cyrilzakka/clinical-trials huggingface dataset:
IBD-OPERA Database, UC Protocol

The investigators believe that patients with ulcerative colitis are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.


Eligibility Criteria:
Inclusion Criteria:

* MD documented diagnosis of ulcerative colitis
* current of past prescription for anti-TNF medication
* at least 18 years of age
* access to medical records to verify information
* 20% of participants will be patients diagnosed within 1 year of inclusion

Exclusion Criteria:

* unwilling or unable to provide informed consent for study participation
* unable to access or use internet
* less than 18 years of age
* diagnosis of crohn's disease or IBD-U
* illiterate or does not possess minimum level of literacy required to complete questionnaire
Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD

The primary objective of the study is to investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

Key Criteria:

Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD.

Exclusion Criteria:

1. Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor)
2. Active neovascular AMD in the fellow eye requiring treatment
3. Scar, fibrosis, or atrophy in the study eye involving the center of the fovea
4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
5. Prior vitrectomy in the study eye
6. Any history of macular hole of stage 2 and above in the study eye
7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
8. History of corneal transplant in the study eye
9. Positive serum human chorionic gonadotropin (hCG)/ urine pregnancy test at the screening or baseline visit

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.
Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma

The purpose of this study is to evaluate the clinical efficacy of transfusions with platelets stored in platelet additive solution II compared to plasma storage.

Introduction: Utilization of platelet additive solutions (PASs) for storage of platelets has several advantages, however randomised studies testing the clinical efficacy are scarce. A prospective, randomised study comparing the efficacy of transfusions with platelets stored in Platelet Additive Solution II (PAS II) versus plasma showed that CCIs after transfusion with platelets stored in PAS II were significantly lower (1). Major drawbacks of this study were the exclusion of patients with clinical factors known to increase platelet consumption and a limited number of patients. A multicenter, randomised study to investigate clinical efficacy of platelets stored in PAS II versus plasma, also including patients with factors of increased platelet consumption, was performed. Methods: After consent patients \> 18 years, without HLA- and/or HPA-alloantibodies, were randomised to receive pooled platelet concentrates (PC) suspended in either plasma or PAS II, leucoreduced, and stored up to 5 days. 1- and 24-hour CCI were the primary endpoints. Secondary endpoints were transfusion interval, adverse reactions and bleeding complications. An inclusion-period was defined as a maximum of 8 transfusions or 30 days after the first transfusion.

Eligibility Criteria:
Inclusion Criteria:patients \> 18 years expected to receive platelet transfusions and informed consent -

Exclusion Criteria:HLA- and/or HPA- alloimmunization

-
Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis

This study is a multicenter, randomized, double-blinded, placebo-controlled trial with two parallel arms. The aim of the study is to evaluate whether Chinese herbal medicine Qing Re Huo Xue (QRHX) combined with methotrexate (MTX) might be better than Qing Re Huo Xue placebo combined with MTX for patients with active rheumatoid arthritis (RA).

To compare the efficacy and safety of Chinese herbal medicine Qing Re Huo Xue (QRHX) and methotrexate (MTX) for patients with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Two hundred and four patients with active RA will be randomly allocated (1:1) to treatment with QRHX 10g bid and MTX 10mg once a week for 24 weeks, or MTX plus QRHX placebo. The primary outcome is the bone marrow edema score in Outcome Measures in Rheumatology Clinical Trials RA MRI Scoring (OMERACT-RAMRIS) at week 24.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
2. Subject has a DAS28 CRP disease activity score of \>3.2 at screening.
3. Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints.
4. Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
5. Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose.

Exclusion Criteria:

1. History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
2. Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature.
3. Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe.
4. Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.
A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects

AK3280 is being developed to further improve the long-term efficacy and tolerability of treatment options for patients with fibrotic disorders.This study will evaluate the effect of AK3280 treatment on renal function and safety, and the PK of AK3280 compared with placebo in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give full written informed consent for participation in the study.
* Healthy male or female subject aged 18-45 years inclusive.
* Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2。
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator in agreement with the Medical Monitor.
* With normal renal function defined as mean plasma eGFR ≥80 mL/min/1.73 m2 at screening.
* Male subjects and applicable female subjects must agree to use effective contraceptive methods to prevent drug exposure of a partner and pregnancy.

