cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Case Management to Improve the Outpatient Care of Alcohol-related Disorders

The purpose of this study is to disseminate and transfer the comprehensive quality management interventions (CQM) for alcohol-related disorders in primary care developed during the first funding phase into routine care. The two steps are (1) to optimize the CQM approach and (2) to investigate the dissemination and transfer into routine care in a randomized controlled trial.

In the first funding phase the project AQAH ("Ambulantes Qualitätsmanagement alkoholbezogener Störungen in der hausärztlichen Praxis"-"comprehensive quality management for alcohol-related disorders in primary care") systematically investigated three issues: (1) the outpatient care system and evidence-base for screening, diagnosis and treatment was examined; it developed (2) a comprehensive quality management system (CQM) consisting of documentation material, a pathway of care and evidence-based practice guidelines; (3) the effects of the CQM on the detection and treatment of alcohol-related disorders were investigated in a randomized controlled pre-post design and the results show positive effects of the CQM. In the second funding phase (a 3 year bi-center project) the purpose is now to disseminate and transfer the CQM into routine care. The two steps are (1) to optimize the CQM approach and (2) to investigate the dissemination and transfer into routine care in a randomized trial. (1) The paper-based AQAH-practice guidelines are transformed into an interactive electronic version with online patient documentation and evaluation, decision support measures as well as links to specialists and an e-learning tool. (2) After pilot testing in the AQAH-study-networks, an active transfer to the greater regions of Südbaden and Südwürttemberg will be performed in a parallel group cluster randomized controlled trial with GP practices as unit of randomization. Outcome data will be collected concerning the acceptance of the system and the quality of care delivered.

Comparison(s): (1) Use of the interactive electronic version of the CQM for alcohol-related disorders with a special training for general practitioners, compared to (2) use of the CQM with additional education for the whole practice team and organizational re-structuring advice, compared to (3) a control group who uses the CMQ without any special training.

Eligibility Criteria:
Inclusion Criteria:

* General practitioner
* Possibility to use broad-band internet

Exclusion Criteria:

* none
Therapy of Alzheimer's Disease With Neurofeedback

The project aims to investigate in patients of Alzheimer's disease in a prodromal state (early state of the disease) compared to healthy subjects whether neurofeedback training with functional MRI (fMRI) can improve cognitive ability. It is of interest if voluntary modulation of brain activation with real-time (rt) fMRI as a novel method affects cognitive ability, as well as functional and structural measures of the brain.

Over the course of the study subjects will learn a real-world footpath. During neurofeedback training subjects are then asked to recall this footpath while simultaneously trying to modulate their own brain activation based on feedback. Feedback is given about the parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial memory, which is known to be affected early by Alzheimer's disease pathology.

Before and after the training cognitive ability is assessed using neuropsychological tests mainly measuring numerous domains of memory.

The investigators hypothesise that the training leads to an improvement of the trained cognitive domain, but also induces changes in brain structure and function.


Eligibility Criteria:
Inclusion Criteria:

* Native speakers of German
* Naive to neurofeedback experiments
* Ability to provide written informed consent

Exclusion Criteria:

* Metallic implants (MR-safety)
* Neurological/psychiatric disease (except Alzheimer's disease in the patient group)
* Use of psychoactive medication (expect medication for Alzheimer's disease)
* Familiarity with the study site
A Multicenter Registry of Adalimumab in Chinese Adult Patients With Active Ankylosing Spondylitis

A multicenter registry to explore the clinical outcome of Chinese adult patients with active Ankylosing Spondylitis \*AS\* treated with adalimumab,prescribed according to the local label,in the real world practice

This registry will be conducted in a non-interventional setting for AS patients using adalimumab in China.The primary objective is to evaluate the effectiveness and safety of adalimumab in Chinese AS patients in real world clinical practice.The secondary objective is to 1)compare the clinical outcome in patients with or without good persistence with adalimumab;2)investigate the predicting factors of a good clinical response after discontinuation of adalimumab.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with established diagnosis of ankylosing spondylitis.
2. Patients eligible to use adalimumab according to the local label without any contraindication.(According to the local label, patients should be screened for active infection,TB,HBV,malignancy and CHF before the prescription of adalimumab,patients with latent TB should start a full course of anti-TB therapy before the use of adalimumab.)

