cyrilzakka/clinical-trials huggingface dataset:
Three Levels of Force Application for Maxillary Protraction

The aim of this study is to evaluate dentoskeletal changes concomitant with different three levels of force application for maxillary protraction in growing patients with skeletal class 3 malocclusion.

Nanda reported that numerous experimental studies on primates have shown orthopedic changes in response to extraoral forces; however, very few studies have made an attempt to analyze the different force variables and their relationship to facial sutures. In consideration of the variables, experimental and clinical studies were initiated in their laboratory in 1972. A study on protraction of midfacial bones on primates reported that the point of force application significantly influences the center of rotation of the maxilla in rhesus monkeys. Our unpublished data also show that centers of rotation are influenced by the magnitude of force. The study showed that the maxilla can be successfully protracted by means of carefully controlled forces.

Based on the aforementioned data, we can hypothesize that the point of force application for maxillary protraction in relation to the center of resistance of maxilla could be utilized in order to correct skeletal class 3 malocclusions with different vertical dimension discrepancies.

Eligibility Criteria:
Inclusion criteria:

The patients will be included in the study if they have the following:

1. An age range from 7 to 10 years.
2. Patients diagnosed to have skeletal class 3 malocclusion due to retruded maxilla and/or combined maxillary retrusion with mild mandibular protrusion. (based on cephalometric analysis)
3. No serious systemic diseases and/or medical treatment that could interfere with orthodontic tooth movement such as analgesics, non-steroidal anti-inflammatory drugs, and hormone supplements or antibiotics.
4. Good oral hygiene and periodontal conditions.
5. No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunctions.
6. No previous orthodontic or orthognathic treatment.

Exclusion criteria:

The patients will be excluded from the study if they have the following:

1. Systemic diseases or medications that could interfere with orthodontic treatment.
2. Poor oral hygiene or periodontally compromised patients.
3. Craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
4. Previous orthodontic treatment.
CERvical Cancer The InFlammatory Index (CERTIFIKO)

Although significant advances in screening and treatment , cervical cancer is the fifth most common female cancer in Europe. Major prognostic factors for oncological outcome are used to categorise patients at high, intermediate and low risk groups and to define the type of radical hysterectomy according "Querleu-Morrow classification". The goal of this prospective observational study is to evaluate the association between several inflammatory markers and risk groups according European guidelines in women with cervical cancer Human Papillomavirus (HPV)-associated, in order to optimize the treatment.

European guidelines have proposed a risk stratification of patients basing on oncological risk. The type of radical hysterectomy (extent of parametrial resection and type according Querleu-Morrow classification) should be based upon the presence of prognostic risk factors.Major prognostic factors for oncological outcome as tumour size, maximum stromal invasion, Lymphovascular space invasion (LVSI) are used to categorise patients at high, intermediate and low risk for treatment failure. The investigators want to identify additional parameters to better define risk profiles. Systemic inflammation indices such as neutrophil to lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and lymphocyte to monocyte ratio (LMR) have shown prognostic value in solid tumors and several inflammatory conditions. Therefore, the primary endpoint of the present study is to assess the role of systemic inflammatory indices and risk groups stratification in patients with early cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* At least 18-year-old patients.
* Patients histologically diagnosed with cervical cancer (squamous cell carcinoma or adenocarcinoma HPV- associated)
* Patients with (2018 FIGO) stage ≤ IB2 ("Early Cervical Cancer")
* Patients undergoing full-body CT-scan 30 days before enrollment.

Exclusion Criteria:

* Patients unfit to plead
* Patients with chronic inflammatory diseases (IBDs; rheumatic conditions)
* Synchronous tumors or cancer diagnosis in the previous 3 years
* Patients undergoing steroid therapy in the last 30 days prior to recruitment
A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.