Exclusion Criteria:

* History of allergy to iohexol or other contrast media, to iodine or to shellfish.
* History of any clinically significant disease or disorder or any other condition that in the opinion of the Investigator renders them unsuitable to participate in the study.
* Regular use of any prescribed or non-prescribed medication within two weeks prior to the (first) administration of IMP.
* Any significant elevation at screening or on Day -2 of liver or urinary or serum or plasma renal test results.
* Subjects with poor venous access.
* Subjects who have smoked cigarettes (including vapour cigarettes), cigars, and/or used nicotine-containing products within 3 months prior to their screening visit.
* Positive screen for a drug of abuse or alcohol at screening or prior to administration of the IMP.
* Subjects who have not abstained from caffeine-containing beverages or products from at least 48 hours prior to screening.
* An abnormal diet within the 30 days prior to the first study drug dose.
* Any use of protein powders, xanthine and/or taurine containing energy drinks within 48 hours prior to screening.
* Blood donation (or corresponding blood loss) during the three months prior to screening.
* Employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
* Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Tolerance of Myocardium to Ischemia Injury

This study aims to understand the impact of time-of-the day on human myocardial tolerance to ischemia-reperfusion by exploring atrial myocardium biopsied during cardiac surgery. Patients scheduled for non-urgent cardiac surgery (coronary artery by-pas graft and/or aortic valve replacement) will be assigned to a morning or an afternoon cardiac surgery based on randomization. Myocardial biopsies will be explored in ex vivo conditions mimicking ischemia-reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for coronary artery bypass graft surgery and/or aortic valve replacement with extra-corporeal circulation
* Patient in sinus rhythm at the time of surgery
* Patient older than 18
* Patient able to understand the information and consent forms

Exclusion Criteria:

* Medical history of type 2 diabetes, atrial fibrillation or use of class III anti-arhythmic drug
* left ventricle ejection fraction \< 40%
* Pregnancy
* Patient in emergency condition
Gait Analysis Meniscal Repair

In the past it was shown, that medial partial meniscectomy (MPM) leads to an increase of the knee adduction moment (KAM) during walking. Other researches found out that an increase of the KAM is an important factor contributing to degeneration joint disease of the knee (osteoarthritis). Today, medial menicus repair (MMR) is favoured by many knee surgeons, because preserving as much of the meniscus as possible is assumed to delay degenerative joint disease.

The investigators hypothesize significant differences in knee adduction moments between patients treated with partial medial meniscectomy vs. patients treated with medial meniscus repair (hypothesis 1; major hypothesis). Additionally, it is hypothesized that: the mentioned groups differ with respect to other kinetic and kinematic key parameters of gait (hypothesis 2) and that the knee adduction moment correlates with the clinical outcome as determined by a typical knee score (hypothesis 3).


Eligibility Criteria:
Inclusion Criteria: patients with traumatic medial meniscus lesions scheduled for meniscal repair or resection

Exclusion Criteria:

* previous or current diseases of the back and the other joints of the lower limbs
* any form of inflammatory arthritis
* diabetes
* neurological disorders
* other conditions that may affect gait
A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease

To assess the efficacy and safety of AGY vs placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet

We propose to conduct a randomized double-blind, placebo-controlled crossover trial in 149 individuals with celiac disease proven by biopsy (or other medically documented confirmation of CD, e.g. TTG counts \> 10 times the upper limit of normal on two occasions) at least 12 months before study entry, and who are following a gluten-free diet but continue to have recurrent symptoms.

AGY is designed to neutralize the hidden gliadin in food, thus preventing gliadin absorption and gliadin induced pathogenesis. The study will test whether AGY is safe and effective in the study population, versus placebo.

Primary Objective: The primary objective will be to evaluate the effect of AGY on celiac symptoms using the daily Celiac Symptom Index (CSI).

Secondary objectives: Secondary objectives will be to evaluate product safety and the effect of AGY on quality of life, autoantibodies, and gut permeability.

