cyrilzakka/clinical-trials huggingface dataset:
Children's Dental Anxiety in Relation to Parental Dental Anxiety, Child's Age and Gender and Caries Experience

Determine the relation of of Children's dental anxiety to Parental Dental anxiety, child's age and gender and caries experience will be obtained through written questionnaires (ACDAS) and (CDAS) to the child and parents of children aged 6-8 years old in the clinic.

1. Soft copies of the Abeer children dental anxiety SCALE (ACDAS) Questionnaire and Corah Dental Anxiety Scale (CDAS) Questionnaire.
2. The child's age and gender will be recorded first.
3. Level of anxiety will be recorded by using Heart rate using fingertip pulse oximeter.
4. Dental caries experiences will record by using Dental caries indices (DMF and def)
5. Child dental anxiety will be evaluated from (ACDAS) Questionnaire: The first part is child self-report part, the operator will be answered by ticking the box that corresponds to child dental anxiety, 1 (happy), 2 (Ok), 3 (Scared). The second part about the cognitive part with five questions: three of them answered with (Yes, No) and the other two questions answered with score, 1 (happy), 2 (Ok), 3 (Scared)
6. Parents dental anxiety will be evaluated from (CDAS) Questionnaire. the parents will answer by ticking the answer. The final scores, \&amp;gt;9 (Mild anxiety), 9-12 (Moderate anxiety), 13-14 (High anxiety), 15-20 (Sever anxiety).
7. Results will be analyzed by the statistician.
8. Data handling will be supervised by the supervisors.

Eligibility Criteria:
Inclusion Criteria:

1. Children range in age from 6-8 years old.
2. First dental visit.
3. Accompanied by their parents.
4. Both male and female included.

Exclusion Criteria:

1. Children with Physical or mental disabilities.
2. Children who refuse to participate.
Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treating Treatment of Type 2 Diabetes

This study was a retrospective study on type 2 diabetes patients that were treated with autologous stromal vascular fraction (SVF) and autologous activated platelet-rich plasma (aaPRP) measuring HbA1c level at baseline, 1-month, 3-month, 6-month, and 12-month post-treatment.

The preparation of SVF used the H-Remedy (Jakarta, Indonesia) method invented by HayandraLab. Manual liposuction was performed to collect the lipoaspirate. The aaPRP was prepared using an in-house method of HayandraLab. The SVF pellet was resuspended in 0.9% normal saline, resulting in a total of 22 mL SVF suspension. 7 mL of cell suspension was used for quality control. A total of 15 mL SVF suspension was mixed with 3 mL aaPRP. A total of 20 mL of SVF and aaPRP suspension was injected into an infusion bag which contained 250 ml of 0.9% normal saline. The mixture of SVF and aaPRP was then infused intravenously to each patient for a duration of around 30 minutes. The infusion was given on the day of the patient's lipoaspiration procedure. The patients underwent three subsequent infusions of SVF and aaPRP combination, followed by four aaPRP infusions. These therapy sessions were scheduled with a 2-weeks interval.

Inclusion criteria:

1. Patients who were diagnosed with type 2 diabetes (T2D) for at least 2 years with the diagnosis of T2D and treatment with oral anti-hyperglycemic therapy with metformin were in accordance with the guideline for management and prevention of T2D by the Indonesian Society of Endocrinology.
2. Patients who have undergone standard oral anti-hyperglycemic therapy with metformin and had not been able to reach normal HbA1c level with the medication
3. Patients who underwent autologous SVF-aaPRP therapy between January until December 2017

Exclusion criteria

1. Patients who were pregnant
2. Patients who were below 18 years of age
3. Patients who were on insulin therapy

Eligibility Criteria:
Inclusion Criteria:

* patients who were diagnosed with T2D for at least 2 years
* patients who have undergone standard oral anti-hyperglycemic therapy with metformin and had not been able to reach normal HbA1c level with the medication
* patients who underwent autologous SVF-aaPRP therapy between January until December 2017

Exclusion Criteria:

* patients who were pregnant
* patients who were below 18 years of age
* patients who were on insulin therapy.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis

This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.


Eligibility Criteria:
Inclusion Criteria:

* Male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50.

