cyrilzakka/clinical-trials huggingface dataset:
High-intensity Strength Training in Myositis

This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group.

Overall aim:

To investigate the effect of high-intensity strength training on quality of life, muscle strength, physical function, and disease activity in patients with myositis

Study design:

60 myositis patients will be included in a 16-week high-intensity strength training study. Patients will be randomly allocated into 2 groups (strength training and control) in a 1:1 ratio.

User involvement:

Myositis patients has been recruited to a patient advisory board. The advisory board's objective is to give patient-oriented project feedback, thus improving the overall research project.

Intervention:

Two training session per week for 16 weeks. Sessions consists of 3 sets of each exercise corresponding to 10 RM. Training progression will be accounted for and training loads will be evaluated weekly. The training protocol will be a full-body protocol, i.e. all major muscle groups will be engaged during each training session.

Outcomes:

The primary outcome is the Physical Component Summary Measure from the quality of life questionnaire (SF-36). Secondary outcomes include strength measures, functional tests, disease activity measures, questionnaires (e.g. International physical activity questionnaire), DEXA whole body scans, blood samples and muscle biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling the criteria for myositis by EULAR/ACR (Bottai et al., 2017; Lundberg et al., 2017)
* ≤ 5 mg/day Prednisolone
* Stable dosage of immunosuppressive treatment for at least 1 months prior to inclusion in the study
* Myositis diagnosis at least 6 months prior to inclusion in the study

Exclusion Criteria:

* Patients with sporadic inclusion body myositis and overlap myositis (myositis combined with another autoimmune rheumatic diseases, except Sjögren's Syndrome)
* Co-morbidity preventing resistance training (severe heart/lung-disease, uncontrolled hypertension (systolic \> 160mmHg, diastolic \> 100mmHg), severe knee/hip arthritis)
* Alcohol- and/or drug abuse. Defined by the guidelines issued by The Danish Health Authority
Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes

This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.

The proposed study is a mixed-effects (single-subject ABA repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. The short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults with post-stroke reading difficulties (phonological alexia)
* \>3 months post-stroke
* native English speaker
* can go in MRI scanner (3 to 6 scans),
* participate in 90 to 120 free treatment sessions
* return for 3-month post-treatment follow-up assessment \& MRI.

Exclusion Criteria:

* mental illness
* degenerative disease, visual or auditory acuity impairment
* drug abuse
* English is not first language
* claustrophobia
* pregnancy
Vitamin D and Immunity: Photosynthesis Versus Supplementation

The optimal way to restore serum 25-hydroxyvitamin D sufficiency is currently debatable. UV irradiation through sunshine exposure promotes endogenous vitamin D synthesis, although this can also be associated with a risk of UVR-induced skin cancer. Dietary supplements represent an alternative, which are increasingly being used in clinical trials to correct deficiency. However, it is unclear whether sunshine exposure and vitamin D supplementation induce comparable changes in immune function, or whether additional UVR-induced molecules may be responsible for proposed health benefits. Several studies report an inverse correlation between exposure to UVR and immune-mediated diseases, further supporting the theory that UVR may also be protective through non vitamin-D mediated pathways. So far it has been difficult to distinguish between immune-regulation by vitamin D and other mediators induced by UVR as the downstream effects are similar. A direct comparison of the biological effects of vitamin D obtained by UVR versus supplementation has never been made. This study aims to elucidate the differences in vitamin D generated by UVR exposure versus supplementation by comparing immunological endpoints


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40
* Fitzpatrick skin type I/II
* Healthy
* Serum 25(OH)D3 \<50nmol/L

Exclusion Criteria:

Serum 25(OH)D3 \>50nmol/L

* Pregnant or nursing women
* Women of child bearing age not using adequate contraception
* Are taking photosensitizing medication (i.e. causes you to be more sensitive to sunlight)
* Have had a history of skin disorders, sensitive skin, sensitivity to sunlight or skin cancer
* Have previously had an organ transplant
* Have partaken in a clinical study within the last 14 days
* Have had recent exposure to sunbeds (last 4 months) or holiday sun (including skiing)
* Are currently or have taken vitamin D supplements in the last 4 months Are asthmatic or suffer from any allergies
Non-exposure Simple Suturing EFTR (NESS-EFTR) With Laparoscopic Sentinel Lymph Node Navigation for EGC (Senorita3-phase 2)

Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing endoscopic full-thickness resection, NESS-EFTR) was recently developed.

