cyrilzakka/clinical-trials huggingface dataset:
The Halland Osteoarthritis Cohort

Osteoarthritis is the most common musculoskeletal disease and is characterized by cartilage destruction, osteophyte formation, subchondral bone sclerosis and cysts. Modern treatment strategies, as well as preventive measures, include early detection and knowledge of the early course of the disease. This includes how stress patterns, physical activity, impaired function and metabolic changes and other comorbidities affect development and possible associations with osteoarthritis.

The overall objective was to study the early development of osteoarthritis of the knee and its association with hand- and general osteoarthritis, metabolic diseases, biomarkers, long-term pain, physical function and stress patterns

The overall objective was to study the early development of osteoarthritis of the knee and its association with hand- and general osteoarthritis, metabolic diseases, biomarkers, long-term pain, physical function and stress patterns.

The project includes 4 different research areas that are studied with the help of several smaller sub-studies:

Research area 1: Metabolic osteoarthritis - to study the connections between metabolic factors and osteoarthritis development in the knee and hand.

A. Relationship between knee osteoarthritis and metabolic factors B. Relationship between osteoarthritis of the hand and metabolic factors Research area 2: Biomarkers in knee and hand osteoarthritis - to study cartilage and bone markers that reflect different processes in osteoarthritis development, e.g. inflammation, matrix degradation both in the short and long term Research area 3: Pain and osteoarthritis - to study pain development and pain pressure thresholds in relation to lifestyle, depression and health-related quality of life in individuals with symptomatic knee osteoarthritis Research area 4: Physical function and osteoarthritis - to study physical function, physical activity and measured stress patterns, as well as changes in stress patterns and the relationship between these and the development of osteoarthritis over time.

Study design This is a longitudinal cohort study including 306 individuals with knee pain in the southwest of Sweden, the Halland osteoarthritis (HALLOA) cohort. The enrolments took place from 2017-2019. The participants were recruited: 1) by primary health care clinics when searching care for knee pain, or 2) by advertisements in local newspapers. The inclusion criterions were current knee pain, aged 30-65 years, with no former known radiographic knee osteoarthritis (RKOA). the exclusion criterions were no cruciate ligament rupture or rheumatologic disorder. A general practitioner examined all participants to confirm the exclusion criteria.

The cohort will be followed for five years with yearly follow-ups.

Eligibility Criteria:
Inclusion Criteria:

Knee pain

Exclusion Criteria:

Cruciate ligament injury and rheumatic disease (RA, PsoA, As, Sponylarthritis etc)
Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy

Numerous studies found that anesthetic methods can influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in clinic for treatment of hepatocellular carcinoma (HCC). Currently, diverse anesthetic methods, including general anesthesia (GA), epidural anesthesia and local anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients randomized to receive either GA or LA during surgery, we investigated the effects of anesthetic methods on proliferation, migration and metastasis in HepG2 hepatic cancer cells in vitro.


Eligibility Criteria:
Inclusion Criteria:

* patients with a single primary liver tumor of 3cm or smaller, who are scheduled for RF ablation surgery

Exclusion Criteria:

* less than 18 or more than 65 years old;
* ASA Physical Status 4 or greater;
* previous surgery in liver (including radiofrequency ablation);
* severe systemic disease (heart, lung, kidney, or immune system);
* INR\>1.5 or platelet count \<45,000 cells/mm3;
* a history of addiction to opioids;
* with known extension beyond the liver;
* Child-Pugh Class C.
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about the drug.


Eligibility Criteria:
Inclusion Criteria:

* Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.

Exclusion Criteria:

* Patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible.
* Patients previously treated with ibrutinib are not eligible.
* Patients enrolled in another interventional clinical study with therapeutic intent are not eligible.
Contribution of the Cerebellum In Sensory-motor Adaptation Via Gamma Oscillations: the Case of Dystonia

Dystonia, a disabling disease with uncontrolled movement disorders was considered to be a manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal and human experiments that the cerebellum plays a prominent role in the pathophysiology of dystonia. Our recent results suggest a deficient cerebellar sensory encoding in dystonia, resulting in a decoupling of the motor component from the afferent information flow resulting from changes in the environment. An overall loss of gabaergic-mediated inhibition is at the forefront in dynamic changes in neural circuitry described in dystonia. In the mature brain gabaergic control the generation of temporal synchronies and oscillations in the glutamatergic neurons. Taken these all together with the results of a pilot experiment, the investigators hypothesize that deficient synchronies in the fast gamma range are one of the key mechanisms leading to abnormal communication inside the cerebello-cortical network in dystonia. The investigators aim first to demonstrate it by means of MEG (Magneto encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma oscillations in the nodes of the cerebello-cortical network. The investigators then aim to re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the cerebellum at high gamma frequency a non invasive transcranial alternative current stimulation.


