cyrilzakka/clinical-trials huggingface dataset:
Effects of DHA on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment

Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.

Will include obese patients (BMI between 30 and 35) who are following a standardized, multidisciplinary weight-loss programme (PronoKal® Method), which consists of a very-low-calorie diet based on protein packets and vegetables with a low glycemic index, into which natural foods are gradually reintroduced, accompanied by physical exercise and emotional support.

Patients who are being treated with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones); and patients with immune disorders (rheumatoid arthritis, Lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) who may alter the biological markers of inflammation,will be excluded.

Treatment: In addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme, the patients will receive an additional 500 mg/day supplement of DHA omega-3 fatty acids in capsule form (study group) or a placebo capsule (control group).

The follow up will be 6 months and patients will be monitored over the course of 6 control visits: baseline, 7 days, 15 days, 30 days, 60 days and 180 days.

The main objective is to assess the effectiveness of providing additional DHA supplements to increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Obese patients with Body Mass Index between 30 and 35
* Patients who, regardless of their inclusion in this study, are going to follow the standardized weight-loss programme (PronoKal® Method)
* Patients who agree to participate and sign the Informed Consent form

Exclusion Criteria:

* Treatment with Omega-3 fatty acid supplements for other reasons during the month prior to inclusion in the trial
* Treatment with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones)
* Pregnant or nursing patients
* Haemopathy, including clotting disorders
* Treatment with dicoumarin anticoagulants (Sintrom®)
* Cancer or a history of cancer who have not received the oncologist's release
* Type 1 or type 2 diabetes mellitus
* Immune disorders (rheumatoid arthritis, lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) that may alter the biological markers of inflammation
* Patients not expected to attend monitoring visits
Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis

This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).

The study will be conducted in 2 parts: Part A (Phase 2) and Part B (Phase 3). There will be 3 periods in both Part A and Part B of this study: Screening Period, Randomized Controlled Period, and Open-Label Extension Period.

Eligibility Criteria:
Key Inclusion Criteria:

* 18 years of age or older at the time of signing the informed consent.
* Body weight ≥ 30 kilograms at the time of Screening.
* Male or female.
* Diagnosis: Meet 2017 American College of Rheumatology/European League Against Rheumatism classification criteria for definite or probable DM.
* Participants who have an inadequate response or are intolerant to 1 or more DM treatments, including systemic corticosteroids or immunosuppressive/immunomodulatory therapies (for example, azathioprine, methotrexate, rituximab, intravenous immunoglobulin), either in combination or as monotherapy.
* Vaccinated against Neisseria meningitidis within 3 years prior to initiating ravulizumab as per national and local guidelines. Participants must receive the vaccination at least 2 weeks before first study intervention. The sponsor recommends that national and local guidelines for prophylactic antibiotics should also be followed.
* Female participants of childbearing potential and male participants must follow specified contraception guidance as described in the protocol.

Key Exclusion Criteria:

* Participants who have been diagnosed with cancer within the last 3 years need to have appropriate negative cancer screening as per local standard of care within 6 months before Screening (basal or squamous cell skin cancer or carcinoma in situ of the cervix needs to have been excised and without evidence of residual disease for at least 3 months before Screening).
* Evidence of active malignant disease or malignancies diagnosed within the previous 3 years including hematological malignancies and solid tumors.
* Participants with other forms of myositis.
* As per investigator discretion, participants with significant muscle damage (for example, severe muscle atrophy, end stage muscle disease, MRI with severe atrophy or fibrofatty replacement)
* History of Neisseria meningitidis infection.
* Human immunodeficiency virus (HIV) infection (evidenced by HIV Type 1 or Type 2 antibody titer).
* Active systemic bacterial, viral, or fungal infection within 14 days prior to ravulizumab administration.
* Presence of fever ≥ 38°Celsius (100.4°Fahrenheit) within 7 days prior to study drug administration on Day 1.
* History of hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab.
* Pregnant, breastfeeding, or intending to conceive during the course of the study.
* Inability or unwillingness to adhere to the protocol requirements.
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.