Eligibility Criteria:
Inclusion Criteria:

* history of CD
* experience periodic celiac related symptoms
* following a gluten free diet for at least 12 months

Exclusion Criteria:

* severe complications of CD or chronic active GI disease
* type 1 diabetic
* pregnant or breast feeding
* daily ASA/NSAID use
* any condition that in the opinion of the investigator, would preclude safe participation
Efficacy of Tai Chi Versus CBT-I in Treating Chronic Insomnia in Older Adults

Insomnia is common in the older population, over 50% of older adults have sleep complaints, and 20-40% are reported to have insomnia. In HK, 38% of adults have reported insomnia. Insomnia is associated with increased mortality and morbidity. As the worldwide population continues to age, insomnia in older adults will increasingly cause substantial economic burdens on healthcare systems and society.

Cognitive behavioral therapy for insomnia (CBT-I) is currently the first-line clinically recommended non-pharmacological treatment for insomnia in older persons. Our group has been actively studying the health-enhancing effects of tai chi. Tai chi has various health benefits including fall prevention, osteoarthritis management, cardiorespiratory fitness and improvement of sleep. In the present study, the investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. This study aims to exam whether three months of CBT-I or three months of tai chi have similar robust effects in treating insomnia in older adults.

The investigators want to validate the clinical effectiveness of tai chi on improving insomnia in older adults. The CBT-I and tai chi classes will be held twice a week with each lasting for 60 mins. The treatment is three months with 12-month follow-up.

The primary outcome of this study is the insomnia severity index (ISI) score at post-intervention measure, which examining sleep-onset and sleep maintenance difficulties, satisfaction with current sleep pattern, inference with daily functioning.


Eligibility Criteria:
Inclusion Criteria:

1. 50 years or older,
2. ethnic Chinese who can communicate by Cantonese or Mandarin, and
3. fulfill the DSM-5 criteria for chronic insomnia including difficulty in initiating sleep, maintaining sleep or non-restorative sleep, with complaints of impaired daytime functioning, sleep difficulty occurring at least three nights per week present for at least 3 months.

Exclusion Criteria:

1. cannot walk without assistive device (e.g., cane),
2. somatic conditions that limit exercise participation (e.g., limb loss),
3. regular aerobic exercise or mind-body training such as tai chi, yoga, qigong or meditation (\>3 times weekly for \>60 minutes per session),
4. serious chronic diseases known to affect sleep (e.g., cancer and autoimmune diseases),
5. dementia or use of anti-dementia medication,
6. under treatment for serious diseases known to affect sleep (e.g., cancer chemotherapy),
7. any chronic pain disorders known to affect sleep,
8. untreated sleep disorder including obstructive sleep apnea, periodic leg movement disorder and narcolepsy (screened by questionnaire followed by polysomnographic confirmation in our Co-I's sleep lab, if needed),
9. having current or past CBT-I,
10. shift-worker.
Vision Care Intervention for Lower Grade School Children in Taiwan

The purpose of this study is making use of school policy- recess outside classroom (ROC7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren.


Eligibility Criteria:
Inclusion Criteria:

All the students in Grade 1

Exclusion Criteria:

No
Cyanoacrylate With Sutures for Fixation of Free Gingival Graft

fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation

Inadequate zone of attached mucosa around implants, gingival recession, inadequate ridge width or height despite there is enouph bone for implant placement are problems that face periodontists and can be treated by soft tissue graft Studies have demonstrated the importance of the tissues stability for the first hours when support is provided by underlying osseous or dental structures.

Movement of the graft during mastication and phonation will disturb healing procedures. Most of the clinicians prefer a protective device during the healing phase.

Transitional dentures are not stable themselves, and hence are not suitable for stabilizing.

Circummandibular wiring and impact posts are seemingly very aggressive for patients and need extra clinical practices, skills, and equipment.

Studies proved that the maximum tissue shrinkage (approximately 20%-40%) occurs during the first 3 months post operation and will proceed until 12 postsurgical months with a persistent, significantly lower rate.

