cyrilzakka/clinical-trials huggingface dataset:
A Controlled Pregabalin Trial In Fibromyalgia

To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
OncoSweep Cancer Spotlight and Spectrum Product Line

CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line'

OncoSweep Cancer Spotlight and Spectrum Product Lines are qualitative in vitro diagnostic devices testing plasma specimens for detecting circulating miRNA expression, ctDNA methylation status, platelet RNA analysis, and tumor marker expressions by utilizing real-time polymerase chain reaction (qPCR) and next-generation sequencing (NGS). This is a two-arm, open-label, non-randomized controlled pilot study intends to screen adults 18 years or older, who are treatment-naïve for cancers and have pulmonary nodules or mass detected by low-dose computerized tomography (LDCT) or standard computerized tomography (CT) scans. OncoSweep Lung Spotlight will be utilized with venous blood samples collected in the healthcare facility where the study is being conducted. The X-ray, LDCT/ standard CT scan, blood laboratory test data, or biopsy results will be collected from the control group, and the blood sample will be analyzed by OncoSweep Lung Spotlight. Results generated from both groups will be evaluated against each other. The result of OncoSweep Lung Spotlight provides additional evidence to support or assist medical diagnoses when used in combination with LDCT/ standard CT scan data.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion

  1. Individual who is not mentally impaired, capable to read, understand, and is willing to provide signed and dated informed consent form.
  2. Individual is aged 18 years old or above.
  3. Individual who is willing to provide information on the given questionnaire. Test group: Individual was diagnosed with pulmonary nodules or masses by low-dose CT (LDCT)/ CT, and evaluated by the physician needed to conduct a biopsy or/ and surgery has been arranged.

     Control group: Individual is willing to undergo LDCT or CT scan with 3-5 mm spatial z-axis resolution, pulmonary function examination, X-ray, laboratory blood test, and blood drawing.
  4. Control group: Individual has no abnormal finding from LDCT or CT scan with 3-5 mm spatial z-axis resolution and pulmonary function examination(FEV1/FVC Ratio≧70%).
  5. Individual did not donate blood or receive blood transfusion within two months before joining the study.

Exclusion Criteria:

* Exclusion

  1. Individual who is not suitable for participating as per Investigator's judgement.
  2. Individual who has undergone gene therapy or related product within one year prior to enrolling in this study.
  3. Individual who is attending another clinical study at the time of enrollment.
  4. Individual who is known to be pregnant.
  5. Individual who has received a vaccine within two weeks.
  6. Individual who has a history of any cancer occurrences other than lung cancer.
Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

The purpose of this study is to characterize emixustat hydrochloride pharmacokinetic and pharmacodynamic parameters in subjects with geographic atrophy associated with dry age-related macular degeneration.

This is a multi-center, randomized, masked, multiple-dose, crossover study of the pharmacokinetics of emixustat hydrochloride (HCl) in subjects with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Subjects will receive study drug during multiple dose periods in a crossover design, and serve as their own controls. There is a 21-28 day washout period between dose periods. The final Study Exit visit is 21 to 28 days after the subject's last dose of study drug at the end of the final dosing period.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age ≥65 years
* Clinical diagnosis of GA associated with AMD
* Able and willing to provide written informed consent
* Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria:

* Geographic atrophy associated with a condition other than AMD
* History of, active or high risk of developing choroidal neovascularization (CNV) in either eye
* Known serious allergy to the fluorescein sodium for injection in angiography
* Pre-specified laboratory abnormalities at screening
* Treatment with any investigational study drug within 30 days of screening or device within 60 days of screening
* Prior participation in any clinical study of emixustat
* History of other disease, metabolic dysfunction, chronic immunosuppression, physical examination finding
* Male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 21 days after the last dose of study drug
Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship

Study Design: Longitudinal Experimental Study

Objective: Analyze the relationship between Upper Limb Neural Tension Test (ULNTT1) and cervico-thoracic spine biomechanics using a new motion-capture spine movement data analyzing model based on Least Square Approximation.

Summary of Background Data: ULNTT1 is a test able to determine cervical nerve roots and brachial plexus displacement within their interface structures. No studies were conducted about ULNTT1 and cervico-thoracic spine motion patterns relationship.

Methods: 12 subjects with ULNTT1 asymmetry \> 10° (AS group) and 11 subjects with ULNTT1 symmetry (S group) at clinical tests will be enrolled for the study. Subjects will be analyzed for ULNTT1 with an electrogoniometer using two parameters, one operator and one patient-dependent. Fine lateral bending cervico-thoracic spine motion patterns will be collected with motion-capturing technique and data will be analyzed with Least Square Approximation tools. Subjects with impairments in cervico-thoracic spine mobility will undergo to correction of those with spinal manipulative therapy. ULNTT1 and spine mobility will be so re-evaluated with same methods.


