cyrilzakka/clinical-trials huggingface dataset:
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

Constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. Clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation.

Colonoscopy is an important method to screen, diagnose and treat colon lesions. The quality of bowel preparation is requisite for the accuracy of diagnosis and safety of treatment. To explore the application effect and safety of Linaclotide combined with Compound Polyethylene Glycol Electrolyte Powder on colon cleansing before colonoscopy in patients with chronic constipation. A prospective mult-centers, colonoscopist-blinded study was conducted. A total of 300 patients with constipation who underwent colonoscopy in 8 hospitals from July to December 2021 were selected as study subjects and divided into the control group, observation group 1, observation group 2 and observation group 3 by random number table method, with 75 cases in each group. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included: The inclusion criteria were patients ≥18 years old suffering from≥2 of the following criteria of chronic constipation under the Rome IV standard: straining, hard stool, residual stool feeling, occlusion feeling, manual bowel movement(BM) performed ≥25% of overall BMs, and BM frequency\<3 times a week . A chronic status was defined as symptoms being present for at least six months, with the symptoms described above being present for at least three months.

Exclusion Criteria:

* Exclusion criteria included: (1)age \<18 or\> 75; (2) severe chronic renal failure, severe congestive heart failure and Liver dysfunction ;(3)with uncontrolled hypertension, diabetes, intestinal obstruction, intestinal perforation and electrolyte disorders, inflammatory intestinal disease and other organic gastrointestinal diseases;(4)with neurologic, endocrine, or metabolic disorders;(5)treatment with other gastrointestinal drivers, laxatives, and antilaxatives within nearly 2 weeks;(6)history of colorectal surgery;(7) dysphagia; (8) compromised swallowing reflex or mental status;(9)with consciousness disorders or examination intolerance;(10)pregnancy or lactation;(11)allergic to the drug composition;(12)Suspected history of alcohol or substance abuse; (13)Recent participants in clinical trials; (14) unable to give informed consent.
Phase II Trial of Double Dose of Icotinib in Treating Brain Metastases From Non-small Cell Lung Cancer

Brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung cancer (NSCLC). Whole-brain radiation therapy(WBRT) and Stereotactic Radiosurgery (SRS) are important approaches to the treatment of brain metastases from NSCLC. Known to us, epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC, especially for EGFR mutation patients. However, due to the lower concentration of tyrosine kinase inhibitors (TKIs) in the cerebrospinal fluid and its inevitable emergence of drug resistance, brain metastases will be refractory or resistant to standard-dose EGFR inhibitors. Icotinib is one agent of EGFR-TKIs. The previous studies have shown that the Icotinib conventional dose (125mg, TID) is far from reached its maximum tolerable dose. It is a challenge whether the further dose escalation of Icotinib will enhance its concentration in cerebrospinal fluid and thereby improve its therapeutic effect. Here the investigators examine the therapeutic effect and side-effect of double dose of Icitinib in treating patients with brain metastases from NSCLC who have suffered from the failure of conventional dose treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytologic diagnosis of NSCLC
* Patients with disease progression after local treatment(WBRT and/or SRS) combined with Icotinib treatment.
* Patients with EGFR mutation or the lesions that remains stable for more than 3 months after local treatment(WBRT and/or SRS) combined with Icotinib treatment.
* ECOG performance status 0-2
* Doctors consider the patients will not benefit from local treatment(WBRT and/or SRS)
* Expected survival of greater than 3 months
* Age: 18-75 years
* The patients with key organs maintenance of basic function: Hemoglobin ≥ 9g/dL, White Blood Cell ≥ 3×109/L, Neutrophil count ≥ 1.5×109/L, platelets ≥ 80×109/L, total bilirubin \< 1.5 times of the upper normal values, Alanine transaminase (ALT) and aspartate transaminase (AST) \< 2.5 of the upper normal values, the serum creatinine \< 1.5 times of the upper normal values
* Signed informed consent document on file.