Eligibility Criteria:
Key Inclusion Criteria:

* Monotherapy-specific criteria for dose escalation cohorts:

  * Participants may have cytologically or pathologically confirmed non-small cell lung carcinoma (NSCLC), colorectal carcinoma (CRC), breast, ovarian, renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), or bladder (including urothelial malignancies of the renal pelvis and ureter) carcinoma that has progressed or was non-responsive to available therapies with no standard of care (SOC) options, or for whom standard therapy has proven ineffective, intolerable, or considered inappropriate; or for whom a clinical study of an investigational agent is a recognized SOC.
* Disease-specific criteria for dose-expansion (NSCLC):

  * Cytologically or pathologically confirmed locally advanced unresectable or metastatic (Stage IIIB-IV per American Joint Committee on Cancer version 8) non-squamous NSCLC negative for actionable mutations in EGFR, ALK, ROS1, NTRK, C-MET, or RET. Mixed SCLC and squamous NSCLC histology is not permitted.
  * Previously treated in the unresectable locally advanced or metastatic setting with a platinum-containing chemotherapy and PD-(L)-1inhibitor.
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) (Section 1.1). The measurable lesion must be outside of a radiation field if the participant received prior radiation unless discussed and approved by the study physician.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Key Exclusion Criteria:

* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
* Underlying medical conditions or adverse events that, in the physician or sponsor's opinion, will make the administration of investigational products hazardous.
* Prolonged QT interval defined as mean corrected QT interval (QTc) ≥ 450 milliseconds (ms).
* Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment.
* Treatment with systemic immunosuppressive medication (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of VPRIV in Participants With Gaucher Disease Previously Treated With Other Enzyme Replacement Therapies or Substrate Reduction Therapies

The main aim of this study is to describe the safety profile of velaglucerase alfa (VPRIV) in participants with Gaucher disease type 1. Participants will be transitioning from other enzyme replacement therapies or substrate reduction therapies to VPRIV. Some participants may have already transitioned to treatment with VPRIV before this study started.

In this study, data on VPRIV will be collected from the medical records of participants who already transitioned to VPRIV before this study started. Other participants will join this study when they transition to VPRIV. All participants will be followed to allow for 12 months of observation from time of transition to VPRIV.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.


Eligibility Criteria:
Inclusion Criteria:

* Participant with GD1 currently being treated with an ERT/SRT other than VPRIV for at least 6 months before baseline enrolment; or participant previously treated with another ERT/ SRT for at least 6 months prior to transitioning to VPRIV..
* Participant or legally authorized representative has provided written informed consent.

Exclusion Criteria:

* In the opinion of the investigator, participant is at high risk of non-compliance.
* In the opinion of the investigator, participant is unsuitable in any other way to participate in this study.
* Participant is pregnant.
Metformin for the Prevention of Episodic Migraine (MPEM)

The investigators will evaluate the safety and efficacy of metformin for preventive treatment of migraine in a randomized, double-blind, placebo-controlled, crossover trial.

This will be a single-center, double-blind, randomized, placebo-controlled, crossover study. The investigators will enroll 40 subjects. Subjects will be recruited from the outpatient Mayo Headache Clinic, Mayo Women's Health Clinic, Mayo Community Internal Medicine, and the Mayo Clinic- Arizona State University Neurology Clinic. The Headache Clinic employs 6 headache specialists and 1 fellow which is sufficient staffing to support this study and recruitment of patients with migraine.

Before study enrollment, patients will undergo a 2-hour oral glucose tolerance test to confirm the absence of diabetes mellitus.

Subjects will then keep a headache diary for 4 weeks to establish baseline characteristics, including number of migraine days per month, number of moderate to severe headache days per month, and number of days per month of acute medication use. The 4-week baseline period will be followed by 2 treatment periods of 12 weeks each, separated by a washout period of 4 weeks (total study duration, 32 weeks). For the 12-week treatment periods, subjects will receive either metformin 500mg twice daily or matching placebo twice daily.

Subjects will have 7 study visits. Routine laboratory studies and a pregnancy test will be performed at enrollment and week 20. Abnormal kidney or liver function will exclude subjects. Pregnancy will exclude subjects. General and neurologic examinations will be performed during 3 of the 7 visits. At each visit, subjects will receive medication for the period until the next visit. A headache diary will be used for the trial. For every day that the subject has a headache of any type, she or he will record headache characteristics, associated features, and medications used.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-65 years
2. a diagnosis of migraine with or without aura for \>1 year according to the International Classification of Headache Disorders-IIIb

Exclusion Criteria:

1. a diagnosis of diabetes mellitus or polycystic ovarian syndrome
2. overuse of acute migraine treatments
3. failure to respond to 3 or more classes of preventive drug treatments
4. change in dose of migraine-preventive medication within 2 months of beginning the baseline diary phase
5. significant somatic or psychiatric disease
6. known alcohol or other substance abuse
7. pregnant or breastfeeding.
Home Ventilatory Support in Children

The study consist of children, who have used home ventilatory support during years 2010-2020 in Tampere University Hospital. The study will describe retrospectively different diagnoses and symptoms which will lead to home ventilatory support. We also study compliance to treatment and it's disanvantages. The prospective part of the study describes the quality of live of these children by using questionnaires (PedSQL).


