cyrilzakka/clinical-trials huggingface dataset:
Using AR Dental Care Training System in HE on Periodontal Status, Blood Sugar Control and QoL in Patients With T2DM

The aim of this study was to evaluate the long-term effectiveness of an AR dental care training in health education on periodontal status, blood sugar control and quality of life in patients with poorly controlled type 2 diabetes. This randomized controlled trial included experimental group: AR group (EG-A), AR-health consulting group (EG-B) and control group (CG), respectively.

The EG-A and EG-B received AR dental care training intervention 2 to 3 times during non-surgical periodontal treatment.

Baseline and follow-up surveys were used to collect the data in periodontal index, blood sugar data, oral health knowledge, attitudes, behavior, oral health-related quality of life.

A randomized experimental design was used. Patients with type 2 diabetes whose aged 35-65 years and HbA1c over 7% in the past six months were recruited through department of Endocrinology and Metabolism in Kaohsiung Medical University Hospital.

Each group was expected for 100 per group, patients will be randomized into each group. G\*Power (version 3.1.9.4) was used for power analysis.

All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month and 1 year follow-ups.

Each patients will be diagnosed periodontal disease by dentist and have more than 12 functional teeth.

Each patients will completed the questionnaire at baseline and at 1-month, 3- month,6-month and 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 35 years old (inclusive) and above
* HbA1c over 7% in the past six months
* There are more than 12 functional teeth to ensure that the patient has enough teeth to evaluate the periodontal condition

Exclusion Criteria:

* Have received periodontal treatment within the previous 6 months
* Habits of smoking, drugs and betel nut chewing
* Taking antibiotics and osteoporosis bisphosphonates and other drugs regularly
* People with cognitive function or physical and mental disabilities
* Severely impaired diseases (for example: cancer, renal function or liver failure, etc.)
Effect of Magnesium Sulphate Pretreatment in Pediatric Abdominal Surgery

In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.

Deep neuromuscular blockade is known to improve surgical conditions in procedures such as abdominal or pelvic laparoscopic surgery, laparotomy and laryngeal surgery. In addition, deep neuromuscular blockade enables a reduction in pneumoperitoneal pressure, postoperative pain and the incidence of intra-operative and postoperative adverse events. Correspondingly, the use of deep neuromuscular blockade is increasing, and for its maintenance neuromuscular monitoring is essential; the use of neostigmine may also be helpful in achieving a rapid recovery. Magnesium sulphate has gained prominence as an adjuvant drug in multimodal anesthesia and pain medicine. It has several clinical indications, including attenuation of the adrenergic response to tracheal intubation and improved peri-operative analgesia. Magnesium sulphate also enhances the action of non-depolarizing neuromuscular blocking drugs, resulting in potentiation of neuromuscular blockade (NMB).The site of magnesium potentiation of neuromuscular blocking drugs is the motor end plate, where magnesium reduces the release of prejunctional acetylcholine, thereby decreasing the muscle membrane excitability. However, limited data exist concerning the effect of magnesium sulphate on the duration of deep or intense NMB and on the period of no response to nerve stimulation. In this study, the investigators will compare the effect of magnesium sulphate pretreatment on the onset and duration of intense and deep neuromuscular Block of rocuronium versus Cis-Atracurium and on the period of no response to nerve stimulation in children undergoing elective open abdominal surgeries.

Eligibility Criteria:
Inclusion Criteria:

1. Age group 2-12 years old
2. Both genders
3. Children who will be scheduled to undergo elective laparoscopic surgeries.
4. Patients with American Society of Anesthesiologist physical status classification of 1 or 2-

Exclusion Criteria:

1. Patients who are beyond the selected age group.
2. Patients on medications that interfered with muscle activity.
3. Allergy to medications used in this study.
4. Neuro-muscular diseases.
5. Renal or hepatic impairment.
6. Hypermagnesemia (\>2.5 mmol) or hypomagnesemia (\<1.7 mmol).
7. Parental refusal to participate in the study
A Follow up Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to assess the long-term efficacy of Olanzapine Pamoate (OP) Depot in patients diagnosed with schizophrenia or schizoaffective disorder.

Since its introduction in the United States and Europe in the mid-1990s, olanzapine has been distinguished from other antipsychotic medications (including other "atypical" compounds) by its superior efficacy and safety profiles (Beasley et al. 1996a, 1996b; Tollefson et al. 1997).

Only older "typical" antipsychotics have been available in long-acting (depot) formulations. They are most frequently prescribed to enhance compliance and, to a lesser degree, for convenience, as the need for daily oral dosing is eliminated. The popularity of depot formulations has diminished since the introduction of highly effective oral atypical antipsychotics with vastly reduced side effects. However, long-acting injections remain an important treatment option for many patients with psychotic disorders, and the need to provide a safer, more effective depot formulation to this population is compelling. Accordingly, an "atypical" depot of olanzapine, which can be administered every 2 to 4 weeks, has been developed to enhance convenience and compliance with antipsychotic therapy.

