cyrilzakka/clinical-trials huggingface dataset:
Changes of Pain and Functional Parameters in Back Pain Patients Over Time

Back pain affects patients' daily life. Patients can suffer from various symptoms which appear intermittent or permanent; pain, sensory malfunction, reduction of muscular strength and coordination. Therefore, patients are impaired in participation and activity.

Physiotherapy is recommended to improve those symptoms and to positively affect the cause of the problem. However, some patients do not benefit from physiotherapeutic treatment and require a surgery.

The investigators intend to attend patients suffering from back pain and to document the changes of pain and functional parameters over a period of 6 months. The investigators include pre-operative, post-operative or non-operated patients which allows to discuss the different treatment options and its effects.

To assess pain and functional parameters physicians, medical staff and physiotherapist often use subjective clinical testings which impede the comparability of testings over time, between testers and between subjects.

Therefore, a second aim of this study is to evaluate each subjective clinical test with a standardized objective measurement tool.

Eligibility Criteria:
Inclusion Criteria:

* appointment at the neurosurgery department due to back pain
* German speaking
* willingness to see a physiotherapist
* willingness to participate in 3 measurements over 6 months

Exclusion Criteria:

* no appointment at the neurosurgery department due to back pain
* not German speaking
* no willingness to see a physiotherapist
* no willingness to participate in 3 measurements over 6 months
Physical Activity on Prescription and Enhanced Individual Support by Physiotherapist

Multimorbidity is common, especially in the elderly population and is associated with a higher risk of mortality and disability, lower quality of life, polypharmacy, increased healthcare use and costs. Physical inactivity increases the risk of multimorbidity and individuals with multimorbidity are more likely to be physically inactive. Physical activity can prevent and treat several diseases. Physical Activity on Prescription (PAP) is an evidence-based method used in health care to increase physical activity. The aim of this study was to investigate whether self-reported physical activity level increase and sedentary time decreases in individuals who have received PAP in health care completed with enhanced individual support by physiotherapist at PAP-reception in wellness center for six months and to compare individuals with one diagnosis to individuals with multimorbidity.

The study population consisted of 331 adults who received PAP in health care and enhanced individual support by a physiotherapist at PAP-reception during six months. Data has been collected retrospectively from a local register with questionnaires from the PAP-reception. Self reported physical activity minutes/week and hours of sedentary time/day were measured at baseline and at six months. Differences in physical activity minutes and sedentary time from baseline to six months have been compared between individuals with one diagnosis and individuals with multimorbidity.


Eligibility Criteria:
Inclusion Criteria:

* Received physical activity on prescription from health care
* Contact with PAP-reception

Exclusion Criteria:
Persistence of Immune Response After Vaccination With Influenza Vaccine

This clinical study will be performed in subjects aged 12-60 years old enrolled in NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination.

Subjects were previously vaccinated at 12 to 60 years of age with 2010 seasonal influenza vaccine.The persistence phase starts 24 months after the primary vaccination and blood samples will be taken at 6, 12, 18 and 24 months after primary vaccination. Subjects whose antibody titer less than 1:40 at 6 months after primary vaccination will receive a booster dose of influenza vaccine.

Eligibility Criteria:
Inclusion Criteria:

* aged 12-60 years old
* male or non-pregnant female
* volunteers received 2010 seasonal influenza vaccine
* clinically healthy as determined by: medical history inquiring and physical examination
* provide written informed consents before joining the trial

Exclusion Criteria:

* without history of 2010 seasonal influenza vaccine administration,
* allergic to any ingredient of vaccine,
* autoimmune disease or immunodeficiency,
* severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain,
* severe acute and chronic diseases
* axillary temperature over 37.0℃ at the time of vaccination.
Comparative Pharmacokinetics of Two Different Oral Delivery Systems of Cholecalciferol

The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.

Deficiency of Vitamin D is highly prevalent in all sectors and regions of Pakistan. Its effects encompass multiple pluripotent physiological impacts on human body, including its classical action on bone health and immune modulation. Health care workers are routinely prescribing supplementations to correct the deficiencies. Different forms of Cholecalciferol are available in the market. It ranges from absorba liquids, drops, tablets, softgels to injectable and oral ampoules. Different delivery systems offer different advantages, challenges and efficacies specific to their specific pharmacokinetics. The aim of this study is to adapt the gold standard of research and to explore the comparative bioavailability and clinical efficacy of the two most commonly used forms of Cholecalciferol i.e. ampoules and softgel capsules.