Eligibility Criteria:
Inclusion Criteria:

- ICD-10 Code for Sleep apnea diagnose G47.3 AND G47.3 diagnose found from pediatric electronic patient records between years 2010-2020 OR Patient name found from pediatric multidisciplinary home respiratory team's clinical list

Exclusion Criteria:

* Age over 16
* Patient starting home ventilation after 31st December 2020 or treatment ending before 1st January 2010
* patients with sleep apnea but without home respiratory support treatment
* Only theophylline treatment
* High-flow oxygen therapy
* Age over 16 at treatment onset
* Never started treatment
* Treatment starting point and ending before year 2010
Energy and Nutrient Profiles When Asians Transit From a Meat-based to a Plant-based Diet: A Modelling Exercise

This study aims to model and present a simulation exercise to assess the nutritional effects of replacing meat-based protein with meat analogues. The hypothesis of our study is to understand if any positive or detrimental effects on nutrition and health will ensue, when people replace a meat-based diet with plant-based and alternative protein substitutes.

A total of up 100 participants (Chinese/Malay/Indian), non-vegetarians, aged between 21 to 99 years, literate and numerate will be recruited for this study. Participants will be required to complete a 4-day food record as part of the exercise. To ensure accuracy of food records, participants will be requested to either weigh their foods or take photographs of all food and drink consumed during the duration of the study. After all the food records have been collected, the data will be analysed using food composition tables. Nutritional profiles of all participants will be generated. Animal-based products will then be substituted with plant-based counterparts and a new nutritional profile will be generated for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* 21-99 years old
* Non-vegetarians
* Access to smart phone devices if participants intend to use photographic methods

Exclusion Criteria:

* Non-english speaking
* Members of any vulnerable populations
* Members of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Validation of Telemedicine Pre-anesthesia Consultation in Low-risk Anesthetic Patients Undergoing Ambulatory Surgery

The purpose of this study is to validate the teleconsultation of anesthesia in anesthetic low risk patients and undergoing outpatient surgery.

Anesthesia consultation is a necessary and obligatory step in the process of anesthesia. Telemedicine anesthesia consultation (TCAD) experiments have been successfully conducted in the United States, demonstrating the technical feasibility and medical relevance of the approach. In partnership with the Rhône-Alpes Regional Health Agency, an Telemedicine anesthesia consultation will be set up at the University Hospital Grenoble for low-risk anesthetic and surgical patients via a telemedicine platform accessible to patients' homes. Avoiding transport, unclog consultations in hospitals, and avoiding absences from work for traditional consultations are some of the advantages of this new method of consultation. This project involves assessing the feasibility, safety, and costs associated with home anesthesia teleconsultation for patients requiring outpatient surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ambulatory surgery with anesthesia procedures
* Patients with American Society of Anesthesiologists score 1 or 2.
* Patients with visual and auditory acuity, language proficiency.
* Non-urgent surgery
* Affiliation to the French Social Security

Exclusion Criteria:

* patient with American Society of Anesthesiologists score 2 and complex treatments
* Complex surgical procedure
* Patient taking anticoagulant and / or antiplatelet treatments
* Patient having a serious problem during a previous surgery
* Pregnant woman
* Patient under guardianship or deprivation of liberty by judicial decision.
Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)

The purpose of this project is to explore the degree to which performance consistency on neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms.

