cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy Subjects

This study is a Phase I, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Administration of DA-8010 in Healthy Subjects.

This study will be a randomised, double-blind, placebo-controlled, dose-escalation, single and multiple oral dose study conducted in 2 parts.

In Part A, each subject will participate in 1 treatment period only and reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 3 (48 hours postdose), except for Group A4, where each subject will participate in 2 treatment periods separated by a minimum of 13 days to evaluate the effect of food.

In Part B, each subject will participate in 1 treatment period only and reside at the CRU from Day -1 (1 day before dosing) until the morning of Day 9 (48 hours after the final dose on Day 7).

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.0 and 32.0 kg/m2
* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

* Subjects who do not agree to use a method of acceptable contraception
* Female subjects of child-bearing potential who do not agree to use a highly effective method of birth control
* Consume more than 28 or 21 units of alcohol per week if male or female, respective
* Subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration
* Subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration
* Systolic blood pressure \< 90 mmHg or \> 140 mmHg
* Diastolic blood pressure \< 50 mmHg or \> 90 mmHg
* Pulse rate \< 45 bpm or \> 100 bpm
* Positive urine drugs of abuse screen at screening or first admission
* Positive alcohol breath test at screening or first admission
* Positive cotinine test at screening or first admission
* Abnormality in the 12-lead ECG at screening, admission or predose on Day 1
* Subjects who are pregnant, breastfeeding, or lactating
* Subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration
* Subjects who have a significant history of drug allergy, as determined by the Investigator
* Aspartate aminotransferase and/or Alanine aminotransferase ≥ 1.5 × upper limit of normal (ULN) or total bilirubin \> ULN at screening or admission
* Subjects who are carriers of HBsAg or hepatitis C antibody, have serum hepatitis or positive result for the test for HIV antibodies
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with PBC.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 75 years.
2. Meet at least 2 of the following 3 PBC diagnoses:

   1. Patients had elevated alkaline phosphatase for at least 3 months before enrolment.
   2. AMA positive (titer ≥1:40), or if AMA negative, PBC specific antibodies (anti- GP210 and/or anti-SP100 and/or AMA-M2) are required.
   3. Liver biopsy suggested PBC 48 weeks before enrollment.
3. ALP \> 1.67× ULN before enrollment.
4. Taking UDCA with stable dose for at least 3 months before enrollment.

Exclusion Criteria:

1. Merging with other virus infected.
2. With other existing liver disease or a history of liver disease.
3. With clinical complications of PBC or clinically significant hepatic decompensation.
4. Child-pugh grade B or C.
5. Creatinine (Cr) ≥ 1.5×ULN and serum creatinine clearance rate \< 60mL/min; \[Calculation formula: Cr:(140-age)×weight(kg) /0.818 × Scr (μmol/L)，female Cr=Cr × 0.85\].
6. ALT or AST\>5×ULN;Tbil \> 2×ULN.
7. Patients with a history of severe pruritus 2 months before enrollment.
8. The presence of clinically relevant arrhythmias or associated history that may affect survival during the study period.
9. With diseases that may cause nonhepatic ALP increases (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years.
Cardioprotective Effect of RIPC in Patients Undergoing TAVI

We aim to investigate whether RIPC (remote ischemic preconditioning) is effective in the TAVI setting to reduce post-procedural myocardial damage and improve patient outcome. Accordingly, we aim to investigate whether RIPC can be introduced as an integral part of the TAVI procedure, in order to reduce post-procedural myocardial damage and potentially improve patient outcome.

Transcatheter aortic valve implantation (TAVI) is associated to myocardial injury, defined as post-procedural cardiac troponin (cTn) elevation. Earlier experiences have shown that myocardial damage can be encountered in a percentage of patients that varies from 1.5% to 17%, depending on the access route (transfemoral and transapical, respectively). The degree of rise in cTn after TAVI emerged as an independent predictor of mortality.

