cyrilzakka/clinical-trials huggingface dataset:
Bariatric Surgery and Pharmacokinetics of Paracetamol

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on paracetamol are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations

The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.

Incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. This research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. Negative pressure wound therapy is commonly used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. Currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure wound therapy and standard dressings in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 18 years or older to participate.
2. Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).
3. Has at least one artery that feeds the closure site.
4. Able to comply with clinical trial procedures and schedule.

Exclusion Criteria:

1. Patients not receiving an amputation.
2. The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating.
3. Surgical incision that is not completely closed.
Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma

This is a prospective phase II clinical trial to observe the efficacy and safety of Camrelizumab combined with AVD in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.

Hodgkin's lymphoma (HL) is a kind of malignant tumor of the lymph system, approximately 95% of which are classical hodgkin's lymphoma (cHL). Currently, ABVD and BEACOPP are commonly used in the first-line treatment for cHL. There are about one third of patients, whose pre-treatment assessment are mainly advanced cHL, suffering relapse and drug resistance. PD-1/PD-L1 signaling pathway plays an important role in the development and progression of cHL. Nivolumab and Pembrolizumab have been used in the therapy in relapsed and refractory patients with cHL. Camrelizumab, a humanized anti-PD-1 IgG4 monoclonal antibody, is independently developed in China. The goal of our trial is to assess the efficacy and safety of Camrelizumab combined with AVD (Epirubicin, Vincristine and Dacarbazine) in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as advanced classical hodgkin's lymphoma based on histopathology
3. Subjects must be untreated (Ann Arbor Stage III/IV or Ann Arbor II with B symptoms along with mediastinal big tumor or extranodal changes)
4. No receiving chemotherapy before enrollment
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
7. Life expectancy no less than 3 months
8. enough main organ function
9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
10. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma
2. Diagnosed as central nervous system lymphoma
3. usage of immunosuppressants before enrollment and the dose of immunosuppressant used \>10mg / day oral prednisone for more than 2 weeks
4. Previously treated with anti-PD-1/PD-L1/PD-L2/CTLA-4
5. Active autoimmune disease
6. Vaccination with anti-tumor vaccine or other immune treatments less than 3 months
7. Serious surgery and trauma less than two weeks
8. Other malignant tumor history or active malignant tumor need be treated
9. Systemic therapy for serious acute/chronic infection
10. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
11. Active tuberculosis
12. Vaccination with live attenuated vaccine less than 4 weeks
13. HIV-positive, AIDS patients and untreated active hepatitis
14. Researchers determine unsuited to participate in this trial
Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy

Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.

Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments.


Eligibility Criteria:
Inclusion Criteria:

patients :

* scheduled for colonoscopy as part of CRC screening, using the bowel preparation with fixed low-dose of simethicone combined with Macrogol 4000 (PEG)
* aged 50-75 years,
* with no family history of CRC or personal history of colon polyps but with a positive Faecal Immunochemical Test (FIT), with a family history of CRC or personal history of colon polyps,
* requiring surveillance colonoscopy after 5 years if diagnosed with one or two tubular adenomas \<10 mm in diameter (low-risk group) or after 3 years if diagnosed with at least 3 adenomas or any adenoma at least 10 mm in diameter or with high-grade dysplasia, according to French recommendations during the study inclusion period.

Exclusion Criteria:

-
Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers

Textile workers are exposed to various harmful substances during work, including cotton dust, which is the dust present in air during the handling or processing of cotton. Previous research found a link between cotton dust exposure and impaired respiratory health. This study will comprise of administration and workers' training regarding preventive measures for protection against respiratory illnesses. Workers will be provided free, disposable face masks and measures to reduce cotton dust exposure will be introduced at the textile mills. The study would then determine the effectiveness of this intervention on reduction in cotton dust levels in the mills, and improvement in respiratory health of workers. This study would help the cotton textile workers and managers reduce the health hazards of cotton dust exposure and also guide researchers from Pakistan and other low-resource countries towards developing relevant strategies for health protection of these workers.

