cyrilzakka/clinical-trials huggingface dataset:
The Natural History and Muscle Fatigability of Patients With Congenital Myopathies.

Core myopathies (CCD/MmD), nemaline myopathies (NEM) and centronuclear myopathies (CNM) are three types of rare congenital myopathies. Not much is known about the natural history and no curative treatment is available for these groups. Also patients report fatigability as one of their symptoms. The goal of this observational study is to study the natural history during 24 months to achieve trial readiness and to study the muscle fatigability in CCD/MmD, NEM and CNM.

Rationale: Patients with CCD/MmD, NEM and CNM report symptoms of weakness in the arms and legs. Other symptoms include weakness of the respiratory, facial and swallowing muscles. No treatments are available for congenital myopathies (CM) to slow down or cure the disease. A few type I-II trials have taken place and more are expected. Therefore it is important to reach trial readiness. To create trial readiness, there is a need for natural history study to create a detailed report of the disease course and a selection of the most sensitive clinical and functional outcome measures and biomarkers. Besides muscle weakness, several patients report muscle fatigability. This has not been investigated systematically in CM. The lack of evidence calls for a cross-sectional study assessing muscle fatigability and neuromuscular transmission in CM.

Objectives: i) To assess the natural disease course of CCD/MmD, NEM and CNM during 24 months. ii) To select relevant and sensitive clinical and functional outcome measures and biomarkers. iii) To assess the severity of muscle fatigability in CCD/MmD, NEM and CNM.

Study design: Patients with a genetically confirmed CCD/MmD, NEM or CNM will be able to participate in this study. The study consist of 2 parts. Part 1: a prospective cohort study with 5 visits every 6 months, for a total of 2 years. 45 patients will be included for this part. Part 2: an observational study with 2 visits. For this part 75 patients will be included. There will be an overlap in patients for the two parts. So a total of approximately 100 patients will be included. A large set of tests will be performed to assess the full capabilities of the patient, e.g. muscle strength/endurance, muscle imaging (MRI/ultrasound), activities, walking ability, quality of life, muscle fatigability and the feeling of fatigue.

Eligibility Criteria:
Inclusion Criteria for the natural history:

* 2 years or older
* Willing and able to complete the measurement protocol
* Willing and able to travel to Nijmegen and Utrecht
* Dutch-speaking
* Genetically-confirmed congenital myopathy (CCD/MmD, NEM, and CNM)

Inclusion Criteria for the fatigability study:

* 8-60 years old
* Willing and able to complete the measurement protocol
* Willing and able to travel to Nijmegen and Utrecht
* Dutch-speaking
* Genetically-confirmed congenital myopathy (CCD/MmD, NEM, and CNM)
* Willing to stop taking pyridostigmine and/or salbutamol 24 hours before the visit.

Exclusion Criteria for both parts:

Other neuromuscular, psychiatric or neurological disorders.
A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer

The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic colorectal adenocarcinoma.
2. Confirmed K-RAS mutant tumor
3. Disease progression on oxaliplatin- AND irinotecan-containing regimens, with at least one of these regimens containing bevacizumab.
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Exclusion Criteria:

1. Use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle.
2. Radiotherapy for up to ≥ 30% of the bone marrow.
3. Surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted).
4. Previous treatment with cetuximab, panitumumab, pomalidomide (CC-4047), lenalidomide or thalidomide.
5. Untreated, symptomatic brain metastases (brain imaging not required).
6. Venous thromboembolism ≤ 6 months before day1 of the first cycle.
7. Current congestive heart failure (classes II to IV of the New York Heart Association).
8. Myocardial infarction ≤ 12 months before day1 of the first cycle.
9. Uncontrolled hypertension.
a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram

The purpose of this study is to determine the predictive value of a composite of 3 simple clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection.