Subjects who are confirmed to meet all of the inclusion criteria and none of the exclusion criteria during screening period (≤ 21 days) will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50. If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study. Self-injection of study drug is permitted for the subjects who are willing to perform self-injection, if the investigator decided as appropriate. Disease activity will be evaluated by Crohn's disease activity index (CDAI) at Screening, Week 0 and every 4 weeks until Week 52. Follow-up will be performed at 70 days after the last dose of study drug by visit or telephone.

Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 15 years of age at the time of informed consent.
* Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®.
* Subject with elevated C-reactive Protein (CRP) at Screening.
* If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug.
* Subject has a negative tuberculosis (TB) screening assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.

Exclusion Criteria:

* Subject with suspicion of colitis other than Crohn's disease.
* Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
* Subject with abscess or suspicion of abscess, or subject with infection(s).
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury

To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female patient, ≥ 18 and ≤ 75 years
2. Patient with severe SAH (GCS ≤ 12) or severe TBI (GCS ≤ 8)
3. Decreased level of consciousness with the need for ICP monitoring for an estimated duration of more than 3 days
4. Negative pre-treatment serum pregnancy test for female patients with childbearing potential
5. In patients with severe SAH or severe TBI with need for ICP monitoring an acute emergency situation exists. The inclusion follows

Exclusion Criteria:

1. Known kidney disease, defined as plasma creatinine \> 120 µmol/l
2. Known liver disease, defined as GOT \> 200U/l
3. History of allergic disorders, including allergic reactions against contrast agents containing iodine, against ICG and against plasters, as well as patients with thyroid disease causing hyperthyroidism
4. Pre-existing disability and/or legal representative
5. Participation in another interventional clinical trial within the last 30 days before start of treatment
Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear

Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes versus normal foot wear in diabetic and healthy subjects.

Every 30 seconds a limb is lost somewhere in the world as a consequence of diabetes. These amputations are preceded by a foot ulcer in 84% of cases. Therefore, prevention of ulceration is of utmost importance.

Approximately one-half of all diabetic foot ulcers occur on the plantar foot surface and are mainly caused by elevated levels of mechanical pressure acting on the foot during ambulation in the presence of lost protective foot sensation from peripheral neuropathy.

Therefore, to reduce risk of ulceration, relief of mechanical pressure (also called offloading) is indicated.

Currently therapeutic footwear is provided by the Health maintenance organizations (HMO's) to diabetic patients that are at risk of developing foot ulcers.

Ideal footwear for a diabetic patient decreases weight-bearing pressure and shear forces applied to the skin of the foot by distributing the acting forces more evenly.

With the growth in the health and fitness industry, sports footwear has shown technological advances and diversification.

The introduction of the KyBoot shoe is an example of this diversification. The Kybun company based their shoe on the experience of walking on soft, muddy rice fields in Korea.

The Kyboot construction is based on a soft, supple air cushioned sole. The honeycomb air structure of the kyBoot sole creates an air cushion between your foot and the ground, with one fifth of the volume of air being pumped into the foot area at every step. This design could offer a better distribution of pressure.

Therefore, in this study we would like to compare the pressure distribution, changes in the movement of the center of pressure and shock absorbing capabilities of the KyBoot in comparison with normal shoes.

Study goals:

Comparison and evaluation of pressure distribution, gait pattern, changes in the movement of the center of pressure, shock absorbing capabilities and comfort of wear using KyBoot shoes versus normal foot wear in diabetic and healthy subjects.