Eligibility Criteria:
Inclusion Criteria:

* AS group: ULNTT asymmetry \>10°
* S group: ULNTT symmetry

Exclusion Criteria:

* History of neck, shoulder or arm surgical interventions or major trauma, peripheral neuropathy, mental disturbance, limitation of shoulder, elbow or wrist range of motion, BMI \>25.
Effect of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy

Purpose: 1. To determine the efficacy of low-dose esketamine in painless gastrointestinal endoscopy. 2. To determine the safety of low-dose esketamine in painless gastrointestinal endoscopy. 3. To provide a theoretical basis and new ideas for the application of esketamine as a new drug in perioperative period.

Keeping spontaneous breathing anesthesia can provide patients with comfortable diagnosis and treatment experience during gastrointestinal endoscopy, which is a vital prerequisite for the large-scale development of this operation as well as the early screening and treatment of gastrointestinal malignancies. Clinically, fentanyl combined with propofol is the most commonly used anesthesia regimen for the painless gastroscopy, however its high incidence of respiratory and circulatory depression will threaten the safety of patients. Instead, esketamine has a good action in anesthesia and analgesics, a slighter respiratory depression, as well as with a remarkable improvement in adverse effects than ketamine. What has already been proved is that low- dose of esketamine can remarkably reduce the dosage of propofol during endoscopic retrograde cholangiopancreatography; In our pilot study, we found that not only the incidence of respiratory depression was significantly lower than that of fentanyl during endoscopic polypectomy, but also the dosage of propofol was reduced at the same time,suggesting that esketamine may have a potential superiority in the painless gastrointestinal endoscopy.Our project plans to collect the patients who have received painless gastroscopy and polypectomy in the hospital, and use a target-controlled infusion (TCI) of propofol in combination with esketamine, by observing the total dose of propofol , the time of recovery and the length of hospital stay, the satisfaction of patients and endoscopists, drug side effects,adverse events of respiratory and circulatory system and other indicators ,to evaluate the efficacy and safety of this anesthetic scheme.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's American Society of Anesthesiologists physical status is I-III.
2. Subject has no symptoms of allergy to anesthetics.
3. Subject has no contraindications for gastrointestinal endoscopy.
4. Subject has given written informed consent to participate.

Exclusion Criteria:

1. Subject's BMI \<18 or \>30
2. Subject has poorly controlled or untreated hypertension.
3. Subject has severe ischemic heart disease.
4. Subject is an untreated or undertreated patient with hyperthyroidism.
5. Subject has used drugs that affect their central nervous system.
6. .Subject has mental illness.
7. .Subject has epilepsy.
8. .Subject has a history of chronic pain.
9. .Subject is pregnant or breast-feeding.
Effect of Abdominal Massage on Patients in Intensive Care Unit

Bowel motility can be affected by many factors such as immobilization, lack of fiber in the nutritional formula, inadequate fluid intake, and lack of privacy for toileting in patients hospitalized in the intensive care unit. Abdominal massage, which is one of the effective methods to increase intestinal motility, is accepted as an intervention that can be safely applied in patients.

The aim of our study was to investigate the effect of abdominal massage applied to patients hospitalized in the intensive care unit on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use.

Hypotheses H0: Abdominal massage application has no effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit.

H1: Abdominal massage application has an effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit.

In this randomized controlled study, the data of patients who received abdominal massage for 5 days during routine physiotherapy applications and those who did not will be recorded. Randomization will be performed in a 1:1 ratio using a computer generated randomization schedule. The effect of abdominal massage on sepsis, survival, discharge time from intensive care, amount and duration of antibiotic use will be examined by using the data of 2 groups with and without abdominal massage in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 to 80 years
* Patients hospitalized in the intensive care unit for more than 3 days
* Body Mass Index less than 30 kg/m²
* Patients who are not mobilized out of bed
* Patients without any intervention contraindicating abdominal massage

Exclusion Criteria:

* History of abdominal surgery
* Active gastrointestinal bleeding
* Patients discharged from ICU within less than 5 days after enrollment
A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly

The number of elderly has been increasing in recent decades. Current studies focused on the risk factors of poor physical performance, poor daily activity performance, and even disability in the elderly. We planned to evaluate the physical performance of elderly dwelling in the community and designed a multimodal exercise program which can improve physical performance, prevent disability and promote quality of life.


Eligibility Criteria:
Inclusion Criteria:

* \>= 65 year old

Exclusion Criteria:

* cognitive impairment and poor understanding for orders
* the elderly has medical problems that the elderly can't perform exercise
Prone or Supine Extubation in Lomber Spinal Surgery

The aim of this study was to investigate the emergence quality of patients extubated on prone or supine position after lumbar spinal surgery.