In this study we give more stabilization for free gingival grafts by using cyanoacrylate tissue adhesive beside sutures Its autogenous character, maintenance of keratinization, predictability, ease of technique tlead CTG to be accepted as the golden standard to increase attached gingival dimensions Cyanoacrylate is a simple, inexpensive haemostatic and biocompatible material It is used as tissue adhesives in paediatric surgery general surgery and also dentistry.

it has been applied intraorally with different purposes such as periodontal dressing,for sealing sinus membrane perforations for stabilizing bone fragments during fracture fixation, and in closing peripheral nerve anastomosis it seems promising in the intraoral field due to their strong sealing, bacteriostatic, and hemostatic properties. Multiple studies examined the use of cyanoacrylate glues as an alternative to suturing intraoral and extraoral wounds concluding that cyanoacrylates are faster, more reliable ,and less painful and cause better hemostasis .

Eligibility Criteria:
Inclusion Criteria:

* Patients with hopeless teeth that need extraction
* Age: between 20 and 60 years
* Both sexes.
* Subjects willing to sign an informed consent form ,participate in the study and return for follow-up visits

Exclusion Criteria:

* • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy),

  * patients on corticosteroids,
  * patients with uncontrolled diabetes mellitus
  * smokers
  * Pregnant or lactating mother.
  * Known systemic diseases and/ or drug therapy which may interfere with wound healing or contraindicate periodontal therapy
  * Allergy to cyanoacrylate
How Fat Influences the Brain

The aim of the current study was to investigate the effect of a high versus a low fat meal (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.


Eligibility Criteria:
Inclusion Criteria:

* male
* healthy

Exclusion Criteria:

* lactose intolerance
* fMRI contraindications (metal implants,...)
Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA

that's comparison between partial and complete pulpotomy techniques in primary teeth


Eligibility Criteria:
Inclusion Criteria:

1. - Medically free children who will be able and cooperative in all steps of the study.
2. - Asymptomatic primary molars with a deep carious lesion.
3. - Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.

3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.

4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.

Exclusion Criteria:

1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.

6 - Parent or guardians who refuse participating in the study
Plasma Soluble Urokinase Plasminogen Activator Receptor and Behçet's Disease .

The purpose of the study is to determine whether plasma levels of the soluble urokinase plasminogen activator(suPAR) can serve as a blood-based biomarker for diagnosis of Behçet's disease and its correlation with disease activity.

Behçet's disease (BD) is a chronic, systemic vasculitis disease that can be evident in many systems and characterized by recurrent attacks, oral and/or genital aphthous ulcers, skin lesions, and inflammatory ocular findings. It was first described in 1937 by the Turkish dermatologist Hulusi Behçet.\[1-3\]

Although with an unclear pathogenesis, BD is considered a type of vasculitis triggered by immunological mechanisms. Increased levels of pro-inflammatory cytokines are reported in patients with BD. In the afflicted organs, a remarkable infiltration of neutrophils and lymphocytes can be seen.\[4-6\]

Diagnosis of BD is mainly clinical, on the association of symptoms, but diagnosis/classification criteria may help. Various sets of criteria were created for BD diagnosis and the recent one is the international criteria for Behçet's disease (ICBD) that was created by 27 countries in 2006 and revised in2014.\[7\]

There is no standard laboratory marker for the diagnosis and follow-up of BD. certain cytokines and increased serum levels of C-reactive protein (CRP) are considered as markers of disease activity.\[8\] Soluble urokinase plasminogen activator receptor (suPAR), a potential new biomarker, is a soluble form of the membrane-bound receptors expressed from and comprising mainly of various immune cells (monocytes, neutrophils, activated T lymphocytes, macrophages, endothelial cells, keratinocytes, smooth muscle cells and even tumor cells. \[9\] Numerous studies on various inflammatory diseases, cancer, tuberculosis, central nervous system infections, sepsis, liver fibrosis and inflammatory bowel disease have shown increased systemic levels of suPAR. In these diseases, suPAR systemic levels are shown to have a prognostic value in determining disease severity.\[10\]

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients diagnosed as Behçet's disease according to international study group criteria (ICBD ) for diagnosis of Behçet's

Exclusion Criteria:

* Age\< 18 years
* Other autoimmune diseases.
* Pregnancy.
* Acute and chronic systemic infection history.
* The presence of chronic diseases such as chronic renal failure, liver and cardiac failure.
* Presence or history of cancer.