Eligibility Criteria:
INCLUSION CRITERIA:

1. Adult (20-70 years of age)
2. Vitamin D deficiency (serum 25(OH)D \< 20 ng/ml)
3. Permanent employees of Medicine ward of Holy Family Hospital, DHQ, BBH hospitals and RMU for easy follow up throughout the study duration
4. Willingness and availability to show-up in the follow up visit and serum testing throughout the study period as needed

EXCLUSION CRITERIA:

1. Vitamin D sufficiency or moderate deficiency (serum 25(OH)D \> 20 ng/ml)
2. Pregnant ladies
3. Participants already taking Vitamin D supplementation, anti-convulsants, barbiturates or steroids
4. Subjects with granulomatous conditions, liver disease, kidney disease, or diabetes
Study of the Effect of Fostamatinib Upon Cutaneous Inflammation in the Setting of Hidradenitis Suppurativa

A 16 week exploratory, Proof of Concept study to evaluate the effect of Fostamatinib (12 weeks of treatment) upon cutaneous inflammation in Hidradenitis Suppurativa.

Sample size: 20 patients Study duration: 16 weeks

Primary Endpoints:

Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 4 compared to Baseline.

Alterations in Gene Expression Profiling, cell counts (CD3+, CD11c+, Neutrophil Elastase+, CD20+, CD138+) at Week 12 compared to Baseline.

Secondary Endpoints:

Safety and Tolerability (Grade 2/3 Adverse Effects); Changes in Disease Activity (Measures by AN count and IHS4 scoring).

Study procedures Clinical Examination, Patient Questionnaires, Skin Biopsy, Blood Draw, medical photography

Eligibility Criteria:
Inclusion Criteria:

* Moderate to Severe (Hurley Stage 2 or 3) Hidradenitis Suppurativa as determined by the PI

Exclusion Criteria:

* Uncontrolled hypertension (systolic blood pressure \[BP\] ≥135 mmHg and/or diastolic BP ≥85 mmHg), unstable angina, congestive heart failure of New York Heart Association classification III or IV, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia) at screening.
* History of myocardial infarction within 3 months prior to screening.
* Shock or hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine at screening or at randomization.
* Renal function impairment with creatinine clearance \<30 mL/min at screening (estimated glomerular filtration rate will be calculated using the modification of diet in renal disease equation).
* Liver function impairment with aspartate aminotransferase/alanine aminotransferase \>=3x the upper limit of normal or bilirubin \>2X the upper limit of normal at screening.
* Neutrophil count \<1000/µL at screening.
* History of an allergic reaction or hypersensitivity to the study treatment or any component of the study treatment formulation.
* Has documented HIV infection or documented, active hepatitis B or hepatitis C infection.
* Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
* Individuals with concurrent use of systemic antibiotics/ oral retinoids/ systemic immunosuppressants (those with prior use of these medications must have conducted a washout period of 4 weeks or 5 half-lives of the drug, whichever is longer).
* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

The purpose of this study is to assess the correlation of vascular parameters, including genetic factors as well as ocular blood flow parameters against the progression rate of glaucomatous damage in patients with progressive OAG.

Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. Genes with products that are involved in the regulation of blood flow to ocular tissues may also be considered plausible candidates as a contributory factor in the development of glaucoma. Little is, however, known about a potential association between glaucomatous optic neuropathy and glaucomatous visual field defects and optic nerve head blood flow in patients with progressive open angle glaucoma (OAG). The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 40 years
* Unilateral or bilateral primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) with visual defect, marked by an AGIS score (1994; 1. Study design and methods and baseline characteristics of study patient) of at least 1 but not more than 16 at the screening visit
* At least 3 reliable visual field tests in the eye that will be studied
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Best-corrected visual acuity of 20/40 or better, spherical refraction within ± 3.0 diopters and cylinder correction within ± 3.0 diopters

Exclusion Criteria:

* Evidence of secondary glaucoma, pseudoexfoliation, pigmentary dispersion
* Any form of retinal or neuroophthalmological disease that could result in visual field defects.
* Mean IOP \> 30 mmHg, or any IOP \> 35 mmHg in at least one eye
* History of acute angle closure
* Closed or barely open anterior chamber angle
* Topical or systemical/oral therapy with steroids
* Standard deviation of visual field testing \> 10
* Ocular inflammation or infection within the last three months
* Intraocular surgery or argon laser trabeculoplasty within the last six months
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Ametropia \> 3 dpt
Long-term Management of Patients With Ruptured HCC

The main objective of this work is to evaluate the prevalence and results of specific management of HCC after spontaneous rupture, since the arrival of sorafenib in 2008.

