cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS)

The proposed observational trial will collect substantial data concerning dietary intake documented by ALS patients complemented by the analysis of fatty acid distribution in erythrocyte lipids. Both data sets are related to disease status and progress.

Amyotrophic lateral sclerosis (ALS) is a currently incurable, multifactorial motor neuron disease characterized by upper and lower motor neuron degeneration, skeletal muscle atrophy, paralysis, and death. Multiple mechanisms caused by genetic and environmental factors proposed as responsible for ALS pathogenesis include decreased availability to neurotrophic factors, disturbances in calcium metabolism, increased neuroinflammatory status, cytoskeletal changes, mitochondrial dysfunction, dysfunction of protein degradation, glutamate excitotoxicity, apoptosis and oxidative stress.

Currently, the only available drug to treat ALS is riluzole which slightly prolongs life. Nutritional management has become more important in the treatment of ALS because body mass index and nutritional status seems to be independent, prognostic factors for survival and disease complications. Malnutrition is common in ALS, so caloric supplementation is essential. Additionally, many ALS patients self-medicate with vitamins, herbs, and other dietary supplements.

The objective of the current project is establishing the link between nutritional intake and disease status and progress. In detail, we like to assess if the improved outcomes are associated with specific nutrients, or simply the provision of excess calories. In this context, one of the most promising dietary candidates are polyunsaturated fatty acids (PUFA) and in particular the long-chain n-3 PUFA docosahexaenoic acid. This important structural component in neuronal membranes plays a role in neurogenesis and neuroprotection as well as exerts well-described anti-inflammatory effects in the brain.

The proposed observational trial will collect substantial data concerning dietary intake documented by ALS patients (Food Frequency Protocols, FFPs, periodic over 5 days) combined with the analysis of fatty acid distribution in erythrocyte lipids which reflects fatty acid distribution of the consumed fatty or oily foods (time period: approximately the last 2-3 months).

The fatty aids distribution in erythrocyte lipids as well as the nutrient intake calculated by FFPs are related to disease status and progress.

Thus, the current research activities focus on identification of dietary factors that are associated with disease progress or survival to develop beneficial interventions and therapy options.

Eligibility Criteria:
Inclusion Criteria:

* ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
* patients should have the ability to comprehend the full nature and purpose of the study, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.

Exclusion Criteria:

* patient's request or if patient compliance with the study protocol is doubtful
Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer

In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

It is well known that HER2-receptor positive and triple negative metastatic breast cancer (MBC) have poor prognosis than hormone receptor positive metastatic breast cancer. However, as new therapies such as trastuzumab and pertuzumab are introduced, overall survival was extended in patients with metastatic breast cancer compared with the previous 10 years. As a result, the number of breast cancer patients with brain metastases has increased, the demand for treatments of brain metastases is increasing.

The incidence of brain metastases in MBC has been reported to be 7.6% and 10.8% in luminal A / B, respectively. However, HER2-positive and triple negative breast cancer with the incidence of more than 30% of brain metastases were at high risk group of brain metastases.

In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 19 years
* Pathologically documented breast cancer that:

  1. is unresectable or metastatic ;
  2. has confirmed HER2 positive expression according to American Society of Clinical Oncology- College of American Pathologists (ASCO-CAP) guidelines or triple negative breast cancer
* No prior systemic palliative treatment of metastatic breast cancer
* Must have provided informed consent for study participation before performance of any study-specific procedures or tests

Exclusion Criteria:

* History of prior treatments about brain metastases or leptomeningeal metastases
* Symptomatic brain metastases at screening period
* Has received more than second-line systemic treatments (including endocrine therapy)
* For subjects who have difficulty lying down or who have claustrophobia, they can undergo sedation during brain MRI
* History of hypersensitivity reaction to contrast or drug allergic reaction
* Patients who inserted metallic prosthesis (pacemaker, denture, hearing aid, aneurysm clip, metallic material of eyeball, artificial joint, insulin pump, chemo-port, temporary tissue expander for breast reconstruction, etc) can be conducted after consultation with investigator before MRI.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Social, familial, or geographical factors that would interfere with study participation or follow-up
Conservative Management of DeQuervain's Tendinopathy With an Orthopaedic Manual Therapy Approach Emphasizing First CMC Manipulation: A Retrospective Case Series

This is a retrospective review of three patients with DeQuervain's Tendinopathy (DQT) that had successful outcomes with a manual therapy focused approach provided by Physical Therapist management.

