cyrilzakka/clinical-trials huggingface dataset:
Study of Tetrathiomolybdate in Patients With Wilson Disease

OBJECTIVES:

Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically.

PROTOCOL OUTLINE: This a double blind, randomized study. Patients are randomized into one of two treatment arms.

Arm I: Patients receive tetrathiomolybdate (TM) 3 times a day with meals and 3 times a day between meals for 8 weeks in the absence of neurologic deterioration or unacceptable toxicity.

Arm II: Patients receive trientine therapy for 8 weeks in the absence of neurologic deterioration and unacceptable toxicity.

Additional therapy (off study): Patients in the TM group may receive maintenance zinc, while those in the trientine group may continue on trientine or switch to zinc.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Wilson disease presenting with neurologic or psychiatric symptoms
* No concurrent seizure activity
* No white matter lesions on brain magnetic resonance imaging

--Prior/Concurrent Therapy--

* No more than 2 weeks of prior therapy
* No penicillamine or trientine for longer than 2 weeks

--Patient Characteristics--

* Hepatic: No severe hepatic failure
* Other: No psychiatric or medical contraindication to protocol therapy
* Not pregnant
A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)

The purpose of this study is to evaluate the safety of ublituximab use in the older MS adult population, as measured by incidence of infection rate

This study is being done to see how safe and effective ublituximab is when given to older adult patients for their RMS. Since RMS patients over age 55 were excluded from previous clinical studies that studied the safety and efficacy of ublituximab, this study is designed to better understand how well this drug is tolerated in RMS patients between the ages of 55-80 years.

Primary endpoints include:

* Incidence of infection rate from Baseline to Month 24/EOS (including UTI and other active acute, opportunistic and/or chronic infection)
* Incidence of TEAS/SAEs from Baseline to Month 24 with consideration to nature, severity, and occurrence rate of AEs

Approximately 20 participants are expected to be enrolled. Participation in this study will last approximately 24 months and will include approximately 6 study visits to the study center.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Aged 55-80 years old
* Diagnosis of RMS according to the 2017 Revised McDonald criteria
* Anticipated to begin treatment with or newly treated with ublituximab (within 6 months prior to study entry) according to the local label

Exclusion Criteria:

* Active participation in an interventional clinical trial for MS
* Received initial dose of ublituximab more than 6 months prior to study entry
* History of life-threatening infusion reaction on any anti-CD20 therapy
* Evidence of clinically significant chronic or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment, or any history of recurrent infection within 6-12 months prior to initiation of ublituximab
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)

The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult Japanese male between the age of 20-40
* body mass index between 18.5-25

Exclusion Criteria:

* clinically significant abnormal physical examination, vital signs or electrocardiogram
* use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
* use of any non-prescription medication within the previous 1 week
* history of drug or alcohol abuse
Evaluation of Risk Factors of Sleep Quality in Intensive Care Unit

The aim of this study was to investigate the relationship between sleep disturbances and delirium in surgical ICU patients. The study set up to test the hypothesis that the occurrence of delirium is associated to the alteration of sleep quality and quantity observed in the critically ill patients.

Sleep disorders are an important clinical entity affecting outcome in respiratory, cardiovascular, metabolic and psychiatric disorders and exacting a potentially significant toll on patients at both a personal and socio-economic level.Delirium is a common organ dysfunction in the critically ill patients characterized by an acute onset of impaired cognitive function \[REF\] associated with prolonged ICU and hospital stay, nosocomial pneumonia, and death.