Exclusion Criteria:

* Any presence of seasonal or non-seasonal allergies affecting the nose, nasal passages, throat or sinuses within 2 weeks prior to dosing.
* Any upper respiratory tract infection or signs or symptoms within 2 weeks prior to dosing.
* Any presence of nasal polyps or structural abnormalities, frequent history of nose bleeding, or any recent nasal surgery (within 12 weeks prior to dosing).
Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.

We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting. In addition, we suggest that the absence of radiolucent lines will correlate with excellent shoulder function.

This will be five year follow-up of glenoid anchor peg component fixation utilizing autologous bone graft in total shoulder arthroplasty. The purpose of this study is to investigate if the use of autologous bone graft around the anchor peg glenoid prosthesis correlates with better shoulder function. Subjects having had this surgery who are five years or more out from surgery will have computed tomography and three plain radiographs to monitor for bony apposition, radiolucent lines and component loosening. These testings are not a study intervention and are for monitoring purposes.

Eligibility Criteria:
Inclusion Criteria:

- Have had a total shoulder replacement with an anchor peg glenoid and autologous bone grafting at the Department of Orthopaedic Surgery at University of Nebraska and The Nebraska Medical Center five years or longer ago.

Exclusion Criteria:

* unable to comprehend the consent form information
* pregnant women
Development of a Tele-monitoring Program for Patients Undergoing Surgery for Pheochromocytoma and / or Paraganglioma

Pheochromocytomas and paragangliomas (PPGL) are rare tumors treated by surgical excision. During follow-up, more than 15% of patients will have recurrences in the form of new tumors, locoregional recurrence or metastases. This subgroup is initially not identifiable. It is therefore usual to perform annual monitoring of all patients throughout their lives by questioning and measuring blood pressure during a medical consultation and by measuring urinary or plasma metanephrines and normetanephrines.

The main objective of this prospective monocentric study is to evaluate the reliability of an optimized remote monitoring program in comparison to a usual in-clinic monitoring of patients surgically-cured and tumor-free at the time of inclusion.

Patients will be included in a follow-up consultation or during a telephone contact prior to a consultation.

The period of follow-up by internet and the date of the next consultation will be fixed. This assessment is annual according to current recommendations. In the two months prior to the consultation, patients will fill out a questionnaire and transcribe their blood pressure self-measurement results as well as their biological assessment on a dedicated, approved data-hosting platform (internet application named HERMES). During the consultation, these items will be collected again without the knowledge of the results entered by the patient on the data hosting site.

Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old
* Follow-up after surgery of a pheochromocytoma or a paraganglioma at the European Hospital Georges Pompidou (Paris, France)
* Free from recurrences and / or metastases at inclusion
* Non-opposition of participation in research

Exclusion Criteria:

* Lack of internet access
* Patient not understanding French
* Patient living abroad, unable to come for consultation
* Patient with co-morbidity involving life threatening within one year of inclusion
* Pregnant or breastfeeding woman
Feasibility of BabyGentleStick- Adult Pilot Study

This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers 18-29 years of age.
* Fluent in written and spoken English
* Sex: male or female

Exclusion Criteria:

* Pregnant women
* Cognitive impairment
* Prisoner
* Individuals with known hematologic conditions or bleeding disorders
* Individuals with immune disorders where a finger lance puts them at risk for infection.
Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh

The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. The trial will also evaluate whether the survival impact of newborn vitamin A dosing is modified by concurrent weekly, routine maternal vitamin A or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.

This is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin A supplementation on mortality in the first six months of life. The trial is being implemented in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a population of \~580,000 in rural northern Bangladesh (Gaibandha/Rangpur area) and is nested within the JiVitA-1 maternal supplementation study. Women residing in the study area are already under 5-weekly pregnancy surveillance conducted by village-based field staff as part of the maternal supplementation trial. During their third trimester of pregnancy, women are visited by a study supervisor who explains the purpose and procedures of the study. After obtaining informed consent, women are interviewed for possible risk factors in the third trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal anthropometry (mid upper arm circumference measurement). Upon birth, household members contact the village-based field staff who immediately administers the vitamin A or placebo to the infant, according to sector assignment. After supplementation, newborns are measured for weight, length and mid-upper arm, head and chest circumference, and then followed weekly for vital status for three months, and again at six months of age. A child death initiates the process of death verification and cause of death determination.