DeQuervain's tendinopathy (DQT) is a musculoskeletal disorder that limits hand function of affected individuals. Management of DQT can include splinting, activity modification, medications, corticosteroid injections, Physical Therapy, and surgery. There is limited evidence to support the combination of manual therapy and exercise interventions within an Orthopaedic Manual Physical Therapy (OMPT) approach when managing patients with DQT. Three patients identified with DQT underwent a multi-modal treatment regimen including carpometacarpal (CMC) thrust and non-thrust manipulation, end range radiocarpal mobilization, mobilization with movement (MWM), strengthening exercises, and grip proprioception training. Outcomes were assessed using the numeric pain rating scale (NPRS), Jamar hand dynamometer grip strength, and the Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. These measures were administered at baseline and discharge.

Eligibility Criteria:
Inclusion Criteria:

Five or more items present on the DQT screening tool devised by Batteson et al.:

* Pain over the radial styloid
* Tenderness over the dorsal thumb
* Pain with active thumb flexion
* Localized swelling over the thumb
* Positive Finkelsteins test
* Thickening of the tendon sheath of the first dorsal extensor compartment
* Pain with resisted thumb extension.

Exclusion Criteria:

* Cardiovascular disorders
* Non-musculoskeletal complaints
* Auto-immune disorders
* Patients who had received previous treatment for their condition
Comparison of RPL554 With Placebo and Salbutamol in Asthmatic Patients

The number of people with of asthma and allergy is still increasing and a large number of patients still do not have their asthma well controlled. There is therefore a need for new asthma treatments that work well and have less side effects. The study compares a new experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.

A seven way crossover study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled RPL554 compared to salbutamol and placebo in patients with mild to moderate chronic asthma.

Salbutamol is a marketed beta-2 agonist typically used to treat bronchospasm (due to any cause, allergen asthma or exercise-induced), as well as chronic obstructive pulmonary disease but has associated dose-related systemic side effects.

RPL554 is a dual PDE3 and PDE4 inhibitor that has bronchodilatory and anti-inflammatory actions and also the potential to stimulate increases in mucociliary clearance via its proven ability to activate CFTR. Four different doses of RPL554 will be compared with placebo and a two doses of salbutamol as benchmarks for bronchodilation and systemic side effects.

Eligibility Criteria:
Inclusion Criteria:

* Provided written informed consent
* Males agree not to donate sperm and either be abstinent or use adequate contraception. Females to be post-menopausal or surgically sterile
* Non-smoker or ex-smoker \>6 months
* Diagnosed asthma for at least 6 months
* Pre-bronchodilator FEV1 ≥60% and ≤90% of predicted normal value and ≥1.5 L at screening
* Increase in FEV1 of 15% within 30 minutes after a 2.5mg dose of nebulised salbutamol
* Systolic blood pressure 90 to 145 mmHg, diastolic blood pressure 50 to 90 mmHg and heart rate 45 to 80 beats per minute (bpm) after resting for 5 minutes in a supine position (average from two measurements)
* Capable of withdrawing from LABAs, LAMAs and SAMAs before screening and during study and SABAs before screening and for 8 hours before each dose

Exclusion Criteria:

* Asthma exacerbation in the last 3 months
* Any prior life threatening episode of asthma (intensive care admission)
* Any clinically significant disease or disorder or clinically relevant screening result
* QTcF interval \>450 ms or QT interval \>500 ms or other abnormality in ECG
* History of ischemic heart disease or heart failure. History of recurrent or current clinically significant arrhythmia or ECG abnormality as judged by the investigator
* Treatment with systemic glucocorticosteroids within 30 days before screening
* A suspected/manifested infection according to WHO risk classification 2, 3 or 4
Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures. The discrimination between IC and IIE is not requested for inclusion.
* Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
* Subjects with a confirmed diagnosis of epilepsy.
* Male/female subjects (≥16 years).

