cyrilzakka/clinical-trials huggingface dataset:
Acceleration of Orthodontic Tooth Movement

EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old.

The rate of orthodontic tooth movement depends on two general factors: the forces used in order to cause orthodontic tooth movement and respectively the individual (biological) response of the body to these forces.

There are many methods for accelerating orthodontic tooth movement. but, every method has its disadvantages, such as pain and root absorption. Locally injected of vitamin d3 was proposed to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical studies to prove this claim.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX
* Healthy patient
* No previous orthodontic treatment
* Vital teeth with periodental tissue without root absorption,

Exclusion Criteria:

* Previous history of orthodontic or orthopedic treatment.
* Presence of craniofacial anomalies.
* Presence of any signs and symptoms of gingival and periodontal diseases.
* Presence of significant medical history (including drug allergy).
* Pregnant and lactating women.
Feasibility of TEE During Cardiac Arrest in Dutch Emergency Departments

The goal of this feasibility study is to learn if Dutch ED providers are able to use transesophageal echocardiography during cardiac arrest.

The main question it aims to answer is:

• are the ED providers able to determine the area of maximal compression of the heart using TEE

Point-of-care ultrasound is a valuable diagnostic tool during cardiopulmonary resuscitation (CPR) in cardiac arrest and its use is recommended by international guidelines. Transthoracic echocardiography (TTE) is most commonly used, but has certain limitations. Image acquisition can be challenging due to patient specific factors such as body habitus. Also image quality may be impacted by the limited acquisition time during CPR pulse checks. Furthermore, observational data suggests that pulse checks are prolonged due to TTE, while minimizing interruption of chest compressions is emphasized for better CPR outcomes in the guidelines. Transesophageal ultrasound (TEE) is a possible alternative for TTE. It has the theoretical advantage of superior image quality and thereby possible reductions of chest compression delays. Furthermore, TEE gives the opportunity determine which part of the heart is compressed most effectively, which is referred to as the area of maximal compression (AMC). Animal studies showed that an AMC located over the left ventricle positively influenced hemodynamics and return of spontaneous circulation (ROSC) compared to an AMC over the aortic root. In human studies, data also suggests that AMC located on the left ventricle, as measured by TEE, may positively influence prognosis.

In the Netherlands, TEE is currently not used in emergency departments during cardiac arrest. The purpose of this study is to investigate if point-of-care TEE can be used effectively and safely by providers and teams that have not previously used this modality. Given the paramount importance of quality of chest compressions, the ability of the providers to assess the location of the AMC will be the main focus of this feasibility study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiac arrest \> 18 year in the emergency department.

Exclusion Criteria:

* Patients with known upper gastro-intestinal malignancy or strictures, previous upper gastro-intestinal surgery or radiation, or known esophageal varices.
* Patient with a do-not-resuscitate order, pregnant patients and traumatic cardiac arrest.
* No trained TEE provider available.
* ROSC at arrival.
* Decision by the team to stop resuscitation at arrival at the emergency department due of prognosis.
* Other life saving interventions which are prioritized over TEE by the resuscitation team.
Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying

Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists
* Inadequately controlled diabetes mellitus

Exclusion Criteria:

* Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
Psychometric Properties of the Elderly Health Questionnaire Among Community-dwelling Older People

The aims of this study are to validate the reliability and validity of Elderly Health Questionnaire in assessing frailty risk of community-dwelling older adults.

The aims of this study are to validate the test-retest reliability, internal consistency, criterion-related validity, predictive validity and construct validity of Elderly Health Questionnaire in assessing frailty risk of community-dwelling older adults.

The investigators conduct a prospective study to require data of health states, function, lifestyle and quality of life in community-dwelling older adults ,and will recruit about 150 subjects in NTUH and communities in Taipei City. The investigators analyze the (change) scores of Elderly Health Questionnaire to test the internal consistency and test-retest reliability. Also, the investigators test the correlation between the scores of Elderly Health Questionnaire and the scores of the other measurements (i.e., HELP-T, WHOQOL-BREF, MoCA, SPPB, UPSA-B) to validate the concurrent validity, and the correlation between the scores of Elderly Health Questionnaire and the scores of CFS to validate predictive validity. The construct validity is validated by exploratory factor analysis.