60 patients with ASA I-II who underwent lumbar spinal surgery between 18-65 years of age were included in the study. Patients with difficult intubation, BMI\> 35kg / m2, asthma and reactive airway problems, cardiovascular disease and obstructive sleep apnea will not be included in the study. Initial data will be recorded after standard monitorization. Induction is made by 2 mg / kg propofol, 1 mg / kg fentanyl and 0.5 mg / kg rocuronium will be added for muscle relaxation. Patients with adequate muscle relaxation will be intubated with appropriate endotracheal tube and mechanical ventilation will be initiated. Patients who are then given prone positions on the operating table will be supported with side gels. The head will be placed in the face gel in a neutral position. For intraoperative analgesia, remifentanil infusion at 0.2mcg / kg / min will be applied.

After laminectomy is completed and control of bleeding, 1 mg / kg Tramalol and 2 mg / kg Metaclopromide will be applied to all patients. At the end of the skin stitching, the inhalation agent will be closed and the fresh gas will be turned 6 lt 100% O2. Patients who want to be extubated in the prone position are left in this position while the other patients will be placed on the stretcher in a supine position for a short time. Patients will be decurarized be neostigmin with atropine. Extubation will be performed in both positions when spontanous ventilation begins at a tidal volume of 6ml / kg and a frequency of 12-20 / min. All the measures will be taken to ensure airway safety while the patient is extubated pron. The stretcher will be brought to the side of the operating table, investigator will be ready for reintubation and all the necessary persons will be with the patient. Aspiration frequency will be recorded for each patient. During recovery after extubation, the severity of cough will be evaluated as mild (only once), less (more than one but not continuous) and severe (continuously for 5 seconds). Aldrate scores of patient will be recorded and first 9-10 time is estimated from extubation time. Vomiting, nausea, respiratory insufficiency, inability to control the airway and obvious desaturation if seen are also recorded.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* 18-65 years old
* need spinal surgery

Exclusion Criteria:

* difficult intubation
* BMI\> 35kg / m2
* asthma and reactive airway problems
* cardiovascular disease
* obstructive sleep apnea
IMP3 and PCNA Expression in Laryngeal Squamous Cell Carcinoma in Sohag Governorate

Laryngeal cancer is responsible for 2-5% of all new cancer cases worldwide. Squamous cell carcinoma of the larynx (LSCC) is the most common malignant tumor of the larynx, accounting for 85-90% of all laryngeal malignancies.

Despite significant therapeutic developments in recent decades, increases in patients' 5-year survival rates are still minimal , which is likely due to late-stage diagnosis and other complex factors. Therefore, to improve the outcome, timely diagnosis, selection of the most appropriate therapy, and an adequate follow-up approach is needed.

The insulin-like growth factor II m-RNA-binding protein 3 (IMP3) is a new biomarker that may be implicated in the carcinogenesis of various malignancies, including head and neck squamous cell carcinoma. IMP3 normally expressed in embryonic tissue but decreases after birth and is no longer detectable in adult tissue With the exception of a few tissues. As a result, IMP3 is expressed only in tumors and not in neighboring normal tissues.

Proliferating Cell Nuclear Antigen (PCNA) is a nuclear protein that acts as a cell proliferation marker. In most forms of solid malignancies, such as colorectal cancer and breast cancer, PCNA is closely linked to prognosis and survival.

In this study, hoping to improve diagnosis of LSCC and assess prognosis better by using both IMP3 and PCNA biomarkers. As IMP3 may have a role in cell growth and proliferation and PCNA is a marker of cell proliferation; studying the association between both markers in laryngeal carcinoma is recommended.


Eligibility Criteria:
Inclusion Criteria:

1. Laryngeal resection (total or partial laryngectomy) and biopsies.
2. Complete clinical data.

Exclusion Criteria:

1. Patients with recurrence of the primary tumor.
2. Patients with a history of preoperative chemotherapy and/or radiotherapy.
Evaluation of Air Abrasion Surface Pretreatment in the Repairing Capacity of Defective Composite Restoration

This study is conducted to compare the efficacy of surface pretreatment using air abrasion sandblasting aluminum oxide particles (Al2O3) versus not pretreatment in the repair capacity of defective composite restoration indicated for repair.

First the rationale for the repair, rather than the replacement of defective direct composite restorations proved a less invasive procedure with decreased tooth loss avoiding weakening and overtreatment of tooth. Less traumatic or stressful than replacement for patients with good acceptance; Increased longevity of the restoration; Reduction of potentially harmful effects on the dental pulp and Less risk of iatrogenic damage to adjacent teeth.

