cyrilzakka/clinical-trials huggingface dataset:
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
* Body mass index from 18.0 to 28.0 kg/m\^2 (both inclusive)
* HbA1c below or equal to 9.5% by central laboratory analysis

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma

By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

Hepatitis B virus (HBV)infection is the major risk factor for chronic liver disease and hepatocellular carcinoma (HCC). Host immunogenetic factors contribute to HBV-associated liver damage and/or carcinogenesis. Variant cytokine alleles, including tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β), might contribute to interindividual difference in inflammatory responses and account for heterogeneous disease outcome of infectious disease.

By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg-positive patients

Exclusion Criteria:

* HBsAg-negative patients
β-Cell Function in Schizophrenic Subjects on Atypical Antipsychotic drugS

The purpose of this study is to determine whether atypical antipsychotic drugs (commonly prescribed for treating schizophrenia) induce changes in anthropometry and metabolism, including alteration in insulin sensitivity and/or insulin secretion by the pancreas, when given to lean, non-diabetic, individuals who are antipsychotic drug(s)-naïve, and free of metabolic syndrome at enrollment.

Atypical antipsychotic drugs (AADs) induce weight gain, truncal adiposity and may engender a metabolic syndrome which may progress to IFG/IGT or DM. AADs effects in lean schizophrenic patients without metabolic syndrome are not documented, especially the relationship between weight gain and changes in insulin sensitivity (S), beta-cell function (β), and circulating adiponectin. We prospectively determined the outcome of 9-month therapy with AADs on anthropometrics, metabolism and adiponectin, including HOMA-modeling of S, β, and βxS (hyperbolic product, assessing individual β adjusted for S)in 36 schizophrenic subjects (M:F 24:12; Caucasian n=23; North-African n=12; South-Asian n=1) aged 35±9 years (mean±1SD) free of MetS (NCEP-ATPIII).

Eligibility Criteria:
Inclusion Criteria:

* age 18-55 years
* body mass index \<25.0 kg/m²
* waist circumference \<102 (men) and \<88 cm (women)
* absence of a metabolic syndrome according to NCEP ATPIII criteria
* normoglycaemic (fasting plasma glucose levels \<100 mg/dl)

Exclusion Criteria:

* previous use of antipsychotic drugs
* concomitant therapy with drugs known to possess an inherent potential to increase weight and/or to alter glucose metabolism (including antihistaminic drugs, glucocorticoids, β-blockers, antiepileptic drugs and mirtazapine)
A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis

To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis

If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The investigator thinks that the subject can continue to benefit from participating in the extension trial;
* Fully understand the extension trial and sign the informed consent form;
* Complete the ZGJAK025 trial for 16 weeks and have good compliance;
* It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;

Exclusion Criteria:

* Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
* The investigator thinks that the subject is not suitable for the trial.
Assessment Of Safety Of UK-390,957

To determine whether UK-390,957 is a safe treatment for premature ejaculation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV

Exclusion Criteria:

* No drug related serious adverse events
Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Primary Objective:

* To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects.
* To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects

Secondary Objective:

- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions

The total study duration is approximately 43 days for each participant, including a screening period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days

Eligibility Criteria:
Inclusion criteria :

- Participants who are overtly healthy as determined by medical evaluation

* Body mass index (BMI) within the range ≥18 and ≤31 kg/m2 (inclusive) and a minimum body weight of 45 kg.
* Female participant is eligible to participate if she is not pregnant or breastfeeding
* Male participants are eligible to participate if they agree to refrain from donating sperm and use contraception/barrier or be abstinent from intercourse

Exclusion criteria:

* COVID-19 infection, positive test result for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus antibody
* Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within 7 days
* Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
* Clinically significant abnormal in vital signs. - Any specific situation during study implementation/course that may rise ethics considerations.

The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma

The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for complex hepatic carcinoma.

