cyrilzakka/clinical-trials huggingface dataset:
Mandibular First Molar Distalization

A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. The second aim was to detect if there is a difference in the amount of distalization in the presence of unerupted mandibular third molars, using the same technique.

Class III malocclusion in adults is one of the most complex malocclusions in clinical orthodontics. For adults, the ideal treatment option for Class III malocclusion is accomplished either by camouflage treatment in mild to moderate cases or orthognathic surgery in severe cases. Camouflage treatment for Class III malocclusion comprises three main techniques; Class III elastics, mandibular first molar distalization, or extraction of mandibular first premolars. Mandibular first molar distalization via the use of skeletal anchorage has the problem of increased failure rate of the inter-radicular temporary anchorage devices (TADs). Accordingly, a randomized clinical trial using extra radicular TADs in the Mandibular buccal shelf area was designed in the current research aiming to test the efficacy of such a technique in inducing mandibular molar distalization with decreased failure rate, and whether the presence of unerupted mandibular third molars will affect the distalization movement or not.

Eligibility Criteria:
Inclusion Criteria:

* Class III dental incisal relation.
* Dental canine and molar relation not more than half unit Class III.
* Presence of unerupted mandibular third molars on both sides.
* Skeletal Class I or mild Class III.
* Full Permanent dentition.
* Medically free subjects.

Exclusion Criteria:

* Patients with systemic diseases or neuromuscular disorders.
* Retroclined lower incisors.
* Sever skeletal dysplasia.
* Patients with periodontal disease.
Lifestyle and Empowerment Techniques in Survivorship of Gynecologic Oncology

This pilot study is evaluating a new smartphone application named the LETSGO app. The LETSGO app is designed to promote empowerment in patients after treatment for gynecological cancer.

Gynecological cancer treatment is increasingly successful, resulting in a rising number of cancer survivors. Many gynecological cancer survivors may experience late side effects from their cancer treatment. In addition, evidence is accumulating that an active lifestyle may increase empowerment and may positively influence well-being after cancer treatment. Through the LETSGO smartphone app, women treated for gynecological cancer will get access to individualized posttreatment information on side effects as well as tailored physical activity advices in order to assume more responsibility for achieving the best outcomes from her care. The participants will also regularly answer patient reported outcomes regarding possible recurrence though the app. As a first step the smart-phone application will be pilot-tested.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed and treated for gynecological cancer who will be followed up at the gynecological outpatient clinic in Kristiansand or Arendal
* No cognitive barriers.

Exclusion Criteria:

* \< 18 years
* Not able to read Norwegian
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men

This study will address a gap in the literature and advance the field of minority men's health. Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing depression symptoms and generally healthy.

Exclusion Criteria:

* Anyone assessed to be unsafe to be enrolled.
Predicting Medication Response in Obsessive Compulsive Disorder

In this study, the investigators hope to study a number of variables the investigators believe may help us predict why some people respond better to some medications than others. Participants will be randomly assigned to receive one of two typical medications for OCD, clomipramine or escitalopram. Individuals who would like to participate but who have previously tried one or both of these medications may instead take a newer drug, duloxetine, and undergo the identical procedures. The factors the investigators will be studying include demographics (i.e. age, gender, age of onset of OCD), genetic markers (such as variants in genes involved in breaking down drugs in the liver (cytochrome P450 system), and genes involved in several brain chemical systems, such as serotonin), the dimensions of OCD symptoms (i.e. checking, washing, and hoarding) and cortical inhibition. Cortical inhibition will be measured transcranial magnetic stimulation and is being studied because deficits in this process may be important in the development of OCD. The investigators hypothesize that certain pretreatment clinical characteristics will correlate with poor treatment response including earlier age of onset, longer duration of illness, increased YBOCS severity and presence of significant hoarding symptoms. The investigators expect that increasing degree of deficit in CI pre-treatment will predict poor treatment response, but that increase in CI from pre- to post-treatment will correlate with a positive treatment response. Differences in genetic marker status for cytochrome P450 genes will correlate with tolerability and/or response, as well as differences in genetic marker status in SLC1A1, GRIN2B, 5HT1B and 5HT2A will correlate with response.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Obsessive Compulsive Disorder
* Must be able to swallow tablets

Exclusion Criteria:

* History of stroke
* History of Parkinson's disease
* History of Epilepsy
* Clinical diagnosis of Schizophrenia or schizoaffective disorder
* Clinical diagnosis of Bipolar Affective disorder
* Active suicidality
Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty

The purpose of this Phase I open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with age-related frailty.