The textile, clothing and footwear sector provides employment to more than 60 million people worldwide, mostly in developing countries. Pakistan's textile industry accounts for 8.5% of the national GDP and employs around 40% of the industrial workforce. High burden of respiratory illnesses, including byssinosis and lung function decrements has been reported among cotton textile workers in developing countries and previous work undertaken by Dr Nafees found a high burden in Pakistan. Dr Nafees recently implemented an interventional study designed to improve workers' knowledge, attitude and practices and respiratory health, and reduce dust exposure at cotton textile mills through a multifaceted intervention (MultiTex pilot study). The preliminary findings from the pilot were helpful in improving the overall design and implementation of a larger and more definitive study (cluster randomised controlled trial). The aim of the trial would be to determine the effectiveness of a multifaceted interventional package for improvement in reducing dust levels at the cotton textile mills as well as improvement in respiratory health of textile workers.This study will add important context-specific knowledge regarding preventive strategies in cotton mills with policy implications for Pakistan and other developing countries.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for textile mills:
* Mills from the formal sector will be included.
* Mills which have either spinning or weaving sections, or both.
* Mills that have at least 50-100 workers (primarily labourers/machine operators) in the spinning and weaving sections.
* Mills with a more stable working population will be preferred.
* Willingness of management to participate in planning and implementation of the study.
* Inclusion criteria for textile workers:
* Those ≥18 years and employed in the bale opening, blowing, carding, spinning, weaving and waste recycling sections (and related sub-sections).

Exclusion Criteria:

* Textile workers from the wet-processing areas as well as support or administrative staff will be excluded.
High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery

High flow nasal cannula(HFNC) ventilation can provide such effects as wash-out effect of the carbon dioxide inside the anatomical dead space,some level of continuous airway pressure and humidified oxygen gases.

Therefore because of its physiological benefits, it has been reported that HFNC can reduce "treatment failure" after extubation in pediatric patients like preterm babies,or infants who suffer from bronchitis.

However there is no evidence showing that HFNC can reduce "treatment failure" after extubation in pediatric patients after cardiothoracic surgery.

This multi-center randomized controlled trial (RCT) involving pediatric patients after cardiothoracic surgery will be conducted to determine whether HFNC,compared with conventional oxygen therapy,after extubation can reduce the rate of"escalation of care due to treatment failure".

The multi-center RCT will enroll 380 pediatric patients after cardiothoracic surgery from the Intensive Care Units (ICUs) in Japan.Informed consent will be obtained from the their parents or legally representatives.They will receive postoperative standard care in ICU and spontaneous breathing test(SBT).If SBT will be done successfully,they will be extubated.Just before extubation,they will be divided randomly into the intervention group or the control group.After randomization,they will be extubated.After extubation,the intervention group will receive HFNC therapy,while the control group will receive conventional oxygen therapy.The flow in the intervention group will surely be maintained to be high,while the flow in control group will surely be less than 2 liter/min.In both groups,outcome measure will be assessed within 72 hours after extubation,or during ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients younger than two years old after cardiothoracic surgery
* pediatric patients who have been ventilated for more than 12 hours after surgery

Exclusion Criteria:

* patients with tracheostomy
* patients with do-not-resuscitate (DNR)
* patients who have be treated by noninvasive positive pressure ventilation or high flow nasal cannula before surgery
* patients who undergo unplanned extubation
* patients who have withdrawn consent from their legal guardian
* patients who don't need oxygen therapy
* patients who are planned to receive treatment with noninvasive positive pressure ventilation after extubation
* patients who are planned to inhale nitric oxide(NO) after extubation
TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease

Digital cardiology is gaining power in the field of preventive cardiology recently, and several trials have already shown good results of dietary therapy with digital cardiology. However, there has been no reports that showed effect of dietary counseling through digital cardiology for secondary prevention of coronary artery disease.

TeleDiet study investigates the impact of dietary therapy with a smartphone application on the content of meals and metabolic parameters for patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

1. Owning a smartphone and able to use it
2. Written informed consent obtained
3. Starting cardiac rehabilitation
4. Coronary artery disease

Exclusion Criteria:

1. Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)
2. Age \<18 years old
3. Pregnancy
An Investigation of Ostomy Devices

Coloplast A/S has developed a new ostomy device in 8 versions.

