cyrilzakka/clinical-trials huggingface dataset:
Effect of Shock Waves on Tooth Movement and Miniscrew Stability

The low-energy extracorporal shockwave is a scientifically approved method to activate respectively increase bone-turnover processes especially in orthopedic medicine. The aim of this clinical study is to apply this effect in orthodontic dentistry and evaluate the orthodontic tooth movement respectively miniscrew stability clinically.

This randomized clinical study is carried out in orthodontic patients undergoing space closure therapy at the university clinic of dentistry. During this period the tooth movement rate as well as the miniscrew stability are evaluated consecutively chairside.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients which don´t fulfill the exclusion criteria

Exclusion Criteria:

* disease (syndroms,infections,...) which influence the bone turnover and the oral health
* medication, which influences the bone turnover and the oral health
* pregnancy
Comparison of Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia

Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only medication that has been approved to treat fibromyalgia in China. Currently, there has been a growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia. This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in managing fibromyalgia symptoms experienced by Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
* be between the ages of 18 to 70 years.

Exclusion Criteria:

* had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
* be less than 40mm of pain VAS score;
* had renal failure, and severe depression or anxiety;
* had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
* pregnancy or planned pregnancy within the study period;
* patients residing more than 70 miles from the research site.
Clinical Study of 18F-FAPI-RGD in Breast Tumors

The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Breast cancer is the most common malignant disease in women worldwide.Early detection, accurate diagnosis and staging are the keys to effective treatment for breast cancer patients.18F-FDG PET/CT has become an important imaging method for the diagnosis and staging of breast cancer.However,FDG PET has certain limitations, including false-positive uptake for acute and chronic infections and false-negative uptake for less aggressive histological subtypes of breast cancer.In a number of studies, 68Ga-FAPI PET was positively correlated with the pathological grade and end-stage of primary breast cancer lesions, and SUVmax could predict tumor grade, final stage and lymph node metastasis. Compared with 18F-FDG,68Ga-FAPI PET/CT had higher specificity and accuracy in judging lymph node metastasis.Integrin αvβ3 is highly expressed in neovascular endothelial cells and tumor cells including breast cancer, and plays an important role in regulating tumor growth, angiogenesis, local invasion and metastasis potential.The use of integrin αvβ3 specific imaging probes derived from RGD peptides in breast cancer patients has also been reported.

Several studies have confirmed that the heterodimer is superior to the corresponding monomer due to the polyvalent effect, thus improving the binding affinity and increasing the number of effective receptors.In order to simultaneously target FAP and integrin αvβ3, we synthesized the heterodimeric peptide FAPI-RGD from FAPI and RGD.FAPI-RGD is a heterodimeric peptide that targets FAP and αvβ3-integrin receptors. 68Ga-FAPI-RGDPET/CT imaging has been used in clinical imaging studies in patients with a variety of tumors.Therefore, we plan to use 18F-FAPI-RGD PET/CT imaging for the diagnosis and treatment of breast cancer, and preliminary experiments have confirmed that this examination has a good imaging effect.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* No gender difference
* Patients who have been diagnosed with, or are clinically highly suspected of, breast tumors and have had no other treatment within 3 months
* Tumor size (T), lymph node status (N), and overall clinical stage of diagnosed patients were determined according to the American Joint Committee on Cancer criteria revised in 2010

Exclusion Criteria:

* Patients with a second primary tumor
* Pregnant or breastfeeding
* Severe liver or kidney disease
* Claustrophobia or other PET/CT scan contraindications
Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars

The aim of this study is to evaluate the effectiveness of pre-emptive analgesia using ibuprofen and paracetamol on reducing post-operative pain following the placement of stainless steel crowns on primary molars compared to placebo

The study will be a parallel, placebo-controlled, triple-blinded, randomized clinical trial. A total of 66 healthy children aged 5-8 years requiring the placement of a stainless steel crown will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The children will be randomly allocated into three groups according to the type of pre-emptive solution used. Group I will receive ibuprofen, group II will receive paracetamol, while group III (control) will receive a placebo solution. Children will self-report their level of pain using a Visual analogue scale (VAS) and/or a Facial pain scale (FPS) after local anesthesia administration, immediately after the cementation of the stainless steel crown, and 2, 6 and 24 hours post-operatively. Children's baseline anxiety and parental anxiety will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

Participant inclusion criteria:

* Age range 5 to 8 years old
* Children without any previous interventional dental experience
* Children free of any systemic disease or special health care needs (ASA 1)
* Children free of any allergies or hypersensitivity reactions to local anesthetics or analgesic drugs
* Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4)
* Parents/caregivers and children who are willing to participate in the study

