cyrilzakka/clinical-trials huggingface dataset:
Precise Percutaneous Coronary Intervention Plan (P3) Study

The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.

Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
* An indication to Percutaneous coronary intervention

Exclusion Criteria:

- Angiographic exclusion criteria

1. Severely calcified lesion/vessel
2. Bifurcation lesions.
3. Ostial lesions.
4. Left main disease.
5. Severe vessel tortuosity.

Clinical exclusion criteria

1. Chronic obstructive pulmonary disease
2. Contraindication to adenosine
3. NYHA class III or IV, or last known left ventricular ejection fraction \<30%
4. Uncontrolled or recurrent ventricular tachycardia
5. Atrial fibrillation, flutter or arrhythmia
6. History of recent stroke (≤90 days)
7. History of acute coronary syndrome (≤90 days)
8. Prior myocardial infarction
9. History of ischemic stroke (\>90 days) with modified RANKIN score ≥ 2
10. History of any hemorrhagic stroke
11. Previous revascularization (PCI or Coronary artery bypass grafting)
12. Active liver disease or hepatic dysfunction, defined as AST or ALT \> 3 times the ULN
13. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
14. Body mass index\>35 kg/m2
15. Nitrate intolerance
16. Contra-indication to heart rate lowering drugs

    Imaging-related
17. Insufficient coronary CT Angiography image quality.
Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE

Primary aldosteronism is the most common cause of secondary hypertension. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling(AVS), but the success rate is only about 80%. Using CXCR4 as a probe for 68Ga-Pentixafor PET/CT imaging can guide the classification diagnosis and treatment strategy of primary aldosteronism, which is a favorable supplement to AVS. Superselective adrenal artery embolization(SAAE) and laparoscopy are the main operation treatments for primary aldosteronism. SAAE is an invasive interventional operation. It is a novel way to evaluate the changes in the structure and function of adrenal tissue pre-postoperative SAAE by using the changes in 68Ga-Pentixafor PET/CT imaging.

Primary aldosteronism: Hypertension is divided into primary hypertension and secondary hypertension. Secondary hypertension refers to hypertension with clear etiology. When the etiology is identified and effectively removed or controlled, hypertension as a secondary symptom can be cured or significantly relieved. The most common secondary hypertension is primary aldosteronism. Primary aldosteronism is due to excessive aldosterone secretion in the adrenal cortex, characterized by clinical syndromes of hyperaldosteronism, low renin activity, hypertension and hypokalemia. Compared with essential hypertension, the risk of cardiovascular and cerebrovascular events and the risk of target organ damage in patients with primary aldosteronism were significantly increased. On the contrary, early detection and treatment mean better blood pressure control, lighter target organ damage and better clinical outcomes. The two main types of primary aldosteronism are aldosteronoma(30%) and adrenal hyperplasia(60%). The gold standard that determines the diagnosis and treatment strategy of primary aldosteronism is adrenal vein sampling (AVS), but the success rate is only about 80 %. Therefore, it is necessary to explore a non-invasive examination method as a beneficial supplement to AVS.

Eligibility Criteria:
Inclusion Criteria:

* adult population (aged 18 years or order);
* patients with suspected or new diagnosed Primary aldosteronism (supporting evidence may include MRI, CT, laboratory tests);
* patients who had scheduled 68Ga-BNU-PSMA PET/CT scan;
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee;
* healthy volunteers(aged 18 years or order).

Exclusion Criteria:

* patients with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Physiological Biomarkers of Cancer Treatment Related Fatigue in Women With Breast Cancer.

Physiological Biomarkers of Cancer Treatment Related Fatigue in Women with Breast Cancer.

As above.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed early stage breast cancer.

Exclusion Criteria:

* Not specified.
SY007 in Patients With Acute Ischemic Stroke

This Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.


Eligibility Criteria:
Key Inclusion Criteria:

* Aged from18 Years to 80 Years
* Within 24h after the onset of stroke symptoms (time the patient was last seen well)
* Score range from 4 to 20 points, inclusive, on the NIHSS at randomization
* Prior to index stroke, patient was able to perform basic activities of daily living without assistance, mRS score≤1
* Absence of intracranial hemorrhage on brain CT or MRI
* Patients or legal representatives can give informed consent

Key Exclusion Criteria:

* Venous thrombolytic therapy or endovascular treatments have been applied for patients; or Patients plan to conduct these kind of treatments.
* Glasgow score of Patients ≤8
* Patients are receiving oral anticoagulants or INR\>3.0
* Baseline blood platelet counts \<80\*109/L
* NIHSS score could not been obtained at baseline
* FPG levels \< 50mg/dL or \>400mg/dL
* Patients with Kidney disorder eGFR \<30 mL/min or patients need dialysis
* Patients with Acute and Chronic hepatitis, or Liver diseases (AST or/and ALT \>2 × ULN(upper limit normal))
* systolic blood pressure≥220mmHg or/and diastolic blood pressure≥120mmHg ; or Blood pressure under 90/60mmHg.
Chinese Colorectal Cancer Database

1. To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China.
2. Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer.
3. Provide academic consultation and data support to national health authorities.


