cyrilzakka/clinical-trials huggingface dataset:
Registry Study of Assistive Devices, Medicines and Healthcare Measures in ALS, SMA and Other Neurological Diseases.

This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with Amyotrophic lateral sclerosis (ALS), Spinal muscular atrophy (SMA) and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes.

This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with ALS, SMA and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes. The collected data include clinical characteristics, medical history, assessment scales, such as ALS functional rating scale-revised (ALSFRS-R), prognosis indicators, such as ALS progression rate, biomarker data, such as serum Neurofilament light chain (sNfL), genetic data, such as the mutation status of SOD1, FUS, c9orf72, TARDBP in ALS, SMN1 in SMA patients, innovative drugs such as Tofersen, Nusinersen, Risdiplam, as well as symptomatic drugs, patient-reported outcome data being captured using questionnaires and established clinical scales on medication expectation and treatment satisfaction.

Eligibility Criteria:
Inclusion Criteria: Diagnosis of a chronic neurological disease -

Exclusion Criteria: Lack of cooperation and unwillingness to store and share medical data collected in the registry study

-
A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia

Uncontrolled diabetes is associated with increased risk for micro-vascular complication. Hypoglycemia is one of the major barriers in achieving good glucose control. Hypoglycemia is associated with a range of unpleasant symptoms including palpitations, tremor, hunger, sweating, confusion, difficulties in thinking as well as other idiosyncratic symptoms. Fear of hypoglycemia (FOH) refers to phobic avoidance reactions associated with hypoglycemia FOH may increase behavioral attempts to avoid hypoglycemia including decreased consumption of insulin and/or increased consumption of carbohydrates, resulting in poor glycemic control and an increased risk of diabetic complication. In this study, the investigators present a novel system, which simultaneously employs BioFeedback and Virtual Reality in order to cope with fear of hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patient, male and females above the age of 18.
* Patients with significant fear of hypoglycemia as indicated in the HFS-W (equals or greater than 3 on at least one of the item on the HFS-W ).

Exclusion Criteria:

Patient with severe hypoglycemia event in the last 6 months will be excluded. Patient with mental illness will be excluded
Ventilator Hyperinflation and Manual Rib Cage Compression

This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.

Ventilator hyperinflation is widely used in hypersecretive patients. It consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. Thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. Patients were evaluated through compliance and resistance of the respiratory system.

Eligibility Criteria:
Inclusion Criteria:

* patients under mechanical ventilation
* diagnosis of pulmonary infection
* hypersecretive

Exclusion Criteria:

* haemodynamic instability (heart rate \> 130 bpm and mean arterial pressure \< 60 mmHg)
* acute bronchospasm
* acute respiratory distress syndrome
* untreated pneumothorax
Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma (HCC)

The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).

Primary Objectives:

1. To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma
2. To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection

Secondary Objectives:

1. To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma
2. To monitor the serum cytokine and expression level of tumor markers such as AFP, CEA and GPC3
3. To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells

Eligibility Criteria:
Inclusion Criteria:

* Expected to survive more than 3 months
* PS 0-2
* Immunohistochemistry was confirmed to be GPC3 positive hepatocellular carcinoma
* Patients with no ability to receive TACE combined with sorafenib
* WBC\>3.5×1e+9/L,Hb\>90g/L,PLT\>75×1e+9/L
* HBV DNA copy number less than 100/ml
* ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L
* Understand this test and have signed informed consent

Exclusion Criteria:

* Hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
* Decompensated liver cirrhosis, liver function Child-pugh C grade
* Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
* Long-term use of immunosuppressive agents after organ transplantation
* Screening indicated that the target cell transfection rate was less than 30%
* Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization
* Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization
* Pregnant or lactating subjects
* In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
* Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study
Genetic Expression Alteration Affect on Lateral Neck Node Metastasis of Thyroid Papillary Microcarcinoma : Microarray Analysis

In this study, the investigators look at the genetic expressional alteration which influenced on the early lateral neck node metastasis in thyroid papillary microcarcinoma.

Papillary thyroid carcinomas (PTCs) measuring 1.0 cm or less in diameter were defined as papillary thyroid microcarcinomas (PTMCs) by the World Health Organization (WHO), emphasizing on their benign behavior, probably of little clinical significance, which do not affect patients' survival. However, some reported that PTMCs may have aggressive behavior, can cause locoregional recurrences, cervical lymph node metastases, and even distant metastases. But till now, the characteristics of PTMCs with early lateral neck node metastasis were only reviewed and described by the clinicopathological parameters, and no analysis of PTMCs by the gene level is available. In these study, we investigate the genetic expressional alteration which influenced on the early lateral neck node metastasis in thyroid papillary microcarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* age≥20 years old
* Conventional type papillary thyroid microcarcinoma (0.5cm≤tumor size≤1.0cm)
* group 1: no lymph node metastasis /group 2: with lateral neck node metastasis

Exclusion Criteria:

* tumor with capsular invasion (T3 tumor)
* distant metastasis
* combined underlying thyroiditis
Risk Prediction Models for Adverse Maternal and Neonatal Outcomes in Preeclampsia

This proposal describes a single centre retrospective cross-sectional study which will address the need to further develop and test statistical risk prediction models for adverse maternal and neonatal outcomes in low-resource settings; this will be the first such research to be carried out in Zimbabwe.