Eligibility Criteria:
Inclusion Criteria:

* aged \> 65 years old
* able to read
* Clinical frailty scale ≦ 6

Exclusion Criteria:

* diagnosed as dementia or schizophrenia
* active cancer receiving treatment
* terminal cancer patient
* hospitalization in 1 month
* with implantable device
* couldn't follow the instructions
* wheelchair bound
Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.

A large proportion of concussion patients with long-term consequences of concussion experience visually related symptoms such as headache, blurred vision, double vision, and fatigue.

These patients often have difficulties coordinating the movement of the two eyes (convergence insufficiency) which is essential for single and clear vision to be obtained and is hence a likely explanation for the symptoms.

100 patients with long-term symptoms of concussion and convergence insufficiency will be offered either exercises or placebo treatment the evaluate the effect of exercises aimed at improving coordination between the two eyes.

The study will provide data to support clinicians in deciding whether to use exercises or not as a treatment of symptoms for patients with convergence insufficiency as a long-term consequence of concussion.


Eligibility Criteria:
Inclusion Criteria:

* Concussion at least 3 month ago
* Convergence insufficiency which has not been diagnosed prior to the concussion

Exclusion Criteria:

* Patient who are unable to fulfill baseline examination
* Manifest or paralytic strabismus
* Self-reported eye disease
Online Mindfulness-based Tic Reduction (Phase Two)

Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments or find them unacceptable. Thus, it is essential that researchers continue to develop and test novel treatment approaches.

In this randomized controlled trial the investigators will compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). The purpose of this study is to determine which intervention is more helpful for adults with a tic disorder.


Eligibility Criteria:
Inclusion Criteria:

1. be 18 years of age or older,
2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
3. be fluent in English
4. reside in the United States,
5. either not be taking any tic suppressant medication or other psychotropic medication or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the study

Exclusion Criteria:

1. be receiving concurrent psychotherapy for the duration of the study
2. have prior extensive experience with mindfulness and/or meditation and
3. have another medical or psychological condition that would prevent the individual from fully engaging in the study or require a higher level of care (e.g., suicidality).
Botulinum Toxin for Neck Rejuvenation

The purpose of this study is to describe a safe and consistent technique for neck rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the intervention and determine the patients that would benefit most.

The abobotulinumtoxinA will be used for the Nefertiti lift The abobotulinumtoxinA will be prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with contraction)

Injection points:

* A series of 4 injection points 1-2 cm apart on a horizontal line under the mandible posterior to the hypothetical line were the nasolabial fold meets the mandible
* If present, injection of each platysmal band every 2 cm with 2 to 4 injection points per band (Injection of platysmal band will be done by holding the band between 2 fingers and injecting intramuscularly) For all injection points 5 units per point of abobotulinumtoxinA will be used

A maximum of 125 units of abobotulinumtoxinA will be allowed for the global neck treatment

Follow up will be done at 15 days for retouching or for post op pictures if no retouching is needed. if retouching is needed post injection pictures will be taken 10 days post retouching

Retouching: each residual platysmal band will be reinjected every 2 cm with 2 to 4 injection points per band (Injection of platysmal band will be done by holding the band between 2 fingers and injecting intramuscularly) (5 units per point of abobotulinumtoxinA will be used)

A total of 30 patients will be recruited

Eligibility Criteria:
Inclusion Criteria:

Female patients presenting to our clinic for neck rejuvenation who:

* Were deemed nonsurgical candidates for neck rejuvenation
* Were not willing to undergo invasive surgical procedures
* Had a medical contraindication to surgery

Exclusion Criteria:

* Patients with lower face botulinum toxin injection in the past 12 months
* Patients with resorbable lower face fillers injection in the past 12 months
* Patients with previous permanent lower face fillers injection
* Pregnant patients
* Lactating patients
* Patients with preexisting neuromuscular conditions (myasthenia gravis, Eaton Lambert syndrome)
* Patients using medication that could potentiate the effect of botulinum (ex: aminoglycoside antibiotics)
* Patients with sensitivity to botulinum toxin or human albumin
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)

Participants were randomized in a 1:1 ratio to the following monthly treatment groups:

* Avacincaptad pegol 2 mg
* Sham

At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis

The participants initially randomized to sham treatment continued with monthly sham administration through Month 23

