French, etc.).
A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients

The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.

Sequential enrollment

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for enrollment in this study, patients must be prescribed oral Medrol® tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing information. The prescription of Medrol® will be separated from the decision to include the patient in the study.
* Medrol® tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol® tablet will necessarily precede and will be independent of the decision to enroll patient into the study. Only those patients who have been prescribed Medrol® tablets will be evaluated for their potential eligibility for the study
* Only those patients, who are ready and willing to sign an informed consent, will be included in the study
* Subject can be contacted through telephone

Exclusion Criteria:

* Based upon history or physical exam in the emergency department (ED) or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
* Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
Population Pharmacokinetics and Dosage Individualization of Antibiotics in Elderly Patients

The investigator's purpose is to study the pharmacokinetics and pharmacodynamics of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients and recommend an individual dosage regimen of those antibiotics.

The use of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly ICU patients during clinical treatment depended mostly on experience. Besides, there was no recommended dose for elderly patients in drug instruction, Therefore, we aim to study the pharmacokinetics and pharmacodynamics in elderly ICU patients and provide a tailormade regimen.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age ≥65 years old; (2) According to the doctor's advice, use biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc for anti-infection treatment;

Exclusion Criteria:

* (1) Patients who are expected to die within 48 hours; (2) Patients with allergic to β-lactam antibiotics, Carbapenems, Ticacycline and Levofloxacin.etc drugs; (3) Patients receiving other investigational drugs; (4) Other factors that the researcher considers unsuitable for inclusion.
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.


Eligibility Criteria:
Inclusion Criteria:

* For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides \<350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
* For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL

Exclusion Criteria:

* Acute significant cardiovascular disease
* Uncontrolled hypertension
Culturally Sensitive Depression Care Management for Latino Primary Care Patients

The purpose of this study is to determine whether telephonic depression care management can improve depression outcomes for Latino primary care patients who are enrolled in Medicaid and are receiving an antidepressant from their primary care doctor.


Eligibility Criteria:
Inclusion Criteria:

* Latino
* Adult
* Received an antidepressant prescription from primary care provider
* Not current receiving care from behavioral health provider
* Diagnosis of major depression, minor depression, dysthymia, or significant depression symptoms
* English or Spanish speaking
* Member, Neighborhood Health Plan of RI
Using 3.3mm Screw Tap and Cutting Resistance to Evaluate Bone Quality Around Dental Implant

Osseointegrated root form implants have been applied successfully in treating fully and partially edentulous patients and patients with single tooth missing. However, the success rate of osseointegrated dental implants was not as good in patients with poor bone quality. The reasons are believed that poor bone quality reduces the initial stability of dental implants and then reduces the success rate. For increasing initial stability of dental implants, some technical modifications are suggested in literature. However, due to lack of an objective method to evaluate bone quality, they are controversial. The purposes of this clinical study are to develop a standard procedure which using cutting resistance measured by Osseocare in surgery to evaluate the bone quality and to compare with the clinical experiences of oral surgeons. The objective outcome, initial stability of dental implant, is measured with Osstell. The analyzed results are also helpful for less experienced surgeons.

Materials \& Methods:

1. Patient eligibility: Six implant surgeons will assist the experiment. The subjects are patient who will receive dental implant treatment in Dental department of NTUH. Sixty subjects are offered by six surgeons. They must fully fill the requirements as following

Eligibility Criteria:
Inclusion Criteria:

* No major systemic diseases
* Mouth opening: \> 35 mm
* Missing teeth at anterior or premolar area and willing to restored by implantation

Exclusion Criteria:

* Uncomfortable or other condition occurring in the surgical procedure make the measuring unacceptable
The Oslo Study of Clonidine in Elderly Patients With Delirium

Delirium ("acute confusional state")is characterized by an acute decline in attention and cognition, and is a common clinical syndrome in elderly patients.

The purpose of this randomised, controlled, parallel group pilot trial is to explore superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at the acute geriatric ward.

We will also study the feasibility of oral clonidine in a geriatric ward and effects of clonidine upon a variety of outcomes as a means to design a more definite study later.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 65 years old admitted to the Medical department
* Delirium or subsyndromal delirium diagnosed within the last 48 hours
* Signed informed consent from patient or relatives
* Expected cooperation of the patients for the treatment and follow up

Exclusion Criteria:

* Symptomatic bradycardia, bradycardia due to sick-sinus-syndrome, second- or third- degree AV-block (not treated With pacemaker) or any other reason causing HR \<50 bpm at time of inclusion
* Symptomatic hypotension or orthostatic hypotension, or a systolic BP \<120 at the time of inclusion
* Ischemic stroke within the last 3 months or critical peripheral ischemia
* Acute coronary syndrome, unstable or severe coronary heart disease (symptoms at minimal physical activity; NYHA 3 and 4) and moderate to severe heart failure (NYHA 3 and 4).
* A diagnosis of polyneuropathy or pheochromocytoma
* Renal insufficiency (estimated GFR\<30 ml/min according to the MDRD formula).
* Body weight \< 45 kg.
* Considered as moribund on admission.
* Not able to take oral medications
* Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
* Previously included in this study
* Adverse reactions to clonidine or excipients (lactose, saccharose)
* Not speaking or reading Norwegian
* Any other condition as evaluated by the treating physician
* Admitted to the ICU
Study to Compare the Effect of Valsartan vs Atenolol on Pro-thrombotic State in Hypertensive Patients.

A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 18 - 75 years of age inclusively.
* Mild to moderate hypertension (MSDBP \>= 95 and \>= 110 mmHg and / or MSSBP \>140mm Hg) at visit 1, requiring pharmacological intervention. For newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. In addition, patients must require therapy despite having been following dietary \& lifestyle advice for at least 3 months.
* Written informed consent to participate in the study, prior to any study procedures.
* Ability to communicate and comply with all study requirements

Exclusion Criteria:

* o Uncontrolled hypertension defined as seated blood pressure of either systolic BP \>180 mmHg and/or diastolic BP \>110mmHg.

