cyrilzakka/clinical-trials huggingface dataset:
Complement C5 mAb in the Treatment of Anti-GBM Disease

Anti-GBM disease is the most severe form of glomerulonephritis. Despite of the standard treatment including plasmapheresis and immunosuppressant, 70% of the patients still go into end-stage kidney disease. Complement has been shown to participate in the pathogenesis of anti-GBM disease. This study aims to the investigate the therapeutic effects and safety of C5 monoclonal antibody in the treatment of anti-GBM disease.

Anti-glomerular basement membrane (anti-GBM) disease is the most severe form of autoimmune glomerulonephritis, characterized by the production of autoantibodies targeting the components of basement membrane within the kidney and/or the lung.Patients with anti-GBM disease typically present rapidly progressive glomerulonephritis, and often accompanied by lung hemorrhage. The hallmark of the disease is the linear deposition of IgG along the GBM on kidney biopsy. Complement activation is a pivotal step for kidney injuries during the development of human anti-GBM disease. Our previous study showed that the The levels of plasma SC5b-9 and urinary C5a were positively correlated with the serum creatinine at presentation and the percentage of crescents in glomeruli. Eculizumab is a recombinant humanized monoclonal antibody that specifically binds to a C5 terminal complement and inhibits the cleavage of C5 to C5a and C5b through complement activation. There are a few case reports showing therapeutic effects in anti-GBM disease. This trial will aim to evaluate the efficacy and safety of Eculizumab plus standard treatment in anti-GBM disease.

Eligibility Criteria:
Inclusion Criteria

1. positive circulating anti-GBM antibody, with proteinuria or hematuria or any clinical signs of kidney injuries.
2. biopsy-proven anti-GBM disease with or without positive circulating anti-GBM antibodies 3.16\~65 years old

Exclusion Criteria

1. allergic to eculizumab, mouse protein or the investigational drug and any of its excipients;
2. uncontrolled meningococcal infection,or those who have not received meningitis prophylactic antibiotic treatment or meningitis vaccination;
3. Diagnosis of anti-GBM disease for more than 12 weeks before signing the informed consent form;
4. ANCA-positive;
5. pregnant or lactating
6. Received investigational drug within 30 days or 4 half-lives (whichever is longer) prior to screening;
7. Other serious poorly controlled comorbid diseases that affect the compliance of the trial protocol or the interpretation of results within 3 months prior to screening, including cardiovascular and cerebrovascular diseases, lung disease, etc.;
8. Presence of any medical history or disease that, in the opinion of the investigator, may expose the patient's participation in the study to an unacceptable risk;
The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus

This study was designed to compare the effects on atrial rhythm control between SGLT2 inhibitor and other oral hypoglycemic agents in patients with atrial fibrillation and diabetes mellitus. We are to compare efficacy and safety between these two groups.

This study is a multicenter, prospective open blinded-endpoint design, 1:1 randomized, and controlled study, with total of 716 patients enrolled from 4-5 centers. The primary outcome is recurrence rate of atrial fibrillation within a year, when recurrence of atrial fibrillation is defined as at least one significant atrial fibrillation documented on 24-hour Holter ECG. Secondary outcomes are atrial fibrillation free survival, atrial fibrillation burden at various time points, ablation rate within a year, atrial fibrillation recurrence rate after ablation within a year, volume of left atrium, NT-ProBNP, Symptom score and Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* At least one episode of atrial fibrillation\* that is documented during the prior year by any kind of ECG recording.
* Diabetes mellitus type II was diagnosed. (HBA1c \>6.5%) and are using oral hypoglycemic agents only
* At least 20 years old and not older than 80 years old.
* Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms, QTc interval \<440 ms, and PQ interval ≤210 ms in a 12 lead ECG)
* Able and willing to give informed consent.