This study is designed to evaluate the safety and efficacy of focused ultrasound in patients with age-related frailty characterized by reduced physical and immunological functioning. The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound. Adverse events will be noted whenever they occur but will be recorded at the time of the procedure and throughout routine follow-ups, which will persist weekly throughout the duration of the active study protocol. Patients deemed potentially appropriate candidates for focused ultrasound therapy will be treated with 8 sessions of transcranial ultrasound, each of which consists of 10 to 30 minutes of active administration. Clinical and safety outcome measures will be obtained throughout and after completion of the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age eligibility requirements fall in a range from 60 to 95 years of age
* Clinical appraisal by physician indicating signs of frailty (apart from a co-occuring condition), scoring 3\<x\<7 as denoted by the CSHA Clinical Frailty Scale (Rockwood, Song, MacKnight, et al, 2005; Golpanian, DiFede, Pujol, et al., 2016)
* MRI of the brain including volume measurement of the hypothalamus

Exclusion Criteria:

* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Pregnancy, women who may become pregnant or are breastfeeding
* Advanced terminal illness
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

This is a prospective, single-center clinical trial designed to evaluate the safety and efficacy of combining stereotactic ablative body radiotherapy (SABR) with the targeted therapy Axitinib and the immunotherapy Toripalimab in patients with recurrent metastatic renal cell carcinoma (RCC). Patients will receive a treatment regimen consisting of Axitinib, Toripalimab, and comprehensive multi-lesion SABR. The primary endpoint is Progression-Free Survival 1 (PFS1), and secondary endpoints include Progression-Free Survival 2 (PFS2), Overall Survival (OS), Local Control (LC), Objective Response Rate (ORR), and Disease Control Rate (DCR). Adverse events will be monitored according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). The aim of this study is to explore a potentially more effective treatment combination for recurrent metastatic RCC.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging.
2. Patients with ≤5 metastatic lesions amenable to complete lesion coverage radiotherapy; or \>5 lesions with at least 3 suitable for radiotherapy as evaluated by the radiotherapy and imaging departments.
3. Age between 18-80 years.
4. Expected survival of ≥12 weeks.
5. Measurable disease based on RECIST Version 1.1.
6. ECOG performance status of 0-2.

Exclusion Criteria:

1. History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy.
2. Use of corticosteroids or other immunosuppressants within 14 days before treatment.
3. Autoimmune diseases.
4. History of other malignancies.
5. History of surgery within 28 days before treatment.
6. Allergy to study drug components.
Effect of Baduanjin Exercise on Metabolic Syndrome Patients

Pre/posttest randomized control trial design.

In this study all patients will be randomly assigned into two groups (30 in each group) :

* Group A will do baduanjin exercise in addition to traditional medical treatment.
* Group B will take traditional medical treatment only.


Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome patients

Exclusion Criteria:

* patients with Respiratory diseases
* patients with pacemaker patients
* patients with Neurological diseases
* patients with orthopedic diseases
Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)

To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Children, Between 12 Months And 12 Years Of Age
* Parent Or Legal Guardian Should Be Willing And Able To Sign The Informed Consent Form Prior To Entry Into The Study

Exclusion Criteria:

* Any Immune Impairment Or Deficiency, Neoplastic Disease, Or Depressed Immunity, Including That Resulting From Corticosteroid Or Other Immunosuppressive Therapy
* Any Immunoglobulin Or Blood Products 5 Months Prior To Or Expected Within 3 Months After Enrollment In This Study