Hypertensive disorders in pregnancy are a leading cause of maternal and perinatal morbidity and mortality, especially in low-resource settings. Identifying mothers and babies at greatest risk of complications would enable intervention to be targeted to those most likely to benefit from them. However, current risk prediction models have a wide range of sensitivity (42-81%) and specificity (87-92%) indicating that improvements are needed. Furthermore, no predictive models have been developed or evaluated in Zimbabwe.

This proposal describes a single centre retrospective cross-sectional study which will address the need to further develop and test statistical risk prediction models for adverse maternal and neonatal outcomes in low-resource settings; this will be the first such research to be carried out in Zimbabwe.

Data will be collected on maternal demographics characteristics, outcome of prior pregnancies, past medical history, symptoms and signs on admission, results of biochemical and haematological investigations. Adverse outcome will be defined as a composite of maternal morbidity and mortality and perinatal morbidity and mortality. Association between variables and outcomes will be explored using multivariable logistic regression.

Critically, new risk prediction models introduced for our clinical setting may reduce avoidable maternal and neonatal morbidity and mortality at local, national, regional and international level.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be included in the study if they have a diagnosis of severe preeclampsia.
* Severe preeclampsia will be defined as high blood pressure (systolic blood pressure (SBP) ≥160, diastolic blood pressure(DBP) ≥110mmHg) and or either severe headaches, epigastric pains and deranged biochemical/haematological blood indices.
* Both singleton and twin/higher order pregnancies will be included.

Exclusion Criteria:

-Women with mild or moderate preeclampsia or less than 20 weeks' of gestation and those with epilepsy will be excluded from the study.
PERMA-Based Intervention on Negative Emotions, Adherence, and Complications in Postoperative Glioma Patients

The goal of this clinical trial is to evaluate whether a PERMA-based integrated psychological intervention can reduce negative emotions, enhance treatment adherence, and decrease the risk of complications in postoperative glioma patients.

The main questions it aims to answer are:

Can the PERMA-based psychological intervention significantly improve anxiety and depression scores in postoperative glioma patients? Does the intervention improve treatment adherence, reduce complications, and enhance quality of life compared to standard care? Researchers will compare an observation group receiving the PERMA-based psychological intervention to a control group receiving standard postoperative care to see if the intervention improves patient outcomes.

Participants will:

Receive either standard postoperative care (control group) or PERMA-based psychological intervention for one month (observation group).

Be assessed on:

Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS). Treatment Adherence Scale and Complication Record Form. Quality of Life Scale. Be followed for complications using Kaplan-Meier survival analysis.


Eligibility Criteria:
Inclusion Criteria:

* ①Meeting the relevant diagnostic criteria from the 5th edition of the World Health Organization Classification of Central Nervous System (CNS) Tumors, and confirmed through postoperative pathological examination;
* ②Underwent surgical treatment;
* ③Clear consciousness, with good communication ability, and capable of cooperating with healthcare personnel to complete the study;
* ④Complete clinical data.

Exclusion Criteria:

* ①Concurrent diagnosis of other malignant tumors;
* ②Coexisting cognitive impairment or other psychiatric disorders;
* ③Combined liver or kidney dysfunction, immune system disorders, or other severe diseases;
* ④Presence of infectious diseases;
* ⑤Pregnant or breastfeeding women.
Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)

The purpose of this study is to investigate inherited genetic factors that play a role in the development of familial pulmonary fibrosis and to identify a group of genes that predispose individuals to develop pulmonary fibrosis. Finding the genes that cause pulmonary fibrosis is the first step at developing better methods for early diagnosis and improved treatment for pulmonary fibrosis. The overall hypothesis is that inherited genetic factors predispose individuals to develop pulmonary fibrosis.

Familial Pulmonary Fibrosis (FPF) is a sub-category of the idiopathic interstitial pneumonias (IIPs). IIPs are progressive lung conditions, with limited treatment options and unknown etiology. Though the IIPs have been associated with both genetic risk factors and environmental exposures, the molecular mechanism underlying disease progression remain poorly understood. This investigation seeks to identify a group of genetic loci that play a role in the development of familial interstitial pneumonia (FIP) or FPF, where 2 or more cases of IIP are seen within a family.

