cyrilzakka/clinical-trials huggingface dataset:
Magnet Anastomosis in Patients Undergoing Gastric Surgery

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a gastro-jejunal anastomosis in participants undergoing gastric surgery.

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating gastric-jejunal anastomoses in patients undergoing gastric surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 22 years or older at screening
2. Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent document
4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure
5. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
6. Able to refrain from smoking during study follow-up period

Exclusion Criteria:

1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
2. BMI \> 55 kg/m2
3. Uncontrolled diabetes (defined as HbA1c \>10%)
4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
5. Diagnosed with obstructed or perforated colon cancer
6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
11. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
12. Active H. pylori infection Participants with active H. pylori may continue with the screening process if they are treated via medication
13. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
14. Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
15. Contraindication to general anesthesia
16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
17. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
18. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib

Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

This is a non-interventional trial. No active patients will participate in this study. Only data generated from the A6181036 study will be utilized for correlational purposes. The A6181036 study data in addition to mutational status data previously analyzed but not collected as part of the A6181036 study in the same patient population

Eligibility Criteria:
Inclusion Criteria:

* GIST subjects that participated in the A6181036 study that had mutational status data analyzed.

Exclusion Criteria:

* Subjects not participating in the A6181036 study
Blood Flow and Vascular Function in Cystic Fibrosis

Cystic fibrosis (CF) has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. The investigators laboratory recently published the first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF. This study will look at how 1) blood flow and 2) artery function contribute to exercise capacity in CF.

The most disturbing aspect of Cystic Fibrosis (CF) is the associated premature death. Low exercise capacity predicts death in patients with CF and is also associated with a steeper decline in lung function and more lung infections. A critical barrier to improving exercise tolerance in patients with CF is the investigators lack of knowledge regarding the different physiological mechanisms which contribute to their lower exercise capacity. We have compelling data to indicate that the blood vessels may contribute to the low exercise capacity in CF. The impact of this proof of concept investigation will test Phosphodiesterase Type 5 inhibitors (PDE5) inhibitors as a potential therapy in CF and will explore blood flow and endothelial function as potential mechanisms which contribute to exercise intolerance in CF. Improvements in exercise capacity will not only contribute to a better quality of live for patients with CF, it will also increase longevity in these patients.

Eligibility Criteria:
Inclusion Criteria.

* Diagnosis of CF and healthy controls
* Men and women (greater than 18 yrs. old)
* Resting oxygen saturation (room air) greater than 90%
* Forced expiratory volume (FEV1) percent predicted greater than 30%
* Patients with or without CF related diabetes
* Traditional CF-treatment medications
* Ability to perform reliable/reproducible pulmonary function tests (PFT)
* Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status)

Exclusion Criteria.

* Children less than 17 years old
* Body mass less than 20 kg
* A diagnosis of pulmonary arterial hypertension (PAH)
* FEV1 less than 30% of predicted
* Resting oxygen saturation (SpO2) less than 90%
* Self-reported to be a smoker
* Current use of any vaso-active medications
* History of migraine headaches
* Pregnant or nursing at the time of the investigation
* A clinical diagnosis of cardiovascular disease, hypertension, or CF related diabetes
Amino-acid Uptake After Meat Protein Intake

The purpose of the project is to provide evidence for the use of hydrolysed meat protein (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily protein intake.

The study will investigate how the meat protein derived amino acids (from either HMP, steak or minced meat) are absorbed and released into the blood circulation of elderly persons. Hereby, the study will explore the the anabolic potential of HMP compared with common meat products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Untrained

Exclusion Criteria:

* below 65 years of age
* BMI above 30
* Smokers
* Vegetarians
* Subjects with diabetes or other metabolic diseases
* Medical treatment affecting protein synthesis
* Gastro-intestinal problems, reduced liver or kidney function, elevated blood pressure, atherosclerosis
* More than 5 ours regular physical activity per week (except physical activity related to commuting)
Exploring the Genome-wide Association Study of the Population With Clinical Cure Advantage in the Treatment of Chronic Hepatitis B With Long-acting Interferon

This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples from subjects as sequencing samples for candidate genes, use high-throughput sequencing technology to detect the whole genome of subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN-α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.