Exclusion Criteria:

1.Patients with contraindication or are not appropriate to use adalimumab according to the local label will be excluded
A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status, refractoriness, and relapsed disease still remains. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diffuse large B cell lymphoma Elderly (\>65 years) or medically ineligible to standard cytotoxic chemotherapy due to poor performance status, or relapsed or refractory patients Eastern Cooperative Oncology Group performance status ≤ 2, age≥ 20 years Relapsed or refractory after autologous hematopoietic stem cell transplantation (auto-HSCT) in young patients with good performance status and indicated to high dose chemotherapy and auto-HSCT More than one measurable lesion
* More than 2cm sized lesion in conventional CT scan,
* More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min) Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit) Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕) patient who agree the purpose and intention of this clinical trial

Exclusion Criteria:

* recent (\<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)

  * hemodynamically unstable due to the recent (\<12 months) history of severe heart disease such as myocardial infarction
  * acute complications of severe lung or metabolic disease
  * Combined severe neurological or psychiatric disease Unrecovered from infection or other medical disease Recent (\<30 days) history of enrollment of other clinical trial Pregnant or breast-feeding woman women of childbearing potential and men not employing adequate contraception at least for 1 year Previous history drug allergy to the content of 131I-rituximab Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled) Young patient with good performance status indicated to autologous hematopoietic stem cell transplantation irrespective of the failure of 1st line chemotherapy
A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

The primary objective of the study was to demonstrate the efficacy of Z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the Disease Activity Score 28 using C reactive protein (DAS28-CRP) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Meet the ACR / EULAR criteria for classification of RA
* Have moderate to severe RA, defined as involving a minimum (≥6 total swollen and ≥6 total tender) of the 28 joints assessed
* Have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score ≥4.5
* Have been on a stable dose of conventional DMARD therapy for at least 90 days without dosage adjustment or modification and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy

Exclusion Criteria:

* Treatment-refractory patients are excluded
* Has active cardiovascular disease, unless well controlled by appropriate treatment for a minimum of 3 months prior to screening
* Is taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg
* Is currently taking steroids at a daily prednisone dose, or the equivalent, of \>10 mg
* Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study
* The need to continue the use of one or multiple NSAID's at the same time, or the use of acetaminophen on a chronic basis
* All opiate use is prohibited
* Use of any other medications or herbs used for the treatment of pain is prohibited
* Patients with a history of or currently active tuberculosis as per specific country guidelines are excluded
* Has uncontrolled diabetes mellitus as defined by a serum glucose \>126 mg/dl
* Knowingly has HIV infection or hepatitis
* Has undergone administration of any investigational drug within 30 days of study initiation
* All biologic agents are excluded for 90 days prior to Screening and throughout the study.
* Has undergone administration of rituximab or any B-cell depleting investigational drugs within 6 months of study initiation
* Has had a history of alcohol or drug abuse within the past 2 years
* Has a history of hypersensitivity to glucocorticoids and/or dipyridamole
KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)

The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy
* 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

* 1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
* 2. Pregnancy and/or breast feeding
* 3. Current participation in any interventional trial
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
* Has HbA1c 6.0% to 11.0%, inclusive, at screening.
* Has a body weight of \>= 50 kg at screening.

Exclusion Criteria:

* Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
* Currently participates in any other interventional study.
* Is currently treated with any of the following excluded medications:

  * Sulfonylurea chlorpropamide
  * Thiazolidinedione within 3 months of screening.
  * Αlpha glucosidase inhibitor within 3 months of screening.
  * Meglitinide within 3 months of screening.
  * Insulin within 3 months of screening.
  * Pramlintide within 3 months of screening.
Effect of Natural Cesarean Section on Breastfeeding

Effect of natural cesarean section in comparison to traditional cesarean section on maternal and fetal recovery.