Eligibility Criteria:
Inclusion Criteria:

* Two or more family members with a clinical diagnosis of Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)
* Additional family members may be eligible to participate if two family members are suspected of or diagnosed as having Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)

Exclusion Criteria:

* Individuals whose pulmonary fibrosis is due to a known cause rather than idiopathic
* Individuals whose pulmonary fibrosis is due to a broader genetic syndrome
Post Concussion Symptoms Risk Stratification Tool

Patients with Persisting Concussion Symptoms (PCS) have a multitude of different symptoms. Some patients are at risk of prolonged symptoms but currently there is no tool to assist in identifying patients at high risk. Intensive, multidisciplinary intervention is time-consuming and expensive and may not be warranted for all PCS patients, so it is essential to identify early on which patients are at risk of prolonged symptoms. The aim of this study is to improve the quality of care delivered to patients, especially those who are at high-risk of prolonged PCS by early identification and treatment of all the symptoms. The purpose of this research is to validate the use of a Persisting Concussion Symptoms (PCS) Risk Stratification Tool (RST).

The information from 500 hundred concussion patients were used to develop the PCS RST. This is a screening tool that will assist in predicting patient outcomes by allocating patients with PCS into a low, medium and high risk group for prolonged PCS symptoms. This categorization would help target those patients at high risk of prolonged symptoms with a multidisciplinary individualized treatment and evaluate the effectiveness of it on return to work and recovery. For this research study, we ask workers who have had concussions and are categorized as high high risk (with PCS RST) for prolonged PCS symptoms to undergo individualized treatments and we will examine their recovery and return to work.

The study will involve 75 patients with persisting concussion symptoms from the Canadian Concussion Centre clinics and Altum Health concussion clinic at Toronto Western Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-60 years old
2. Clinical diagnosis of PCS for 1-12 months with at least 3 symptoms
3. Must be employed at time of injury
4. Full-time or part-time worker prior to concussion and cannot return to work
5. Must speak English and be sufficiently literate to complete questionnaires and perform assessments
6. Must be able to give consent

Exclusion Criteria:

1. Abnormalities on MRI such as contusion, hemorrhages, siderosis, or other non-traumatic conditions
2. History of neurological conditions (e.g. stroke, seizures) or major psychiatric disease
Effect of Prolotherapy in Knee Osteoarthritis.

Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .

Aim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.

Sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain X-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done.

The intervention:

1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done.
2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose.

   * Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals.

Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .

Eligibility Criteria:
Inclusion Criteria:

* Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III)
* consent obtained

Exclusion Criteria:

* Early Knee osteoarthritis (KL grade I)
* Severe Knee osteoarthritis (KL grade IV)
* Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases.
* received oral or systemic steroids 1 year prior to the procedure
* received intra-articular steroids or hyaluronic acid 1 year prior to the procedure
* BMI \>45Kg/m2
* poorly controlled diabetes mellitus, on anticoagulation therapy, history of cancer
A Psychoeducational Intervention for Brain Awareness, Metacognition, Self-efficacy and Treatment Motivation

The aim of this study is to examine the effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders. It is an experimentally designed study with a randomized control group and repeated measurements (pre-test, mid-test, post-test).

The aim of this study is to examine the effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders. It is an experimentally designed study with a randomized control group and repeated measurements (pre-test, mid-test, post-test). 77 inpatients at the Alcohol and Drug Addiction Treatment and Research Center included between April and October 2021. In addition to standard treatment, psychoeducation and counseling provided as part of the Brain Awareness Intervention for the experimental group of 39 patients. The control group of 38 patients will receive education about Being Healthy in addition to standard treatment and standard follow-up. Patients' pathological metacognitive activities, self-efficacy perceptions and treatment motivation will assessed with the Metacognition Scale-30, Self-Efficacy Scale and Treatment Motivation Questionnaire using one-way and two-way repeated measures analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 18-65 and able to read and write
2. Inpatient treatment with alcohol or substance abuse problem
3. To not have a psychiatric (severe depression, bipolar disorder or psychosis) or mental illness that would prevent participation in the study

Exclusion Criteria:

1. Failure to participate in more than one session despite agreeing to participate in the research
2. Taking the decision to terminate treatment or early discharge by violating treatment rules during the treatment process
3. Not participating in post-discharge follow-up or post-test application
Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

The purpose of this study is to determine the effects of belatacept on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam


Eligibility Criteria:
Inclusion Criteria:

* BMI 18 to 30 kg/m2
* Men and women ages 18 to 45

Exclusion Criteria:

* Active tuberculosis
* Any recent infection requiring antibiotic treatment within 4 weeks of dosing
* Positive urine screen for drugs of abuse
A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CML

Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose is not yet determined and randomized studies addressing this question are on-going. First results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for patients treated with imatinib high dose. Recent studies revealed that initial Imatinib plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).

Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.

Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (\> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient ≥ 18 years
2. Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (≤ 4 months) in first chronic phase.
3. Not previously treated with tyrosine kinase inhibitors other than imatinib
4. Prior treatment with imatinib during less than 13 weeks
5. Signed written inform consent
6. Women of childbearing potential (WOCBP) must be using an adequate method of contraception

Exclusion Criteria:

1. Patients with BCR-ABL positive, Philadelphia negative CML
2. Patient previously treated with TKI other than imatinib
3. Pregnancy
4. Active malignancy
5. Concurrent severe diseases which exclude the administration of therapy