Eligibility Criteria:
Inclusion Criteria: Infants born to women enrolled in a maternal supplementation trial, alive and less than 30 days of age during a newborn dosing visit Exclusion Criteria: Infants who died before the dose could be administered or infants older than 30 days at the time of dosing
Endometriosis Pelvic Pain Interdisciplinary Cohort Data Registry

The purpose of this data registry is to prospectively collect data from patients referred to an interdisciplinary clinic for pelvic pain and endometriosis to investigate long-term patient outcomes, prognosis, predictors, causes, and treatment of pelvic pain and endometriosis.

The BC Women's Centre for Pelvic Pain and Endometriosis is the tertiary referral centre for endometriosis/pelvic pain in British Columbia, Canada. The Centre offers a unique interdisciplinary approach including minimally invasive surgery, hormonal and other medical therapy, pain education, physiotherapy, and CBT/mindfulness.

After informed consent, patients prospectively consent to data collection in the online registry. The registry consists of patient intake questionnaires (including validated measures), physical and ultrasound examination, review of medical records, surgical findings, and annual outcomes to 5 years.

The online data registry is housed in the Research Electronic Data Capture (REDCap) platform located at BC Children's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* All new and re-referred patients at the BC Women's Centre for Pelvic Pain and Endometriosis.

Exclusion Criteria:

* Patients at the BC Women's Centre for Pelvic Pain and Endometriosis seen for reasons other than chronic pelvic pain and/ or endometriosis as well as patients who decline to complete the online questionnaire.
Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease

The purpose of this study is to compare:

* the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in subjects with glaucoma or ocular hypertension and ocular surface disease.
* the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan Z® in subjects with glaucoma or ocular hypertension and ocular surface disease.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age at Visit 1 (IOP Screening), of either sex and any race or ethnicity.
* Be willing and able to provide written informed consent prior to any study procedures being performed.
* Be willing and able to follow all instructions and attend all study visits.
* Have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or chronic angle closure glaucoma with a patent iridotomy requiring treatment with an ocular hypertensive therapy in the study eye.
* Agree to submit to a pregnancy test at Visit 1 and at Visit 4, or not be of childbearing potential.
* Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential. Acceptable methods of birth control include: spermicide with barrier, oral, transdermal, injectable, or implantable contraception, IUD, abstinence, and surgical sterilization of partner. Female subjects are not of childbearing potential if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to latanoprost or travoprost or any other component of the study medications.
* Have any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component), ocular hypertension or chronic angle closure glaucoma with patent iridotomy in either eye.
* Have an IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of \> 34 mmHg in either eye.
* Be currently pregnant, nursing, or planning a pregnancy during the study period; or be a woman that has a positive pregnancy test.
* Have a history of any significant ocular condition(s) in either eye that would contraindicate the use of latanoprost or travoprost, or that might affect the study conduct or the interpretation of the study results.
* Have any abnormality preventing reliable Goldmann applanation tonometry of either eye.
* Have been previously non-responsive to prostaglandin analog therapy for reduction of IOP.
* Have prior (within 30 days of Visit 1) or anticipated concurrent use of an investigational drug or device during the study period.
* Have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy

A randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . Participants will include 80 patients between 40 and 55 years experiencing chronic discogenic lumbosacral radiculopathy with a definite hypolordotic cervical spine and forward head posture and will be randomly assigned a comparative treatment control group and a study group. Both groups will receive TENS therapy and hot packs, additionally, the study group will receive the Denneroll cervical traction orthotic.

Despite the fact that there is some evidence of a link between low back pain and head posture , there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. Accordingly, a prospective, randomized, controlled study will be conducted at a research laboratory of our university to investigate if cervical curve restoration and forward head posture correction will have short and long term effects on three dimensional spinal posture parameters as well as lumbar radiculopathy management outcomes such as symptoms, disability, and neurophysiological findings .In this study we will use an orthotic cervical traction termed the Denneroll to help restore normal sagittal spinal configuration based on principles of 3-point bending traction methods. Interventions will be applied at a frequency of 3 times per week for 10 weeks and groups will be followed for an additional 6-months.