Any Medical Condition Which, In The Opinion Of The Investigator May Interfere With The Evaluation Of Teh Study Objectives

* Any Other Inactivated Vaccine Administered Within 14 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination
* Any Other Live Vaccine Administered Within 30 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination
* Female Subjects Who Are Pregnant Or Nursing
* History Of Anaphylactic Or Other Immediate Allergic Reactions
* Hypersensitivity To Any Of The Components Of The Vaccine Administered Under This Protocol Such As Gelatin Or Neomycin
* Past History Of Varicella
* Previous Vaccination With Any Varicella Vaccine In Either Monovalent Or Combination Form
* Recent Household, Daycare, Or School Exposure(In The Last 4 Weeks) To Varicella
Effects of Music Combined With CBT on Chronic Subjective Tinnitus

This study retrospectively analyzed the first and second visit data of chronic subjective tinnitus patients who received music combined with cognitive behavioral therapy in our hospital in recent years. Behavioral tests and tinnitus questionnaires, as well as sleep and depression scores, were used to analyze the therapeutic effects of this approach. EEG results were analyzed as a potential neurobiological marker to explore the neural mechanism of tinnitus symptom improvement.

The subjects of this study were chronic subjective tinnitus patients and normal controls who were treated with music therapy combined with cognitive behavioral therapy (music-CBT) in the Department of Otolaryngology of Sun Yat-sen Memorial Hospital from December 2016 to March 2024 and who had completed re-examination. The pre- and post-music-CBT data of past patients who met our study conditions were collected for retrospective statistics. The complete sample data included medical history, pure tone audiometry, tinnitus matching, tinnitus questionnaires (Tinnitus Handicap Inventory, Visual Analog Scales, tinnitus Functional Index), sleep quality questionnaire (Pittsburgh Sleep Quality Index), and depression questionnaire (Hamilton Depression Scale -24 items). The resting state electroencephalogram (rs-EEG). Retrospective statistical analysis was conducted to determine the clinical efficacy and influencing factors of music-CBT for chronic subjective tinnitus at 3 months and long term. Finally, the neural mechanism of music-CBT for tinnitus treatment was analyzed based on rs-EEG results.

Eligibility Criteria:
Inclusion Criteria:

* adults aged between 18 and 60
* a total score of 18 or higher on THI
* a constant tinnitus that can be matched
* right-handed
* no significant medical or psychiatric conditions

Exclusion Criteria:

* intermittent, pulsating or objective tinnitus
* central nervous system disease
* cognitive impairment
* other contraindications for EEG testing
Local Infiltration Analgesia With Ropivacaine in Posterior Vaginal Wall Prolapse:a Randomized, Double-Blind Study

The purpose of this study is to compare systematic local infiltration with ropivacaine or placebo in patients undergoing repair of posterior vaginal wall prolapse.

The hypothesis is that LIA technique is opioid-sparing and a better postoperative treatment.


Eligibility Criteria:
Inclusion Criteria:

* eligible for elective repair of posterior vaginal wall prolapse
* able to speak and understand Danish
* able to give informed consent

Exclusion Criteria:

* alcohol or medical abuse
* allergies to local anesthetics
* age \< 18 yrs.
* intolerance to opioids
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)

This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.

The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* \>18y
* Stable Angina or Unstable Angina
* Single restenotic lesion in a previously stented coronary artery

Exclusion Criteria:

* Acute Myocardial Infarction within 72h
* Serum Creatinine\>2.0 mg/dL
* Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel
* Contraindications to contrast media
* Life expectancy \< 2y
* Target Lesion length \> 30mm
* Target Lesion diameter \<= 2.5 mm
* Target stenosis \< 70%
* Massive Calcifications in the target segment
* Evidence of intra-coronary thrombus
Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults

Purpose of the study is to examine the vessel density of healthy adults' optical coherence tomography angiography images with two semi-manual methods and an automated quantification program.

Optical coherence tomography angiography (OCTA) is a software upgrade on conventional spectral-domain or swept-source optical coherence tomography devices that enables non-invasive, dye-free, three dimensional analysis of the retinal vessels.