  * Clinically significant laboratory abnormalities that may interfere with the assessment of safety and/or efficacy of the study drug
  * Patients with severe medical condition(s) that in the view of the investigator may prohibit participation in the study
  * Renal artery stenosis
  * Diabetes Mellitus
  * Any condition resulting from or leading to platelet or clotting abnormalities (eg. hemophilia, von Willebrand's disease).
  * History of a vascular event or intervention (e.g. MI, PTCA or CABG) within 6 months preceding the study.
  * History of clinically significant angina, LVH, transient ischemic attack, stroke, intermittent claudication, deep vein thrombosis (DVT), pulmonary embolism or peripheral vascular disease.
  * Uncontrolled atrial fibrillation (\>100 b.p.m. at rest) or other conditions which may require anti-aggregant or anti-vitamin K therapies.
  * Clinical evidence of congestive heart failure.
  * Evidence of second or third degree heart block or sick sinus syndrome.
SMS Turkey: Harnessing the Power of Text Messaging to Promote Smoking Cessation

The purpose of this study is to develop and test a text messaging-based smoking cessation program for adults who are currently smoking and want to quit, living in Turkey.

Smoking has long been recognized as a significant public health concern associated with great morbidity and mortality. Although smoking rates have decreased in high income countries, these trends have not been noted for tow and middle income countries. This is especially true in Turkey, which was ranked 6th in the world in smoking consumption. Between 51-63% of Turkish men and 24-26% of Turkish women 15 years of age and older are smokers. With lung cancer the leading cancer-related cause of death for both men and women, effective and accessible smoking cessation interventions are needed. Cell phone technology represents a unique opportunity to deliver evidenced-based smoking cessation behavioral treatments through a delivery mechanism already widely adopted by adults. An estimated 35 million Turks were using cell phones, making them 1.8 times more common than land lines. Cell phone interventions are a unique delivery method because of their 'always on' capability. The rapid uptake of cell phones allows us to potentially reach those who might otherwise not utilize smoking cessation services.

We designed and evaluated SMS Turkey, an evidenced-based smoking intervention that takes advantage of technologies adopted by adult smokers in Turkey. The primary outcome measure is sustained abstinence 12 weeks after quit day, confirmed with a carbon monoxide (CO) reading of 8 ppm or less. Sustained abstinence was defined as 5 or fewer cigarettes smoked since the quit date, per West et al. Secondary outcome measures included: 7-day and 30-day point prevalence of smoking behavior at 3 months; CO-verified 7-day point prevalence at 4 weeks; and reduction in cigarettes per day for those who are smoking at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Currently smoking every day
* Owning a TXT-capable cell phone
* Sent or received TXT messages at least once in the past year
* Living in Ankara (to ease technology support if necessary)
* Agreement to set quit day in 15 days from enrollment date
* Agreement to verification of smoking cessation using a carbon monoxide breath monitor

Exclusion Criteria:

• No chronic disease.
Momordica Charantia and Dihydroartemisinin-piperaquined-primaquine for Uncomplicated Plasmodium Falciparum Malaria Patients in Southwest Sumba Regency

Currently, the first-line combination of artemisinin, piperaquine and prima-quine is quite effective in controlling malaria, however, the threat of spread of drug-resistant parasites has been reported. A study is conducted to assess the efficacy and safety extract of bitter melon (Momordica charantia/MC) regimens compared to the combination of dihydroartemisinin piperaquine primaquine (DHP+PQ) on the sexual and asexual stage of P. Falciparum uncomplicated in Sumba Barat Daya District, Indonesia

The Study was conducted in Kori Primary Health Cender, Sumba Barat Daya District, East Nusa Tenggara Province on Sumba Island.

The study subject received either 3 day of dihydroartemisinin-piperaquine and primaquine 1 day on first day (DHP+PQ) or extract of bitter melon (Momordica charantia/MC) + Placebo 1 day on first day according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of giemsa stained tihick blood films to detect Plasmodium falciparum infection.

All Patient were allocated by single blind randomization to receive DHP (on day 0 to day 2)+PQ (on day 0 only) or extract of bitter melon (Momordica charantia/MC) (on day 0 to day 2)+placebo (on day 0 only). The procedures of drug administration in the study were as follows:

Eligibility Criteria:
Inclusion Criteria:-

1. Age ≥ 18 years old male or female up to 60 years old
2. Single Plasmodium falciparum infection based on microscopic examination.
3. Count the parasites for Plasmodium falciparum at least 2 large visual field asexual parasites (LPB) by examining 15 LPB
4. Density of parasites 1000-100,000/micro liter
5. Has no history of uncontrolled comorbidities
6. History of fever in the last 24 hours for falciparum malaria
7. Not taking other antimalarial drugs in the last 2 weeks.
8. Have no previous history of malaria.
9. Willing to come to the health facility according to the specified follow-up schedule.
10. Willing to participate in research and established procedures.
11. There is no history of allergy to antimalarial drugs.

Exclusion Criteria:

1. Signs of general weakness, or decreased consciousness or recurrent seizures or circulation failure or pulmonary edema or signs of anemia or yellow body and slightly red urine.
2. If the examination results show mixed Plasmodium and non-Plasmodium falciparum.
3. Has a history of severe liver, kidney and heart dysfunction, bradycardia and heart rhythm disturbances.
4. Does not control regularly according to the research schedule
5. Pregnant and lactating women
6. There are signs of severe malaria
7. Patients with chronic diseases, for example: heart, kidney, liver, HIV.
8. Mixed infection.