Remote ischaemic preconditioning (RIPC) consists of brief episodes of ischaemia applied to remote organs or tissues and has shown to result in a significant reduction in postoperative troponin levels in cardiac and non-cardiac surgery patients. Lately, growing evidence suggests that post-procedural troponin decreases due to RIPC application protocols protocols and is associated with improved outcome.

The patients will be divided into two Groups. In Group 1, RIPS will be induced with three cycles of Inflation of a blood-pressure cuff on the left arm to 200 mmHg for 5 min., followed by 5 min. of reperfusion while the cuff is deflated. In controls (Group 2), the cuff will be placed around the left arm without being inflated.

Eligibility Criteria:
Inclusion Criteria:

* Indication for elective TAVI following Heart Team discussion
* Stable hemodynamic conditions without circulatory support or catecholamines

Exclusion Criteria:

* Myocardial infarction at least 3 months before enrollment
* Stroke/TIA at least 3 months before enrollment
* Severe chronic kidney disease (defined as a baseline serum creatinine of \> 1.5 mg/dl or an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m2 )
* PCI at least 3 months before enrollment
* Abnormal (\>99th percentile of laboratory cut-off) baseline values of biomarkers of myocardial ischemia (i.e. TnT, CK-MB)
* Abnormal NSE values at baseline (local laboratory cut-off values)
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion

EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).

Surgical site infections (SSI) after instrumented spinal fusions are not rare, and patients with SSI after instrumented spinal surgery often require repeat operations and prolonged intravenous antibiotic therapy. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) has recently become a novel strategy to facilitate wound healing.

The study doctor will give an EPIFLO® unit along with standard wound care to some subjects in this study to see if it is safe and can help them. Another purpose of this study is to find out if using EPIFLO® is better than getting only standard wound care for Surgical site infections (SSI). The sponsor also wants to compare the cost of using the study device and standard wound care to the cost of standard wound care alone. The U.S. Food and Drug Administration (FDA) has approved EPIFLO® to treat skin ulcers (including diabetic skin ulcers), bedsores, amputations, skin grafts, burns, and frostbite.

Eligibility Criteria:
Inclusion Criteria:

* Elective spinal fusion - posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions
* Patient Age 18-80
* Patients must be considered high risk for infection, meeting one or more of the following criteria:

  * Anticipated Surgical duration ≥ 3 hours
  * Diabetes Mellitus type I or II
  * Anesthesiology ASA score of 3 or above
  * BMI ≥35
  * Patients with malnutrition as indicated by Pre-albumin value of \<20
  * Chronic corticosteroid use
  * Smokers
  * Patients on immune modulators

Exclusion Criteria:

Major Study Exclusion Criteria include:

* Pregnancy
* Active infection at the time of surgery
* Persons with decubitus or diabetic ulcers
* Patients undergoing \>5 level fusion (Level is defined as crossing a disk space; e.g.,an L3-5 fusion is a 2 level fusion)
* Disseminated Cancer Patients
Heart Rate Variability to Predict Hypotension Following Spinal Anesthesia in Cesarean Delivery

Based on the patient's heart rate variability, the analgesia nociception index (ANI) measures the activity of the autonomic nervous system and the sympathetic/parasympathetic nervous system and expresses it as a numerical value through a specific algorithm. The investigators will analyze it and see if it has the ability to predict severe hypotension following spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult pregnant women scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Emergency cesarean section
* When performing general anesthesia or epidural anesthesia
* Multiple pregnancies
* Surgery in which massive hemorrhage and massive blood transfusion are expected due to placenta previa
* Cardiac arrhythmias, congestive heart failure, ischemic heart disease, congenital heart anomalies
* Cranial nervous system disease
* Autonomic nervous system-related underlying diseases not related to pregnancy
* Fetal malformations
* Those who have an allergic skin reaction to adhesive substances such as bandages
ICF in Cochlear Implant Users

The current project proposes a multi-center prospective follow-up cohort study aiming to realize an international framework to classify human functioning and disability in Cochlear Implant (CI) recipients using a standardized ICF framework. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified to enable comparison of data across countries and health-care disciplines. Adult subjects (≥18 years old) eligible for cochlear implantation, considering the local criteria of reimbursement, will be assessed one month preoperatively and six months post the activation of the speech processor using three audiological examinations, evaluating the participants' localization abilities, speech recognition and hearing thresholds, and six questionnaires, each evaluating different aspects of daily life functioning and disability in hearing-impaired persons.