Eligibility Criteria:
Inclusion Criteria:

* primary upper limb dystonia
* normal physical and neurological examination except for dystonia
* no treatment with botulinum toxin during the three months preceding the study

Exclusion Criteria:

* Writing tremor
* current neurological or psychiatric illness other than dystonia
* uncontrollable medical problems not related to dystonia
* pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
Evaluation of Type I IFN Level and Disease Activity in SLE Patients

Elevated level of IFN type I in SLE patients associated with certain serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, TNF-RII, BAFF, APRIL), clinical and laboratory manifestations, activity and duration pf the disease and SLE patients quality of life. Standard immunosuppressive and anti-B-cell therapy can reduce the IFN type I and associated biomarkers levels in patients with high and moderate disease activity (SLEDAI-2К ≥6).


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years old
2. Patients with SLE (SLICC/ACR 2012) confirmed by rheumatologist
3. Provided written informed consent before any study-related procedures are performed.
4. Ability to attend scheduled visits
5. No positive changes in the course of standard of care SLE therapy (glucocorticoids in stable doses, hydroxychloroquine and/or immunosuppressant therapy) at least 30 days before screening.

Exclusion Criteria:

1. Participation in any other clinical study
2. Pregnancy or pregnancy planning in next 12 months, lactation
3. Acute infectious disease or relapse of chronic infectious disease.
4. Receiving any of biologic agent or Janus-kinases inhibitors during 24 months prior to screening.
5. Active severe or unstable neuropsychiatric SLE manifestations (convulsion, psychosis, delirium, hallucinations, coma, transverse myelitis).
Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes

Eating a diet rich in tomatoes has been associated with decreased risk for a variety of diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments called carotenoids), which has been associated with the decreased risk of disease in those consuming tomato products; however, tomatoes also contain flavonoids, which may also have health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in a different form that in red tomatoes and this contributes to their characteristic orange color. This "orange lycopene" is more similar to the most common form of lycopene found in the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by the body.

The objectives of this study are to determine if carotenoids and flavonoids from Tangerine tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances by the body).

The primary goal of this research is to determine if a processed Tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. This primary objective will be accomplished by quantifying carotenoids from post-prandial triglyceride-rich lipoprotein (TRL) fractions of plasma and flavonoids from whole plasma and urine, after subjects consume a meal containing Tangerine or red tomato juice. A secondary goal is to examine if short-term delivery of bioactives from Tangerine and red tomatoes impact markers of inflammation in humans. This secondary objective will be accomplished by analyzing plasma for both interleukin-6 (IL-6), a marker for inflammation, and RNA to assess alterations in transcription of genes that regulate inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Total cholesterol ≤200 mg/dL
* Triglycerides ≤ 200mg/dL
* BMI 18.5 to 30.0kg/m2
* Not anemic (hemoglobin at or above 10g/dL and hematocrit at or above 30%)
* Age 18-70 years

Exclusion Criteria:

* Lactating, pregnant, or plan to be pregnant during study
* Tobacco (cigarettes and chewing tobacco)
* Metabolic disease, such as diabetes mellitus or thyroid dysfunction
* Malabsorption disorders (e.g. ileus, Crohn's, ulcerative colitis, pancreatic insufficiency)
* History of cancer, esophageal, gastric, or intestinal ulcers
* History of liver or kidney insufficiency or failure
* Auto-immune disorders
* Chronic inflammation (e.g. rheumatoid arthritis)
* Allergies to tomatoes or tomato products
* Obesity (BMI \> 30kg/m2) or underweight (BMI \<18.5kg/m2)
* Hypercholesterolemia (Total cholesterol \> 200 mg/dL)
* Triglycerides \> 200mg/dL
* Subjects taking non-steroidal anti-inflammatory medications (e.g. Aspirin, Advil, Tylenol, Aleve) for 72 hours prior to each day-long visit.
* Anemia (hemoglobin below 10g/dL or hematocrit below 30%)
* Blood donation within the last 8 weeks
Treatment of Primary Type I Pterygia With Argon Laser

Introduction: Pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. Management of pterygium can be medical, surgical or combined. Alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia.