The depot formulation of olanzapine (LY170053) to be evaluated in this study is olanzapine pamoate monohydrate (OPM) (the salt of pamoic acid and olanzapine), suitable for deep intramuscular injection. Olanzapine Pamoate (OP) Depot (formerly referred to as IM olanzapine depot in previous versions of protocol) consists of OPM powder, which is suspended in an aqueous vehicle immediately prior to use. Several pamoate salts of other registered drug products are currently approved for chronic oral administration in the United States (for example, hydroxyzine pamoate and imipramine pamoate). Another pamoate salt depot for intramuscular injection has also been approved in the US (TrelstarTM LA, triptorelin pamoate for injectable suspension) for the treatment of prostate cancer.

As of March 2002, the pamoate formulation of OP Depot has been tested in 12 healthy subjects and approximately 250 patients with schizophrenia in 2 clinical pharmacology studies, F1D-EW-LOAZ and F1D-EW-LOBE, respectively, and one receptor occupancy (positron emission tomography) study, F1D-EW-HGJW. Dosages included single doses up to 450mg and multiple doses up to 405mg every 4weeks.

This open-label study will assess long-term efficacy 280 mg to 405mg of OP Depot administered on a 3-week interval in patients with schizophrenia or schizoaffective disorder

Eligibility Criteria:
Inclusion Criteria:

* Two patients that have been stabilized on OP Depot will be enrolled to the follow-up study
Single Versus Double Row Suture Anchor Repair in Medium to Large Rotator Cuff Tears

The purpose of this study is to determine whether double row repair is better in healing than traditional single row repair in arthroscopic rotator cuff repair.

Our null hypothesis is there are no differences in clinical and structural results


Eligibility Criteria:
Inclusion Criteria:

* Rotator cuff tears
* tear size between 2cm\~4cm

Exclusion Criteria:

* Subscapularis tear requiring repair
* open repair
* any prior history of surgery on the affected shoulder
* any fracture history around shoulder girdle(clavicle, humerus, acromion)
* glenohumeral joint arthritis
* inflammatory arthropathy
A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects

This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its effect on QT interval prolongation.

This study was terminated on October 30th, 2009. While the study was terminated due to adverse events and altered benefit/risk ratio in healthy subjects, the findings in healthy volunteers are not considered to alter the benefit/risk evaluation of figitumumab in cancer patients. No changes due to the termination of this study are anticipated in the conduct of the ongoing cancer patient studies with figitumumab at this time.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* 12-lead ECG demonstrating QTc \>450 msec at screening or other clinically significant abnormalities at screening.
* History or family history of risk factors for QTc interval prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction); family history of sudden death.
Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. This prospective randomized study aimed at comparing the early and long-term results of these two techniques (TEP vs. Lichtenstein).

Various studies comparing the laparoscopic totally extraperitoneal (TEP) and Lichtenstein techniques have been reported. These studies have shown that TEP repair is associated with less postoperative pain and faster recovery. However, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. This study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(Lichtenstein) and laparoscopic repair technique(TEP).

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral)
* American Society of Anesthesiologists (ASA) score of I and II
* Gave informed consent to participate in the study

Exclusion Criteria:

* Patients with scrotal, strangulated, or obstructed hernia
* Periumbilical or subumbilical incision scar (median, right or left paramedian)
* Undergoing prostatectomy or abdominal bladder surgery
* Pfannenstiel incision scar
* ASA score \>3
Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)

The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction for more than 6 months
* Informed consent
* Positive effect of phosphodiesterase type 5 inhibitor (PDE5i)
* IIEF-15 score less than 20
* No neurological disease
* Stable partnership for more than 3 months
* Age 18-75

Exclusion Criteria:

* Total prostatectomy
* Another reason for ED except for vascular disorder
* Clinically significant hematological disease
* Heart stroke, Arrythmia during the last 6 months
* Cancer during the last 5 years
* Intake of antiandrogen
* ED treatment with the last 7 days
* IIEF score higher than, equal to 20
* Previous shockwave treatment
Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation

Arthroscopic transosseous fixation of rotator cuff tears has become an alternative to arthroscopic suture anchor.

This novel technique that allows surgeons to perform a standardized arthroscopic transosseous (anchor free) repair of rotator cuff tears can improve postoperative pain and reduce the incidence of shoulder stiffness.

The aim of the this study is to compare clinical outcomes of two groups of patients: patients that received an arthroscopic transosseous fixation using the ArthroTunneler tunneling device (Tornier Inc, Edina, Minnesota) versus patients that received an arthroscopic rotator cuff repair using suture anchors.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18, \<65
* Rotator cuff tears
* Patients given written informed consent
* BMI ≤ 33

Exclusion Criteria:

* Age \> 65, \< 18
* previous surgical intervention
* Informed consent not accepted
* Serious comorbidity
* Diabetes
* Metabolic Disorders
* Active infections
* Muscular Atrophy
* Biceps Tenodesis
Cathflo Activase Pediatric Study

This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at \~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two serially instilled doses of Cathflo Activase.