Eligibility Criteria:
Inclusion Criteria:

* Adult, postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU

Exclusion Criteria:

* Defined a priori
* Were history of chronic dementia, psychosis, mental retardation, stroke syndrome or other primary neurologic disease
* Patient refusal to participate
* Alcohol and drug abuse.
Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia

In Post-Herpetic Neuralgia(PHN) patients:

* To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study
* To measure the plasma concentration of TRK-700 and its metabolites


Eligibility Criteria:
Inclusion Criteria:

* Patients with pain persisting for at least 3 months after the onset of herpes zoster
* Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4

Exclusion Criteria:

* Patients with another skin disease that may affect the evaluation of the pain at the site of PHN
* Patients with pain other than PHN that may affect the evaluation of pain
* Patients with pain that is suspected to be mainly psychogenic
* Patients who have received neurolytic or neurosurgical therapy for PHN
DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.

Patients selected for DIEP breast reconstruction were examined with preoperative CTA, Doppler Ultrasound, dynamic infrared thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) for perforator mapping. DIRT and ICG-FA were used to evaluate perfusion of selected perforators. Following anastomoses for the DIEP flap to internal mammary vessels , patency of the anastomosis was evaluated with DIRT and ICG-FA. Recorded images from all the modules were compared.

Introduction:

'The primary aim of our study is to compare invasive and non-invasive techniques to select a dominant perforator when harvesting a DIEP-flap for autologous breast reconstruction.

The secondary aim is to compare Dynamic Infrared Thermography (DIRT) and Laser Fluorescence Angiography (LFA) of Indocyanine green (ICG) in order to see whether they could be useful in the early detection of insufficient perfusion following the microvascular anastomotic procedure in DIEP flaps.

Material and Method:

Patients selected for breast reconstruction with autologous tissue were examined with preoperative CTA and a handheld Doppler Ultrasound for perforator mapping. Thereafter visual images from same area was obtained with dynamic infraredeed thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) before and after dissection of the skin flap with preserved medial and lateral DIEP perforators. Reconstructed breasts with hemi-DIEP-flaps were intraoperatively evaluated with DIRT and LFA immediately after the completion and opening of the microvascular anastomosis.The recorded images from the different techniques were assesses in relation to clinical outcome.

.

Eligibility Criteria:
Inclusion Criteria:

* Post mastectomy.
* Previously breast cancer patent treated with radiation therapy.
* Breast implant reconstruction is not possible or undesired.
* Healthy patient with moderate amounts of abdominal skin laxity.
* Patient who requires a minimal to moderate volume breast reconstruction.
* The patient willing to undergo the long, complex procedure and prolonged postoperative recovery.
* The patient willing to accept an abdominal scar and a potential for donor site morbidities.
* Patients operated with prophylactic salpingo-oophorectomy due to BRCA gene mutation.

Exclusion Criteria:

* Pregnancy and lactation.
* Patents below the age of 18 year.
* Renal failure or hepatic failure.
* Previous allergic reactions to ICG and iodide.
* Abdominal donor site that cannot be closed primarily.
* Previous TRAM flap or abdominoplasty.
* Significant medical comorbidities that make the patient a poor surgical candidate.
* Sigarette smoking or snuff.
* Obesity / BMI \> 30.
* Previous abdominal suction-assisted lipectomy.
Ultrasound Elastography Application in Cesarean Section Scar Defect

Cesarean Section Scar Defect(CSD) is one of the complications after cesarean section. CSD will cause many long term complications, such as abnormal uterine bleeding, infertility, uterine scar pregnancy and uterine rupture. Transvaginal ultrasound was used to detect uterine scar defects commonly. Ultrasound elastography is a modern imaging technique that has developed rapidly in recent years. Thus, this study intend to investigate the application of Ultrasound Elastography in Cesarean Section Scar Defect.


Eligibility Criteria:
Inclusion Criteria:

* Clearly diagnosed with CSD
* No serious medical problems (important viscera function in the normal range). uterine fibroids no more than 5cm
* Sign the informed consent.

Exclusion Criteria:

* Indefinite diagnosis.
* Malignant tumors.
* With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
* Pregnant.
* Mental diseases.
* Unwilling to comply with the research plan.
Backpack Carrying in Children With Cystic Fibrosis

Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a progressive decline in lung function.

School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle strength is also impaired.