This study is a real-world case-control study conducted on 120 patients with chronic hepatitis B (CHB) who were continuously treated with pegylated interferon-α (PEG-IFN-α) for more than 24 weeks. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples as candidate gene sequencing samples, use high-throughput sequencing technology to detect the whole genome of the subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B with PEG-IFN-α therapy, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ age ≤ 70 years old, Han ethnicity, gender not limited;
* According to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022)", patients with HBsAg and/or HBV DNA positivity for more than 6 months and chronic inflammatory liver disease caused by persistent HBV infection are diagnosed with chronic hepatitis B (CHB);
* The patient receives subcutaneous injections of PEG-IFN-α for at least 24 consecutive weeks;
* Patients voluntarily sign an informed consent form before the start of the study.

Exclusion Criteria:

* Patients with co infection of HCV, HDV, HIV, and Treponema pallidum;
* Patients with evidence of alcohol abuse, decompensated cirrhosis, liver tumors (liver cancer or AFP\>100 ng/ml), or autoimmune diseases.
* Patients who become pregnant during PEG-IFN - α treatment;
* Other situations that the patient deems unsuitable for inclusion in this trial.
Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil

To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.

OBJECTIVES:

Primary objective:

To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 16 and anti-HPV 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.

Secondary objectives:

1. To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 6 and anti-HPV 11 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
2. To describe the safety profile of the administration of Gardasil® according to each of the four schedules by assessing:

   (i) immediate reactogenicity (reactions within 30 minutes after each injection); (ii) solicited (local reactogenicity and fever) and unsolicited events occurring during the first 7 days following each vaccination; (iii) serious adverse events occurring up to one month following the last dose of vaccine; (iv) deaths or adverse events occurring at any time determined to be vaccination-related.

Eligibility Criteria:
Inclusion Criteria:

1. 11-13 years of age.
2. Signed informed consent form (both parent's \& daughter's signature).
3. Good health status.
4. Able to comply with trial protocol.
5. Plans to stay at current school for duration of study.

Exclusion Criteria:

1. Prior HPV vaccination
2. Pregnant or lactating or intends to become pregnant during study period.
3. Apparent moderate or severe acute illness.
4. Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy.
5. Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes.
6. Hypersensitivity to the active substances or to any of the excipients of the HPV vaccine, or such reactions to other vaccines received in the past.
7. Investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of HPV vaccine.
An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks


Eligibility Criteria:
Inclusion Criteria:

* Patient between 35 and 75 years old
* Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:

  * Knee pain
  * Positive radiography (presence of osteophytes)
  * Morning stiffness \< 30 min and/or crepitus while walking
* Symptoms related to knee osteoarthritis for at least 6 months
* Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
* Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
* WOMAC pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
* Contralateral knee pain \< 10 mm (VAS) compared to treated knee
* Patient signed inform consent form-

Exclusion Criteria:

* Inability to understand the study or language used to be informed/sign the consent
* Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
* Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
* Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
* Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
* Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
* Rheumatoid arthritis, joint condition or any other inflammation and arthritis
* Lupus
* Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
* Visible joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella
* Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee
* Osteonecrosis (1 or both knees)
* Daily dosage \> 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose \< 101 mg, must be maintained during the study
* Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
* Fibromyalgia
* Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study
* Excessive and repeated consumption of alcohol or illicit substances
* Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)
A Registered Cohort Study on FSHD1

The data to be collected is intended to help healthcare providers make important medical and financial decisions concerning FSHD1, through an enhanced understanding of the prevalence, progression and natural history of FSHD1.

The China FSHD1 patient registry is a nationwide, population-based, non-interventional, observational cohort clinical study of all age groups of genetically-confirmed FSHD1 patients from families (with at least 1 affected member), collecting data retrospectively at study entry and prospectively during follow up. The data to be collected is intended to help healthcare providers make important medical and financial decisions concerning FSHD1, through an enhanced understanding of the prevalence, progression and natural history of FSHD1.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of all ages at baseline
* Subjects, with or without symptoms, with FSHD1 genetic confirmation through PFGE-based Southern blotting
* Unrelated healthy controls

Exclusion Criteria:

* Decline to participate
* Other neuromuscular disease (such as Limb-girdle muscular dystrophy or Myotonic dystrophy)
* Serious systemic illness (such as heart, liver, kidney disease or major mental illness)
Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

Purpose: The overall aim is to investigate the effect of interdisciplinary rehabilitation in primary health care (PHC) for patients with chronic pain. Specific questions: What is the effect of extended access to the interdisciplinary PHC pain team + a booster session after finishing the rehabilitation program? Does participation in PHC interdisciplinary rehabilitation contribute to health improvements and are there predictors of this? Method: A randomized controlled trial (RCT). 200 patients with chronic pain that participate in interdisciplinary rehabilitation in primary healthcare in Region Västra Götaland (VGR) in Sweden will be included in the RCT and randomized to Intervention; standard care by the interdisciplinary teams in PHC + extended access to the team and a booster session 3 months after the end of the rehabilitation, or Control; only standard care by the interdisciplinary teams. Outcomes are health related quality of life, pain intensity and other health aspects.