The purpose of this study is to determine the predictive value of a composite of 3 simple, clinically practical, diagnostic tests (Mekhail, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection. The goal is to test these 3 tests and compare their predictive value to the 6 tests commonly reported in the literature in order to provide a clinician with clinically practical special tests to aide in the diagnosis and treatment of SIJ mediated pain. . Specifically, we seek to evaluate the prognostic capacity for a series of three clinical tests (Mekhail's Test, thigh thrust and Patrick's Test) combined with a pain referral diagram to accurately predict the response (change in VAS) of a single diagnostic Sacroiliac joint and extra-capsular joint injection.

Eligibility Criteria:
Inclusion Criteria:

* any patient presenting with low back pain with or without radicular symptoms, regardless of prior history of back surgery from 18-90 years old whom after being evaluated by an independent clinician in the Cleveland Clinic pain clinic has been scheduled for a diagnostic SIJ injection.

Exclusion Criteria:

* any patient less than 18 or greater than 90 years old, has any medical condition that would not allow them to complete the study, diagnosis of any recent fractures in the lumbar spine, recent infection, pregnancy, taking anticoagulants.
Omentectomy and Metabolic Syndrome

The aim of the present study was to evaluate the additional effect of sudden visceral fat reduction by omentectomy on Metabolic Syndrome, acute phase reactants and inflammatory mediators in patients with morbid obesity undergoing Laparoscopic Roux-en-Y Gastric Bypass.

Although weight loss controls Metabolic Syndrome and reduces the level of inflammatory markers in patients with Morbid Obesity, patients may enjoy the benefit achieving metabolic control before significant weight loss occurs.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35 Kg/m2
* Metabolic syndrome diagnosed

Exclusion Criteria:

* Type 1 diabetes
* Uncontrolled type 2 diabetes
* Cirrhosis or active hepatitis
* Pregnancy
* Recent MI or stroke
Mental Health Literacy and Mental Health Promotion With Urban Refugee Youth in Kampala, Uganda

From our previous studies, we know that urban refugee youth commonly report depressive symptoms. The primary aim of this study is to compare the effectiveness of youth-tailored interventions to improve mental health literacy and reduce mental health stigma among urban refugee youth in Kampala, Uganda. There will be two intervention arms and one control arm. The first intervention arm will involve a VR experience that focuses on mental health literacy and coping strategies, as well as SMS check-ins from peer navigators (PN) trained in psychological first aid. The second intervention arm will involve an adapted version of the WHO's Group Problem Management Plus. The primary outcomes are to a) increase mental health literacy (knowledge and understanding of mental health generally and of specific disorders; b) increase attitudes towards mental health help-seeking, c) reduce depression, d) increase adaptive coping strategies; e) reduce mental health stigma, f) improve mental wellbeing, and g) increase level of functioning. Participants will complete a pre- and post-intervention survey as well as a follow-up survey.


Eligibility Criteria:
Inclusion Criteria:

1. living in one of the 5 informal settlements in Kampala we already work with (Nsambya, Katwe, Rubaga, Kabalagala, Kansanga);
2. self identify as a woman or man (transgender inclusive);
3. identify as a refugee/displaced person/having refugee parents;
4. aged 16-25;
5. own a mobile phone;
6. speak Swahili, Luganda, Kirundi, Kinyarwanda, French or English and can provide informed consent.

Exclusion Criteria:

-
Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia

In this clinical study, meloxicam will be used to the patients who are older than 2 years and underwent Kasai portoenterostomy to treat their biliary atresia before. Before and after the medication, their liver stiffness scores will be checked using hepatic Fibroscan. Liver stiffness scores will be compared before and after the medication of meloxicam, and the roll of the COX-2 inhibitor (meloxicam) in the patients with biliary atresia in releasing their hepatic fibrosis. Also, the side effect of the drug will be checked. The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who had undergone a Kasai portoenterostomy for BA, and who were postoperatively managed in our outpatient clinic
2. Patients who made informed consent for clinical study of COX-2 inhibitor
3. Patients who were followed up with liver fibroscan study
4. Patients who were over 2 years old and less than or equal to 17 years

Exclusion Criteria:

1. Patients who were impossible to join the clinical study because of their underlying diseases (renal disease, liver disease, diabetes mellitus, GI disease, including bleeding, perforation, or ulceration, etc.) other than biliary atresia, ii) H. pylori infection, iii) asthma, iv) nasal polyp, v) hypertension, vi) hematologic disease, vii) coagulopathy, viii) cardiac disease, ix) vascular disease
2. Patients who did not get the drug (COX-2 inhibitor)
3. Patients who did not check liver fibroscan
4. Patients who were impossible to join the clinical study because of their complication after Kasai portoenterostomy
5. Patients who did not make informed consent for clinical study of COX-2 inhibitor
6. Patients who cannot take drug because of their allergy, skin disease or asthma attack to drug (COX-2 inhibitor)
7. Patients who were decided to withdraw because of their severe drug adverse events
Implementation of Nutritional Efforts on Discharged Older Patients

The aim of the study is to implement a nutritional treatment when discharging older patients at risk of malnutrition.

Data collected in the study will include an assessment of whether a combination of nutritional treatment and a liaison team reduces the risk of readmissions and mortality, improves nutritional status, physical function and quality of life

During hospitalization, many older patients are at risk of malnutrition. Malnutrition in older adults is related to reduced physical function, more complications, re-admissions, days in hospital and reduced quality of life. As hospitalizations are often short (approximately 5 days), it is important to focus on nutritional intake during the convalescence period.

Upon discharge, a "Nutrition Gap" often occurs in practice, where the patient does not consume sufficient nutrition to ensure an optimal convalescence period. The lack of nutritional follow-up in connection with the discharge of older patients has been shown to have a markedly negative effect on, among other things, functional ability and readmissions. A study from Herlev Hospital, where the effect of a nutritional treatment upon discharge of older patients was investigated, showed a significant effect on muscle strength, quality of life and nutritional status. Another study from Herlev Hospital has shown that by associating a clinical dietitian with a liaison team and thus focusing on nutrition, the readmission rate was halved.

The problem is that it has not been investigated whether such a cross-sectoral effort can be implemented in practice and the results confirmed.

Hypothesis 1 is that it is possible to include and retain the older patients who are discharged with the liaison team for an effort that includes treatment of the risk of malnutrition and that the older participants find the effort relevant

Hypothesis 2 is that nutritional treatment will be able to reduce the number of unintended readmissions and thereby be cost-effective. Furthermore, it is expected that the nutritional treatment will increase the participants' nutritional status, muscle strength, muscle mass, quality of life and possibly have a positive effect on mortality.

Eligibility Criteria:
Inclusion Criteria:

Prescription of the Liaison team At nutritional risk according to NRS2002 Age 50+ Can read, hear and understand Danish or English Cognitive able to participate in the study, based on whether they are informed in time, place and own data

Exclusion Criteria:

Receives enteral or parenteral nutrition Following a special diet including texture modified food and drinks Short life expectancy Not deemed eligible by the project staff
LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction

The study will assess the effects of 36 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented stable chronic heart failure (NYHA II-IV):

  * LVEF ≥ 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography)
  * the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction.
* Plasma NT-proBNP \> 500 pg/ml at Visit 1.
* Patients with documented stable chronic heart failure (NYHA II-IV).
* Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit 1.
* Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted).
* Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2).
* Patients with at least one of the following symptoms at the time of screening (Visit 1):

  * Dyspnea on exertion
  * Orthopnea
  * Paroxysmal nocturnal dyspnea
  * Peripheral edema
* Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
* Patients with a potassium ≤5.2 mmol/l at Visit 1.

Exclusion Criteria:

* Patients with a prior LVEF reading \<45%, at any time.
* Patients who require treatment with both an ACE inhibitor and an ARB.
* Isolated right heart failure due to pulmonary disease.
* Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity.
* Presence of hemodynamically significant mitral and /or aortic valve disease.
* Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
* Presence of hypertrophic obstructive cardiomyopathy.
* Other protocol-defined inclusion/exclusion criteria may apply
A Trial of an Online Mindfulness Based Programme for Informal Caregivers of People With Chronic Illnesses

This is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses

The primary aim of the project is to pilot test the delivery of an online Mindfulness Based Stress Reduction (MBSR) programme to informal caregivers of people with chronic illnesses in one region in Ireland so as to determine the feasibility of delivering the intervention to caregivers in Ireland.