Vessel density is a very important parameter almost in all retinal disorders. In the recent past, automated quantification software was built into some OCTA devices which can automatically calculate the retinal vessel density as well.

In this study two semi-manual techniques are used in order to analyze the vessel density of healthy subjects' OCTA images. Vessel density is also measured with a new automated quantification program, and results of the three methods are compared.

OCT machines are approved in the EU and the US and are not experimental devices.

The device used in this study is the commercially available Zeiss Cirrus HD OCT Angioplex 5000 that operates with spectral-domain technology.

Eligibility Criteria:
Inclusion Criteria:

* healthy patients without eye disease

Exclusion Criteria:

* incapacity
* any history or clinical evidence of retinal disease or glaucoma
* previous ocular surgery or laser photocoagulation
* optical media opacities that would disturb imaging
Gut Microbiome in Colorectal Cancer

This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer

This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer (CRC). Three patient cohorts will be followed. Cohort A: patients treated with oral fluoropyrimidine CAP as part of standard of care (SOC) chemotherapy. Cohort B: patients treated with TAS-102 including those receiving it in combination with Y-90 radioembolization as part of a clinical trial. Cohort C: patients receiving CAP plus immunotherapy (pembrolizumab) and bevacizumab as part of a clinical trial. Investigators will replace participants as needed to ensure a minimum of 10 evaluable participants per cohort (or minimum total of 30 evaluable patients). Evaluable participants are defined as patients with two analyzable stool samples including a baseline sample and at least one on-treatment sample to be used in endpoint analysis

Eligibility Criteria:
Inclusion Criteria:

1. The patient has histologically proven colorectal adenocarcinoma
2. The patient is starting treatment with oral fluoropyrimidine therapy: CAP or TAS-102 as SOC or on a clinical trial. This also includes those patients receiving treatment in the adjuvant setting or post-metastasectomy with no evidence of disease on imaging.
3. Combination of oral fluoropyrimidine with other cancer-directed therapies, including oxaliplatin, bevacizumab, Y-90 radioembolization, or immunotherapy checkpoint inhibitors, is permitted.
4. Combination of CAP with concurrent radiation is permitted, including patients undergoing radiotherapy to a rectal primary or a metastatic site.
5. Male or female patient aged 18 years of age or older at the time of obtaining the signed and dated informed consent (no upper age limit).
6. Be able to read and speak English.
7. Be willing and able to provide written informed consent for the study

Exclusion Criteria:

1. Patient has had prior chemotherapy, biologic or immunotherapy in the previous 2 weeks.
2. Patient has completed a course of antibiotics longer than 2 weeks in preceding six months or a course of antibiotics of any duration in the 4 weeks prior to starting oral chemotherapy. Any patient who requires treatment with antibiotics during the study may be removed at the investigator's discretion.
3. Known HIV positive.
PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

The aim is to investigate the incidence of headache, migraine attacks and flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with migraine

Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients. We are investigating whether treatment with sumatriptan has an effect on the PACAP38-induced flushing and on whether headache and migraine is induced.

The purpose of this study is to investigate PACAP38-induced headache and migraine in patients with migraine who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The study will be conducted with a double-blind, placebo-controlled crossover study design.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of migraine, according to IHS criteria
* weight between 50 - 100 kilograms
* women in fertile age must not be pregnant and must use adequate contraception

Exclusion Criteria:

* migraine more than 5 days per month in average over the past year
* any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
* headache \< 48 hours before experimental day
* migraine \< 72 hours before each experimental day
* daily / frequent use of any medication apart from contraceptive medication
* use of any drug less than 5 times the half-life of the drug at the time of the experiment
* women who are pregnant or breast-feeding at the time of the experiment
* anamnestic or clinical signs of hypertension (systolic blood pressure \> 150 mmHg and/or
* diastolic blood pressure \> 100 mmHg) or hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg)
* anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs
* patients with glaucoma or prostate hyperplasia
* anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study