cyrilzakka/clinical-trials huggingface dataset:
Non-Motor Features of Cervical Dystonia (CD)

This study will examine the prevalence of four previously identified non-motor markers in a population of cervical dystonia patients, unaffected family members, and healthy volunteers in an attempt to identify a distinct combination of non-motor symptoms that may be indicative of disease development.

The primary aim of this study is to identify the prevalence of four previously identified non-motor markers - (1) spatial discrimination threshold, (2) temporal discrimination threshold, (3) vibration-induced illusion of movement, and (4) kinesthesia - in a population of cervical dystonia patients, unaffected family members, and healthy volunteers (control group). Consenting participants will receive a neurological examination performed by a movement disorders neurologist, followed by an assessment of the four non-motor symptoms.

The investigators hypothesize that a distinct combination of non-motor symptoms will be more prevalent in the CD group, and therefore this set of symptoms may be indicative of disease development. This combination will be identified through analysis of the concurrence of the non-motor features across the three groups of participants. This study will fill an important unmet need, as to the investigators' knowledge there are no published studies assessing the comorbid presentation of these four non-motor symptoms in a single cervical dystonia population. The exploration of a distinct combination of concurrent non-motor symptoms as a marker for the development of cervical dystonia will improve the ability of movement disorders neurologists to diagnose the condition.

The results of this study will facilitate the investigators' longstanding aim of improving rates of cervical dystonia diagnosis. Cervical dystonia is currently diagnosed based upon the exclusion of other movement disorders; therefore, characterization of non-motor features in cervical dystonia patients will help to refine the diagnostic criteria for this condition. This investigation will also improve understanding of the factors associated with CD. Future studies can examine the source of these associated factors in order to help understand the cause of CD, since the etiology is currently unknown.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of cervical dystonia, OR a first order relation of a Vanderbilt patient diagnosed with cervical dystonia, OR a healthy volunteer who is neurologically normal
* Capable of participating in all study procedures
* Willing and able to provide written or verbal informed consent.

Exclusion Criteria:

* Subjects for whom participation in the study may cause medical harm
* Subjects who are not considered competent to make their own medical decisions
* Subjects who display sensory deficits during a short screening examination prior to study enrollment
Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment

The study is a prospective interventional study with three main aims:

1. Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients.
2. Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population.
3. Investigate how the health care providers experience having to adhere to such an algorithm.

Patients \< 18 years of age treated in an intensive care unit for 5 days or more with infusion of opioids and/or benzodiazepines, are eligible for inclusion. Patients are included at the time tapering of these drugs is initiated. Part one of the study is observational. Drugs administered, complications, Comfort score and WAT-1 (Withdrawal Assessment Tool-1) score is recorded. Before part two of the study, an algorithm for tapering of analgosedation is implemented, and the data set is obtained as in part one.

For part three of the study, focus group interviews will be used.

Eligibility Criteria:
Inclusion Criteria:

* \< 18 years
* treated in PICU
* Infusion of opioids and/or benzodiazepins for 5 days or more.

Exclusion Criteria:

* Neuromuscular disease
* Cognitive/neurological disturbance caused by a disease
* Multiple disabilities
Post-acute Care for Patients With Hip Fracture

Background and purpose: Hip fracture, a common injury occurred in people aged over 50, may result in disability, poor quality of life, and higher care stress for their families. Aging population and growing number of hip fractures have increased medical expenses, so developed countries implemented post-acute care (PAC) to reduce acute hospitalization, and to improve the quality of care. PAC services can be delivered by hospital/facility-based and home-based services. Previous studies showed that both services could significantly improve patients' activities of daily living and quality of life, and reduce readmissions, long-term care and costs. Taiwan has implemented PAC plan for hip fractures since 2017, but relevant evidences are limited. Therefore, the purpose of this study is to analyze the efficacy and cost-effectiveness of PAC for patients with hip fractures.

Methods: This is a prospective cohort study which will recruit patients aged over 50 with hip fractures receiving surgical treatment in the Taipei City Hospital. They will be provided home-based PAC, hospital-based PAC, or no formal PAC based on the medical judgment and patients/families' willingness. The period of PAC will be two to three weeks after the acute hospitalization. Assessments include physical function (30 seconds sit to stand, Barthel index, and Harris Hip Score), numerical pain rating scale, EuroQol instrument (EQ-5D), Caregiver Strain Index, and using of medical resources. The assessments will be on the day before discharge from acute hospitalization, and on the discharge day from post-acute care. The follow-up assessment will be at 1, 3, 6, and 12 months after operation. The cost-effectiveness ratio will be defined as the New Taiwan dollars paid for 1-unit improvement of functional performance and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 50
2. First hip fracture
3. Stable medical condition

Exclusion Criteria:

1. Hip fracture caused by major trauma or pathological condition
2. Multiple fractures
3. Severe physical disability before the hip fracture
4. Unable to cooperate with treatment
5. Further inpatient treatment
Cardiovascular Disease Risk in Women With Endometriosis

To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

Our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation. This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.