Exclusion Criteria:

* Brain metastasis without local treatment before
* Patients without the treatment of Icotinib before or the therapeutic time less than 3 months
* More than 3 extracranial organs have metastatic lesions
* The patient with other type malignant tumors before
* The patient with fertility capacity, but without contraceptive application
Epidemiology of Thromboembolism Disease: A Cohort Study

The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
2. Is it necessary to obtain a detailed history of thromboembolic disease ?
3. Do older patients have particular risk factors ?
4. Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
5. Do predictive clinical scores have the same performance for both in and outpatients ?
6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
7. The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

The OPTIMEV study is a prospective epidemiological multicenter cohort study, including in-and outpatients clinically suspected of thromboembolic disease. Deep vein thrombosis is diagnosed using a duplex ultrasound examination, whereas pulmonary embolism is investigated by lung scan scintigraphy or computed helical tomodensitometry and/or duplex ultrasound examination. Initial data on medical history, clinical symptoms, presence of transient and chronic risk factors, diagnosis at the end of the medical examination, diagnostic tests results, treatment (type and duration) are collected by the physician into an electronic medical record. Other general medical considerations are collected (particularly on cardiovascular diseases). A phone follow up at 3 months, 1, 2 and 3 years is realised by the Centre for Clinical Research of Grenoble. All Venous ThromboEmbolism (VTE) positive patients (including superficial vein thrombosis) are contacted. For each VTE positive a negative one is selected (same site, same season). Data on mortality, development or recurrence of VTE, treatments prescribed (type + duration), major bleeding, cancer onset, cardiovascular events and venous insufficiency (leg ulcer) are collected. All these serious adverse events are documented and reviewed by an independent critical events committee.

Eligibility Criteria:
Inclusion Criteria:

* patient aged more than 18
* male or female
* patients with clinical thromboembolic signs (deep vein thrombosis or pulmonary embolism)

Exclusion Criteria:

* patient less than 18 years old
* patient unable to understand
* patient who refused to participate
Operative Versus Nonoperative Treatment for Scapula Fractures

The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.

The potential impact is a clearer set of choices in treatment options for this type of injury.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years of Age or Older
* Displacement of glenoid neck and scapula body of greater than 2 cm
* Angular deformity between the fracture fragments of greater than 45 degrees.
* A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees
* A glenopolar angle less than 22 degrees
* A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC)

Exclusion Criteria:

* Age Less Than 18 years Old
* Brachial Plexus Injury
* Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation
* Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage
* Ipsilateral Upper Extremity Injury
* Previous Shoulder Surgery
* Insufficient English proficiency to complete the DASH Questionnaire
Wet-to-dry vs Petrolatum & Non-stick Dressings After Hidradenitis Suppurativa Surgery

Hidradenitis suppurativa (HS) is a chronic, severe, inflammatory skin disease associated with pain, drainage, odor, and disability characterized by recurring abscesses, nodules, and tunneling sinuses in intertriginous locations such as the groin, buttocks, and axillae. HS has more negative impact on patients' quality of life than all other common dermatologic diseases and is common, affecting \~1% of the general population, with higher risk for females (3:1) and Black patients. The onset is often in adolescence. As HS has been under-studied historically, there is an unmet medical need to develop more effective treatment for this disease. While many patients are managed with medications and lifestyle modifications alone, a subset of HS patients benefit from surgical intervention. Proper wound care following HS surgery is paramount, as facilitating proper healing and minimizing infection can prevent post-operative complications, morbidity and the need for future procedures. While many physicians continue to use wet-to-dry dressings as the standard of care for HS patients post-operatively, it is likely that the drawbacks of this dressing technique outweigh the benefits. This study hopes to answer the question of whether or not wet-to-dry dressings should truly be standard of care or whether an alternate form of wound dressings, such as petrolatum with non-stick bandaging, is at least equitable if not superior in effect, and associated with fewer drawbacks such as associated pain and time dedicated to dressing changes. This study will be a randomized, single-blind trial of two postoperative bandaging techniques: wet-to-dry dressings vs. petrolatum with non-stick bandaging. Primary outcomes will be tracked using the photographic wound assessment tool (PWAT), pressure ulcer scale of healing (PUSH) tool, and Wound Quality of Life (QOL) Survey. There is potential for this study to apply to surgical interventions outside of HS, as the study addresses the bandaging technique (wet-to-dry) that is standard of care after many surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male \& females \> or = 16 years of age
* Patient must have undergone a standard-of-care surgical procedure for HS with planned secondary intention healing of the wound.
* Must be able to provide adequate informed consent for themselves
* Patient must be capable of performing either of the recommended wound care regimens on their own or have someone available to consistently assist with wound care.