Because of the complexity of complex hepatic carcinoma,the limitations of 2D images of CT/MRI and the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for complex hepatic carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years≤ Age ≤70 years
2. Compling with the diagnosis criteria of complex hepatic carcinoma.
3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
4. Preoperative liver function is Child - Pugh grade A or B.
5. The patients are volunteered for the study.

Exclusion Criteria:

1. Patients with mental illness.
2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
3. The patients refused to take part in the study.
4. There are other co-existed malignant tumors.
5. Benign liver diseases.
Hydroxychloroquine in Mild Graves' Orbitopathy

This study is aimed to investigate the effect of hydroxychloroquine in patients with mild Graves' orbitopathy (GO).

Graves' orbitopathy (GO) is one of the common manifestations of Graves' disease (GD), which results in proptosis, eyelid retraction, soft tissue swelling, diplopia or even visual acuity impairment. In addition, mental health and quality of life are often affected. In current guidelines, limited treatment options are suggested for patients with mild GO.

Recently, cell study revealed that there are multiple effects of hydroxychloroquine (HCQ) on orbital fibroblasts in patients with mild GO, including suppression of cell proliferation, adipogenesis and production of hyaluronic acid, which poses a great potential in the treatment of mild GO clinically. This randomized controlled trial is aimed to investigate the effects of HCQ in patients with mild GO on the effects of ophthalmic outcomes, quality of life, orbital volumetry on orbital computed tomography, serum inflammatory and fibrosis markers.

Eligibility Criteria:
Inclusion Criteria:

* Mild GO according European Group on Graves' orbitopathy (EUGOGO) guidelines diagnosed by endocrinologist and ophthalmologist.
* No previous treatment of GO except for eyedrops
* Euthyroidism (normalized free T4 and TSH) for at least 2 months. If radioactive iodine is used for hyperthyroidism, euthyroidism needs to be achieved for at least 6 months.

Exclusion Criteria:

* Moderate-to-sever or sight-threatening GO according to EUGOGO guidelines diagnosed by endocrinologist and ophthalmologist.
* Pregnancy
* Drug or alcohol abuse
* Unable to comply with the study protocol
* Unable to obtain informed consent
* Use of hydroxychloroquine or systemic steroid within 3 months prior to enrollment
* History of side effects of hydroxychloroquine
* History of retinopathy
* Renal dysfunction (estimated glomerular filtration rate (eGFR) \< 60ml/min)
* Hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 x upper limit)
* Anemia (hemoglobin (Hb) \< 10g/dl)
* Neutropenia (absolute neutrophil count \< 100/uL)
* Thrombocytopenia (platelet (PLT) \< 150000/uL)
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Porphyria cutaneous tarda
* Allergy to 4-aminoquinoline
Posterior cerebraL ArTery Occlusion Study

For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment).

The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.

The primary aims of the research are to evaluate, in patients presenting with posterior artery occlusion (PCA), whether favorable outcome would be superior for EVT compared to Medically Management (MM), inclusive of intravenous thrombolysis (IVT), as measured by:

* 90-day modified Rankin Scale (mRS) ordinal shift or
* decrease in NIH Stroke Scale/Score (NIHSS) by two points at 24 hours or at hospital discharge

The secondary aims are to evaluate in patients presenting with PCA occlusion, other outcome and safety metrics:

* 90-day functional independence, mRS 0-2
* 90-day excellent outcome, mRS 0-1
* Visual field recovery (none, partial, complete) by 90-days
* rate of reperfusion by modified thrombolysis in cerebral infarction (TICI) scale grade
* any intracranial hemorrhage
* symptomatic intracranial hemorrhage
* mortality

In subgroup analysis, the investigators aim to identify subgroups that may confer differential treatment benefit by:

* location of occlusion on the PCA segment (P1, P2, P3)
* NIHSS strata (0-6, 7-15,\>16)
* time from symptom onset to treatment (0 to \<6h vs 6-24h)
* posterior circulation (PC) Acute Stroke Prognosis Early Computed Tomography Score (ASPECTS)
* visual field defect on presentation

The investigators hypothesize that greater benefit in outcomes would be seen in EVT treated patients with higher NIHSS, more proximal PCA occlusion, higher PC ASPECTS scores, and shorter time from symptom onset to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Had an ischemic stroke with isolated posterior cerebral artery occlusion (P1, P2, or P3 segments) and was medically managed or managed with EVT during the study time period.