Eligibility Criteria:
Inclusion Criteria:

1. primigravida or para one section
2. full term
3. cephalic
4. single baby
5. average weight
6. spinal anathesia

Exclusion Criteria:

1. High risk pregnancy.
2. Women with known or suspected fetal malformation.
3. Women with uterine malformations.
4. Breech or transverse lie.
5. Emergency caesarean section.
6. Previous two or more caesarean section
Evaluation of the Efficacy and Safety of a Hyaluronic Acid Gel in Adhesion Prevention After Open Thyroidectomy.

The aim of this study is to assess the safety and efficacy of HANBIO BarriGel to prevent thyroidectomy postoperative adhesions

The objective of this study is to evaluate the efficacy of HANBIO BarriGel in the prevention of postoperative adhesion for patients who will undergo open thyroidectomy. The dysphagia and adhesion severity will be assessed at specific visits pre and/or post-operation for both treatment group and control group. The post-operative condition, and the adverse event information will be collected for evaluation of tolerability and safety of the product.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between 20 and 70 years of age.
* Patients diagnosed with benign goiter or thyroid cancer that will undergo open thyroidectomy (either unilateral or bilateral total thyroidectomy with or without central lymph node dissection).
* Naïve patients to thyroid surgery.
* Subjects are willing to comply with all aspects of the study and have signed informed consent form.

Exclusion Criteria:

* Pregnant or lactating female patients.
* Presence of severe and uncontrolled illness such as stroke, hypertension, diabetes, chronic renal failure, coagulopathy, drug abuse.
* Patients with previous neck radiotherapy within 1 year.
* Concurrent diseases/conditions which will be unable to evaluate the outcomes.
* Patients receiving any adhesion prevention adjuvant.
* Previous history of Keloid or hypertrophic scar.
* Anticoagulant used within a week from surgery.
* Subjects are hypersensitive to sodium hyaluronate.
* Participate in another clinical trial within 1 month.
* Patients presence of surgical site infection.
* Patients are with abnormal clinical test (appendix 1) result within one month or ECOG performance status (appendix 2) score ranged from 3-4.
Copeptin Changes After Food Intake

The purpose of this study is to determine whether copeptin levels are affected by food intake.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years

Exclusion Criteria:

* Intake of any kind of medication (except birth control pill)
* BMI \>30 kg/m2
* Evidence of any acute illness
* History of chronic illness
* Pregnancy
* Known galactosemia or maltose malabsorption
* Baseline glucose level \>5.5 mmol/l Baseline sodium level \<135 mmol/l or \>145 mmol/l
A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients

This study will evaluate the efficacy, safety and patient reported outcomes of chidamide 20 mg biw PO day1-14 and rituximab 375 mg/m2 IV given on day 1 and methotrexate 3.5g/m2 IV given on day 2 of every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma.

The primary study endpoint will be complete response (CR) rate as assessed by the investigator. The hypothesis is previously untreated patients with primary central nervous system lymphoma could achieve a CR rate of 80% with C-R-HDMTX.


Eligibility Criteria:
Inclusion Criteria:

1. ECOG Performance Status of 0, 1, or 2
2. Previously untreated patients with primary central nervous system lymphoma with pathologically confirm
3. At least one bi-dimensionally measurable lesion, defined as \>1.0 cm in its longest dimension as measured by MRI
4. Signed written Informed Consent Form
5. hematologic function,defined as follows:

   * Hemoglobin ³ 9.0 g/dL without packed RBC transfusion during 14 days before first treatment
   * ANC ³ 1,000/µL
   * Platelet count ³ 80,000/µL
6. Adequate liver and kidney function function,defined as follows:

Serum AST and ALT≤ 2.5 \*ULN ，Total bilirubin ≤ 1.5 \* ULN Serum creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula)

Exclusion Criteria:

1. Evidence of extracranial involvement (such as testis and breast) and secondary CNS involvement
2. Evidence of pleural fluid, ascites and pericardial effusion
3. History or presence of prolonged QTc interval in ECG, QTc interval\>470ms in female and \>450ms in male
4. History of other malignancy in 5 years
5. Positive test results for hepatitis C, HIV and RPR.
6. Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is less than 10E4 at the time of screening.
7. Pregnancy or lactation or intending to become pregnant during study
8. Prior organ transplantation
9. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or significant infections within 2 weeks before the start of Cycle 1.
10. Evidence of significant, uncontrolled, epilepsy
Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC

To evaluate the safety and efficacy of aprepitant combined with ondansetron and dexamethasone to prevent nausea and vomiting induced by Intensity-modulated Radiotherapy (IMRT) cisplatin-chemotherapy regimen in locally advanced squamous cell carcinoma of head and neck

To evaluate the complete response rate, nause-free rate, vomiting-free rate, and the quality of life of aprepitant combined with ondansetron and dexamethasone for the nausea and vomiting induced by chemoradiotherapy in HNSCC.