A two-group randomised pilot-feasibility trial comparing the online MBSR programme (intervention) with no programme (control). The MBSR programme is delivered online over 8 weeks. Weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. Participants are encouraged to practice mindfulness exercises and homework between sessions. The online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. The study sample are caregivers in the Dublin region who are members of Family Carers' Ireland. A total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator.

Baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and QoL) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. Other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. Feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. Mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and QoL.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age and over
* Provide unpaid care to an adult or child with a chronic illness
* Not suffer from a severe mental illness
* Be ready to commit to the course at this point in their lives.

Exclusion Criteria:

* Caregivers who are under the age of 18 years.
* Caregivers who have a serious mental illness, such as severe anxiety/depression.
* Caregivers who are in receipt of current and regular treatment from a psychologist or psychiatrist.
* Caregivers with an active or recent physical addiction to alcohol or drugs.
* Caregivers who are already engaged in similar research.
* Caregivers who have already participated in mindfulness based stress reduction (MBSR) or MBCT training.
Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat

The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.


Eligibility Criteria:
Inclusion Criteria:

Participants will be physically active males and females between the ages of 18 and 45. Participants will be able to run continuously for at least 60 minutes. All will be able to speak and read English.

Exclusion Criteria:

1. non-English speakers, prisoners, pregnant women, or persons requiring a LAR will not be included
2. previous history of heat stroke or heat illness
3. currently experiencing a sunburn or other burn injury
4. have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment
5. has resided in a hot climate within 2 months prior to the trial
6. answered "yes" to at least one question on the physical activity readiness questionnaire,
7. show signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire
8. are a current smoker,
9. history of regular gastrointestinal distress,
10. known history of stomach ulcers or taking blood thinning medication,
11. known allergy to caffeine
12. have a resting blood pressure greater than 140 systolic or 90 diastolic, and
13. do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.
Characteristics and Medical Resource Utilization of Postoperative Patients

The objective of this study is to assess and analyze the characteristics and usage of conventional and Korean medical services in postoperative patients. This study therefore investigates the proportion of patients with a history of surgery out of patients visiting a spine-specialty Korean medicine hospital, and the prognosis and preference for conventional and Korean medicine treatment by previous treatment history in postoperative patients.

A considerable number of patients suffer prolonged chronic pain that does not retract or diminish after surgery, and are thus unable to achieve the desired results in receiving surgical treatment. Postoperative pain is gradually being perceived as a social issue as opposed to a personal health condition. Meanwhile, although efforts to address chronic pain with integrative medicine are continued in answer to the lack of success of pain management through surgery, there is still a lack of supporting evidence.

The objective of this survey study is to assess the characteristics, usage of conventional and Korean medical services, and prognosis by period before and after surgery in postoperative patients visiting a Korean medicine hospital, and analyze the associations between the preference for conventional and Korean medicine treatment. This study therefore investigates the usage of conventional and Korean medical services in postoperative patients, and is expected to provide information that will potentially aid patient decision making.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chief complaint(s) of at least one or more of the following: low back pain (or radiating leg pain), neck pain (or radiating arm pain), knee pain, or shoulder pain
* Patients with a history of musculoskeletal surgery related to the chief complaint(s)
* Patients capable of effective communication with the researcher(s) and understanding the survey items
* Patients who have given written informed consent

Exclusion Criteria:

* Patients without a history of musculoskeletal surgery associated with the low back, neck, shoulder, or knee region(s)
* Patients whose current pain is mainly attributed to traffic accident injury
* Patients incapable of answering the researcher interviews and surveys
* Patients with other reasons rendering study participation inappropriate as judged by the researcher(s)