Eligibility Criteria:
Inclusion Criteria:

* Young women between the ages of 18 and 45 years (Controls);
* Young women between the ages of 18 and 45 years with endometriosis.

Exclusion Criteria:

* Subjects who smoke
* Subjects who have diabetes,
* Subjects with sleep apnea or BP\>140/90 will be excluded.
* Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.
Using Ultrasound in Infraclavicular in Upper Limb Surgeries

Comparison of 3 approach of infraclavicular brachial plexus

Comparison of retroclavicular \& costoclavicular and classic type of infraclavicular brachial plexus block for upper limb surgeries

Eligibility Criteria:
Inclusion Criteria:

* age: between 18 and 60 years ASA I and II BMI between 18 and 35 surgeries to forearm and hand

Exclusion Criteria:

* patient refusal pregnancy allergy to local anaesthetics local infection neuropathy ,coagulopathy anatomical abnormality in clavicular region
To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier

Eligibility Criteria:
Inclusion Criteria:

* the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding
* Written informed consent
* Patients without clinically significant lab

Exclusion Criteria:

* having enrolled another clinical trials within 1 month
* Immunosuppression or autoimmune disease
* Anticoagulant, general steroids within a week from surgery
* Incompatible medications
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients

This study enrolled patients who underwent R0 resection of tumor and had elevated tumor biomarkers (CEA, CA19-9). After enroll the study, a CTC test will performed and patients who had positive CTC will be randomly assigned to two groups. The control group will continue follow-up until radiological recurrence appear, the treatment group will start treatment or change the current adjuvant regimen. First endpoint is OS. The secondary endpoint is DFS, adverse event.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years;

Histologically proven colorectal cancer

All the lesion (s) has been R0 resected

Have elevated tumor biomarker (CEA or CA19-9) in three consecutive tests

More than 1 CTC has been detected (including 1)

ECOG 0-1

Hematology tests suggest that they can tolerate chemotherapy

Written informed consent for participation in the trial

Exclusion Criteria:

* Have any radiological evidence of recurrence

Other previous malignancy within 5 years
Relative-dose-response Test (RDR) Adaptation for Chronic Liver Disease

The relative-dose-response test (RDR) is considered to be the most accurate method for evaluating vitamin A nutritional status (VANS) in patients suffering from liver disease, as it infers the reserves of the vitamin in the liver. However, for the RDR test to reflect VANS in patients suffering from chronic liver disease, factors inherent to the disease need to be considered, such as possible malabsorption, advanced age, a drop in synthesis and/or the release of retinol binding protein (RBP), which would result in an inadequate response to the RDR test. Thus, the objective of present study is to assess the adequacy of two different protocol for using the RDR test in patients with cirrhosis and cirrhosis-related hepatocellular carcinoma.

Methods: The sample group was comprised of 178 patients at Federal University of Rio de Janeiro University Hospital (111 men) with several etiologies of liver cirrhosis at different stages in the progression of the disease. They were sorted into two groups, according to the retinyl palmitate dosage (1500 IU or 2500 IU) received at T0 (blood sample taken following a 12-hour fast). Following supplementation, the investigators took further blood samples five and seven hours later (T5 and T7). The investigators assessed VANS via concentrations of serum retinol and RBP, as well as by way of the RDR test. The cutoff points the investigators used for denoting inadequacy in the indicators retinol and RDR were, respectively, \< 1.05 µmol/L and ≥ 20%. To classify the degrees of severity of the disease the investigators used the criteria established by Child \& Pugh (1973).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of liver cirrhosis of viral etiology, alcoholic or metabolic action

Exclusion Criteria:

* malabsorption syndromes
* moderate or severe infection
* diabetes mellitus using insulin renal, cardiac or respiratory
* therapeutic doses of vitamin A in the 6 months prior to data collection
BRING-UP 3 Heart Failure

The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF).

Observational, prospective, multicenter study conducted in a large, representative sample of Italian cardiology centers.

Phases 1:

1. First educational intervention to discuss the recommendations of guidelines and treatment patterns in specific phenotypes of patients.
2. Data collection for 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening).
3. Evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up.
4. Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice.
5. New data collection for other 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening).
6. Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up.
7. 12-month follow-up for all patients included in both enrolment phases of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old.
2. Males and females at birth.
3. Any ejection fraction level (level of ejection fraction measured in the 6 months preceding enrollment).
4. Ambulatory chronic HF or Hospitalized de-novo or worsening HF.
5. Signed informed consent

Diagnosis will be made by the local attending physician following the ESC guidelines recommendations.

Exclusion Criteria:

1. Active neoplasia or very severe disease compromising short-medium term life expectancy.
2. Participation in interventional studies.
3. Patients already enrolled into the study from another participating center or in the previous enrolling phase.
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis

The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses.

Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters.

This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.

The duration of the extension study per participants was 40 weeks broken down as follows:

* 24-week double-blind treatment period,
* 16-week post-treatment elimination follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* PDY6045 or PDY6046 participant who:

  * completed the week 24 visit of either study PDY6045 or PDY6046,
  * was still meeting eligibility criteria for receiving treatment,
  * had agreed to continue stable dose of Interferon-β \[IFN-β\] or Glatiramer Acetate \[GA\] and consented to continue on treatment.

Exclusion Criteria:

* Any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study

The above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
Re-operative Surgery in Children:A Technique for Sternal Re-Entry

Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Background Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Methods This will be primarily a technique paper. The only clinical data points I am interested in are how many re-operative sternotomies we performed and on how many patients. I will also need to confirm that we did not have any complications due to cardiac injury while opening the sternum. I estimate about 450 patients.

Primary Aim: Present an effective technique for sternal re-entry in children

Secondary Aim: Present a zero incidence of complicated sternal re-entry over the past 5 years (February 1, 2001 through February 28, 2006) at Children's Healthcare of Atlanta, Egleston Hospital.

Inclusion / Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Eligibility Criteria:
Inclusion Criteria:

* Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Exclusion Criteria:

* Those who do not fall under the above inclusion criteria
Searching for the Optimal tDCS Target Combined With Peripheral Electrical Stimulation in Chronic Low Back Pain

Low back pain (LBP) has been associated with severe impairments, primarily related to activities of daily living, functional ability and quality of life. A multimodal approach to pain management, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES), may improve outcomes in chronic LBP. However, the optimal cerebral target for stimulation still remains controversial. This pilot trial aims to investigate whether active stimulation could promote additional gains to the PES results in LBP participants. The secondary objective is to investigate whether the stimulation of primary motor cortex and dorsolateral prefrontal cortex results in distinct clinical effects for the participants involved.

For this, a pilot, sham-controlled, double-blind, randomized clinical trial in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Sixty participants with chronic low back pain will be randomized into one of three tDCS groups associated with PES: motor primary cortex, dorsolateral prefrontal cortex and sham stimulation. Each group will receive transcranial direct current stimulation at an intensity of 2 mA for 30 minutes daily for 10 consecutive days. Participants will be assessed with a Brief Pain Inventory (BPI), Roland Morris Disability Questionnaire (RMDQ), Medical Outcomes Study 36-item Short - Form Health Survey (SF-36) and electromyography at baseline, endpoint (after 10 sessions) and 1-month follow up. This study will help to clarify the additive effects of tDCS combined with peripheral electrical stimulation on pain relief, muscle function and improvement in quality of life. Additionally, the investigators will provide data to identify optimal targets for management of chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Diagnosis of chronic low back pain, lasting more than 6 months (The diagnosis of chronic lumbar pain will be based on clinical and neurophysiological criteria, according to the European Guidelines on Low Back Pain);
* Pain intensity of at least 4 in 10 in Visual Analogue Scale (VAS);
* Stable pharmacological treatment for at least one month before the study and throughout the study;

Exclusion Criteria:

* Intense pain from another origin, such as neuropathic pain;
* Alcohol or substance abuse;
* Associated diseases of the peripheral or central nervous system;
* Contraindications for non-invasive brain stimulation.
Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation

The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects or patients with COPD ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for predicting CO2 rebreathing.

Non-invasive ventilation circuit consists of single-limb tubing for inspiration and expiration, including a plateau exhalation valve. As exhaled gases was vented out the plateau exhalation valve at a constant rate, during exercise, with the increase of exhalation flow, single-limb circuit with a plateau exhalation valve might cause carbon dioxide(CO2) rebreathing. Therefore, our aim in the present study was to evaluate whether CO2 rebreathing occurs in COPD patients ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve and estimate a potential threshold for predicting CO2 rebreathing.

Eligibility Criteria:
Inclusion Criteria:

* presented clinically stable (no exacerbation in the 4 weeks prior to study participation or with no change in medications);
* physician diagnosed COPD, forced expiratory volume in 1s (FEV1) \< 50% predicted;
* dyspnea as a main symptom that limited daily activities.

Exclusion Criteria:

* subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray;
* examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy;
* a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations;
* a history of uncontrolled hypertension, or other respiratory diseases;
* oxygen saturation(SpO2) \< 88% at rest with a fraction of inspired oxygen (FiO2) ≥ 0.5;
* patients with musculoskeletal or neurological disorders;
* or failure to comply with the research protocol.