No studies assessed aerobic capacities during children's gait while carrying a backpack.

The investigators hypothesized that backpack carrying will induce an acute decline in lung function in children with cystic fibrosis compared to healthy children. Investigators also hypothesized that aerobic capacities will be impaired.


Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis
* School-aged children (10 to 18)

Exclusion Criteria:

* Backpack carrying contraindication
* Acute exacerbation
* Impossible gait
* Other respiratory disease (asthma ...)
A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain

The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS).

Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:

* Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score
* Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score
* Change from baseline in the average daily LBPI NRS score


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female ≥35 years of age at the screening visit
2. Clinical diagnosis of chronic moderate to severe LBP (nonradiculopathic)for ≥3 months
3. History of regular analgesic medication
4. History of inadequate pain relief or intolerance to analgesics used for chronic LBP
5. Willing to discontinue current pain medication

Key Exclusion Criteria:

1. History of lumbosacral radiculopathy within the past 2 years
2. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
3. Recent use of longer acting pain medications
4. Evidence of destructive arthropathy
5. Other medical conditions that may interfere with participation or accurate assessments during the trial
Phase 1 Study of URC102 in Healthy Subjects

To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the food effect on PK.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Received other investigational drug within 12 weeks prior to the first dose of study drug
Spine MRI in Patients With Deep Brain Stimulation (DBS)

Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is under strict safety guidelines. Depending on the body part being imaged, the safety may vary.

Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom safety data, we designed a set of MR pulse sequences deemed as safe as possible and the protocol allows acquisition of diagnostic quality MRI images.

The patients who clinically require a spine MRI will undergo a spine MRI with our designed protocols to obtain diagnostic quality images. Furthermore, a limited brain MRI will be done before and after to ensure no peri-electrode tissue changes.

Eligibility Criteria:
Inclusion criteria

* Age between 18 and 85 years of age
* Participants must have undergone implantation of DBS electrodes.
* Participants must be able to understand the purpose of this research and must sign the informed consent form.
* Participants must understand that the role of this research is demonstrate the safety of spine MRI in patients with DBS.

Exclusion criteria

* Participants who have serious cognitive or psychological impairments and cannot give informed consent.
* Participants who are unable to effectively or efficiently communicate, for example patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.
Aromatherapy and Pain

Effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain.

The study will explore the effect of aromatherapy on pain and discomfort in patients who are receiving intramuscular stimulation therapy or trigger point injections for chronic pain. This will be a blinded study where patients will act as their own control over two treatment visits. On one visit patient will be exposed to either the aromatherapy or a placebo. On their second visit patients will be exposed to the other compound. The study will collect demographic data, pain intensity and affect, and catastrophizing information.

Eligibility Criteria:
Inclusion Criteria:

* Have received at least one (1) prior IMS or trigger point injection treatment with researcher
* 18 years of age or older
* English language speaker
* has completed Pain Tracker (clinic standard of care) questionnaire prior to study visit
* any analgesic medication taken must be consistent for both sessions

Exclusion Criteria:

* Non-English language speaker
* Age \<18
* Allergy to essential oils
* Asthmatic
* Patient unable to self-administer aromatherapy
Digital Ulceration

The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.


Eligibility Criteria:
Inclusion Criteria:

For all patients:

* Signed informed consent prior to enrollment
* Male or female, ≥ 18 years of age
* Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria

For patients with no history of digital ulcers (DU) and no DU at enrollment only:

- Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature

Exclusion Criteria:

* SSc sine scleroderma (without any skin involvement)
* Patients who underwent stem cell transplantation
* Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study
* Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)
Serum Vitamin D and Gingival Crevicular Fluid Levels of Osteocalcin and N-Terminal Telopeptide

This study examines the relationship between serum vitamin D levels and bone metabolism markers-osteocalcin and N-terminal telopeptide (NTx)-in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients. A total of 120 male participants (60 healthy, 60 with periodontitis) aged 25-40 were included and categorized based on their serum vitamin D levels.

