cyrilzakka/clinical-trials huggingface dataset:
Phase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults

This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will use the Benvitimod cream at the skin with psoriasis for 12 weeks.

This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will apply the Benvitimod cream on the skin with plaque psoriasis for maximum 12 weeks. All participants will complete follow-up visits at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and continuing up to one year.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants ages at least 18 years.
* The participant with diagnosis of mild to moderate stable psoriasis vulgaris.
* BSA involvement \<10%.
* Capable of giving written informed consent.

Exclusion Criteria:

* Planned Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation during the study period.
* Known allergies to the active ingredient or excipients of the drug.
* Pregnant females, lactating females.
* The patients who were considered unsuitable to participate in the study by the investigators.
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.

This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.

Eligibility Criteria:
Inclusion Criteria:

* has type 2 diabetes mellitus
* has body mass index \>20 and \<43 kg/m\^2
* is a male, or a female who is unlikely to conceive
* currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus

Extension Study Inclusion Criteria:

* completed the base study either on double-blind study medication or as part of the post-treatment follow up population
* had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period

Exclusion Criteria:

* has any history of Type 1 diabetes mellitus or ketoacidosis
* has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
* has had ≥2 episodes during their lifetime or \>1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
* is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
* has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes

Investigators hypothesized home-based exercise intervention was beneficial to those who have had diabetic risk factor for type 2 diabetes mellitus

This randomized clinical trial was designed to investigate whether a home-based exercise could improve adiponectin levels, exercise behavior and metabolic risk factors (insulin resistance, metabolic components and physical fitness) in subjects with at least a diabetic risk factor for type 2 diabetes mellitus. Participants were randomly allocated to either a control group or a home-based exercise group. All participants were evaluated for outcome measures at baseline, and at 3-month 6-month and 9-month follow-up after engaging in the intervention.

Eligibility Criteria:
Inclusion criteria:

* At least one of the following criteria as following: BMI \>=24 kg/m\*m, hypertension, dyslipidemia, fist-degree relatives of parents with type 2 diabetes, impaired glucose tolerance, gestational diabetes and delivering a babt weighing \>=4.0 kg
* Ability of understanding Chinese or Taiwanese

Exclusion Criteria:

* Diabetes
* Receiving treatment with insulin or oral hypoglycemic agents
* Any other serious illness that prohibit them to undertake fitness evaluation
Duration and Force Variations in Applied Kinesiology Manual Muscle Testing

To investigate the effect of duration of Applied Kinesiology manual muscle testing on "strong" versus "weak" result of the test.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* willing to participate

Exclusion Criteria:

* Major injury or conditions which would prevent muscle testing of the shoulder.
Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract

A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with complicated bile duct stone (stone size \> 1.5 cm or number of stone \> 3 )
* Patients with indeterminate biliary stricture or obstruction

Exclusion Criteria:

* Pregnant woman;
* Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).
Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation

This study, which was planned to examine the effects of cognitive behavioral approach-based psychoeducation on addiction profiles, self-efficacy levels and addiction courses in patients with substance use disorders, was carried out as a randomized controlled experimental study.

It can be said that alcohol/substance nurses, by applying cognitive behavioral approach-based psychoeducation to patients with substance use disorders, can have a positive effect on reducing the severity of addiction, increasing their self-efficacy levels, and providing the care, education and counseling support that patients need.

The aim of this study is to examine the effects of cognitive behavioral approach-based psychoeducation applied to patients with substance use disorder on addiction profiles, self-efficacy levels and addiction courses.

Eligibility Criteria:
Inclusion Criteria:

1. To be diagnosed with "Substance Use Disorder" according to The Diagnostic and Statistical Manual of Mental Disorders-V,
2. To be over 18 years old,
3. Volunteering to participate in the research.

Exclusion Criteria:

1. Other than Substance Use Disorder, chronic, requiring ongoing help and care the presence of a medical illness,
2. Being illiterate (the types of scales to be used must be self-report forms) because of).
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH

The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in the body following a regular daily pattern. The objective of the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease.

This study is a Phase 2 pilot study to characterize and examine the pharmacokinetics and efficacy profile of Chronocort® in adults with congenital adrenal hyperplasia (CAH). It is designed as a two-part, single cohort, open label, multiple dose Phase 2 pilot study to: (Part A) characterize and examine the pharmacokinetics (PK) and disease bio-marker behavior following short-term dosing with Chronocort®; and to (Part B) examine the disease control after six months dose titration with Chronocort® in adults with CAH.

Eligibility Criteria:
Inclusion Criteria:

1. Known CAH due to 21-hydroxylase deficiency (classic CAH) based on hormonal and genetic testing currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone on a stable dosage for a minimum of 3 months.
2. Male or female patients aged 18 and above.
3. Provision of signed written informed consent.
4. Good general health.
5. Females of childbearing potential must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using a medically acceptable method of contraception (as defined in the protocol, section 10.5).
6. Plasma renin activity must be within the clinically acceptable range at screening (less than 1.5 times upper normal range).

Exclusion Criteria:

1. Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of glucocorticoids.
2. Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (ALT or AST) \> 2 times the upper limits of normal.
3. Females who are pregnant or lactating.
4. Women taking an estrogen-containing oral contraceptive pill and who have taken it within 6 weeks of recruitment.
5. Patients taking spironolactone.
6. Patients on inhaled or oral steroids apart from treatment for CAH.
7. Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
8. Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
9. Patients with history of bilateral adrenalectomy.
Linear Growth of Children With Congenital Adrenal Hyperplasia

The congenital adrenal hyperplasias (CAHs) comprise a family of autosomal recessive disorders that disrupt adrenal steroidogenesis. Three specific enzyme deficiencies are associated with virilization of affected women. The most common form is 21-hydroxylase deficiency (21-OHD) due to mutations in the 21-hydroxylase (CYP21A2) gene. Other virilizing forms include 3b-hydroxysteroid dehydrogenase type 2 (HSD3B2) and 11b-hydroxylase deficiencies associated with mutations in the HSD3B2 and 11b-hydroxylase (CYP11B1) genes, respectively.

It has been reported that approximately one child in every 18000 born in Great Britain has CAH. In North America, the incidence varies from 1:15000 to 1:16000. The reported rates of CAH have been as high as 1:280 among the Yupik people of Alaska and 1:2100 on the French island of Réunion in Indian ocean; both of these populations are geographically isolated. The reported incidence of CAH in the two Brazilian states that have routinely included CAH in their public newborn screening programs is 1:11655 in the South (Santa Catarina) and 1:10325 in Midwest (Goiás).

Salt-losing CAH accounts for about three quartes of cases reported and non-salt losing CAH for one quarter. Non-classic is more common ;Estimated as 1 in 1000-2000 in white populations. It is more frequent in certain ethnic groups, such as the Ashkenazi Jewish population. The mild non-classic form is a common cause of hyperandrogenism.

Treatment of classic 21-OHD consists of replacement doses of gluco- (GC) and mineralocorticoids aiming to reduce excess androgen, and to allow adequate linear growth. However, several series report that growth in these children is below expectation, as compared with both the reference population and the target height (TH).

The reasons for the inadequate growth and impairment of the final height (FH) are not completely understood. A major cause is the difficulty in accomplishing a fine balance between inhibition of excess androgen production which accelerates bone maturation and adequate GC replacement itself which even at slightly supraphysiologic doses can be deleterious to growth.

Eligibility Criteria:
Inclusion criteria:

* Age: 1-18 y.
* Both sexes.
* All patients who were diagnosed as having CAH of at least 1 y duration.
* On glucocorticoid replacement therapy .

Exclusion criteria:

* Patients diagnosed as CAH for less than 1 year duration.
* Patients with deficient data at the time of diagnosis.
* Patients missed for follow up.
* Syndromatic patients.
Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma

The anti-CD20 monoclonal antibodies, rituximab (R) and obinutuzumab (G), are used as standard maintenance therapy every 2 months for 2 to 3 years in patients with follicular lymphoma (FL) or mantle cell lymphoma (MCL).

This treatment is associated with profound and prolonged B lymphopenia, hypogammaglobulinemia and increased infections. Severe forms of COVID-19 on Rituximab with prolonged carriage of the virus have been reported due to significant impairment of humoral immunity in this context of maintenance therapy.

Therefore, during the COVID-19 epidemic, clinicians are faced with the question of whether to discontinue maintenance therapy or continue treatment. However, the half-life of rituximab is 29 days and lymphopenia continues for up to 9-12 months after stopping injections. Therefore, it is not clear that discontinuation of maintenance therapy will alter the risk of severe SARS-CoV-2.

However, post-vaccination immunization against SARS-CoV-2 by an mRNA vaccine is not known in this context of prolonged treatment with rituximab or obinutuzumab. It is however well established that post-vaccination responses against diphtheria, tetanus, pneumococcus, HBV, or influenza in particular are altered after anti-CD20 antibodies. If the humoral response is crucial in the post-vaccination response, it is also suggested that the preservation of innate immunity and the CD8 response, unaltered by anti-CD20, could also play an important role in the post-vaccination response and virus clearance.

The aim of our study is to evaluate the humoral and post-vaccination T-cell response based on serological data and T-cell production of interferon gamma in response to SARS-CoV-2 specific antigens (Elispot interferon gamma) in this group of patients treated for lymphoma with a long-term anti-CD20 antibody.