Secondary using surface treatment strategies aim to prepare a clean surface with high surface energy to provide better wettability with adequate surface roughness and surface area by removing the superficial layer of the aged composite which lead to increase integrity between old and new resin restoration.

Eligibility Criteria:
Inclusion Criteria:

* Co-operative patients approving to participate in the trial.
* patient with occlusal defects class I or class II composite resin restorations indicated for repair.

Exclusion Criteria:

* Allergic history concerning methacrylate.
* Rampant caries.

  * Disabilities patient
  * Pregnancy
  * Heavy smoking.
  * Xerostomia.
  * Lack of compliance.
  * Evidence of parafunctional habits.
  * Temporomandibular joint disorders.
Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry

The purpose of this study is to examine if an internet-based exposure therapy is more effective in reducing excessive worry amongst patients who suffer from this problem than is internet-based stress management training.

Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can reduce the degree of excessive worry to a significantly greater extent than Internet-based stress-management training. The secondary objective is to a) investigate the cost-effectiveness of this treatment b) to study if any variables could moderate/mediate the treatment outcome, c) and to investigate the importance of sudden gains for the treatment outcome

Trial Design: Randomized controlled trial with an active control and a waitlist control, who also will recieve treatment after the first group has finished.

Duration: Ten weeks

Primary Endpoint:

Difference in worry symptoms between the treatment groups at week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).

Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)

Safety Parameters: Adverse Events is assessed via the internet.

Description of Trial Subjects: Patients \> 18 years old with a PSWQ score more than 56 points

Number of Subjects: 300

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* ≥ 18 years
* Situated in Sweden
* Informed consent
* PSWQ score more than 56 points

Exclusion Criteria:

* Substance dependence during the last six months
* Post traumatic stress disorder, bipolar disorder or psychosis
* Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
* MADRS-S score above 25 points
* Psychotropic medication changes within two months prior to treatment that could affect target symptoms.
* Received exposure based CBT for pathological worry the last 2 years.
Robotic Rehabilitation for Spinal Cord Injury

Individuals with spinal cord injury (SCI) have significant functional loss and poor quality of life. Individuals with cervical SCI are suffering much worse sickness within the SCI population. Tetraplegia resulting from cervical SCI bring a formidable emotional, physical, and financial burden in our society. Hand function is especially important to people with tetraplegia. Hand function is associated with independence in many activities, and impairments in upper extremity function can compound difficulties in many other areas, such as bowel and bladder management. Thus, it is not surprising that restoring hand function was found to be a priority for individuals with tetraplegia.

Nowadays, magnetic resonance imaging (MRI) plays an essential role in the diagnosis of SCI and helps to monitor disease progression and efficacy of therapies. Advanced MRI techniques, such as diffusion tensor imaging (DTI) and functional MRI (fMRI), have shown the potential to improve the understanding of human spinal cord in healthy and pathological condition, and serve as imaging biomarkers to characterize damage degree, monitor the response to treatment, and predict the outcome of intervention. Meanwhile, multi-channel EMG (Electromyography) recordings can provide a mapping of neuromuscular activities from an electrode-array.

The application of robotics in upper extremity function restoration of SCI patients has been started to help SCI patients to recovery upper extremity function. Combined DTI and fMRI to monitor the recovery of upper extremity function of SCI patients, this project will provide a tailored-made EMG driven soft-robotic hand prosthesis for tetraplegia individuals. We will provide the individuals with neuromuscular rehabilitation to preserve the residual function and to enhance the functional recovery. The eventual goal is to further design a useful robotic hand for regaining partial daily function to improve the quality of life for those individuals with tetraplegia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with tetraplegia under the care of Department of Orthopaedics and Traumatology, LKS Faculty of Medicine, The University of Hong Kong in Queen Mary Hospital.

Exclusion Criteria:

* Subjects with any neurological abnormality in brain, intellectual disability or other communication difficulty, subjects with pacemaker or metal implants, subjects with claustrophobia
Oral Paracetamol as Preemptive Analgesia for Labor Pain

It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.

Eligibility Criteria:
Inclusion Criteria:

* primigravida
* The gestational age between 37- 42 weeks
* Not seeking analgesia
* Singleton pregnancy
* vertex
* Spontaneous onset of labour
* 1st stage of labour (less than 5 cm)

Exclusion Criteria:

* Extreme of age (below18-above 40)
* Multiparous
* Multiple gestation
* Malpresentation
* Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)
* Any medical disorder with pregnancy
* Induction of labour
* Advanced 1st stage \> 5 cm
* Use of any other kind of analgesia before recruitment in the study
* Scared uterus
* Fetal distress