cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-55 years(both inclusive) at the time of signing informed consent
2. Body mass index 18.0-26.0kg/m2(both inclusive)
3. Body weight ≥50.0kg(male),≥45.0kg(female)
4. Fasting serum/plasma glucose \<6.1mmol/L

Exclusion Criteria:

1. Known or suspected of being allergic to any ingredient in the study drug.
2. Participated in any drug or medical device-related clinical trial within 3 months before screening.
3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration
4. Donated blood within 1 month before screening; or donated blood ≥400 mL or had blood loss ≥400 mL during trauma or major surgery within 3 months before screening.
5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.
WGS of Korean Idiopathic Bronchiectasis

Whole genome sequencing of Korean patients with idiopathic bronchiectasis and their family will perform to identify disease-causing variants.

Idiopathic bronchiectasis may be a manifestation of genetic diseases such as cystic fibrosis, primary ciliary dyskinesia, etc. Diagnosis of these rare genetic diseases is crucial not only because some of the rare diseases developed already effective treatment options, but also the detection of syndrome enables us to detect other organ damages before the deterioration of them.

Several diagnostic tools have been developed; however, the genetic panel has limited screening efficacy due to the genetic heterogeneity of diseases. Even more, especially in Korea, the incidence of idiopathic bronchiectasis caused by the genetic disease is rare, most clinics have limited to assess specialized diagnostic tools such as the specialized genetic panels, sweat chloride test, and the electromagnetic detection tools for ciliary movement.

Whole genome sequencing may be an excellent solution to identify the neglected genetic diseases causing idiopathic bronchiectasis and explore the heterogeneity of disease-causing variants in Korean patients.

Eligibility Criteria:
Inclusion Criteria:

* If the patient has bronchiectasis proved by computed tomography (CT).
* The clinical features of the patient are suitable for ciliary dysfunction disease (primary ciliary dyskinesia, cystic fibrosis), alpha1-antitrypsin deficiency, and primary immune deficiency (hyper-immunoglobulin E syndrome, hypogammaglobulinemia, activated phosphoinositide 3-kinase (PI3K) delta syndrome, bare lymphocyte syndrome)
* The patient has no apparent medical events causing bronchiectasis.

Exclusion Criteria:

* If the patient does not agree or withdraw
* If the patient has any clear etiology causing bronchiectasis including AIDS, malignancy, receiving immunosuppressant or chemotherapy.
Surufatinib Combined With Sintilimab for Advanced MSS-Type Colorectal Cancer : a Phase II Study

A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.


Eligibility Criteria:
Inclusion Criteria:

1. For inclusion in study, patient must provide a written informed consent.
2. Male or female, age18-75 years.
3. Pathologically confirmed unresectable locally advanced or advanced MSS-Type metastatic colorectal adenocarcinoma .
4. The patient had previously failed standard first-line systemic chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
6. Life expectancy \> 12 weeks.
7. Have measurable disease based on RECIST 1.1.

Exclusion Criteria:

1. Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulatory or checkpoint pathway) or fruquintinib treatment in previous.
2. Prior receipt of Surufatinib.
3. History of any active autoimmune disease or autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except patients with hypothyroidism that can be controlled only by hormone replacement therapy and patients with type I diabetes who only need insulin replacement therapy).
4. History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel disease, or extensive enterotomy (partial colectomy or extensive enterotomy with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6 months prior to first dosing.
5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood transfusion, endoscopy, or surgery with 3 months prior to dosing.
Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

Zoledronic acid is an adjuvant treatment for primary osteosarcoma. Zoledronic acid has been widely used in the treatment of metastatic bone tumors. In addition to its inhibition of tumor osteoclasis, it also produces certain killing of tumor cells. effect. Foreign studies have shown that zoledronic acid also has a killing effect on osteosarcoma and has a certain inhibitory effect on distant metastasis. We hope that it can reduce tumor recurrence and lung metastasis through this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with osteosarcoma who were diagnosed with initial pathology and pathology were excluded from lung metastasis or other metastatic lesions by CT and total body emission-computed tomography, and patients with standard chemotherapy were evaluated.

Exclusion Criteria:

* Pulmonary metastasis, pregnancy or lactation, renal insufficiency (creatinine clearance \<70 ml/min/1.73 m2), liver dysfunction, obvious oral disease, and unsuitable for bisphosphonate treatment after evaluation, have been found. With diseases that still require hormone therapy, abnormal blood system, heart disease
Indiana University Gastric Electrical Stimulation Registry

The purpose of this study is to develop a clinical registry in patients with Gastric Electrical Stimulation (GES) therapy for gastroparesis to support future gastrointestinal therapies, medical procedures and diagnostics.

This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device

The study will be conducted at one center and approximately 1,000 subjects will be enrolled.

Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergo implantation of a new GES device for medical refractory gastroparesis

Exclusion Criteria:

* Non-ambulatory patients: bed-ridden, nursing home resident, etc.
* Pregnancy
* Unable to give own informed consent.
* Prisoners
Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis


Eligibility Criteria:
Inclusion Criteria:

1. Male and Female age 18 or more
2. Pathologically proven non-small cell lung cancer
3. MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid
4. Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. KPS score \<60
2. History of autoimmune diseases
3. With severe hepatic and renal dysfunction
4. Has a history of (non-infectious) pneumonitis that required steroids
3D Ultrasound, Specimen Examination by Surgeon, and MRI in Surgical Margin Assessment

In the current protocol, application of 3D ex-vivo ultrasound, MRI, and clinical evaluation (palpation and examination) by the surgeon is proposed to analyze the margin status in tongue squamous cell carcinoma and correlate the results to the histopathology findings.

Cancer surgery is the primary treatment in the early stages of tongue squamous cell carcinoma (SCC), and the goal is the complete resection of the tumor with an adequate margin of healthy tissue around to ensure proper cancer removal. Inadequate margins lead to a high risk of local cancer recurrence and the patient will need re-surgery or adjuvant therapies. Ex-vivo imaging of the resected surgical specimen has been suggested to provide information for margin assessment and thus improve cancer surgery. In this manuscript, a protocol to investigate the clinical benefit of three-dimensional (3D) ultrasound imaging of the surgical margins and comparing the results to magnetic resonance imaging (MRI) and the clinical examination of the surgical specimen by surgeon (palpation to inspect the resected tissue) has been designed. Tumor segmentation and margin measurement (Anterior towards apex of tongue, posterior towards base of tongue, medial towards back of tongue, lateral towards floor of mouth, and profound/deep margins) will be performed by head and neck surgeons on 3D ultrasound images and by two consultant radiologists on MRI of the ex-vivo specimen. Accuracy of each method will be evaluated by computing the proportion of correctly classified margins (positive, close, and free) by each technique with respect to the gold standard histopathology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven oral tongue squamous cell carcinoma scheduled for surgical treatment
* T1-T3 staging on cross-sectional imaging

Exclusion Criteria:

* T4 staging
* Unable to understand the verbal or written information
* Prior radiotherapy treatment of oral cavity cancer
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients

Children with levothyroxine (T21) have developmental delay and other functional gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption. For an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended in water, breast milk or formula for administration in order to treat children with hypothyroidism. For this age group, ease of administration may have a significant impact on compliance and ability to remain euthyroid. We propose that Tirosint-SOL® will be more favorably received due to ease of administration, improved tolerability and palatability, therefore leading to improved adherence when compared to L-T4 tablets.

Hypothyroidism is a common medical disorder in children with Trisomy 21 (T21). Treatment with oral tablet levothyroxine (L-T4) is primarily used to treat this condition. However, children with T21 have developmental delay and other functional gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption. For an age group unable to swallow tablets whole by mouth, tablets must be crushed and suspended in water, breast milk or formula for administration in order to treat children with hypothyroidism. For this age group, ease of administration may have a significant impact on compliance and ability to remain euthyroid. Until recently, there was no liquid preparation of L-T4 in the United States for use in children. Tirosint-SOL® (liquid stable L-T4) is now FDA-approved for use in children. The Investigator proposes that Tirosint-SOL® will be more favorably received due to ease of administration, improved tolerability and palatability, therefore leading to improved adherence when compared to L-T4 tablets.

Eligibility Criteria:
Inclusion Criteria:

* Trisomy 21 children age 2 months to less than 5 years of age
* Prior confirmed diagnosis of congenital or acquired hypothyroidism

Exclusion Criteria:

* Gestational age ≤ 35 weeks, concomitant anticonvulsant medications, history of nonadherence with medication or medical visit schedule
* Subjects must be able to take oral medication, no G-tube or parental fed subjects
Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery

the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension.

In this study the investigators want to assess the safety of using SGA devices in cranial surgery and comparing the effect of these devices with ETT regarding hemodynamics stability throughout the procedure and intracranial tension.

Eligibility Criteria:
Inclusion Criteria:

1. Study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position.
2. Aged 18 to 60 years.
3. ASA 1 or 2.
4. GCS ≥ 13.

Exclusion Criteria:

1. Patients who are known hypertensive, history of cardiac diseases or chest diseases
2. Patients with risk of aspiration (Obesity with BMI ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery).
3. Risk of difficult intubation
4. Extensive intracranial tumours that may affect recovery of patients.
Assessment of the Effects of Early Proprioceptive Stimulations in Patients With Spinal Cord Injury

"Spinal cord injury (SCI) is a dramatic event resulting in a long-term handicap. Appropriate care from admission to the intensive care unit (ICU) is a key element not only for the survival of these patients but also to promote their recovery. Moreover, the studies on natural history of SCI have shown that most of the recovery occurs within the first 3 to 6 months post-injury. This period is therefore crucial for these patients. However, the environment of the ICU and the acute condition of the patients limit the rehabilitation possibilities. In such a context, functional proprioceptive stimulations (Vibramoov™ system, Techno Concept, France) could be a tool of interest.

By using tendon vibrations, the Vibramoov™ system allows to reproduce the proprioceptive signatures of cyclic movements such as walking. Some studies have already demonstrated the benefits of proprioceptive vibrations. However, so far, these benefits have only been studied at the chronic stage of neurological diseases.