Objectives: To determine whether Argon laser treatment reduces the symptoms and pterygium size in primary type I pterygia patients when compared with medical treatment. Subjects and Methods: Prospective, comparative and interventional study. Patients with type I pterygia in both eyes were included. The eyes were randomly divided to receive either Argon laser treatment or only topical medical treatment

Pterygium is a wing shape degenerative and hyperplastic growth of the bulbar conjunctiva extending onto the cornea, most commonly on the nasal side. Management of pterygium can be medical, surgical or combined. Alternative treatments as photocoagulation of blood vessels of the pterygium, have been described, especially in recurrent pterygia.

To determine whether Argon laser treatment reduces the symptoms and pterygium size in primary type I pterygia patients when compared with medical treatment. Subjects and Methods: Prospective, comparative and interventional study. Patients with type I pterygia in both eyes were included. The eyes were randomly divided to receive either Argon laser treatment or only topical medical treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients who had had symmetric type I pterygia in both eyes
* Assessments for the 6 month follow-up period after argon laser treatment

Exclusion Criteria:

* Patients with diabetes Mellitus, collagenopathies, previous ocular surgeries, and pregnant patients
Extended Oral Tranexamic Acid After Total Knee Arthroplasty

The utilization of intraoperative tranexamic acid (TXA), whether administered intravenously or orally, has become a standard practice in total joint arthroplasty (TJA). Multiple studies have demonstrated the positive impact that TXA application has on clinical outcomes, including decreased blood loss and transfusion rates, decreased early swelling and ecchymosis, improved early recovery, and potentially superior long-term outcomes. Its ability to mitigate risk of blood loss made ambulatory total knee arthroplasty (TKA) safer for patients. The safety of intraoperative TXA use has also been documented. Sabbag et al. showed that TXA does not increase the risk of venous thromboembolism (VTE), even in those patients who are deemed high-risk. Multiple routes of TXA administration have been studied with each route demonstrating effectiveness in reducing blood loss. Findings showed that oral TXA is noninferior to intravenous TXA, though the median time to reach a target concentration is longer via the oral route and bioavailability is lower. With the benefits of intraoperative TXA clearly documented in literature, multiple centers investigated the utilization of extended TXA postoperatively in hopes of enhancing patient safety and reducing length of stay and healthcare cost. However, these studies reported conflicting outcomes and mostly focused on estimated blood loss, instead of patient reported outcomes.

The purpose of this study is to assess the effectiveness and safety of a varying extended oral TXA regimen during the postoperative period. Further, the investigators aim to determine the optimal duration of the TXA regimen to maximize its impact. The investigators hypothesize that an extended oral TXA regimen is safe and effective in improving clinical outcomes in TKA patients.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older.
2. Primary TKA at a Campbell Clinic Surgery Center, with implant at the discretion of the treating surgeon.
3. Willing to participate in the study.
4. Fluent in oral and written English.

Exclusion Criteria:

1. Revision TKA.
2. Preoperative use of anticoagulants (81mg aspirin is allowed).
3. Prior history of deep vein thrombosis.
4. Prior history of cancer (with the exception of non-melanoma/metastatic skin cancers, low-grade non-metastatic benign soft tissue tumors, thyroid cancers and low grade, non-metastatic prostate cancers).
5. Known allergy or hypersensitivity to TXA.
6. Patients who are using combination hormonal contraception.
7. History of seizure disorder.
8. History of adult onset colorblindness.
Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis

The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum (SC) hydratation and barrier function.

In the present study, 24 subjects with AD will be treated for 3 weeks twice daily by using 3 different moisturising creams. Duration of the study is based on literature. Various moisturising creams containing glycerol have been reported to be beneficial for AD lesions. The optimal glycerol content in moisturising creams is not known. The secondary objective is the comparison of change in the SC water content and in the TEWL from the skin surface from the baseline to the end of study between different moisturizing creams containing different amount of glycerol.