Eligibility Criteria:
Inclusion Criteria: ( for the group of diabetic patients)

* Signing of informed consent
* Diabetes mellitus Type 2
* No major foot deformations necessitating fitting of personalized foot wear
* Absence of diabetic foot ulcers and existence of sensory neuropathy confirmed by a physician
* Intact cognitive function
* Normal Gait

Exclusion Criteria:

* An orthopedic or rheumatic disease that negatively influences range of motion, strength, gait or balance
* Neurological diseases that influence proprioception , strength, balance, cognitive function / understanding, sight: Cerebro-vascular accident, Dementia, Spinal Cord injury, Head injury, Parkinson etc.
* Injury or disease that can influence normal gait
* Need for assistive devices : Crutches, cane, walker
* Dialysis Treatment
Identification of New Biomarkers for Patients With Cholangiocarcinoma and Gallbladder Cancer

No validated biomarkers exist that can identify patients with biliary tract cancer at an early stage or predict treatment outcomes. The objective of the present study is to find diagnostic, prognostic and predictive biomarkers.

Biliary tract cancer (BTC) is a heterogeneous disease and includes both gallbladder cancer and cholangiocarcinoma. Combined BTC is the fifth most common gastrointestinal cancer. The prognosis is poor with a median overall survival of less than a year and estimated 5-year survival of about 20 % for all stages. The poor survival is related to aggressive malign nature, late diagnosis, and limited treatment options. Today, only CA 19-9 is used in routine practice but its use as a prognostic or diagnostic biomarker is very limited.

The objective of the present study is to find diagnostic, prognostic, and predictive biomarkers, which can be used to 1) diagnose BTC early in the disease course with high specificity and sensitivity, 2) improve prognostication, or 3) predict and monitor treatment effectiveness and tolerability for the individual patient.

CHOCA is an observational and translational open cohort study with a prospective collection of biological materials (blood samples and tissue) and clinical data in patients with BTC receiving standard or protocolized treatment. Blood samples (i.e. serum, EDTA plasma and buffy coat, and blood in PAXgeneRNA tubes) are collected from all patients before operation or start of chemotherapy and during treatment with blood sampling before the 2nd cycle of chemotherapy and longitudinally at the time of follow-up CT scan (about every 3 months) until disease progression. Tissue removed during routine diagnostic procedures or treatment will be requisitioned.

The patients are followed until death. The following data are collected: Demographics, disease characteristics, comorbidities and lifestyle factors, routine blood tests (i.e. hematology, creatinine, liver enzymes, bilirubin, carbohydrate antigen 19-9, C-reactive protein); type of operation; types of chemotherapy, reason for termination of therapy; date of disease recurrence in operated patients; date of disease progression for each line of chemotherapy; and date of death. Biomarker analyses will include a range of molecules with different characteristics such as DNA, Single Nucleotide Polymorphism (SNPs), RNA, microRNA, proteins, proteoglycans, and metabolites. Controls will be included from other studies in order to identify potential diagnostic biomarkers,. Controls include patients with other diseases or healthy subjects. Biomarkers will be analyzed using appropriate methods and statistical analysis following REMARK guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of BTC
* Patients referred for treatment of BTC
* Signed informed consent

Exclusion Criteria:

* None
Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome

Down syndrome occurs due to abnormal cell division of extra chromosome 21. It is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent. Strengthening exercise of lower limb and core strengthening of trunk muscle will provide postural stability and lower limb strengthening. Aim of this research is to determine the effects of manual Ankle rocking training on postural control and foot function in children with Down syndrome. Those who are diagnosed with down syndrome and are between age 8-15 and both of the genders are included in this research and those who have any surgical issue, visual impairment and musculoskeletal contractures are not included in the study we will use static standing balance test to check postural control and foot function index for Ankle rocking training from two group in which one will be given the baseline treatment of lower limb exercise and core strengthening with ankle rocking training and the other group without ankle rocking training and then the collected data will be analyzed by SPSS. 22


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed children with down syndrome
* Age 8 to 15
* Both gender (male and female)

Exclusion Criteria:

* Musculoskeletal contractures
* Visual or other sensory input impairment
* Any surgical procedure
Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study

This is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care.