Exclusion Criteria:

* Patients with surgically closed wounds (sutures, staples)
* Patients with preference for specific types of bandaging protocols
* Patients that have not been able to tolerate either wet-to-dry or petrolatum and non-stick bandages in the past
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please in Korean Patients With Coronary In-stent Restenosis

The purpose of this study is to evaluate the safety and efficacy of Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-segment late lumen loss at 6 months after the procedure in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please)

In a randomized controlled trials to compare with the same-category medical device (Sequent® Please), 82 patients with in-stent restenosis (ISR) were recruited from a total of 7 institutions, and the enrolled subjects were 1: 1 through randomization. The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.

Drug release "stents" for PCI usually follow 9 months or 12 months, but the medical device for this clinical trial has a drug coated "balloon catheter" and the mechanism of action is different from the stent and the duration of follow up was set to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥19 years old
* Patients with significant coronary artery stenosis including left main coronary lesion (\> 50% diameter stenosis on coronary angiography)
* Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
* Patients suitable to receive coronary revascularization of any type
* Restenosis Mehran type I-III after stent implantation for the first time
* Patients with In-stent restenosis after 90 days of the stent implantation, and the degree of restenosis corresponds to Mehran type I-Ⅲ.
* Diameter of the stent with restenosis should be 2.0-4.0mm (included). Length of the stenosis lesion should be no more than 40mm
* In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form

Exclusion Criteria:

* Patients with Infarct related artery (IRA) lesions among patients with acute myocardial infarction
* Patients have restenosis lesions with thrombosis
* Patients with a history of cardiogenic shock
* Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
* Patients with graft vessel lesion
* Patients who are contraindicated in aspirin, heparin, clopidogrel, ticlopidine, and paclitaxel
* Patients with renal insufficiency (eGFR\<30mL/min)
* Pregnant or lactating women
* The patients have a life expectancy of less than 12 months
* Patients who had reduced immunity or clinically significant abnormalities in the laboratory tests (hematological, serum biochemical, and urine tests) performed at the time of screening
* Patients who had clinically significant disorders in cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or mental illness that significantly affects this study
* Patients who are unsuitable for the study according to the investigator judges
Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

Allergic rhinitis is an importance disease in Taiwan with its high incidence about 20-30% and gradually increased annually. However, symptom relapse still bothered the majority of patients though there were certain advances in western medicine. In addition, side effects of western medicine, such as lethargy, mouth dryness were noted. Traditional Chinese medicine, especially qi-tonifying regimen has been used and proved benefit to the allergic diseases by many researchers.This study will provide the evidences of gut microbiota changes and immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.

Recently studies reported that gut microbiota is related to the human immunity modulation of allergic diseases. Investigators are interested to know weather qi-tonifying herbal medicine is through the changes of gut microbiota to modulate human immunity. In this study, a double-blinded, randomized, placebo control design is applied and total 60 perennial allergic rhinitis patients will be enrolled in our study. All subjects will be divided into Bu-Zhong-Yi-Qi-Tang (BZYQT) and placebo control groups, 40 and 20 subjects each. Subjects of BZYQT group will receive capsule of BZYQT, 4gm tid, 12gm a day, while control group will receive similar placebo capsule with same scheme. Total 2 months treatment course will be done. Gut microbiota will be assayed before and after 2 months treatment. Additionally, various parameters for immunologic response will be checked before and after the treatment, including the total IgE amount, the ratio of CD4/CD8 of T lymphocytes, the profile of cytokine such as IL-10 and IL-12 as well as functional change of dendritic cells and T cells. Results will be analyzed statistically including gender analysis. This study will provide the evidences of gut microbiota changes and immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