Retrospective, observational, multicenter study over the period from January 2008 to April 2024.

Cases had to be 18 years or older. They were identified by two different methodologies adapted to the 4 participating centers. In particular, a request for ICD10 C22.0 (CHC) codes associated with K66.1 (hemoperitoneum) was carried out by the medical information departments (DIM) of the Caen University Hospital and the Avicenne hospital. Secondly, the automated keyword selection tools "Cohort 360" and "i2b2" were used at the La Pitié Salpetrière and Paul Brousse hospital centers to identify the terms "CHC" and "ruptured" in the computerized patient files. Secondarily, duplicates and coding errors were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Ruptured hepatocellular carcinoma with or without cirrhosis

Exclusion Criteria:

* Liver adenoma without histologically proven HCC
* Other benign or malignant liver tumors
* ATCD of potentially triggering interventional procedure in the previous month.
* Hemorrhagic ascites without tumor
* Intratumoral hemorrhages without hemoperitoneum or capsular rupture
Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease

This study consists of two parts. Part A will evaluate the safety and tolerability of multiple doses of OXB-102 (AXO-Lenti-PD) in participants with Parkinson's disease. Part B will assess the safety and efficacy of the selected dose of OXB-102 in participants with Parkinson's disease.

This study consists of two parts. Part A is an open-label dose-escalation phase in which participants are enrolled in cohorts and will receive one of approximately three escalating doses of OXB-102 (AXO-Lenti-PD). Part B is a randomized, double-blind phase in which participants will be randomized to either an active group receiving the selected dose from Part A, or to a control group receiving an imitation surgical procedure (ISP).

Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosed with bilateral idiopathic PD
2. Males/females between 30 and 70 years at the time of surgery
3. Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) score of between 30 and 60 in the "OFF" medication state
4. Presence of motor fluctuations and/or dyskinetic movement
5. Candidate for surgical intervention
6. Hoehn and Yahr (H\&Y) Stage 3 or 4 in the "OFF" medication state
7. Stable dosing of PD medication, including L-DOPA, for four weeks prior to screening with Levodopa equivalent daily dose (LEDD) of at least 900 mg

Key Exclusion Criteria:

1. History of psychosis or current treatment with dopamine blocking agents and prior regular exposure to antipsychotic agents
2. History of stereotactic or other surgery for the treatment of PD, including Deep Brain Stimulation (DBS)
3. Participation in a prior cell or gene transfer therapy study
4. Contraindications to use of anaesthesia
5. Current or anticipated treatment with anticoagulant therapy or the use of anticoagulation therapy that cannot be temporarily stopped around the time of surgery
6. Diagnosis of multiple system atrophy
7. Abnormal MRI findings such as mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumours, vascular diseases, trauma or arteriovenous malformations
8. Presence of dementia
The Effectiveness of Dental Health Home Visits on Caries Prevention in Young Children

Tooth decay affects 75% of Malaysian preschool children, most of which remain untreated. Untreated decay can cause pain, and impair nutritional status and physical growth. In 2012, nearly 4,000 children in Malaysia were referred for hospital paediatric dental services because of early childhood caries. The realistic management of these children would have been treatment under general anaesthesia or sedation, at considerable cost to the state, and distress to the children and families. The amount of dental disease in young children who have been referred to the hospital children's dentistry service for severe caries is disturbing, particularly given the fact that each district has a dental clinic and that the water is very likely to be fluoridated. It is unlikely that there will ever be enough dental clinics and dental practitioners to manage the amount of disease. Clearly, existing health services need to be supplemented with a population-based approach to promote child oral health. The investigators, therefore, propose a community trial study to investigate the effectiveness of a dental health visiting service for caries control in young children. It is likely that such a home-based intervention is influenced by the family dynamics in which the child lives. The investigators further propose to assess the cost-effectiveness of dental home visits (DHVs). Health economic evaluation can be used to assess health services to ensure there is cost-efficient resource allocation. Economic evaluation is defined as the comparative analysis of alternative courses of action in terms of both their costs and consequences. A health intervention is considered cost-effective when it produces acceptable costs and health benefits. Economic data are now recognized as important due to the fact that dental disease is very common and expensive for the health care system.