Exclusion Criteria:

* Any disease that limits life expectancy under 1 year
* Subject for another clinical trial within the past 2 months
* Under 20 years old or over 80 years old
* Pregnant women
* Lactating women
* Drug abuser
* Type 2 DM treated by recombinant insulin
* Diagnosis of Type 1 DM, MODY, or secondary DM
* HbA1c ≥12% or HbA1c \<6.5% at diagnosis
* Previous treatment with any SGLT2 inhibitor
* Renal dysfunction (eGFR-CKD-EPI \<30ml/min/1.73m\^2)
* Chronic cystitis and/or recurrent genitourinary tract infections (3 or more in the last year)
* Unexplained hematuria at baseline study
* Systolic BP \>180mmHg or diastolic BP \>100mmHg at baseline study
* Systolic BP \<95mmHg at baseline study
* Previous treatment with AF ablation
* Acute cardiovascular event \[e.g., stroke, acute coronary syndrome (ACS), revascularization, decompensated HF, sustained ventricular tachycardia, return of spontaneous circulation (ROSC)\] \<8 weeks prior to baseline study
* Severe valvular disease or have prosthetic valve
* Treatment with chronic oral steroid (\>30 consecutive days) at a dose equivalent to oral prednisolone ≥10mg/d, within the past 1 month
* History of any malignancy within 5 years
* Clinically profound hepatic dysfunction
* Clinically uncontrolled thyroid dysfunction
* Patients incapable of completing the trial due to any severe medical condition by clinical decision
* Patients with poor compliance (defined as 80 - 120%), except for reasonable situations judged by physician
Quality of Life in Systemic Nickel Allergy Syndrome

This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy Syndrome (SNAS).

Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it has been reported to be one of the most common causes of allergic contact dermatitis (ACD), affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is characterized by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective diagnostic and therapeutic tool in the control of systemic manifestations, determining a significant clinical improvement.

It is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for the management of Ni allergy, especially in a subset of patients with SNAS, inducing immunological and clinical tolerance to metal at the doses normally taken with the diet.

Although a large number of clinical trials focused on the health-related quality of life (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics of patients affected by SNAS are limited and no data exist pre- and post-treatment and specifically with NiOHT. Given the high safety profile and beneficial effects of immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive results even after oral Ni desensitization.

Eligibility Criteria:
Inclusion Criteria:

* history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms),
* positive Ni-patch test,
* clinical improvement at least 70% from baseline after 4 weeks on a low-Ni diet,
* positivity of a double blind placebo-controlled oral Ni challenge (DBPCO),
* written informed consent.

Exclusion Criteria:

* age \< 18 years and \> 65 years,
* other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth,
* diabetes mellitus,
* hepatic, renal or cardiac dysfunction,
* thyroid disease or tumor,
* concomitant treatment with steroids and/or antihistamines in the previous 4 weeks, pregnancy, lactation,
* smoking, abuse of alcohol, coffee, tea, and cola intake,
* refusal to participate.
Root Coverage Using a Xenograph for Treatment of Gingival Recession

Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.

PriMatrix (TEI Medical Inc) is a promising collagen membrane derived from fetal bovine dermis. The acellular porous structure of the membrane permits rapid re-vascularization and cellular re-population. The membrane contains a high proportion of type III collagen. Type III collagen helps regulate tissue healing by promoting neoepithelialization and angiogenesis. Wounds grafted with PriMatrix exhibited significantly faster healing rates compared to control wounds while having a minimal foreign body response and early repopulation by progenitor cells.

The ability of PriMatrix to permit neovascularization, reepithelialization, minimal immune response, and population by progenitor cells suggests that it may serve as an ideal alternative to CTG under CPF for root coverage. In this regard, the current study aims to serve as a pilot to test the feasibility of the use of PriMatrix as a graft material under a CPF to attain root coverage of Miller Class I \& II defects.

Eligibility Criteria:
* Inclusion Criteria:

  * Adults 18-90 years of age
  * Miller Class I \& II defects on maxillary or mandibular teeth
  * At least 1 adjacent non-involved tooth on either side of the included recession defects
  * Keratinized tissue width of ≥2.0 mm
  * Periodontal probing depths of 3 mm or on included teeth
  * Plaque index of 2 or less
  * Bleeding on probing at 30% or less sites
  * Current non-smoker
  * No active infected wounds
* Exclusion Criteria

  * Patients less than 18 years of age
  * Miller Class III, or IV mucogingival defects
  * Miller Class I \& II defects without adjacent non-involved teeth
  * CEJ not identifiable
  * Root surface restoration at the defect site
  * Periodontal probing depths greater than 3 mm
  * Plaque index of 2 or greater
  * Bleeding on probing at more than 30% of sites
  * Uncontrolled oral disease
  * Moderate to severe generalized chronic or aggressive periodontitis
  * Oral manifestations of a systemic disease
  * History of previous root coverage procedure, graft, or GTR
  * Current smoker or other tobacco use
  * Alcohol abuse problems
  * Traumatic occlusion impinging on the recession defect
  * Use of intraoral appliances that impinge on the recession defect
  * Intra-oral piercings that impinge on the included defect
  * Uncontrolled systemic health conditions
  * Debilitating systemic or infectious disease
  * Diabetes
  * Heart Disease
  * Uncontrolled heart disease
  * Delayed wound healing
  * Immunocompromised status due to medication or immune system dysfunction
  * Active infection or non-healing wounds
  * Currently pregnant or lactating
  * Long-term steroid use
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

* Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their stable background treatment.
* During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG1205 present in the blood (Pharmacokinetics) as well as the effects of GLPG1205 on disease- and mechanism of action-related parameters (Pharmacodynamics) in blood, stool and colonic biopsies will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 75 years
* Documented history of UC
* Presence of active UC for a minimum period of 14 days prior to screening and spread beyond the rectum, Mayo score ≥ 6 with rectal bleeding score ≥ 1 and endoscopy score ≥ 2
* Absence of infectious colitis
* Tumor necrosis factor alpha (TNFα) inhibitor-naive subjects should have failed at least 1 prior conventional therapy
* Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), immunosuppressants and 5-aminosalicylates at stable dose is allowed
* Female subjects must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year
* Subjects will have to use highly effective contraceptive methods

Exclusion Criteria:

* History of sensitivity to any component of the study drug, or a history of drug or other allergy
* Any concurrent illness, condition, disability, or clinically significant abnormality that, in the investigator's opinion, represents a safety risk for the subject's participation, may affect the interpretation of data, or may prevent the subject from safely completing the assessments
* History of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, GI (other than UC), pulmonary, or metabolic disease
* History of active infections requiring intravenous antibiotics within the past 4 weeks prior to screening.
* History of malignancy within the past 5 years; presence or history of intestinal malignancy
* History of bowel surgery within 6 months prior to screening; history of colon resection with \< 30 cm of the colon remaining
* Suspicion of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, diverticular disease-associated colitis, or radiation-induced colitis
* Subject who has received non-permitted UC therapies within specified timeframes, depending on the medication, as stated in the protocol
* Subject who is pregnant or lactating
Metabolic Effect of High-protein Meals in Men

The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.

It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms.

The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.

Eligibility Criteria:
Inclusion Criteria:

* 20 - 50 years, male
* Healthy as determined by a medical questionnaire
* Normal weight: BMI 20 - 24.9 kg.m-2
* Normal fasting glycemia and insulinemia
* Normal fasting lipidemia (cholesterol and triglycerides)
* Normal liver function (transaminases, γ-GT) and kidney function (urea, creatinine)
* Capable of fast ingestion of the meal replacement (5-10 min)
* Having signed informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
* Hypertension \>150/95 mmHg
* Have had a gastrointestinal surgery
* Have a regular consumption of medication
* Vegetarian, vegan, under dietary supplements
* Have an alcohol intake: \> 2 units a day or smoker
* Currently participating or having participated in a clinical trial during the last month
* Having given blood in the last month
* More than 5 x 45 min of intense exercise per week
* Volunteer who cannot be expected to comply with treatment
Cognitive Sensorimotor Training With Whole Body Vibration for Cognitive Impairment

Aging is associated with cognitive decline, ranging from normal to mild cognitive impairment or dementia. This leads to physical and cognitive impairment, which are risk factors for loss of autonomy therefore physical and cognitive training are important for cognitively impaired older adults. Cognitive somatosensory exercise (CSE) is a special comprehensive rehabilitation program for retraining sensory-induced motor control, and whole-body vibration (WBV), which enhances neuromuscular function, cognition, and balance. This study aims to investigate the effects of combined cognitive sensory-motor training with whole-body vibration on cognition and balance in older adults with mild to moderate cognitive impairment.

A double-blinded randomized control trial will be conducted for ten months. The sample size was calculated through G-power and 50 participants will be recruited through the non-probability convenience sampling technique. Those who meet the inclusion criteria will be randomized into two groups (25 in the experimental group and 25 in the control group) through the online randomizer tool. The experimental group will receive cognitive sensorimotor training along with whole-body vibration. The control group will receive the cognitive sensorimotor training and Motor-cognitive dual-task training (mCdtt) simultaneously. Participants of each group will receive 60 minutes of training 3 times per week for 12 weeks. Outcome measures include the Montreal Cognitive Assessment (MoCA), the Stroop test will be used for the measurement of cognition and cognitive flexibility, the Mini bESTest for static and dynamic balance, and the Short physical performance battery for functional mobility. Assessment will be done at baseline, after the 6th week, 12th week, and at 16th week. Data analysis will be performed by using SPSS 26 software. Mixed ANOVA and repeated-measures ANOVA will be used for within-group analysis whereas between-group analysis will be performed by using one-way ANOVA.


Eligibility Criteria:
Inclusion Criteria:

* Participants fulfilling given criteria will be included in this study

  * Both male and female participants will be included
  * The age limit for the participants will be 60 to 75
  * Participants with mild to moderate cognitive impairment having a Montreal Cognitive Assessment (MoCA) score of 13-25 (out of 30)
  * Participants with mild to moderate balance impairment having Mini BESTest cut-off score 13-28

Exclusion Criteria:

* Participants having given criteria will be excluded from this study

  * Participants having major depressive and anxiety disorder
  * Participants having significant visual and auditory impairment
  * Participants having a prior history of neurological disease or brain injury, and psychiatric disorders
  * Participants having cerebrovascular infarction
  * Participants having a neurological condition (epilepsy, loss of consciousness leading to a fall (e.g. vertigo syndrome)
SEEG Investigation of Mood Dysregulation in Epilepsy

Using the novel analysis of stereo-electroencephalography (SEEG) recordings, this proposal will investigate the activity and connectivity of mood regulation circuits in subjects with suspected epileptic focus who have undergone SEEG electrode implantation for monitoring of seizure activity.

It is well known that epilepsy is associated with mood dysregulation including symptoms of labile mood, impulse control problems, anxiety, depression and increase in incidence of suicide. However, until present the neurobiological basis of mood dysregulation in epilepsy has not been clear and has been mostly attributed to a psychological reaction to the illness. This has severely limited our understanding of the impairments in mood regulation that people with epilepsy often experience and has also limited the development of effective treatment for ameliorating psychosocial dysfunction in people with epilepsy. The identification of these circuits will not only increase our understanding of mood-regulation in epilepsy but also possibly provide biomarkers with which the effectiveness of new treatments can be investigated. Developing better diagnostic measures and treatments for mood dysregulation will be highly beneficial to the quality of life of subjects suffering from epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis

Exclusion Criteria:

* Subjects that experience surgical complications during the implant procedure will be excluded from the study
A Holistic Dietary Intervention for Persons With Spinal Cord Injury

People with spinal cord injury are at increased risk for overweight and obesity, type 2 diabetes, cardiovascular disease and decreased quality of life compared With able bodied.

This pilot aims to assess the impact of a nutrition intervention that combines several methods to help people change their lifestyle.

The pilot project combines individual interviews and personal lifestyle goals (diet) with group classes for people with long-standing spinal cord injury.

In addition to nutrition theory and practical exercises for diet-planning, motivational interviewing and mindfullness are incorporated into the course. The course is interdisciplinary, but is led primarily by a dietitian. Data is collected before the course starts and right after the 9-week course ends. The measurements involves self-perceived quality of life, food diary, weight, waist circumference and body composition (measured by BIA and DXA).


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Long-standing Spinal Cord Injury (\> 2 years after injury)
* Motivated for lifestyle change
Central and Peripheral Adiposity and Iron Absorption

Adiposity is a state of sub-clinical inflammation, thus hepcidin is increased in adiposity, often leading to iron deficiency in this population group. Central adiposity is generally considered having a greater negative effect on health compared to peripheral adiposity. Whether this can be also seen in hepcidin and thereby in iron absorption is uncertain.


Eligibility Criteria:
Inclusion Criteria:

* either normal-weight (BMI 18-25kg/m2) or overweight/obese (BMI 28-50kg/m2) with either central or peripheral fat deposits based on DEXA

Exclusion Criteria:

* Iron Supplement or antibiotic intake within 2 weeks before study start
* diagnosed chronic disease or gastrointestinal disorders
* regular use of medication (except contraceptives)
* pregnancy
* lactation
* smoking
* blood donation or surgery within the last 4 months.