Exclusion Criteria:

* History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
* History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. \< 20 minutes, with or without function regained between 2 ictal events.
* History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.
Safety and Effectiveness Study of the Precision SCS Systems Adapted for High-Rate Spinal Cord Stimulation

To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain

To evaluate the safety and effectiveness of high rate spinal cord stimulation (HR-SCS) therapy as an aid in the management of chronic intractable pain of the trunk using the Boston Scientific (BSC) PRECISION Spinal Cord Stimulator Systems Adapted for High-Rate Spinal Cord Stimulation

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with chronic, intractable pain of the trunk (NRS ≥ 5) which has been refractory to conservative therapy for a minimum of 90 days.
* Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
* Be 22 years of age or older at the time of enrollment
* Be willing and capable of giving informed consent
* Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

* Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
* Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
* Have previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
* Have a current systemic infection, or local infection in close proximity to anticipated surgical field
* Pregnant or plan to get pregnant during the course of the study or not using adequate contraception.
* Be participating in another clinical study that may influence the data collected for the study
The Effects of Manual Therapy in Hemophilic Patients

Uncertainty about how to treat existing hemophilic arthropathy (HA) is the most important issue that will increase functionality and joint health. Recent studies have shown that MT can be used safely for improving joint health, pain and ROM with no bleedings in PwH with elbow and ankle HA. Unlike MT studies in hemophilia, we investigated the effects of MT on important parameters such as muscle strength (MS), functional level, joint health, functional independence score in hemophilia (FISH) and kinesiophobia. These parameters are closely related to functional level and quality of life of PwH. Therefore, evaluation of these parameters and determining the effects of the MT on these parameters are very important for both PwH and also clinicians.

The aim of this study was to investigate the effects of manual therapy in addition to home exercise program on hemophilia functional independence level, joint health, kinesiophobia, functional level, range of motion, muscle strength and pain level in hemophilic individuals with lower extremity joint arthropathy. Hemophilic arthropathy was developed in at least one of the lower extremity joints and aged between 18-30 years 17 severe type hemophilic men were participated in the study. The participants were divided into two groups as Home Exercise Group (HEG) and Manual Therapy Group (MTG) by randomization method. While the HEG was performed the exercise program at home, in addition to the same HEG manual therapy were applied to the MTG by the same physiotherapist 3 days a week for 1 hour. Both groups were followed for a total of 5 weeks and pre-treatment evaluations were repeated post-treatment. The joint health of the hemophilics in both groups were evaluated with Hemophilia Joint Health Score (HJHS), their kinesiophobia level were evaluated with Tampa Kinesophobia Scale, their functionality with the Functional Independence Score in Hemophilia (FISH). In addition, Functional Reach, Timed Up and Go and 5 Times Sit-to- Stand tests were used for functional level. The range of motion was evaluated with a goniometer, muscle strength was measured with a digital dynamometer and pain level was assessed with a Visual Analogue Scale (VAS). Number of hemarthrosis decreased in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia who have arthropathy developed in any of the lower extremity joints due to severe hemophilia and to be receiving regular prophylaxis (3\*1500 IU/ per week), but not having regular physical activity and sports.