Tooth inclusion criteria:

* Maxillary first or second primary molar teeth with extensive and/or multisurface caries where other restorations are likely to fail but without pulp exposure
* Absence of clinical and radiographic signs or symptoms of irreversible pulpitis
* Absence of fistula or abscess near the selected tooth clinically and radiographically
* Absence of spontaneous pain
* Absence of pulp exposure
* Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal fossa, and gently rocking the tooth bucco-lingually
Cardiac Performance System Data Collection Study

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* 22 years of age or older
* Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria:

* Previous Heart Transplant
* Presence of Left Ventricular Assist Device
* Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
* Surgical scars/wounds/bandages/ports at the site of sensor placement
Cognitive Reserve on Pain Catastrophizing and Cognitive Function in Geriatric Patients With Chronic Pain

To investigate the association between cognitive reserve, pain catastrophizing, and cognitive function in geriatric patients with chronic pain, and to explore whether cognitive reserve moderates the relationship between pain catastrophizing and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 to 85 years
* Experiencing chronic pain (≥3 months) attributable to osteoarthritis or neuropathic conditions
* Able to read, write, and speak the language in which assessments are administered
* Willing and able to provide informed consent

Exclusion Criteria:

* Diagnosed with a neurodegenerative disorder (e.g., Alzheimer's disease, Parkinson's disease)
* History of significant head injury, stroke, or brain tumor
* Current substance abuse or dependence
* Severe psychiatric illness (e.g., schizophrenia, bipolar disorder)
* Significant sensory or motor impairments that may interfere with the ability to complete assessments
Cemented vs. Cementless Unicompartmental Knee Arthroplasty

The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.

This is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. Inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. Minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age18-85 years old
* medial fixed bearing partial knee replacement
* bone suitable for both cemented and cementless fixation after review of the preoperative radiographs.

Exclusion Criteria:

* Non-English speakers
* current smokers
* grossly porotic bone
* advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (TKA)
* previous high tibial osteotomy with prior hardware
* patients who are randomized but are deemed unsuitable to receive the assigned implant by the surgeon due to bone quality or bone cuts
Gross Motor Abnormalities in Relation to Balance and Weight Indicators in Diplegia

The goal of this observational study is to investigate the correlation between BMI and balance and gross motor capacities in children with spastic diplegia. The main question it aims to answer is:

Is there a correlation between BMI, balance disturbances and gross motor capacity in children with spastic diplegic cerebral palsy? Researchers compared between results of biodex balance system , GMFM and BMI measures participants stood on biodex balance platform for balance measurement and performed Gross Motor Function Measurement items for gross motor capacities assessment

Spastic diplegia is the most common type of CP that results in problems with posture, balance, as well as gait control. For children suffering from spastic diplegic CP, balance problems provide a significant difficulty since they make it difficult for them to achieve and maintain balance . Additionally, they commonly demonstrate delayed development of gross motor function that has been connected to functional outcomes, such as daily living tasks . The prevalence of obesity in the CP population has risen over the last decade from 7.7 to 16.5 %. . Obesity is associated with health risks and difficulties in balance and walking. this cross-sectional-correlation study was conducted at the Outpatient Clinic at the Faculty of Physical Therapy, Cairo University. The study included 104 diplegic children aged from 5-10 years, 53 in normal weight group and 51 in overweight group. Dynamic balance was evaluated by overall stability index (OSI) in biodex balance system and gross motor capacities (GMC) were evaluated by standing \&walking dimensions in GMFM

Eligibility Criteria:
Inclusion Criteria:

Children selected according to the following criteria:

* Diagnosed with diplegic CP
* Their ages will range between 5 and 10 years
* Subjects will participate according to BMI classification ; normal weight in the first group and (obese , overweight) in the second group .
* They must be able to stand independently.
* Have minimum height of 100 cm.
* Have a developmental level of grade I or II according to gross motor function classification system GMFM.
* Able to understand and follow instructions.

Exclusion Criteria:

* Auditory defects.
* Visual defects.
* Cognitive or vestibular defects.
* Use of an assistive device.
* Fixed deformity, bony or joint limitation.
* Surgery (tendon lengthening).
Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients

Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older.
* Presence of platinum-sensitive relapsed ovarian cancer.
* Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.
* Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.
* Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.

Exclusion Criteria:

* None
Direct Effect of Caffeine on Diaphragmatic Muscles

The mechanism of methylxanthines is thought to increase chemoreceptor responsiveness to CO2 in central nervous system. Besides, effect of methylxanthines on diaphragmatic contractility has also been found in experimental studies. A study of premature newborns has showed caffeine increase diaphragmatic activity and tidal volume. But, there is limited data about caffeine direct effect on diaphragma.