Change in the SC water content and in the TEWL can be demonstrated with noninvasive instrumental measurement. The treated skin will be followed up instrumentally, and one measurement area will serve as an untreated control. The primary evaluation is the comparison of change in the SC water content and in the TEWL on the skin surface from the baseline to the end of study between the 4 treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. 18-55 years of age, Caucasian, Finnish speaking, male or female subjects.
3. Weight at least 50 kg.
4. Body mass index (BMI) 18-30 kg/m2.
5. Clinical assessment for the diagnosis of mild or moderate atopic dermatitis

Exclusion Criteria:

1. Any clinically relevant medical condition judged by the investigator.
2. Any known allergy to ingredients of the test treatments.
3. Any systemic immunosuppressive or cortisone medication.
4. UV-Light therapy and sunlight exposure within 30 days prior to the start of the study and during study.
5. Any abnormal physical finding which may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
6. Anticipated difficulty related to stopping of caffeine intake during study centre visits.
7. Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and inability to refrain from the use of nicotine containing products during the study.
8. Recent or current drug abuse or suspected abuse or positive result in screening of drug abuse.
9. Recent or current alcohol abuse (more than 16 units/week for women and more than 21 units/week for men) or suspected abuse.
10. Participation in another clinical study within 30 days prior to the start of the present study.
11. Predictable poor compliance or inability to communicate well with the investigator.
12. Inability to participate in all treatment periods.
13. Pregnant or lactating females.
14. Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilization, spermicidal foam in conjunction with condom on male partner) (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
Cognitive Training in Mild Cognitive Impairment

Older adults (60+ years of age) who meet criteria for mild cognitive impairment and insomnia will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and arousal at baseline, and post-intervention. For cognitive training, participants will be provided with login information to access the computerized training, and will complete 8 weeks (45 mins 3x/week) of cognitive training. For trivia training, participants will receive weekly emails that contain trivia assignments that they will complete for 8 weeks (45 mins 3x/week). We will evaluate short-term (i.e., post-training) effects of the two training conditions on subjective anxiety, sleep, arousal, and subjective and objective cognition.


Eligibility Criteria:
Inclusion Criteria:

1. 60+ yrs of age
2. meet criteria for mild cognitive impairment
3. no neurological or psychiatric illness or dementia
4. non-gamers (\<2 hour of video/brain training games/week over last 2 yrs)
5. proficient in English (reading and writing)
6. meet clinical dx criteria for Insomnia (e.g., insomnia complaints for 6+ months, complaints occur despite adequate opportunity and circumstances for sleep, consist of one of the following: difficulty falling asleep, staying asleep, or waking up too early, and daytime dysfunction due to insomnia)

Exclusion Criteria:

1. unable to provide informed consent
2. unable to undergo randomization
3. other sleep disorder (e.g., sleep apnea, restless legs syndrome)
4. severe untreated psychiatric comorbidity
5. psychotropic or other medications that alter sleep (unless stabilized for 6 months)
6. uncorrected visual/auditory impairments
7. participation in nonpharmacological tx for sleep/fatigue/mood/cognition outside the current study
Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

This prospective, double-blinded randomized controlled trial aims to compare the efficacy of the serratus anterior plane block (SAPB) ultrasound guided versus anatomical landmark guided for gynecomastia surgery. And to detect if the anatomical landmark technique is inferior or not to the ultrasound guided technique. We hypothesize that anatomical landmark guided SAPB is not inferior to ultrasound guided SAPB.

Gynecomastia means enlarged male breast. Minimally invasive liposuction and surgical intervention are possible remedies for such cases. Postoperative pain can be controlled by opioids or regional blocks like serratus anterior plane block. Ultrasound guided blocks are associated with high success rate; however, anatomical landmark guided blocks may give similar results. Our hypothesis was that landmark guided serratus anterior plane block would be non-inferior to ultrasound plane block. Subjects presenting for gynecomastia surgery will receive ultrasound guided block in one side (US group) and landmark guided block in the other side (LM group) with the same volume (25) ml and concentration (0.25 %) of bupivacaine. The primary outcome will be visual analogue score. Secondary outcomes include patient satisfaction and incidence of complications like pneumothorax. It will be carried out over 40 male patients, aged from (18 - 60) year-old, with ASA I or II classes who will undergo elective gynecomastia surgery. Patient with BMI ≥ 35, history of previous chest surgery, drug abuse, allergy to local anesthetics, psychiatric problems or patient refusal will be excluded from participation

Eligibility Criteria:
Inclusion Criteria:

* male patients, aged from (18 - 60) year-old, with ASA I or II classes who will undergo elective gynecomastia surgery

Exclusion Criteria:

* Patient with BMI ≥ 35, history of previous chest surgery, drug abuse, allergy to local anesthetics, psychiatric problems or patient refusal will be excluded from participation.