Eligibility Criteria:
Inclusion Criteria:

Subjects had to meet the following inclusion criteria to be eligible for study entry:

* Less than 17 years of age
* Clinically stable
* Occlusion of CVAD (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
* For subjects who weighed \>= 10 kg, inability to withdraw 3 mL of blood from the CVAD
* For subjects who weighed \< 10 kg, inability to withdraw 1 mL of blood from the CVAD
* Ability to infuse fluids at the volume necessary to instill Cathflo Activase into the CVAD
* Written informed consent and assent (if appropriate) provided by parent or legal guardian and compliance with study assessments for the full duration of the study

Exclusion Criteria:

* Ability to withdraw blood following subject repositioning
* CVAD insertion \< 48 hours prior to enrollment
* Selected study catheter implanted specifically for hemodialysis
* Evidence of mechanical, non-thrombotic occlusion of the CVAD (e.g., kink in the CVAD or suture constricting the catheter)
* Previous enrollment in this study
* Use of fibrinolytic agent (e.g., alteplase, reteplase, tenecteplase, urokinase, streptokinase) within 24 hours of enrollment
* At high risk for bleeding events, embolic complications (i.e., recent pulmonary embolism, deep vein thrombosis, endarterectomy, clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constituted a significant hazard
* Known hypersensitivity to alteplase or any component of the formulation
A Novel Social Emotional Learning Curriculum for Youth With Epilepsy

Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor.

Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically.

The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored.

The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.


Eligibility Criteria:
Inclusion Criteria:

* Able to read, write, and communicate in English at 3rd grade level
* Active epilepsy diagnosis (currently on anti-seizure medication or does not yet meet remission standards of 10 years without seizure and off all medication)
* Epilepsy diagnosis clinically established for at least 6 months prior to the time of recruitment
* The pediatric neurologist feels the patient would benefit from program participation.
* Able to consistently join meetings on Zoom with functional audio and video reception

Exclusion Criteria:

* During the consent process, if an eligible potential participant feels that participation would pose too much of a burden on their health or mental wellbeing, they will be excluded.
Postoperative Analgesia in Laparoscopic Gynecological Surgeries

The aim of this study is to compare intraperitoneal instillation of magnesium sulfate versus sodium bicarbonate as an adjuvant to lidocaine 1% , on reducing postoperative pain in laparoscopic gynecological surgeries.

Patients undergoing laparoscopic surgery experience postoperative pain especially in the abdomen, lower back, and shoulders, Relieving postoperative pain, especially with certain types of analgesic agents, may reduce postoperative morbidity and mortality. It is also important to prevent adverse events such as myocardial infarction, cardiac arrhythmia, ileus, and poor wound healing and pulmonary complications. There is evidence that the main source of pain after laparoscopic surgeries is the peritoneum . Due to CO2 insufflation constitutes the commonest means of creating the pneumoperitoneum. Co2pneumoperitoneum is known to cause systemic acidosis. Which is responsible for damaging of the mesothelial lining of the peritoneum and consequent peritoneal irritation . Moreover, the phrenic nerve could be damaged by the acidic environment The use of local anesthetics has been advocated as a method for reducing postoperative pain local anesthetic intraperitoneal administration has shown good effects on reducing postoperative pain in laparoscopic cholecystectomy and gynecological surgeries . intraperitoneal sodium bicarbonate instillation may neutralize effect of the acid milieu on peritoneal cavity and the phrenic nerve damage which consecutively will lead to a reduction of postoperative pain. Magnesium sulfate, a non-competitive NMDA antagonist, has been proven in animal and human being models to have antinociceptive properties. The antinociceptive effect of magnesium sulfate relieves chronic pain and it can also decrease the duration and intensity of postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* age 18:60years
* patients undergoing laparoscopic gynecological surgeries,
* ASA 1\&2

Exclusion Criteria:

* patient dissatisfaction for participating in the study
* opioid use within 24 hr before the study
* allergy to the drugs used in the study and alcohol use
* chronic pain syndrome.
* neurological disease.
* steroid treatment

  * conversion of laparoscopic surgery to open surgery
  * use a drain
Pharmacokinetics Study of CJ-30060 After Single Dose Administration in Health Male Volunteers

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 20 to 45 years at the screening
* Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive)
* Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

Exclusion Criteria:

* Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease.
* Subject who have symptoms, result from acute disease within 28days before first administration.
* Subject who have chronic persisting disease with clinical significance.
* Subject who fall under the criteria below in laboratory test.

  * AST/ALT \> UNL (upper normal limit) x 2
  * Total bilirubin \> UNL x 1.5
  * In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault
  * CPK \> UNL x 2.5
* Subject who with low blood pressure with clinical significance at screening test.

(systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg)

* Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.
A Study of RG7625 in Healthy Volunteers

This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers.

The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants, 18 to 60 years of age, inclusive
* A body mass index between 18 to 30 kg/m2 inclusive
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
* Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
* Any significant allergic reaction to drugs
* Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
* Women who are pregnant or lactating or of childbearing potential
* Clinically significant abnormal ECG or other risk factors for QT prolongation
* Use of prescribed or over the counter medication
* Inability or unwillingness to comply with study requirements