cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders

ABSTRACT

Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. Exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. Objectives: The objective of this study is to analyze the effects of workplace muscle strengthening kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. Methods: After a priori sample size calculation based on pain numeric scale, 166 volunterrs will be recruted and assigned randomly to the "labor kinesiotherapy" group (GCL) or to the "control group" (CG), considering 10% sample size lost and intention to treat. The primary outcomes will be the pain perceived by the Numerical Pain Scale (NDT) and Nordic Questionnaire, and isokinetic muscle strength through the mean peak torque work of shoulder abduction. The discomfort and disability will be evaluated by the PSFS and QuickDASH questionnaires. The Ergonomic Analysis of Work will be evaluated by the manual "Ergonomic Analysis Focused on Activities" - EAFA and application of QEC, RULA, REBA and HARM tools. Statistical analysis will be performed through PASW Statistics ™, version 20.0. The independent sample T test will be used to compare the groups. The Cohen index will be set for the effect size calculation. All analyzes will be conducted with 95% confidence interval and p \<0.05 significance.


Eligibility Criteria:
Inclusion Criteria:

* Workers who have or do not have musculoskeletal complaints in the cervical, shoulder, elbow, wrist or hand and / or fingers, without clinical diagnosis and who are not away from their professional activities.

Exclusion Criteria:

* Workers presenting:

  * Pregnancy;
  * Congenital abnormality of the spine and significant musculoskeletal deformities (such as amputation, dysmetria);
  * Severe cervical spine disorders, postoperative conditions in the neck or upper limb region;
  * Uncontrolled cardiovascular disease, cardiac arrhythmia, angina or related symptoms, and postural hypotension or other contraindications to exercise;
  * Workers who engage in some form of regular physical activity involving muscle strengthening and endurance exercises.
  * Workers who have a proven diagnosis of upper limb musculoskeletal dysfunction and are undergoing physical therapy treatment.
Clinical Study of ARD103 CAR-T Therapy for Patients with R/R AML or MDS

This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

The investigational product (IP) for this study is ARD103, a C-type lectin-like molecule-1 (CLL-1) autologous chimeric antigen receptor T-cells (CAR-T). CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and hence other potential myeloid malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic status:

  * Absolute lymphocyte count (ALC) \> 100/mm3
* Adequate renal, hepatic, cardiac and pulmonary function:

  * ALT and AST \< 3.0 × the ULN
  * Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis
  * Total bilirubin ≤ 2.0 mg/dL
* Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test
* Contraception: males and females of childbearing potential must agree to use an effective method of contraception
* Participant is capable of giving signed informed consent

Exclusion Criteria:

* Participants with acute promyelocytic leukemia
* Presence of active and clinically relevant central nervous system (CNS) disorder
* Autoimmune disease requiring immunosuppressive treatment
* Participants with known hepatic bridging cirrhosis
* Currently active infection with hepatitis B or C
* Previous treatment with investigational gene or cell therapy (including CAR therapy)
* Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent)
* Previous chemotherapy including biologic/targeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration
Testing the Effectiveness of the Full and Abridged Relationship Smarts Curriculum for 9th Grade Students

This evaluation will test the program effectiveness of a relationship education program (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on outcomes of knowledge. It will test 1) whether the Relationship Smarts (RS) Curriculum is more effective than a control curriculum of job-readiness programming, and 2) whether an abridged 8-lesson version of the RS Curriculum can be as effective as the full 12-lesson version.

MTCI plans to deliver the Relationship Smarts PLUS (RS+) education curriculum to youth in high schools during the regular school day. RS+ is a widely-implemented healthy relationship education curriculum that aligns with the Georgia Department of Education performance standards in health education. The curriculum features 12 lessons covering such topics as healthy relationships, dating violence prevention, communication skills, conflict management, and decision making. MORE THAN CONQUERORS, INC. (MTCI) plans to deliver the curriculum to 9th grade students as part of a required, semester-long health class. The program will be delivered by trained facilitators from MTCI in coordination with each participating school.

To be eligible to participate, students must be enrolled in one of the targeted health classes and have permission from a parent or guardian to participate in both the MATURE Plus II program and the STREAMS evaluation.The study plans to enroll 1,840 students over the entire two-year evaluation period.

At the start of each semester, the targeted sections of 9th grade health class will be randomly assigned into one of three research groups: (1) a group that receives the full, 12-lesson RS+ curriculum, (2) a group that receives a "summary" 8-lesson version of the RS+ curriculum and four lessons on career planning and job readiness, or (3) a control group that receives lessons on career planning and job readiness without any lessons from the RS+ curriculum.

All students for whom consent and assent have been obtained will be asked to complete three surveys: (1) a baseline survey administered in health class near the start of the semester, (2) a post-program survey administered in health class near the end of the semester, and (3) a one-year follow-up survey administered about 12 months after the baseline survey, during 10th grade

Eligibility Criteria:
Inclusion Criteria:

* high school students in 9th grade health classes
* must be enrolled in one of the targeted health classes
* permission from a parent or guardian to participate in both the program and the evaluation

Exclusion Criteria:

* non-students
* students in other grades of high school
* students not enrolled in health class
* students without parental permission to participate
Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)

The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users.

Reduced activity at certain sites in the brain called "voltage-gated potassium channels", has been linked to hearing problems. The study drug, AUT00063, has been developed to help improve the recognition of speech by aiming to improve the action of the voltage-gated potassium channels in the hearing pathways in the brain and so help to treat the hearing problem.

The main purpose of this study is to find out whether AUT00063 can improve the understanding of speech after 28 days of treatment compared with a placebo (dummy drug which does not contain the study drug) in patients who have received a cochlear implant (CI) for post-lingual deafness.

Efficacy will be investigated through a number of assessments including speech recognition testing, parameters of central auditory processing measured using tests that involve direct stimulation via the CI, and questionnaires.

Safety assessments will also be conducted throughout the study including physical examinations, ECGs and blood sampling.

It is planned that up to 20 people who have received a cochlear implant within the last 9 to 36 months will take part in the study. The people will be recruited from around 4 hospital sites in the UK.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years.
* Native English speaking.
* Received a unilateral cochlear implant within the last 9 to 48 months for post-lingual deafness.
* Less than optimal speech perception at the time of enrolment (defined as a score of 25% to 95% for Bamford-Kowal-Bench (BKB) sentences.
* Fully trained and optimised at the time of enrolment.
* CI device working satisfactorily and no interventions in the 4 weeks prior to the first dose of study medication.
* Signed and dated informed consent.

Exclusion Criteria:

* Not able to understand and comply with the requirements of the study.
* CI undertaken primarily for the management of severe tinnitus.
* Moderate or severe depression or generalised anxiety.
* Currently taking or planning to take medications that are prohibited by the study protocol.
* History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant.
* Clinically significant ECG abnormality or prolonged QT interval.
* Screening laboratory safety test results outside the normal ranges that are deemed to be clinically significant by the investigator.
* Any acute disabling illness.
* Clinically significant alcohol or drug abuse.
* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug.
* For women: Pregnant or nursing.
* For men and women: Not willing or able to use adequate methods of contraception.
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults

The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin products.

This study is about collecting data available in the participant's medical record. No study medicines will be provided to participants in this study. Each participant will fill out a study questionnaire during a routine doctor visit. Blood will be taken from participants who have a higher risk of developing hypersensitivity reactions to immunoglobulin products.


Eligibility Criteria:
Inclusion criteria:

* At least 2 years of age except PID participants with selective IgA deficiency (the lower age limit in this group of participants is 4 years of age).
* Participant has previously received at least one infusion of Gammagard S/D prescribed for any approved indication (PID, B-cell Chronic Lymphocytic Leukemia, Idiopathic Thrombocytopenic Purpura, Kawasaki Syndrome) OR PID participant with IgA deficiency (serum IgA level of \< 7 mg/dL (0.07 g/L) or below the detectable limit in participants older than 4 years) and has received other therapies (prophylactic antibiotics or immunoglobulin treatment other than Gammagard S/D).
* Participant/legally authorized representative is willing to sign an informed consent form or assent form as applicable and is able to comply with the requirements of the protocol.

Exclusion criteria:

-There are no applicable exclusion criteria for this study.
Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing

The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.

Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.

Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.

Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.

Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).

Eligibility Criteria:
Inclusion Criteria:

* Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6 months
* Children with asthma who had at least 3 wheezing attacks in the last 6 months

Exclusion Criteria:

* Chronic lung disease
* Immun deficiency
* Malabsorption
* Anatomic abnormalities of the respiratory tract
* Gastroesophageal reflux disease
Regulation of Lipoprotein Metabolism in Obese Men

Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key characteristics of metabolic syndrome (MetS). Recent evidence has clearly established that the risk of CVD is increased in subjects with the MetS. The precise reason for this remains unclear, but appears to be closely related with dyslipidaemia. Effective management of dyslipidaemia is important to reduce the risk of CVD in these subjects.

Hypothesis: Inhibition of hepatic cholesterol synthesis by statins and triglyceride synthesis by fish oils improve lipoprotein metabolism in visceral obese men.