Eligibility Criteria:
Inclusion Criteria:

1. General

   * Adults aged 18 years or older with postlingual HL
   * Signed and dated informed consent, informed permission and/or minors assent.
   * Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
   * Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.
   * Fluency in the language of the implanting centre.
2. Audiological

   * Completion of hearing assessment battery showing suitability of the CI candidates.
   * Compliance with cochlear implant candidate selection criteria of the implanting centre.
   * First cochlear implantation
3. Medical

   * Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).

Exclusion Criteria:

1. General

   * Re-implantation of the cochlear implant
   * No motivation to participate in the study and/or unreasonable expectations.
2. Medical

   * Presence of contra-indications for surgery in general and cochlear implantation in particular.
   * Presence of central auditory lesions.
   * Autoimmune disease, meningitis or ossification of the cochlea.
   * Radiological evaluation indicating malformation or obstruction of the cochlea.
   * Unstable psychological status.
   * Any disorder that may relate to an increased risk of skin flap problems
   * Having received chemotherapy
   * Be a burn victim
3. Use of one of the following electrodes for implantation

   * Compressed
   * Split
   * Any type of custom made electrodes
Orthodontic Retention on the Maxillary Stability After SARME Using Laser Scanner

The objective of this study was to evaluate the effect of the orthodontic retainer on transverse maxillary dental and skeletal stability after SARME.

Methods: Ninety digitized dental casts of 30 adult patients (18 males and 12 females) submitted to SARME using the Hyrax expansion appliance were evaluated. Patients were distributed into two groups: Group Without Retention (GSC) n = 15; and Group With Retention (GCC) n = 15. In the GCC group, a Transpalatal Arch (TPA) was installed for retention soon after removal of the expander. The dental casts were scanned using a Vivid 9i 3D laser scanner (Konica Minolta, Wayne, NJ). The plaster models were performed preoperatively (T1), 4 months after the expander was removed (T2), and 10 months after the end of the expansion (T3). The distances measured were Inter-Cusps of Premolars and Molars (Inter-Cusp PM) (Inter-Cusp M), Inter-Cervicals of Premolars and Molars (Inter-Cervical PM) (Inter-Cervical M), Inter-WALA edges of Premolars and Molars (PM Inter-BW) (BW Inter-M), palatal height at the molar, and palatal area and volume at T1, T2, and T3.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with bilateral transverse maxillary deficiencies greater than 5 mm

Exclusion Criteria:

* Patients with previous histories of maxillary surgery,
* congenital craniofacial malformations and
* unilateral transverse maxillary deficiencies
The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment

An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment
* ECOG score 0-1;

Exclusion Criteria:

* arm 1 ： Previous treatment with BRAF inhibitors or MEK inhibitors
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
* Active clinical severe infection;
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.

Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including ACEI and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot completely block its development. Cordyceps sinensis is a traditional Chinese medicine and Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However, its clinical application in diabetic kidney disease is not well-defined so far. The aim of this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in T2DM.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with written informed consent.
2. Type 2 diabetes according to 1999 WHO criteria.
3. Age: 30-75 years.
4. HbA1c \< 11%.
5. Stage III diabetic kidney disease:

   5.1 microalbuminuria: 30 mg / g \< urinary albumin creatinine ratio (ACR) \< 300 mg / g, positive for at least two in three times.

   5.2 renal function: eGFR ≧ 30 ml / min / 1.73 ㎡.
6. Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months.
7. Childbearing-age women with contraceptive measures.