This is the phase2 study to identify the efficacy of NESS-EFTR with sentinel node navigation in early gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* single lesion of adenocarcinoma in preoperative endoscopic biopsy
* clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
* tumor size: less than 3cm
* location: 3cm far from the pylorus or cardia
* aged 20 to 80
* ECOG 0 or 1
* patient who signed the agreement
* patient who is suspected to underwent laparoscopy assisted gastrectomy

Exclusion Criteria:

* absolute indication of endoscopic submucosal resection
* inoperable due to poor cardiac, pulmonary function
* pregnant
* having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
* diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
Supporting Children's School Readiness.

The aim of this project is to test whether training parents to ask their children 'inference- eliciting' questions during book reading is effective in promoting story comprehension for 4-year-olds from a range of socio-economic backgrounds.

Language comprehension relies on the ability to make local and global inferences (e.g., inferring what a pronoun refers to, or inferring why a protagonist in a story did something based on information distributed through the text). These skills develop in the preschool years and are demonstrated when children make sense of stories that are read to them. While important for later reading ability and academic success, relatively little is known about whether anything can be done to improve inference-making skills in the preschool years. One possibility is that parent-child book reading would help. During book reading, some parents naturally ask their children questions about the story that would require them to make inferences about the text. The current study is designed to test whether doing this promotes children's ability to make inferences. Half the parents in this study will be given books with inference eliciting questions added to them and will be provided with training about how to ask these questions and respond to their children's answers. The other half of the parents will be given a maths exercise book and asked to spend the same amount of time per day working through this.

Eligibility Criteria:
Inclusion Criteria:

Children are:

First born Full term (i.e. born no more than 3 weeks prematurely) With birth weight over 2.5 kg Being raised as monolingual English speakers

Exclusion Criteria:

Neither caregivers nor infants have any significant known physical, mental or learning disability.
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions

The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to ropinirole or any other comparable product.
e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish Trial

To compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish population.

Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.

Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care.

The trials will be conducted in 8 European countries. In Spain the trial will be carried out in routine primary, comparing the clinical and cost-effectiveness of CBT and TAU for adults with major depressive disorder (MDD). Respondents will be followed until 12 months after baseline (measures will be taken at BL, 3 months, 6 months and 12 months).

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
* a score a score of 5 or higher on the PHQ-9 screening questionnaire.

Exclusion Criteria:

* Current high risk for suicide according to the MINI Interview section C
* Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
* Currently receiving psychological treatment for depression in primary or specialised mental health care
* Being unable to comprehend the spoken and written language (Spanish)
* Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
* Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment
Coblation Tonsillotomy Versus Radiofrequency and Cold Knife Dissection Tonsillectomy

This study aims to assess and compare the outcomes between coblation intracapsular tonsillotomy versus extracapsular Radiofrequency and cold knife dissection tonsillectomy efficacy in managing patients requiring tonsil surgery as regards (time of operation, Intraoperative blood loss, postoperative pain, postoperative bleeding, complications, tonsillar fossa healing)


Eligibility Criteria:
Inclusion criteria:

Recurrent Acute tonsillitis Tonsillitis resulting in febrile convulsions Enlarged tonsils that cause upper airway obstruction, dysphagia, sleep disorders Chronic tonsillitis Chronic or recurrent tonsillitis in a streptococcal carrier not responding to beta-lactamase-resistant antibiotics

Exclusion criteria:

Patients with known bleeding disorders Acute infections of tonsil Contraindications for general anesthesia Anemia Patients unwilling or unable to give informed consent were excluded from this study patients
Randomized Controlled Trial of Stress Reduction and Lifestyle Modification for Ulcerative Colitis

Patients with ulcerative colitis often suffer significant limitations to their quality of life, which are also conditioned by particular stress and psychosocial accompanying symptoms of the disease. A multimodal program for stress-reduction and lifestyle-modification has been shown to be effective in promoting the quality of life. The study will examine the promotion of the quality of life of patients with ulcerative colitis and the positive Influence on stress, psychological symptoms and physiological parameters. 92 patients with ulcerative colitis will be randomized in an Intervention group and a control group for 10 weeks. The primary outcome is the disease-specific quality of life, the secondary outcomes are stress, psychological symptoms, inflammatory parameters, disease activity parameters, bowel parameter and the microbiome.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years
* diagnosis of ulcerative colitis
* Currently in remission, remission not longer than 12 months
* limited quality of life or increased subjective stress level

Exclusion Criteria:

* Infectious or chronic active ulcerative colitis
* Taking glucocorticoids or immunosuppressants within the last 3 months, except stable medication using azathioprine
* colectomy
* serious psychological disorder (for example: major depression, addiction, schizophrenia)
* serious comorbid somatic disease (for example: diabetes mellitus, oncological disease)
* pregnancy
* participation in stress reduction program or clinical studies to psychological interventions
Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells

The purpose of this study is to assess the human herpes virus reactivation 6 post autologous stem cells in 196 patients. The aim of our study was to describe the incidence of reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic role in this target population.