Eligibility Criteria:
Inclusion Criteria:

Pathology confirmed squamous cell carcinoma. The primary sites included nasopharynx, mouth, oropharynx, hypopharynx, larynx, nasal cavity and paranasal sinuses; Aged 18 to 70 years old; Stage III-IVB diseases; Eastern Cooperative Oncology Group Performance Status 0-1; Normally functioning of liver, kidney, bone marrow; Concurrent chemoradiotherapy is recommended after multi-disciplinary team discussion; Must be able to swallow tablets; At least 12 weeks lifetime was expected; Fertile male or female patients volunteered to use effective contraception within 90 days of the study period and at the end of study.

Exclusion Criteria:

Nausea and vomiting occurred 24 hours before the start of the chemotherapy; Corticosteroid or benzodiazepines used; Combination Medicine which metabolism through drug-metabolizing enzyme CPY3A4 and CYP2D6; Serious cardiovascular, pulmonary, diabetes, mental and other diseases; Perinatal women or refused to take contraception during treatment; Other induced vomiting factors. (The transfer of the central nervous system, intestinal obstruction or hypocalcemia, and so on)
A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin

The main aim of this study is to describe how effective and safe the re-treatment of adults with cutaneous T-cell lymphoma (CTCL) with brentuximab vedotin is. Another aim is to describe treatment patterns of persons with CTCL who have received brentuximab vedotin again.

No treatment will be provided during this study. Information already existing in the participants' medical charts will be reviewed and collected.

This is a non-interventional, retrospective study of participants from France, Germany, Spain and Italy with CTCL who were retreated with brentuximab vedotin (BV) after a relapse in at least two different lines of therapy. The participants will be identified from their medical charts and those who meet the eligibility criteria will be included.

The study will enroll approximately 50 participants.

This multi-center trial will be conducted in Europe. The participants are assessed after the last dose of BV for approximately 4 months and followed up for at least 12 months after the re-treatment.

Eligibility Criteria:
Inclusion criteria:

* Participant with a confirmed diagnosis of CTCL (including Mycosis fungoides (MF), Sézary syndrome (SS), Primary cutaneous CD30+ anaplastic large cell lymphoma (pcALCL) and others) who reached a complete response (CR), partial response (PR) or stable disease (SD) on a previous treatment with BV and whose disease relapsed
* Participant who was treated with BV in at least 2 lines of therapy, other treatments could have been administered in between
* Participant has received three or more cycles of BV in retreatment

Exclusion criteria:

There are no exclusion criteria for this study.
Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI

Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications.

Exclusion Criteria:

* Type 1 diabetes.
Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT

Further studies are needed to establish the effects of WALANT in performing most common hand surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore, this study aims to identify the best interval time to perform elective hand surgeries using WALANT technique, document clinical outcomes and identify potential complications

To propose the optimal time delay from the injection to skin incision for most WALANT surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also postoperative pain scores and complication rates

To determine if there is a difference between performing the WALANT technique with a waiting interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss, pain scores, and complications.

Initiate the use of WALANT technique and its application in practice of Orthopaedic Residents in East Avenue Medical Center

Eligibility Criteria:
Inclusion Criteria:

1. . Signed Consent Form
2. Elective Hand Surgeries
3. Minor Hand Surgeries
4. Adult Male/Female ages 18 and above
5. Multiply injured

Exclusion Criteria:

1. No Consent
2. Multiply injured patient
3. Traumatic Hand Injuries
4. Known allergic reaction to either Epinephrine or Lidocaine.
5. Known heart condition
6. Patients on anticoagulants
7. Patients diagnosed with bleeding disorders