This study was conducted in collaboration with the National Oral Health of Pre-school Survey (NOHPS), in which a sub-sample will be followed up for two years. The NOHPS is a national survey of the oral health of 5-year-olds that takes place every 10 years.

This is a randomized controlled trial to assess the cost-effectiveness of home-based DHVs with families of children at high risk of caries in caries prevention compared to children receiving oral health information in the form of an education leaflet (ELs) alone. A collaborative project with the Oral Health Division (OHD) at the Ministry of Health is proposed. The OHD will provide access to a sub-sample from the National Oral Health Preschool Survey (NOHPS), with clinical dental health data.


Eligibility Criteria:
Inclusion Criteria:

* All the children age of 5 or 6-year-old with parents' consents to participate from these kindergartens will be included as the subjects of this study

Exclusion Criteria:

-
Impact of Energy Drink Brands on Heart Rhythm

To assess the cardiac effects of energy drink brands in healthy volunteers

Energy drinks are widely available and globally consumed. There are many brands of energy drinks on the market, and there are differences in the ingredients included. Previous studies have tried to evaluate the safety of energy drinks and have demonstrated a signal for some electrocardiographic (ECG) and hemodynamic effects. However, product related differences need further exploration. This study is designed to assess the effects of 2 different energy drink products on heart rhythm and blood pressure in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adults 18 - 40 years old
* Participants must be willing to refrain from caffeine and alcohol use ≥48 hours prior to sessions on Day 1, 8, and 15

Exclusion Criteria:

* Presence of any known medical condition confirmed through participant interview
* QTc interval greater than 450 milliseconds (ms).
* Blood pressure greater than 140/90 mmHg.
* Current smokers
* Concurrent use of prescription, over-the-counter (OTC) or herbal supplements taken on a daily basis (except oral contraceptives).
* Pregnant or currently breast-feeding
Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients

This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries.

The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

The opioid epidemic continues to create a lasting impact on society, leading researchers to focus on ways to decrease opioid prescription rates and subsequently, opioid consumption. Opioid-naïve patients undergoing minor to major surgeries have been shown statistically to be largely affected.1 This includes significant numbers resulting from forefoot surgery specifically with around 6.2% of the mentioned population being at risk for new persistent opioid use.

This has provoked researchers to seek a new route that decreases exposure to opioid use through proposals for multimodal pain regimes.

A recent addition to some of these proposed treatments has been a 6-day low-dose oral methylprednisolone taper beginning on the day of surgery. This has been tested with "terrible triad" elbow injuries, distal radius fractures, and total shoulder arthroplasties with promising results showing decreased consumption of the as-needed opioid prescription. Furthermore, the results of these studies show a significant decrease in pain and increased range of motion following surgery. This is likely due to the anti-inflammatory functioning of glucocorticoids, without inhibiting the healing process.

Based upon the findings stated above, the proposed research will attempt to apply this new pain regime to foot and ankle surgeries, specifically forefoot, ankle, and Achilles surgeries, to take another step towards bettering perioperative care with opioid-free treatment

Eligibility Criteria:
Inclusion Criteria:

-Emory Orthopedic patients undergoing foot and ankle surgery

Exclusion Criteria:

* Concurrent or significant injuries to other bones or organs
* Local infections
* History of alcohol or medical abuse, including prior opioid abuse
* Smoking
* History of severe heart disease, renal failure, liver dysfunction, active peptic ulcer disease, diabetes, rheumatoid arthritis, neurological or psychiatric diseases that could influence pain perception
* Pre-existing immune suppression
* Those deemed possibly non-compliant by the study team and,
* All vulnerable populations (those unable to give consent, juveniles, pregnant women, prisoners, cognitively impaired and non-English speaking).