This non-interventional study will observe the effect of Ofatumumab treatment compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS-COMB157G3301) in MS patients in a real-world setting in Switzerland over an observational period of 12 month.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before participating in the study.
2. Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to initiation of Ofatumumab.
3. Adult patients who have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
4. Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients with active, relapsing forms of MS)
5. Patient is willing and able to complete patient diary during course of the study, as well as to complete PRO questionnaires.

Exclusion Criteria:

1. Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 3 months before Ofatumumab initiation, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
2. Subjects who are not able to provide consent due to incapable judgement
Effects of a Thoracic Manipulation on Hip Adductor, Extensor, and Latissimus Dorsi Force in Those With Adductor Weakness

The goal of this trial was to determine if a mid-thoracic high velocity low amplitude spinal manipulation improves force output in those with unilateral hip adductor weakness. The main aims were to determine if the intervention:

Improved hip adductor force and muscle activation immediately and 48 h post manipulation compared to a control group.

Improved gluteus maximus and latissimus dorsi force and muscle activation immediately and 48 h post manipulation compared to a control group.

Strength and muscle activation of the hip adductors, hip extensors (gluteus maximus), and shoulder extensors (latissimus dorsi) were measured prior to, immediate after, and 48 hours after receiving a high velocity low amplitude manipulation to the thoracic spine. The manipulation was performed by a licensed chiropractor.

A control group received a validated sham manipulation to the thoracic spine. Participants were blinded to group assignment.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral hip adductor weakness, as assessed by manual muscle testing
* Pain free hip motion
* No contraindications to high velocity thoracic spine manipulation including:

Any known active cancer/ Metastatic Bone Cancer Osteoporosis or other metabolic bone disorders Signs of spinal cord compression Nerve root compression with increasing neurologic deficit Signs of Vertebrobasilar insufficiency/ cervical artery abnormalities Bleeding Diatheses Angina pectoris

Exclusion Criteria:

* Current pain in the adductor muscle group
* Past history of hip surgery
* Past history of hip fracture
* History of spine or rib fractures
* Psoas muscle group (hip flexor) weakness as determined by manual muscle testing
* Received a chiropractic manipulation in past week
Outpatient Treatment of Low-risk Pulmonary Embolism

This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.


Eligibility Criteria:
Inclusion Criteria:

1. Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan
2. Total Pulmonary Embolism Severity Index (PESI) score \<86

Exclusion Criteria:

1. Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram
2. Sustained Systolic Blood Pressure (SBP) \<95 mmHg during Emergency Department or observation stay.
3. Age \<18
4. Pregnant
5. Renal insufficiency (Creatinine Clearance \<30)
6. Hepatic Dysfunction (AST/ALT/ALP \> 3 times upper limit of normal)
7. Unreliable social situation or inability to follow up
8. Contraindication to enoxaparin, warfarin and rivaroxaban
9. Atrial or ventricular dysrhythmia(s)
This Study Evaluates the Clinical Effect of Adding Spermidine Gel to Minimally Invasive Non-surgical Periodontal Therapy (MINST) to Improve Periodontal Health.

This study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary outcome is to assess whether the addition of spermidine gel reduces pocket depth (PPD) compared to MINST alone. Secondary outcome include evaluating other periodontal parameters like bleeding on probing, FMBS and FMPS and CAL over a 12-month period.


Eligibility Criteria:
Inclusion Criteria:

Age 18 years or older. Presence of untreated periodontitis with at least 2 sites showing clinical attachment loss (CAL) \> 2 mm and probing depth (PD) \> 4 mm.

Voluntary signing of informed consent.

Exclusion Criteria:

Presence of systemic diseases (e.g., diabetes mellitus, cardiovascular, renal, hepatic, or pulmonary conditions).

Smokers (≥10 cigarettes per day). Pregnancy or breastfeeding. Allergy to any ingredients in the products used in the study. Diseases affecting bone and/or connective tissue metabolism.