All participants had a final follow up visit at Month 24

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years
* Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

* Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
* Any intraocular surgery or thermal laser within 3 months of trial entry.
* Any prior thermal laser in the macular region, regardless of indication
* Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
* Previous therapeutic radiation in the region of the study eye
* Any sign of diabetic retinopathy in either eye
Endoscopic Capillary Oximetry for Tumor Diagnosis in Head and Neck Cancer

Endoscopy is a standard part of the evaluation of patients with head and neck cancer used for determining the extent of tumor involvement. However, not all areas involved by tumor are apparent visually. Preliminary results indicate that compared with normal tissues, tumors have abnormal levels of capillary oxygenation. The purpose of this study is to determine the ability of non-pulsatile visible light tissue oxygen monitoring to differentiate normal and tumor tissue based on capillary oxygenation during endoscopy Should this be possible, this method could be used to mark tumor extent and invasion, even when that invasion is up to 5mm blow the tissue surface.


Eligibility Criteria:
Inclusion Criteria:All patients with newly diagnosed head and neck cancer as well as those being seen for routine follow up with no evidence of current disease and healthy volunteers are eligible for this study.
Continuous Correction

The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump.

The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* T1D ≥ 3 years
* CSII ≥ 1 year
* HbA1c ≤ 8.0% (64 mmol/mol)

Exclusion Criteria:

* Pregnancy or nursing
* Hypoglycemia unawareness
* Gastroparesis
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.

OBJECTIVES:

* Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa.
* Assess the toxicity of this regimen.

OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden.

All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited.

Patients are followed for survival.

PROJECTED ACCRUAL: 14 patients will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven renal cell cancer that is metastatic

  * No greater than 50% estimated hepatic replacement by tumor on CT or MRI
  * No symptomatic involvement of the CNS or a major nerve
* Measurable disease required
* Ineligible for treatment with low-dose interleukin-2 on another CMC protocol

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 50%-100%

Life expectancy:

* More than 3 months

Hematopoietic:

* No coagulopathy (i.e., platelet count less than 80,000/mm3)

Hepatic:

* AST and ALT no greater than 5 times normal

Renal:

* Creatinine less than 4.0 mg/dL

Cardiovascular:

* No symptomatic angina
* No untreated coronary artery disease
* No refractory arrhythmia
* No abnormal left ventricular function

Pulmonary:

* No dyspnea on minimal exertion

Other:

* No site of ongoing bleeding
* No systemic infection
* No HIV antibody
* No HBsAg
* No requirement for steroids
* No psychiatric disease that precludes informed consent or protocol treatment
* No second malignancy except:

  * Basal cell skin carcinoma
  * Carcinoma in situ of the cervix
* Not pregnant or nursing
* Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior interleukin-2

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 28 days since prior treatment for renal cell cancer
A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers

The purpose of this research study is to demonstrate a lack of effect of multiple doses of GSK189075 on the PK of an oral contraceptive pill in healthy female subjects. To estimate the effects of GSK189075 on hormonal levels and on birth control.


Eligibility Criteria:
Inclusion Criteria:

* healthy, non-smoking menstruating female age 18 to 45 years old, inclusive.
* able to take a specific oral contraceptive \& KG2107494.
* female unable to have any more children, still has ovaries and uterus, and has a negative pregnancy test.
* female who can have children and who has regular periods and are willing to use an oral contraceptive pill and/or have a sterile partner.

Exclusion Criteria:

* pregnant or a nursing female.
* female subject able to have children of who is unwilling or unable to use an appropriate method of birth control at least 2 weeks prior to first dose of study drug until completion of the Follow-up visit.
* Have suffered with certain infection within 4 weeks prior to the first dose of study drug
A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204

A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe acne
* 20 inflammatory and 25 non-inflammatory acne lesions

Exclusion Criteria:

* Pregnant, trying to become pregnant, or nursing
* Known allergy to any component of the topical SB204 formulation
A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.

Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken.

At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year).

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged greater than or equal to 18 years at the time of signing informed consent.
* Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
* Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.
* HbA1c below10% at screening visit based on analysis from central laboratory.

Exclusion Criteria:

* Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
* Chronic heart failure classified as New York Heart Association (NYHA) Class IV at screening.
* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.