1. With at least one of the following clinical symptoms: itchy nose, sneeze, rhinorrhea, nasal congestion
2. Diagnosed as intermittent allergic rhinitis (Less than 4 days per week and for less than 4 weeks)
3. CAP panel :allergy to mite
4. Will to complete questionnaires and take medicine as schedule in this study
5. Volunteer for study enrollment and sign inform consent

Exclusion Criteria:

1. Under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month
2. Under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on
3. vasomotor type allergic rhinitis
4. history of allergy or adverse effect to Chinese herbs, poor compliance of herbal medicine
5. severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR \<60 mL/min/1.73 m2)
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Negative urine analysis.
* Normal Pap smear test from the recent 3 years.
* No previous gynecological laser treatments.
* Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

* Active genital infection.
* Subject presenting abnormal Pap result from the last three years.
* Recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year).
* Transvaginal mesh implant.
* Serious systemic disease or any chronic condition that could interfere with study compliance.
* Any vaginal bleeding of unknown reason.
Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)

The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrollment into GENA-11

Exclusion Criteria:

* Development of FVIII inhibitors (\<=0.6 BU), during the course of the GENA-01 study
* Development of any severe liver or kidney disease (ALT and AST level \> 5 times of upper limit of normal, creatine \>120 micro mol/L) during the course of the GENA-01 study
Validation of the Norwegian VISA-G Questionnaire

The aim of this study is to translate, cross-cultural adapt and validate the Norwegian VISA-G (VISA-N-G) questionnaire. The study will test the psychometric properties for the VISA-N-G in terms of test-retest reliability, internal consistency, construct validity and responsiveness.

The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) questionnaire have already been developed and used as a measurement tool in research on English speaking Greater trochanteric pain syndrome (GTPS) populations.

The aim of this study is to translate, cross-cultural adapt and validate the Norwegian VISA-G (VISA-N-G) questionnaire.

The translation of the original VISA-G into Norwegian has been done following the official guidelines.

The patients will be recruited from the outpatient clinic at the Department of Physical Medicine and Rehabilitation, Oslo University Hospital and will follow the ordinary patient care.

After given written consent, patients will be asked to fill out the following Norwegian questionnaires: VISA-N-G, Harris Hip Score (HHS), Oswestry disability index (ODI) and a numeric rating scale (NRS) for assessment of pain intensity. The aforementioned questionnaires will be used to test the construct validity with various hypothesis at baseline. Within one week the investigators will ask the patients to fill out the VISA-N-G once more to test the test-retest reliability.

To investigate responsiveness the patient will be asked to fill out the VISA-N-G together With HHS, ODI, NRS and a 11-Point Global Rating of Change scale (GROC) after seven weeks. Responsiveness will be tested with various hypothesis and measured by the area under the receiver operating characteristics curve (ROC).

Eligibility Criteria:
Inclusion Criteria:

* Hip pain
* Ability to read and write Norwegian
* \> 18 years old

Exclusion criteria:

* Not able to read and write Norwegian
* \< 18 years old
Electronic Cigarette and Surgery (ECigarSurg)

Since decades, literature has shown that smoking has negative effect on postoperative outcome. Recent systematic review and meta-analysis on clinical impact of smoking and smoking cessation showed that postoperative healing complications occur more often in smokers compared with nonsmokers.

The use of electronic cigarette (e-cigarette) is spreading through the world. Despite this fact, the health risk assessment studies on e-cigarette are limited and scientific evidences are inconsistent.

This prospective multicenter study aimed at assessing the use of e-cigarette whether patient undergoing elective surgery. The main objective of this study was to evaluate the prevalence of e-cigarette consumer in perioperative period. Secondary objectives were to analyze when patients consume e-cigarette in regard of surgery, how many dose they consume and if they also consume nicotine cigarette.

this study used a standardized questionnaire that was filled in preoperative period

Eligibility Criteria:
Inclusion Criteria:

* protocol approval
* patients scheduled for elective surgery

Exclusion Criteria:

* \< 18 ans
* refusal
* not speaking
* emergency surgery