Eligibility Criteria:
Inclusion Criteria:

* all patients hospitalized in the Hematology Clinic of Saint-Etienne and Clermont-Ferrand and receiving autologous hematopoietic stem cells, according to the decision of the Consultative Meeting Multidisciplinary service;
* Autologous recipients are included irrespective of causal hemopathy (myeloma, lymphoma, acute leukemia, mainly).

Exclusion Criteria:

* The non-consenting patients or unable to give consent
Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

This pilot clinical trial studies perfusion computed tomography (CT) in predicting response to treatment in patients with advanced kidney cancer. Comparing results of diagnostic procedures done before, during, and after targeted therapy may help doctors predict a patient's response to treatment and help plan the best treatment.


Eligibility Criteria:
Inclusion Criteria:

* Suspected or biopsy-proven renal cell carcinoma
* Treatment planned with sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, nivolumab alone or in combination with an investigational agent
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Serum creatinine greater than or equal to 1.7 mg/dL
* Severe allergy to contrast agent
* Any contraindication for undergoing a CT scan
* Pregnancy or unwillingness to use preventative measures if a woman of child-bearing potential
Outcomes for Patients With Gastro-Esophageal Reflux Disease

Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE), remains highly prevalent worldwide.

GERD poses substantial burden on both patients and society. EE treatment patterns and unmet needs have been well-studied overseas, but evidence gaps still exist in China.

To fill these evidence gaps, real-world evidence for GERD and EE are needed. To understand GERD market we will analysis :Patient profile,GERD patient journey within hospital (first present, get diagnosed, receive initial and maintenance treatment),medication cost,department differentiation.

To investigate current treatment patterns of GERD / EE in China we will analysis: Current agents used and treatment duration in clinical practice treatment patterns by different reimbursement status treatment pattern by EE/NERD.

To get healing rate of EE we will analysis: Real-world efficacy of the current standard treatment (i.e. PPIs) for patient with two test results of gastroscopy.

The data required for this project are accessible in hospital electronic system; no specific data collection tools or methods are required for this project design. Only algorithms for retrieving and extracting eligible patients' records are required and will be developed by HLT based on the eligibility criteria defined in this protocol.


Eligibility Criteria:
Inclusion Criteria:

* Medical records of GERD, NERD and/or EE diagnoses （ICD code scope will be confirmed later）from January 1st, 2015 to December 31st, 2017.

oGERD is typically characterized by symptoms of heartburn and acid regurgitation. A diagnosis of EE or NERD can only be confirmed upon endoscopic examination.

* All ages, males or females
* A primary diagnosis of GERD/NERD/EE

For treatment patterns, patients are also required to have received one episode of treatment during the analysis period.

For RW treatment efficacy, the population will be restricted to the EE treatment population who underwent at least two endoscopy examinations.

Exclusion Criteria:

- No exclusion criteria will be applied for investigating diagnosis since all patients diagnosed with GERD, NERD, or EE should be captured regardless of whether they have medical conditions that affect their treatments.

A patient will not be eligible for investigating treatment patterns and RW treatment efficacy if he/she has any of the following exclusion criterion:

* A post-operative diagnosis of gastrointestinal cancers
* A diagnosis of esophageal foreign bodies or neoplasms
* A history of gastric or esophageal surgery
* Zollinger-Ellison syndrome
* Primary esophageal motility disorders (ex: achalasia)
* Esophageal strictures
* Eosinophilic esophagitis
* Identified as pregnant or lactating
* Hospitalized (inpatient) patients (to be confirmed by expert.) due to GERD as primary or secondary diagnosis
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy

This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.

Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
* Minimum BCVA is required in the study eye

Exclusion Criteria:

* The presence of diabetic macular edema or macular disease in either eye.
* Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
* Uncontrolled diagnosed glaucoma in the study eye