Eligibility Criteria:
Inclusion Criteria:

* Age superior to 18 years old
* Patient undergoing maintenance treatment for Mantle Cell Lymphoma or Follicular Lymphoma treated with rituximab or obinutuzumab in complete remission or stable disease between injection #1 and injection #13 or 19 (end of second year or third year)
* Inform consent signed

Exclusion Criteria:

* Documented history of SARS-Cov-2 infection less than 3 months old
* Progressive lymphoma
* Contraindication SARS-Cov-2 vaccination (allergy)
* Refusal of SARS-CoV-2 vaccination
* Patient who has been off rituximab or obinutuzumab therapy for more than 6 months
* Patient not covered by health system
* Pregnant or nursing woman
Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients

Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation.

The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients who undergo a non urgent colonoscopy
* Patients who give informed consent to participate in the study
* Patients older than 18 years
* Patients who undergo total colonoscopy

Exclusion Criteria:

* Non compliance with the 48 hours diet prescribed
* The endoscopy planned is a rectosigmoidoscopy
* Previous colonic surgery
* Mental/cognitive impairment preventing the study assessments
* Severe renal failure
* Electrolytic disbalance(hyponatremia, hypokaliemia, Hyperphosphatemia, hypocalcemia and hypomagnesemia)
* Intestinal obstruction, perforation or toxic megacolon
* Pregnant or nursing women
* Allergy/intolerance to PEG, bisacodyl or adjuvants
* No informed consent
ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.

Prospective, multi-center, non-randomized single-arm study of the Wingman Catheter to cross a single infrainguinal peripheral chronic total occlusion (CTO). Safety and effectiveness will be evaluated during the index procedure through 30-day follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to provide informed consent.
* Patient is willing and able to comply with the study protocol.
* Patient is \> 18 years old.
* Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
* Patient has at least one but not more than two occluded infrainguinal arteries that are 99-100% stenosed and no flow is observed in the distal lesion except the flow from collateral circulation.
* Target lesion(s) is ≥ 1 cm and \< 30 cm in length by visual estimate.
* Target vessel is ≥ 2.0 mm in diameter.
* Patient has Rutherford Classification of 2-5.
* Lesion cannot be crossed by concurrent conventional guidewire.
* Reconstitution of vessel at least 2cm above bifurcation/trifurcation.
* Occlusion can be within previously implanted stent.

Exclusion Criteria:

* Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
* Patient has a known sensitivity or allergy to all anti-platelet medications.
* Patient is pregnant or lactating.
* Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
* Target lesion is in a bypass graft.
* Patient has had a failed crossing attempt without an intervening intervention on the target limb within the past 14 days.
* Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients

This will be a phase I, open, multicenter, international study performed by 3 participating centres across two countries (Italy and Switzerland). Fifteen to 24 patients affected by SPMS will be enrolled, according to a "standard" phase I design over 18 months. All patients will enter a 3 months run in phase. Thereafter they will receive one of four different doses of allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millions hNSCs; dose C=16 millions hNSCs; dose D=24 millions hNSCs). Following hNSCs injection, all SPMS patients will receive immunosuppression with tacrolimus for 6 months. Patients will be clinically followed monthly for 1 year and then every 6 months for the 5 years following the study completion (possibly all life long).

MRI assessments will be performed monthly for the first 6 months and then every 3 months for 5 years following the study completion.


Eligibility Criteria:
Inclusion Criteria:

1. SPMS with progressive accumulation of disability after initial relapsing course, with or without disease activity (Lublin et al. 2014).
2. EDSS ≥ 6.5 and ≤ 8
3. EDSS progression over the 2 years prior to study start of ≥ 1.0 point for patients with EDSS =6.5 at the time of inclusion , and of ≥ 0.5 points for patients with EDSS \> 6.5 at the time of inclusion
4. Age ≥ 18 and ≤ 60 years
5. Failure of best medical treatment as judged by the treating neurologist and declared absence of therapeutic alternatives

Exclusion Criteria:

1. Neurological conditions other than MS.
2. Psychiatric disorders, severe cognitive decline and personality and relational disorders.
3. History or known presence of significant systemic, infectious, oncologic or metabolic disorders.
4. Presence of any other autoimmune disease.
5. Chronic infections (HBV, HCV, HIV, tuberculosis).
6. Inability to perform MRI scans.
7. Immunomodulant/immunosuppressive treatments in the last 6 months before inclusion.
8. Current participation to other experimental studies.
9. Inability to provide informed consent.
10. Any contra-indication to lumbar puncture and the surgical procedure (e.g. use of anticoagulants)
11. Pregnancy and breast feeding.