Mild TBI outcome studies are traditionally limited to single administration or baseline/post-injury assessment models and they often fail to show enduring deficits among persons complaining of such problems. It may be the case that our standard approach to deficit measurement in mTBI has confounded our ability to elicit the actual impairment. The proposed study could generate an assessment paradigm shift (performance over time) and afford professionals the direction to better assess and ultimately serve persons with mTBI. Additionally, research on the impact of PTSD symptoms on throughput and cognitive performance has been mixed (Bremner et al., 1995; Brenner et al, 2010; Vasterling et al., 1998, 2002, 2006) and the proposed study will yield additional data in that area.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-45 years old
* At least one OEF/OIF deployment
* Currently receiving physical and/or mental health care through the VA Eastern Colorado Health Care System
* For TBI group - veteran must have a history of at least one deployment- related mild TBI with persistent symptoms

Exclusion Criteria:

* Effortful performance on the Test of Memory Malingering (TOMM)
* History of other significant neurological disease (other than mild TBI for the appropriate group) as assessed by interview and chart review
* History or diagnosis of deployment-related moderate or severe TBI or mild TBI without persistent symptoms for the TBI groups, or any history of deployment-related TBI for the non-TBI group, as assessed by interview and chart review
* History or diagnosis of non-deployment-related TBI
* Diagnosis of Schizophrenia or Bipolar Mood DisorderI Disorder as assessed by interview and/or chart review.
* Problematic drinking behavior that consistently exceeds recommended drinking limits per day, e.g., Diagnosis of Alcohol Abuse Disorder or Alcohol Dependence Disorder per the MINI; or five or more alcoholic drinks per day, four out of seven days per week for the previous two weeks or during the assessment process
* Use of illicit substance(s) more than five times in the two weeks before enrollment or during the testing process.
* Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure
Effects of Mollii Suit in Children With Non-Ambule Cerebral Palsy

The aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with cerebral palsy (CP).

Our study includes children diagnosed with spastic type cerebral palsy at GMFCS level 4 or 5 who applied to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.

After the patients are separated according to the specified exclusion and inclusion criteria, they will be divided into two groups by simple randomization method.

Evaluations will be made before and after treatment. In addition to normal neurodevelopmental therapy (NGT) and Mollii Suit method will be applied 2 days a week. The total duration of treatment will take 8 weeks. Groups; The first group will consist of children with CP who will receive neurodevelopmental treatment.

The second group will consist of children who will receive the Molli Suit method in addition to neurodevelopmental treatment.

Eligibility Criteria:
Inclusion Criteria:

* GMFCS 4 or 5 with spastic cerebral palsy children
* Volunteering to participate in the study

Exclusion Criteria:

* Botulinum toxinA injection in the last 3 months
* Surgical intervention involving the musculoskeletal system in the last 6 months
* Having an invasive medical pump (baclofen, insulin, etc.)
Global Burden and Treatment Trajectiories in Italian Patients With Fabry Disease

GROUND study is an Italian, multicenter retrospective longitudinal cohort study with a cross-sectional phase with the aim to quantify the severe clinical burden in terms of severe and fatal outcomes and extension of clinical impairment in the Italian Fabry Disease patients' population


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients living or deceased of either sex (age ≥18 years) with a documented FD diagnosis in the last 10 years from the beginning of the study.
2. Patients with at least 3 years of follow-up or early occurrence of severe/fatal outcomes. Also, adult patients who were lost by their care provider or physician and cannot be traced, but for which it is possible to retrieve data for at least 3 years before the last available follow-up visit or from diagnosis to the occurrence of severe/fatal outcomes if earlier, can be included.
3. Written informed consent to undergo in the cross-sectional protocol clinical visit and to retrospectively collect genetic/clinical data. In case of deceased or untraceable patients, the written informed consent is not required to collect retrospective clinical data (excluding genetic data).

Exclusion Criteria:

* Not applicable
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Clinical symptoms of biliary obstruction
* Inoperable extrahepatic biliary obstruction by any malignant process
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

* Participation in an Investigational Study within 90 days prior to date of patient consent
* Strictures that cannot be dilated enough to pass the delivery system
* Perforation of any duct within the biliary tree
* Presence of a metal biliary stent
* Presence of any esophageal or duodenal stent
* Patients for whom endoscopic procedures are contraindicated
* Patients with known sensitivity to any components of the stent or delivery system
* Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
* Patients with an anticipated life expectancy of \< 3 months
Detection of COVID-19 Using Breath Analysis - Validation Study

DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY

A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 75 years at the time of consent
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs

Exclusion Criteria:

* Age under 6 years old
* Under guardianship or deprived of liberty
* Pregnant or lactating woman