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the colon by biopsy
* tolerable to surgery
* be able to understand and willing to participate in this trial with signature

Exclusion Criteria:

* can not tolerate the surgery
* history of serious mental illness
* the researchers believe the patients should not enrolled in
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease

This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo. Participants who consent to be part of the sub study will undergo positron emission tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is 104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2, followed by an open-label extension (Part 3) until July 2020.

The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a low probability of meeting the primary outcome measure with the doses studied. The study has converted to open-label to investigate higher gantenerumab doses.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, 50-85 years of age
* Participants with prodromal Alzheimer's disease who are not receiving memantine or cholinesterase inhibitors
* Has a study partner who in the investigator's judgement has frequent and sufficient contact with the participant as to be able to provide accurate information as to the participant's cognitive and functional abilities, who agrees to provide information at clinic visits which require partner input for scale completion
* Has had sufficient education or work experience to exclude mental retardation
* Study partner has noticed a recent gradual decrease in participant's memory (over the last 12 months), which the participant may or may not be aware of
* Screening Mini Mental State Exam (MMSE) score of 24 or above

Additional inclusion criteria for sub study:

* Able and willing to travel to PET imaging center and complete the planned scanning sessions
* Past and planned exposure to ionizing radiation not exceeding safe and permissible levels

Exclusion Criteria:

* Other prior or current neurologic or medical disorder which may currently or during the course of the study impair cognition or psychiatric functioning
* A history of stroke
* A documented history of transient ischemic attack within the last 12 months
* History of schizophrenia, schizoaffective or bipolar disorder
* Currently meets criteria for major depression
* Within the last 2 years, unstable or clinical significant cardiovascular disease (myocardial infarction, angina pectoris)

Additional exclusion criteria for sub study:

* Inclusion in a research and/or medical protocol involving PET ligands or other radioactive agents within 12 months
* Present or planned participation in a research and/or medical protocol involving PET ligands or radioactive agents other than study WN25203
* Have planned or are planning to have exposure to ionizing radiation that in combination with the planned administration with study amyloid PET ligand would result in a cumulative exposure that exceeds local recommended exposure limits
Effects of Neural Mobilization With or Without Soft Tissue Mobilization in Cervical Radiculopathy

This study will evaluate Effects of Neural Mobilization with or without Soft Tissue Mobilization in Cervical Radiculopathy, half of the subjects will receive treatment of Neural Mobilization along with Soft Tissue Mobilization whereas half of the subjects will receive only Neural Mobilization.

Neural mobilization and Soft Tissue Mobilization both treatments are used to treat Cervical Radiculopathy but they work differently.

Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. Neural Mobilization Technique target the single nerve which is being compressed and showing symptoms.

Soft Tissue Mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age 18 to 55years
* Patients having pain more than 3months
* Radiating pain in one of the upper limb
* Spurling's test positive

Exclusion Criteria:

* Traumatic injury of upper limb or cervical spine
* Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
* Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
* Circulatory disturbance of upper extremity
* Known history of high level of spinal cord injury and malignancy
* Thoracic Outlet syndrome
Intravenous Remifentanil for Labor Analgesia

Labor analgesia is an essential health caring procedure for women. However, epidural analgesia cannot be performed on all subjects for different contraindications, such as lower platelet counter, back infection at the puncture site, and fear of epidural injection etc. Therefore, intravenous analgesia is an alternative for such conditions. Given the influence of intravenous administration of drugs on fetus, the drug selection is very important. Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection, which is similar in both maternal and fetal environment. Thus the fetus-associated side effects would be less than other drugs. The investigators hypothesized that remifentanil would be a superior intravenous drug used with patient-controlled technique for labor analgesia.


Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous women
2. \> 18 years and \< 45 years
3. Spontaneous labor
4. Analgesia request
5. Epidural puncture contraindications
6. Tendency of bleeding

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years or older than 45 years
3. Those who were not willing to or could not finish the whole study at any time
4. Using or used in the past 14 days of the monoamine oxidase inhibitors
5. Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
6. Subjects with a nonvertex presentation or scheduled induction of labor
7. Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization
8. Diagnosed diabetes mellitus and pregnancy-induced hypertension
9. Twin gestation and breech presentation
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.

Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75μg eldecalcit daily or open-label oral 0.5μg calcitriol daily for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years of age and older will be considered postmenopausal.
2. BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:

1) low BMD: -2.5\<T\< -1.0, without vertebral and fragility fracture history 2) mild osteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatory outpatients 4. Written informed consent

Exclusion Criteria:

1. Severe vitamin D deficiency at screening (defined as serum 25OHD\<10 ng/ml);Vitamin D repletion will be permitted and dosage will be at the discretion of investigators and subjects may be re-screened
2. Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c\>9%), or other conditions that can cause secondary osteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry
3. Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate oral for 6 months or more in the 3 years prior to study entry; or had received parathyroid hormone once or more in the 3 years before entering the study; or received 2 weeks or more of calcitonin or vitamin K or active vitamin D or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for bone pine within 2 months prior to study entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry
4. Urolithiasis at screening
5. Hypercalcemia (serum calcium \>10.4 mg/dL), or hypercalciuria (urine calcium\>400 mg/gCr), or hyperuricemia (above 420 μmol/L in men and 360 μmol/L in women)
6. Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
7. Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
8. History of allergy to vitamin D
9. Any condition which in the opinion of the investigator unfit for the study
Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease

The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC).

The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC). Our study design is as follows: Prospective observational study of 20 pediatric sickle cell disease patients with refractory pain to conventional analgesic regimens seen in the pediatric emergency medicine department. Consenting patients with refractory pain meeting inclusion criteria will be given a single intravenous bolus of Ketamine at a set dosage of 0.25 milligrams per kilogram of weight. Participants' perception of pain will then be recorded using standard pain scoring scales (FLACC score). Physiologic criteria such as heart rate, blood pressure, blood oxygen saturation, total analgesic pharmacologic requirements for adequate analgesia during hospitalization, and duration of hospitalization will be measured. Observational study group will continue to get standard of care outside of single bolus of Ketamine. 48 hour follow up after hospital discharge will be obtained to assess degree of pain control and general clinical status.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (\> 3 yrs and \<18yrs) with a previous diagnosis of sickle cell disease (including Hgb S Beta Thalassemia +, Hgb S Alpha Thalassemia, Hgb S HPFH) ) seen in the pediatric emergency room setting for acute vaso-occlusive pain crisis.

Exclusion Criteria:

* Patients not to have sequelae indicative of complicated disease outside of acute VOC:

  1. Acute chest syndrome (new pulmonary infiltrate and hypoxemia)
  2. Aplastic Episode
  3. Evidence of infection
  4. Pregnancy or CHF
  5. Fever (\> 38.4)
  6. Cholangitis or cholecystitis
  7. Hypoxia (SaO2 \<90% on RA), or O2 saturation decrease of more than 5% from patient's baseline
  8. Unstable Vital Signs
  9. Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department.
  10. History of allergic reaction or serious reaction to Ketamine.
  11. History of significant psychiatric illness
  12. Patients with no refractory pain after receiving conventional analgesia regimen per protocol.
Postpartum Screening for Anxiety and Comorbid Conditions

The goal of this project is to facilitate the design of individualized postpartum anxiety (PPA) screening strategies in British Columbia (BC), Canada. A cohort of postpartum people (n=550) will be invited to complete the following seven questionnaires at 4-8 weeks after delivery:

1. State-Trait Anxiety Inventory
2. Edinburgh Postnatal Depression Scale
3. Multidimensional Scale of Perceived Social Support
4. PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a
5. Short Form Brief Pain Inventory
6. WHOQOL-BREF for assessing quality of life
7. PROMIS Sleep Disturbance Short Form 8-b and PROMIS Sleep-Related Impairment Short Form 8-a

The investigators will evaluate the feasibility of screening for postpartum anxiety and comorbid conditions through a web-based platform in a diverse BC population. They will assess the usability of the platform and questionnaires through 12-15 follow-up interviews with study participants and responses to the System Usability Scale. Their analysis will also identify patient characteristics and comorbidities (e.g., anger, pain, sleep disturbance) associated with a positive screen for postpartum anxiety.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 19 years
* 4-8 weeks postpartum
* Proficiency to participate in English
* Delivered within the province of British Columbia, Canada

Exclusion Criteria:

None.
Vaginal Progesterone for Treatment of Threatened Miscarriage

The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant with gestational age less than 24 weeks
2. Presented by bleeding with or without pain
3. Single viable fetus (confirmed by Ultrasound examination)
4. Accepting to have vaginal medication

Exclusion Criteria:

1. Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
2. Hypersensitivity to progesterone
3. Any documented congenital fetal anomaly in the current pregnancy
4. Women received hormonal treatment in the current pregnancy
5. Patients conceived via ART