Objective: The investigators aimed to show the direct effect of caffeine on diphragmatic contractility.

Method: The babies under 32 weeks with respiratory support, are being enrolled in this study if caffeine treatment is decided to receive. Evaluation of muscle contraction is being made by ultrasound before and 30 minutes after caffeine loading dose. Right and left sides of diaphragm thickness are being measured by two clinicians on B mode ultrasound by anterior subcostal view. The velocity before and after caffeine administration will be calculated, dividing excursion frequency (parameter) for inspiratory time. Movement of the diaphragm at inspiratory and expiratory phases are also observed on M mode and the difference between the two phases are measured.


Eligibility Criteria:
Inclusion Criteria:

* newborns under 32 weeks with respiratory support
* caffeine is decided to give

Exclusion Criteria:

* babies with congenital malformations
Institutional Registry on Outpatient and Hospitalized COVID-19 Infected Patients

Creation of an Institutional Registry system for patients with confirmed COVID-19 infection with the collection of epidemiological data, risk factors, diagnosis, prognoses, treatment, follow-up and survival.

Ambispective observational cohort with administrative admission date corresponding to the day of positivity of the PCR test for COVID-19, and discharge date of the cohort to the date corresponding to the epidemiological discharge, last contact with the health system and / or date of death.

Due to its institutional nature, the registry will collect data from the different patients who are assisted at different levels of the institution: emergency department, hospitalization in the general ward, critical areas, outpatient monitoring (including telemedicine) and home hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patient assisted by HIBA adult services
* Patient diagnosed with COVID-19
Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)

Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo.

The primary treatment objective is to assess the global efficacy of nepicastat in the treatment of hyper-arousal in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo. The secondary treatment objectives are to assess the ability of nepicastat to induce PTSD remission; treat PTSD and other PTSD symptom clusters and improve quality of life and overall functioning. A medical safety objective is to assess the tolerability and side effects of nepicastat in the treatment of PTSD in veterans who served in conflict zones at least one time between 1990 -2008 \[includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc .

This is a 6-week study with the long-term objective is to define the best approach to treating PTSD and enhancing the quality of life in patients. Results from this pilot study will assist clinicians in treating active military service members or veterans with PTSD by developing new treatment algorithms for future larger studies.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Patient understands the risks and benefits and agrees to visit frequency and procedures
3. Male or female
4. Any race or ethnic origin
5. Served in conflict zones at least one time between 1990 -2008 \[includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc\]
6. Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
7. DSM-IV Diagnosis of Post-Traumatic Stress Disorder (PTSD)
8. No substance use disorders (except for nicotine and caffeine) in the previous 2 months
9. Free of psychotropic medication for 2 weeks prior to randomization (a low dose sedative hypnotic is allowed for severe insomnia if used sparingly)
10. Physical and laboratory panel are within normal limits or not clinically significant
11. Women of childbearing potential must be using medically-approved methods of birth control
12. 18 to 65 years of age

Exclusion Criteria:

1. Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders
2. Actively considering plans of suicide or homicide
3. Psychotic symptoms that in the investigator's opinion impair the patient's ability to give informed consent or make it unsafe for patient to be maintained without a neuroleptic
4. Unstable general medical conditions or a contraindication to the use of nepicastat
5. Intolerable side effects or allergic reaction to nepicastat
6. Women planning to become pregnant or breastfeed during the study
Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System

Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. Therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG episodes detected. And the investigators test the effects of this SSS device on FOG, fall, and walking function.

Methods: The first-year study is to build and validate this wearable SSS device. The customized device has sensor part and stimulator part; the former is an inertial sensor module to detect FOG episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are recruited and conduct FOG-provoking tasks during their medication "OFF" or "late On" state in a laboratory setting. The investigators test if the SSS device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. The second-year study is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and randomly assign them into the experimental and control groups. Both groups wear the SSS device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. The stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. The effect of the SSS device is evaluated by the outcomes including FOG severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase.

Clinical relevance: This project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve FOG and fall in people with PD. The results of this projects might also provide an objective, long-term assessment tool to measure the FOG phenomenon for clinical and research fields.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinsonian with Hoehn-Yahr score between 2 to 4
* Suffering freezing-of-gait in the recent week
* Able to walk unassisted over 30 meters in medication OFF period

Exclusion Criteria:

* Non-idiopathic Parkinsonian
* Comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility
* Impaired cognitive function
* Abnormal plantar sensory function
* Abnormal coagulation function