Eligibility Criteria:
Inclusion Criteria:

* Absolute rotatory angle less than 25° and greater than 0.
* Anterior head translation distance greater than 15mm
* Confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse .
* Symptoms lasting longer than 3 months

Exclusion Criteria:

* Previous history of lumbosacral surgery.
* Metabolic system disorder.
* Peripheral neuropathy.
* History of upper motor neuron lesion.
* Spinal canal stenosis.
* Rheumatoid arthritis.
* Osteoporosis
Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer

The aim of this study is prospectively to determine the diagnostic sensitivity of Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration (TBNA) in the diagnosis of peripheral nodules and masses of the lung.

The yield of transbronchial forceps biopsy under fluoroscopy in the diagnosis of peripheral lesion of the lung lies between 32 and 57%. Several studies prove an amelioration of success rates by addition of cytological methods such as TBNA, TBCA and bronchial brushing. Furthermore, for TBNA and TBCA a significantly higher yield was reported in comparison with transbronchial forceps biopsy. TBNA and TBCA are routinely used methods, both techniques are safe, the instruments used are certificated.

Eligibility Criteria:
Inclusion Criteria:

* informed consent prior to the procedure
* radiologically peripheral pulmonary lesions between 10 and 60 millimeters in diameter

Exclusion Criteria:

* endoscopically visible lung carcinoma
* no consent in further diagnostic procedures, when bronchoscopy fails to establish a diagnosis
* haemorrhagic syndrome; grave cardiac disease; oxygen saturation lower than 90 percent
BCD With or Without Doxycycline in Mayo Stage II-III Light Chain Amyloidosis Patients

Survival of intermediate and high-risk primary light chain amyloidosis (pAL) remains poor due to high mortality within 3-6 months of diagnosis. Rapidly effective regimens such as bortezomib, cyclophosphamide and dexamethasone (BCD) still failed to overcome the poor prognosis in very advanced pAL amyloidosis patients. Recently, doxycycline was demonstrated to induce disruption of fibril formation and reduce the number of intact fibrils in transgenic mouse model of pAL amyloidosis. Furthermore, case-control study suggested that adjuvant oral doxycycline could improve response and survival in cardiac pAL amyloidosis, which necessities further confirmation through a randomized trial. Therefore, we designed a multi-center randomized open-label controlled study to investigate the efficacy and safety of co-administration of oral doxycycline with BCD regimen in treatment-naïve patients with Mayo stage II-III pAL amyloidosis. The primary outcome progression-free survival, and secondary endpoints including overall survival, hematologic response, organ response and toxicity of doxycycline will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old adults.
* Biopsy proved treatment-naïve pAL amyloidosis.
* Mayo 2004 stage II-III.
* dFLC \> 50mg/L.
* Patient must provide informed consent.

Exclusion Criteria:

* Co-morbidity of uncontrolled infection.
* Co-morbidity of grade 2 or 3 atrioventricular block.
* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia.
* Co-morbidity of other active malignancy.
* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia.
* Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
* Allergic history of doxycycline.
* Neutrophil \<1×10E9/L，hemoglobin \< 7g/dL，or platelet \< 75×10E9/L.
* Severely compromised hepatic or renal function: ALT or AST \> 2.5 × ULN, total bilirubin \> 1.5mg/dL，or eGFR \< 60mL/min.
Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

The patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan. The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in psoriasis patients treated with ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.

The participants included in this study will be drawn from the Ingenix Normative Health Informatics Database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse US health plan. This study will include cohorts of participants who have claims consistent with a diagnosis of psoriasis and who initiate ustekinumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments. Participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of ustekinumab for up to 8 years. A sample of enrolled health plan members without claims evidence of diagnosis or treatment of psoriasis will also be selected. The claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. Potential cases of the study outcome identified through claims may be confirmed through medical record review. No study agents will be administered in this study. All patients will receive standard-of-care treatment as prescribed by their physician.

Eligibility Criteria:
Inclusion Criteria:

* Complete medical coverage and pharmacy benefits
* Six months of continuous enrollment prior to the date of cohort entry

Exclusion Criteria:

* Participants will be excluded if they do not have information on age, gender or enrollment