Exclusion Criteria：

1. Type 1 Diabetes Mellitus.
2. Non-diabetic urinary system diseases (Urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.)
3. Other serious diseases \[severe hypertension ((defined as SBP \> 200 mmHg and/or DBP \> 110 mmHg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x UNL), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.\]
4. Allergic to Cordyceps sinensis, use of ACEIs, any use of Cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc.
5. Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.
6. Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.
Reflexology's Effect on Polycystic Ovary Syndrome: A Pilot Study

Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of reproductive age, and impacts not only on quality of life, but also has long-term health consequences for many sufferers, such as increased risks of developing Type II diabetes, cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other symptoms are less successful. Alternative methods to regulate periods would be helpful, especially ones which avoid the long-term use of steroids in patients who may already be overweight. Reflexology is poorly represented in scientific papers, with nothing published regarding reflexology and its effect upon PCOS. However patients who use reflexology report more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to investigate the effect of reflexology on:

1. The menstruation cycle (normal being every 21-35 days).
2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.
3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair, and obesity.
4. Quality of life. Government and NHS agendas agree that if there's evidence of an effective complimentary therapy the NHS should provide it. Therefore the results may have an influence on the care pathways of patients with PCOS towards a more holistic, patient centred and empowered approach. It is also non invasive and liable to result in higher patient satisfaction regarding their treatment. This research may also inform policy makers so that complementary medicine provision is provided on a wider basis within the NHS, which at the moment is dictated by the individual Trust's budget allocation. However this research could save money overall as in America, the yearly cost of treating PCOS is $4.36 billion.


Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS

Exclusion Criteria:

* use of complimentary therapies within 6/12 prior to recruitment
* BMI \>35
* taken combined oral contraceptives, metformin, or cyclical progestogens within 3/12 prior to recruitment
Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)

This study will evaluate the effectiveness of an individually tailored suicide prevention treatment program called SAFETY in reducing suicide and suicide attempts in adolescents.

Suicide is consistently a leading cause of death among adolescents in the United States, making suicide prevention a serious public health concern. The risk factors for suicide vary but are often related to depression and other mental disorders, substance abuse, a major stressful event, and family history of suicide. Despite the morbidity and mortality associated with suicide attempts in adolescents, there is a lack of empirically supported treatment strategies and consensus regarding the best practices for suicide prevention. The SAFETY intervention is an individually tailored treatment strategy that integrates family- and community-based interventions and cognitive behavioral therapy and links youth to needed services and resources. SAFETY may be an effective means of reducing suicide attempts and improving mental health in at-risk adolescents. This study will evaluate the effectiveness of SAFETY in reducing suicide and suicide attempts in adolescents.

This study will be divided into two phases. Participants in Phase I will all receive 12 weeks of the family-based cognitive behavioral therapy intervention SAFETY. Phase I will be used to develop the intervention manual, protocols, and adherence measures for SAFETY in Phase II. Phase I participants will undergo assessments at baseline and Week 12. Assessments will last 90 minutes and will include a series of interviews and questionnaires concerning family, general health, and mental health-related issues.

Participants in Phase II will be assigned randomly to receive 12 weeks of SAFETY or enhanced usual care. The frequency of sessions, which will involve both youth and parent participants, will vary on the basis of the individual needs of participants. SAFETY sessions will be individually tailored for each participant's specific needs and will include the following elements: (1) family- and community-based interventions aimed at mobilizing family and community networks that support youth safety, adaptive behavior, and reasons for living; (2) cognitive behavioral treatment modules that focus on decreasing suicidality and preventing repeat suicide attempts; and (3) an individualized care linkage strategy that links youth to needed services and resources. At baseline, Week 12, and Month 6, all youth and parent participants will undergo the same assessments that were performed during Phase I.

Eligibility Criteria:
Inclusion Criteria:

* Suicide attempt or repetitive self-harm in the 3 months before study entry

Exclusion Criteria:

* Psychosis
* Substance dependency
* Immediate risk of out-of-home placement
* Symptoms/conditions that would interfere with assessment and/or intervention protocols