The investigators hypothesized that early functional proprioceptive stimulations (FPS) may reduce spasticity and promote sensorimotor recovery in tetraplegic and high paraplegic patients.

To test their hypothesis, the investigators conduct a randomized controlled trial on 40 patients with traumatic SCI. These patients will be stratified into two groups according to the completeness of their lesion. Every patient will be included within ten days post-injury and receive either FPS, either sham stimulations to the joints of the lower limbs, 4 times a week during 8 weeks. the primary outcome measures will assess spasticity. the investigators also assess sensorimotor recovery, pain, muscle wasting, cognitive impairment and functional status. "


Eligibility Criteria:
Inclusion Criteria:

* • Traumatic Spinal Cord Injury at or above level T6

  * Age ≥ 18 years old
  * No pregnancy
  * Not being under guardianship
  * Be affiliated to the French social security system

Exclusion Criteria:

* Orthopedic lesions or any medical condition that prevent the implementation of the protocol within ten days post-injury
* Severe brain injury
High Fiber Rye Foods for Body Weight and Body Fat Reduction

The overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypo-caloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 30-70 y
* BMI 27-35 kg/m2
* Hemoglobin ≥117g/l for women and for men ≥134g/l
* Thyroid stimulating hormone (TSH) ≤4.30 mIU/L
* Low density lipoprotein (LDL) cholesterol ≤5.30 mmol/L
* Triglycerides ≤2.60 mmol/L
* Signed informed consent

Exclusion Criteria:

* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
* Unable to satisfactorily complete the 3-day weighted food record between screening visits.
* Unable to lose ≥0.5 kg during the run-in period for men and women not having menstruation during the run-in period
* Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.
* Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
* Using e-cigarettes (regardless of nicotine content)
* Following any weight reduction program or having followed one during the last 6 months prior to visit 1.
* Diastolic blood pressure 105 mmHg or more at visit 1
* Systolic blood pressure 160 mmHg or more at visit 1
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* More than 10 hours physical activity per week
* History of heart failure or heart attack within 1 year prior to screening
* Having type I diabetes
* Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)
* Previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
* Thyroid disorder
* History of eating disorder
* History of drug or alcohol abuse
* Stroke or transient ischemic attack (TIA) within 1 year prior to screening
* Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
* Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
* Food allergies or intolerances preventing consumption of any products included in the study
* Strict vegetarian (participants must be able to consume the standardized meals used for appetite assessment)
* Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
* Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or PI.
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan

The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).


Eligibility Criteria:
Inclusion Criteria:

* Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.

Exclusion Criteria:

* Diagnosis of Idiopathic Pulmonary Fibrosis
* Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease
A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

This 2 arm study will provide optional continuation of double-blind treatment with CellCept or placebo, in patients with myasthenia gravis who have achieved good symptom control in study WX17798. Patients who have completed 36 weeks of treatment in study WX17798, with stable prednisone dosing for the last 4 weeks, can continue on blinded treatment with CellCept (1g bid) or placebo until the database for WX17798 is locked and unblinded. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* subjects who have completed 36 weeks of treatment in study WX17798, and who have demonstrated good symptom control with a stable prednisone dose for the final 4 weeks of that study.

Exclusion Criteria:

* regularly scheduled plasma exchange or intravenous immunoglobulin treatment;
* medical condition, adverse event or intolerance of double-blind treatment which would preclude continuation.
Spinal Cord Stimulation in Patients With Disorders of Consciousness

Disorders of consciousness(DOC) is the most serious complications and has been widely paid attention to by the government. DOC patients cause large social and economic burden to our society for there has no effective cure so far. Spinal cord stimulation(SCS) for wake-promoting therapy has aroused scholars' attention and become a hot area recently. There was much debate about the effectiveness of SCS therapy, but because of the limitation of our understanding of consciousness and the uncertainty of parameters of the stimulation, So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.

The spinal cord stimulation therapy is explorative at best at the moment. Attempts to improve the level of consciousness of patients in the different stages of DOC have shown some promise. Spinal cord stimulation(SCS) seem promising in some studies, suggesting that further research is needed. Current publications of DOC spinal cord stimulation therapy was not convincing because of the small number of patients and no randomized controlled trial. Therefore, there was much debate about the effectiveness of spinal cord stimulation therapy because of the limitation of our understanding of consciousness and the uncertainty of parameters of neuromodulation. The better understanding of brain function and large randomized trials are necessary. Future research should also focus on identifying specific neuro-biomarkers (i.e. neural network). So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.

Scientific Issues Targeted:1) To figure out the effectiveness of spinal cord stimulation therapy using random controlled trial. 2) To explore individual parameters of SCS techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 14 to 65 years old;
2. DOC patients, including vegetative state and minimally consciousness state.
3. With normal body temperature, stable vital signs, spontaneous breathing without an extra oxygen supply, no tracheotomy using metal trachea cannula, and feasible for magnetic resonance inspectors;
4. Written informed consent from patient families

Exclusion Criteria:

1. History of nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
2. With contraindications of spinal cord operations.
3. Body temperature is abnormal, vital signs are not stable, still need a ventilator to support breathing; Plentiful sputum needed suction during MRI scans.