The study employed a factorial study design, stable isotopy and mathematical modelling to examine the independent and combined effects of decreasing cholesterol substrate availability with atorvastatin and decreasing triglyceride substrate availability with fish oils on lipoprotien kinetics (apoB, apoA, apoC-III and chylomicron remnants) in insulin-resistant men with visceral obesity.

Eligibility Criteria:
Inclusion Criteria:

* Obesity was defined as a waist circumference \>100 cm, waist:hip ratio \>0.97 and BMI \>29 kg/m2.
* Subjects were selected for having insulin-resistance, defined as a homostasis model assessment (HOMA) score (21) \>5.1 (i.e. one SD above the mean for a reference population of 22 lean, normolipidemic healthy males of similar age).
* All subjects had plasma triglyceride \>1.2 mmol/L and cholesterol \>5.2 mmol/L at screening while consuming ad libitum, weight-maintaining diets

Exclusion Criteria:

* diabetes mellitus, apolipoprotein E2/E2 genotype, macroproteinuria, creatinemia, hypothyrodism, or abnormal liver enzymes.
* Subjects did not consume fish oil supplements or drank more than 30g alcohol/day.
* None reported a history of CVD, or was taking medication or other agents known to affect lipid metabolism.
Transcranial Direct Current Stimulation of the Primary Motor Cortex to Treat Levodopa-induced Dyskinesias

The main objective of the study is to evaluate the efficacy of 10 sessions of transcranial direct current stimulation of the primary motor cortex to reduce levodopa-induced dyskinesia


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria and levodopa-induced dyskinesia;
* age between 30 and 80 years;
* ongoing therapy with levodopa;
* fulfillment of requirements for the application of transcranial magnetic stimulation (TMS), assessed by completion of the TMS screening questionnaire.

Exclusion Criteria:

* patients unable to give informed consent;
* cognitive impairment (MMSE ≤ 24);
* history of epilepsy;
* pregnant women.
Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected from each site and conduct programmed cell death 1 ligand 1 (PD-L1) assay and next generation sequencer (NGS) assay for tumor mutation burden (TMB). Based on these data, prevalence of PD-L1, TMB and overall survival (OS), progression free survival (PFS) from start of 1st line treatment in stage IV will be assessed.

In this study, 150 patients will be enrolled from approximately 30 sites in Japan. The patients should have received at least 1 cycle of chemotherapy and never receive immune oncology drug as 1st line treatment in stage IV. The patients will be enrolled continuously from the 1st patient who is enrolled in this study until target number of patients in each site.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20, Japanese men and women.
* Patients who have started at least 1 cycle of chemotherapy.
* Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.
* Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between January 1st in 2017 and December 31st in 2018.
* Patients who have FFPE primary tumor sample collected after January 1st in 2017. The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is possible to send sliced undyed section of primary tumor including 1 HE-stained section of same sample in case that patients cannot send FFPE primary tumor block.

Exclusion Criteria:

-Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
Comparative Evaluation of the Results of Facet Joint Injections

Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location.


Eligibility Criteria:
Inclusion Criteria:

* Patients with facet joint syndrome diagnosis

Exclusion Criteria:

* pregnant patients
* breastfeeding patients
* patients with cardiac pacemaker
The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

To determine changes in retinal and choroidal capillaries with optical coherence tomographic angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous chorioretinopathy (CSC).

PDT was hypothesized to have a primary effect on the choroidal capillaries, and a number of studies have reported choriocapillary damage and choroidal vascular remodeling after PDT. More recently, although OCTA related CSC research has been conducted, no quantitative report has thoroughly investigated the microstructural changes in the superficial, deep retinal and choroidal capillaries after hd-PDT. The purpose of the present study is to determine the changes in the retinal and choroidal capillaries quantitatively with OCTA after hd-PDT in eyes with CSC.

This is a prospective observational study of patients undergoing hd-PDT for CSC with active leakage in retinal pigment epithelium (RPE) and followed for 3 months. Fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were performed at baseline; best corrected visual acuity (BCVA), fundus photography, optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up visit after hd-PDT.

Eligibility Criteria:
Inclusion Criteria:

1. CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT
2. Patient age ≥18 years
3. BCVA ≥35 letters on ETDRS charts
4. Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment
5. Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug
6. The provision of written informed consent -

Exclusion Criteria:

1. The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)
2. Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC
3. Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns
4. Patients with high myopia, defined as a refractive error (spherical equivalent) \< -6.00 diopters, or an axial length \>26.5 mm
5. Patients with media opacities, or signal strength index of the images \< 60
6. Patients under corticosteroid therapy -