Exclusion Criteria:

* Patients with hemophilia who had any disease related to connective tissue, any surgery that affects lower limb function (joint debridement, fracture, prosthesis), any neurological disease or cognitive impairment that may affect functional level, any sensorial loss of peripheral nerve injury and did not attend their sessions and evaluations regularly.
Specific Preoperative Dynamic Contrast-enhanced MRI Semi-quantitative Markers Can Correlate With Vascularity in Specific Areas of the Glioblastoma Tissue and Predict Recurrence

Radiological Markers of vascularity as wash-in rate, washout rate, and capillary time to peak in different single tumour regions were extracted for all glioblastoma patients before being surgically resected from preoperative DCE-MRI. Tissue samples were obtained from different intratumoral regions and peritumoral oedema and evaluated for the vascular endothelial growth factor (VEGF)


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed glioblastoma with a maximum diameter from 3-5 cm as a single lesion identified by MRI.
* The lesions should be surgically resected at the time of the presentation.

Exclusion Criteria: N/A
Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.


Eligibility Criteria:
Primary inclusion criteria:

* Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction
* Measurable disease (revised RECIST; Version 1.1) based on computed tomography
* Eastern Cooperative Oncology Group performance status 0 or 1
* Treatment with only 1 prior regimen (as first-line therapy) and that regimen included a fluoropyrimidine and/or a platinum analogue
* Documented disease progression within 4 months of the last dose of the 1 prior regimen
* Adequate bone marrow, hepatic, and renal function, as defined in the protocol
* At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy, with an approved or investigational agent
* Ability to swallow an oral solid-dosage form of medication

Primary exclusion criteria:

* Nonmeasurable disease only (revised RECIST; Version 1.1)
* History or presence of brain metastasis or leptomeningeal disease
* Operable gastric cancer or operable cancer of the esophagogastric junction
* Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the patient's usual number of bowel movements on at least 2 days within the 14 days prior to enrollment
* Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the administration of standard antiemetic therapy
* Known malabsorptive disorder
* Significant medical disease other than cancer, as defined in the protocol
* Presence of neuropathy \> Grade 1 (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]; Version 4.0)
* Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Delving Into Participation Trends of Scleroderma Clinical Trials

Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.

The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with scleroderma
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient is pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Using Nudges to Recruit for Health-Related Research

The goal of this clinical trial is to examine the effect of using behavioral nudges in recruitment into a minimal risk interview study among healthy adult volunteers.

Individuals will be randomized to receive recruitment materials that do or do not contain a set of behavioral nudges. Researchers will compare the effect on participation in an interview study (primary outcome) between these conditions.


Eligibility Criteria:
Inclusion Criteria:

English-speaking; 18 years of age or older

Exclusion Criteria:

None
Cost Utility Analysis of Erythropoietin for Anemia Treatment in Hemodialysis Patients

To study the cost utility analysis of Erythropoietin (EPO) for maintaining the different hemoglobin (Hb) target levels in anemic hemodialysis patient in routine clinical practice.

In Thailand, the studies that were conducted to find the most useful target Hb have not included the cost effectiveness and/or cost utility analyses. The level at which quality of life is maximized and risk is minimized would be the optimal target. Dialysis patients carry higher risk of death than general population. Anemia is the common complication found in dialysis patients that could lead to mortality. Risk of anemia is occurred in HD patients more than CAPD patients because blood loss is less marked and residual renal function maybe better preserved in patients who receive peritoneal dialysis.Although EPO has been included in the National List of Essential Drugs (NLED) for the treatment of anemia caused by end stage renal disease for maintaining the target hemoglobin but the cost of EPO is so expensive. Cost utility analysis is economic technique for assessing the efficiency of healthcare intervention measuring combined outcomes as the effectiveness, i.e., survival and quality of life in combination as quality adjusted life years (QALYs).This study is a benefit measure at the care giving level by using as a part of planning patient management program and at the policy level for decision making.

Eligibility Criteria:
Inclusion Criteria:

* Patients use EPO at least 6 months with titration of EPO therapy is permitted

Exclusion Criteria:

* Patients under 18 years old.
* Patients who have blood transfusion for anemic treatment within 6 months before EPO treatment and before the study starts
* Patients who change the modality of dialysis
* Patients who switch to other anemia treatment method between the study
* Patients who cannot answer the questionnaire and are not willing to participate in the study