The participants will be randomly allocated to intervention or active control. All participants in both arms receive the standard care for interdisciplinary rehabilitation at any of the six PHC pain teams in VGR. The teams consist of a physician, physiotherapist, occupational therapist and psychologist. All teams provide person-centred rehabilitation, aiming to increase physical activity and support behavioural changes, and to decrease symptoms and the impact of pain on the patients´ daily lives. The standard care interdisciplinary rehabilitation period contains both theoretical and practical components such as patient education, physical exercise and behavioural interventions. The sessions are mainly group-based. The duration of the rehabilitation period varies between 5 to 7 weeks + a follow-up visit after 3 months.

The participants in the intervention arm also receive an extra booster-session 3 months after the standard follow-up. At the booster-session, the participant´s individual rehabilitation plan is followed-up and adjusted. This extra period also includes extended access to the team, meaning that the participants have the possibility to contact the team and, if needed, have digital or telephone contact.

The participants complete a battery of questionaires included in the Swedish Quality Registry for Pain Rehabilitation an also extra questionnaires provided to the participants through an electronic research form.

Data collection is made at baseline before starting the rehabilitation, directly after the 5 to 7 weeks rehabilitation period and 6, 12 and 24 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Persons participating in interdisciplinary team rehabilitation in primary healthcare in Region Västra Götaland, Sweden.

Exclusion Criteria:

* Severe psychiatric disease, language difficulties that makes it impossible to complete the questionnaires
Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke

Persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb. Improving walking is therefore a primary rehabilitation goal for such patients. Robotic-Assisted Rehabilitation (RAR, e.g. exoskeletons) and Functional Electrical Stimulation (FES) are promising techniques to facilitate the functional recovery after stroke. allowing benefits to be maintained over long term.

Exoskeletons were originally developed for subjects with spinal cord injury where they demonstrated a positive impact on rehabilitation and relative costs. The investigators expect the same trend also for stroke. Based on prior exploratory activities using an overgorund exoskeleton (TWIN_Acta) in gait rehabilitation post stroke, in this project the aim is to merge the potential of an overground exoskeleton and FES to treat the lower limb motor deficits in persons post-stroke, strengthening their residual abilities. Synchronized pairing of the two devices might boost the functional recovery of gait post-stroke by promoting neural reorganization The persons post stroke will undergo 20 gait rehabiliation sessions with the exoskeleton and with FES applied to the lower limb muscles during execution of gait with the aim of improving various gait and quality of life parameters. This experimental intervention will be compared to a control intervention using an exoskeleton alone for gait rehabiltation post stroke.

Eligibility Criteria:
Inclusion Criteria:

18 years or older

* Diagnosis of first unilateral ischemic or hemorrhagic ictus, at least two weeks from the event, ischemic or hemorrhagic
* diagnosis confermed with Computer Tomography or Magnetic Resonance Imaging
* 1 ≤ FAC (Functional ambulation category) ≤ 3
* 50 kg ≤ weight ≤ 90 kg
* 150 cm ≤ height ≤ 192 cm
* Femor length: 355-475 mm
* Tibia length: 405-485 mm
* Pelvic width 690-990 mm
* shoe size 36-45
* Capable of standing unsupported for at least one minute

Exclusion Criteria:

* Mini Mental State Examination score (corrected for age and education) \< 24
* Clinical evidence in the medical records of visuospatial and ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders or those which prevent use of the device
* patients at risk of fractures or with strategic fractures (unstabilized fractures or spinal instability)
* Major head trauma
* Subarachnoid hemorrhage, cerebral thrombosis
* Cardio-respiratory or internal clinical instability
* Pregnant or breastfeeding status;
* Recent malignant neoplasm
* Chronic inflammatory diseases with joint involvement of the lower limbs;
* Severe spasticity (Ashworth\>3)
* Significant limitations in passive ROM of the hips and knees
* Problems with the integrity of the skin at the interface surfaces with the device or which would prevent sitting.
* Implanted electronic devices
* Epilepsy
* Severe peripheral neuropathies