Exclusion Criteria:

* Patient with documented basilar artery occlusion and concomitant PCA occlusion
* Patient with documented basilar artery occlusion, migration with secondary PCA occlusion
Various Serving Sizes of Lentils on Blood Glucose and Insulin

The purpose of this study is to assess the effects of consuming either 1/2 or 1/4 cup servings of lentils on post-prandial blood glucose and insulin as compared to 4 types of starchy foods (corn, macaroni, white potato, white rice).

Eligible participants will undergo a total of 6 study visits. During each visit, a fasted blood sample will be taken by fingerprick, and approximately 500 µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: two types of lentils, corn, macaroni, white rice, or white potato. All study days will be randomized. Each meal will be served in either 1/4 or 1/2 cup servings depending on the study block. Six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.

Eligibility Criteria:
Inclusion Criteria

* Healthy men and women
* Age 18-40 years
* Body mass index (BMI) 20-30 kg/m2

Exclusion Criteria:

* Tobacco use
* Pregnant or breastfeeding
* Fasting blood glucose ≥ 7.0 mmol/L
* Two hour blood glucose ≥ 11.1 mmol/L after consuming 75g glucose drink (Oral Glucose Tolerance Test beverage)
* Any major medical condition including a history of AIDS or hepatitis
* Medical or surgical event requiring hospitalization within 3 months of randomization
* Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications
* Blood pressure \>140/90 mm Hg
* Natural health products (NHPs) used for glycemic control
* Probiotic supplements
* Dietary fibre supplements
* Consumption of \>4 servings of pulses per week
* Food allergy or non-food life threatening allergy
* Shift workers
* Alcohol consumption \>14 drinks/week or \>4 drinks/sitting
* Recent or intended significant weight loss or gain (\>4 kg in previous 3 months)
* Elite athletes
Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa

A randomized, controlled, three-arm study to investigate the effects of footbaths with ginger, mustard or warm water alone in female, adolescent patients with Anorexia nervosa and in healthy, female adolescents on psychophysiological parameters.

In a cross-over study design, the subjects (21 female patients with Anorexia nervosa, 20 healthy, female controls) receive footbaths with either ginger, mustard or warm water alone in a randomized order with a wash-out period of at least 1-3 days. The effects of each intervention on the objective warmth generation are measured by infrared thermography, whereas the subjective warmth perception is determined by the 'Herdecke warmth perception questionnaire'. All parameters are determined at specified times (t1 = right before, t2 = right after and t3 = 10 minutes following the footbath), which enables an evaluation based on pre-post-comparisons. The statistical analysis comprises analyses of variances based on linear mixed effects models (after checking for carry-over effects).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent of the parents
* Age 12-18 years

Exclusion Criteria:

* Infectious disease with body temperature above 38 °C
* Skin damages at the lower legs/feet
* Known intolerance/ anaphylaxis to mustard or ginger preparations
* Cardiac arrhythmia
* Pregnancy
* Insufficient knowledge of the German language
* BMI percentile \< 10% (for control group)
Use of a Novel Neuroplasticity-based Neurobehavioral Intervention for PTSD

The present study will explore the effectiveness of a computer based neurobehavioral intervention in alleviating symptoms and improving emotion regulation in individuals with PTSD. It will increase understanding of psychopathology at a neural-circuit level and aid development of new non-pharmacological treatment for PTSD. The study is managed by the Etkin Lab at Stanford University in California, but participants from the entire US are welcome to participate as the study is delivered online.


Eligibility Criteria:
Inclusion Criteria:

* current PTSD
* internet access

Exclusion Criteria:

* lifetime psychotic disorder,
* past-year substance dependence
Zirconia Vs Titanium Implants in Deficient Ridges

The aim of this study is to evaluate clinically and radiographically soft tissue around single-implant crowns and peri-implant bone resorption respectively by using zirconia implants or titanium implants in horizontally deficient partially edentulous ridges.

Experimental: Main treatment group Zirconia implants will be placed in a prosthetically guided position in horizontally deficient ridges in main treatment group.

Active Comparator: Control group Titanium implants will be placed in a prosthetically guided position in horizontally deficient ridges in control group.

Eligibility Criteria:
Inclusion Criteria: Based on the classification of alveolar ridge width given by Tolstunov, subjects with

* partially edentulous (2/3 teeth missing)
* systemically healthy subjects within the age group of 25-44 years
* Class III ridges characterized by moderate i.e., 4-6mm of alveolar ridge width will be included.

Exclusion Criteria:

* Medically compromised patients

  -. Subjects who underwent radiotherapy or chemotherapy and with
* Habit of smoking, tobacco and alcohol abuse
* Subjects with active periodontal disease to residual dentition and lack of oral hygiene will be excluded from this study.
To Investigate the Efficacy and Mechanism of ZBP Powder Product in the Treatment of Osteopenia in Patients With Pain.

This study investigates the efficacy and mechanism of traditional Chinese medicine formula power product in the treatment of osteopenia in patients with pain. Half of participants will receive Chinese medicine formula power product, while the other half will receive a placebo.

Osteoporosis is a major public health problem, resulting in potentially pain and increasing risk of fracture. Treatment of osteoporosis consists of pharmacotherapy, lifestyle measures, dietary changes, mineral supplementation. Traditional Chinese medicine is a major component of health care in Taiwan and provides one treatment alternative for osteoporosis.

Investigators investigate the efficacy and mechanism of traditional Chinese medicine formula powder product in the treatment of osteopenia patients with pain.This trial is a 12 weeks' randomized, placebo-controlled study. The study was approved by the Wan Fang hospital, and signed informed consent was obtained from each participant. 80 Osteopenia participants with pain were enrolled in this study. There were 80 participants aged 50 years or older included. Before random assignment to treatment, participants were at least moderate pain during 2 weeks as identified by visual analogue scale (VAS) for more than 4. Bone mineral density (BMD) of all participants was -2.5 or below without diabetes, hyperthyroidism, hypoparathyroidism, liver or kidney function disorder, ovariectomy, rheumatoid arthritis, bone cancer, ever used hormone agent within 6 months before assignment to treatment, ever used steroids more than 3 week before assignment to treatment, Primary outcome measures were the change of VAS scale, Oswestry Disability Index and WHOQOL-BREF Taiwan at week 1 and 12. Secondary outcome was the genetic loci associated with a susceptibility to osteoprosis treated by traditional Chinese medicine formula powder product.

Result : To provide evidence of the efficacy and mechanisms of ZBP powder product in the treatment of osteoporosis patients with pain.

Eligibility Criteria:
Inclusion Criteria:

1. aged 50 years or older.
2. VAS score≧4.0 in a week.
3. bone mineral density (BMD) of all participants was -2.5 or below.

Exclusion Criteria:

1. diabetes.
2. thyroidism function disorder.
3. parathyroidism function disorder.
4. liver or kidney function disorder.
5. ovariectomy
6. rheumatoid arthritis.
7. bone cancer.
8. ever used hormone agent within 6 months before assignment to treatment.
9. ever used steroids more than 3 months before assignment to treatment.
10. ever used analgesics, excepted acetaminophen, more than 1 week before assignment to treatment.
An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303

This is an extended access study for participants who have completed Rufinamide Study E2080-G000-303 to continue to have access to rufinamide until it becomes commercially available in Poland or until no participants remain in the EAP.


Eligibility Criteria:
Inclusion Criteria:

* Participants who were on rufinamide treatment and have completed Study E2080-G000-303 in Poland.

Exclusion Criteria:

* Participants were randomized to the other antiepileptic drug (AED) treatment group in study E2080-G000-303.