Recent evidence suggests that vitamin D, a key regulator of bone metabolism, may play a role in periodontal health by influencing bone turnover markers such as osteocalcin and N-terminal telopeptide (NTx). This study aims to investigate the effects of serum vitamin D levels on these bone metabolism markers in gingival crevicular fluid (GCF) of periodontally healthy and periodontitis patients.

A total of 120 male participants aged 25-40 years were enrolled, comprising 60 periodontally healthy individuals and 60 patients diagnosed with periodontitis. Participants were further categorized into subgroups based on their serum vitamin D levels (0-10 ng/ml, 11-20 ng/ml, and 21-30 ng/ml). GCF samples were collected from maxillary premolar and molar sites and analyzed using enzyme-linked immunosorbent assay (ELISA) to measure osteocalcin and NTx concentrations.

Eligibility Criteria:
Inclusion Criteria:

* One hundred and twenty male patients, consisting of 60 periodontally healthy patients and 60 patients with periodontitis, aged between 25 and 40 years, non-smoking, who had not received periodontal treatment in the last 6 months, with no systemic diseases, and whose Vitamin D levels had been determined, were included in the study.

Exclusion Criteria:

* Female individuals
* Smokers
* Individuals with systemic diseases (Diabetes Mellitus, Hyperthyroidism, -Malabsorption, Liver and Renal Failure, or those receiving osteoporosis treatment)
* Individuals who have undergone periodontal treatment within the last 6 months
* Individuals on regular medication
* Individuals who did not provide informed consent
* Individuals with poor cooperation
Pain Treatment in a Breast Cancer Population. PaiNEd Study.

The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information.

This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.

People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects over 18 years of age.
2. Having undergone surgery and finished adjuvant treatment (radiotherapy and / or chemotherapy) six months or two years ago.
3. Not having active cancer.
4. Having pain in the regions related to the tumor area (cervical and / or brachial and / or shoulder), pain ≥ 4 (VAS 0 to 10) for\> 4 weeks
5. Present musculoskeletal or functional alterations in the previous regions.

Exclusion Criteria:

1. Identification by the research team of physical or mental impossibility to carry out the tests of the study.
2. Suffering from chronic pain or having suffered a previous trauma to the spine, head, temporomandibular joint or upper extremities.
Prediction of Functional Disability in Subjects With Scapular Dyskinesis

Background: Patterns of scapular dyskinesis have unique scapular kinematics and associated muscular activation. The characteristics of scapular dyskinesis may be associated with functional disability. The investigators investigated whether the level of shoulder function and primary dysfunction items were different in each unique pattern of scapular dyskinesis. The factors associated with shoulder dysfunction in different patterns of scapular dyskinesis were identified.

Methods: Participants with unilateral shoulder pain were classified as having a single dyskinesis pattern (inferior angle prominence, pattern I; medial border prominence, pattern II) or a mixed dyskinesis pattern (patterns I+II). Clinical measurements with the Flexilevel Scale of Shoulder Function (FLEX-SF score), shoulder range of motion, anterior/posterior shoulder tightness, and pectoralis minor index were recorded. These clinical measurements, 3-D scapular kinematics (electromagnetic-based motion analysis), and associated muscular activation (electromyography on the upper, middle, and lower parts of the trapezius and serratus anterior muscles) during arm elevation were analyzed for associations with functional disability.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were from 18 to 50 years old and had unilateral shoulder pain around the shoulder complex, including the glenohumeral, scapulothoracic, sternoclavicular, and acromioclavicular regions, while performing shoulder movement.

Exclusion Criteria:

* Subjects were excluded if they had a history of shoulder dislocation, fracture, or shoulder surgery within the past 1 year, or a history of direct contact injury to the neck or upper extremities within the past 1 month. Subjects who had neurological disorders or demonstrated pain (VAS\>3) during the overall testing procedures were also excluded.