The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.

The secondary objective is to investigate several performance and safety parameters of the various devices.

The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.

Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.

The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.

Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Have signed the declaration of informed consent
* Have an ileostomy in a concave area
* Have had an ileostomy for at least three months
* Have used convex plates (for convex users) or flat plates (for flat plate users) for the last month
* Be users of 1-piece or 2-piece open ostomy devices
* Have an ileostomy with a diameter of less than 33 mm

Exclusion Criteria:

* Are pregnant or breast-feeding
* Have a double-loop ileostomy
* Have known hypersensitivity or allergy to the devices' component ingredients
* Are receiving/have received radiation treatment and/or chemotherapy within the last 3 months.
* Are receiving/have received local peristomal or systemic steroid treatment within the last month
* Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer

This nationwide, multicenter observational study aims to develop and validate a multimodal artificial intelligence (AI) model for detecting occult lymph node metastasis in early-stage non-small cell lung cancer (NSCLC) patients. Despite advances in lymph node staging, 12.9%-39.3% of occult nodal metastasis cases remain undetected preoperatively, affecting treatment decisions. This study will use deep learning to extract imaging features of occult metastasis and combine them with clinical data to build an AI model for risk prediction. This study will provide insights into the feasibility of AI-driven detection of occult metastasis, supporting clinical decision-making and potentially revealing underlying biological mechanisms of lymph node metastasis in NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer;
* Clinical stage I (AJCC, 8th edition, 2017);
* Age≥18 years old;
* KPS score≥70;
* Patients who have undergone primary NSCLC radical surgery or SBRT treatment;
* Complete systemic lesion imaging assessment before primary NSCLC radical surgery or SBRT treatment (Note: Tumor size ≥ 3 cm or centrally located tumor requires PET/CT and/or invasive mediastinal staging);
* Patients willing to cooperate with the follow-up after primary NSCLC radical surgery;
* informed consent of the patient.

Exclusion Criteria:

* Poor quality of computed tomography imaging;
* Baseline imaging shows pure ground-glass nodules (GGO);
* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
* Loss to follow-up.
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

The study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab. Enrollment in the European Union may also include participants 6 to 11 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 \[2018\]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.

Exclusion Criteria:

* Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
* Known hypersensitivity monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
* Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
* History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
* History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
* Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
Acupuncture for Insomnia: a Randomized Controlled Trial

Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association
* PSQI score \>7
* AIS score ≥6
* SDS ≤60
* SAS ≤60
* Age between 18 and 65 years old
* Not involved in other clinical trial in the lasted 6 months before screening
* Have the ability to write the informed consent.

Exclusion Criteria:

* Breathing-related sleep disorders
* Circadian rhythm sleep-wake disorders
* Medication-induced sleep disorder
* Substance induced sleep disorders,such as alcohol, coffee, strong tea
* Secondary insomnia caused by systemic diseases or caused by external environment disturbance
* Pregnant or lactating women
* Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases
* Advanced malignant tumor or other serious debilitating diseases
* Location of acupoints combined with infection and bleeding
* Declined to acupuncture
* Couldn't provide the written informed consent.
A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males

The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.

The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.

Eligibility Criteria:
Inclusion Criteria

Subjects may be eligible to participate if they:

* Are males with HIV infection with a positive HIV antibody test
* Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)
* Have CD4+ cell counts ≥ 50 cells/ml
* Are 18-45 years of age, inclusive
* Have a body mass index (BMI) ≥ 18 kg/m2
* Are antiretroviral nucleoside reverse transcriptase inhibitor-naive
* Have read and understand the informed consent,and is able and willing to comply with study procedures

Exclusion Criteria

Subjects may not participate if they:

* Have clinically significant ECG abnormalities
* Have clinically significant abnormalities in any safety laboratory parameters
* Have an ALT value ≥ 3xUNL
* Have previously participated in this trial
* Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug
* Have a history of chronic alcohol or drug abuse within the last 6 months
* Have a positive urine drug screening
* Have a positive alcohol breath test
* Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial
* Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol