cyrilzakka/clinical-trials huggingface dataset:
A Clinical Prospective Study to Validate a Risk Scoring Model for the HMGC After Curative Surgery

A previous study of investigators established a risk scoring model for the occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therapy. In order to further validate the clinical applicability of abovementioned model, investigators designed this prospective study, which also included patients who received neoadjuvant therapy before surgery, with the aim of exploring the applicability of the risk scoring model to this group of patients.

The study was a single-centre, prospective study. Prospectively collected data were used to analyze the consistency between the actual outcomes of patients with or without hepatic metastases after curative gastrectomy and the predicted outcomes of the risk scoring model, in order to assess the clinical applicability of the model. In addition, analyses were performed to compare the differences in the risk of hepatic metastasis and the time interval of occurrence between patients who did not receive neoadjuvant therapy and those who received neoadjuvant therapy, as well as between patients with different outcomes after receiving neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).

Eligibility Criteria:
Inclusion Criteria:

1. Received curative gastrectomy (D2 lymph node dissection);
2. Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
3. No hepatic tumors and other occupying diseases, no chronic diseases such as cirrhosis and hepatitis, no hepatic schistosomiasis, no hepatic echinococcosis, no hepatic tuberculosis, and no severe fatty liver disease before the curative surgery;
4. No history of intraperitoneal chemotherapy;
5. No other serious concomitant diseases with satisfactory organ function;
6. No history of other malignant tumors;
7. Comply with the protocol during the whole study period;
8. Sign informed consent and permission of withdraw in the whole study period;
9. Estimation the overall survival after surgery no less than 12 months;
10. Consent to analysis of clinicopathological data and prognostic follow up;
11. Karnofsky Performance Scores (KPS) more than 60.

Exclusion Criteria:

1. Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell, hepatoid adenocarcinoma or others);
2. Gastro-esophageal junction cancer;
3. Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months;
4. Immunosuppressive therapists for organ transplantation;
5. Seriously uncontrolled recurrent infection;
6. History of other malignancies;
7. No abilities of self-knowledge or mental disorders;
8. Combination of other serious diseases;
9. Concurrent participation in other clinical trials.
Oxycodone vs Fentanyl for Pain Treatment After Laparoscopic Cholecystectomy

To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of postoperative pain after laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Planned outpatient laparoscopic cholecystectomy
* \>18 years

Exclusion Criteria:

* Intolerance to study drugs
* Treatment with MAO inhibitors
Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients

The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain for at least 6 months
* If lower extremity pain present, must be present for at least 3 months
* Visual analog scale (VAS) score for low back pain at least 50 out of 100
* Lumbar or lumbosacral surgical intervention without pain relief
* Central sensitization symptoms
* Agrees to follow randomized treatment plan
* 18 years of age or older
* Signed informed consent form

Exclusion Criteria:

* Significant change to low back or lower extremity pain within 4 weeks prior to enrollment
* Nociceptive and/or neuropathic pain symptoms in the spine due to structural and/or mechanical instabilities
* Three or more lumbar or lumbosacral surgical interventions; one or more surgical interventions in areas other than lumbar or lumbosacral spine
* Three or more lumbar vertebral segments fused
* Lumbar or lumbosacral surgical intervention in last 9 months; areas other than lumbar or lumbosacral in last 12 months
* Any additional surgical intervention required 3 months post-enrollment
* Symptoms consistent with sympathetically-maintained pain
* Evidence of serious neurological deficits or impairments
* Significant changes in pain medications within 4 weeks prior to enrollment
* Psychosocial issues that conflict with valid reporting by patient
* Prior treatment with percutaneous electrical stimulation or sensitivity to electrical stimulation
* Current use of another electrical stimulation device for low back or lower extremity pain
* Current enrollment in another clinical trial within the last 30 days
* Current or prior malignancy or cancer
* Serious or uncontrolled systemic illness
* Body mass index (BMI) greater than 40
* Pregnant or intends to become pregnant during the study
* Implanted medical device
* Relationship with study staff
* Unable to attend study office visits or complete study measures
Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4

Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain spectacle freedom.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cataracts

Exclusion Criteria:

* Preexisting conditions confounding results; \> 1 Diopter preoperative astigmatism
A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential

This is a two-part study to determine the relative bioavailability of two different prototype capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and fasted conditions. The study is open to healthy female participants of non-childbearing potential.


Eligibility Criteria:
Inclusion Criteria

* Body mass index (BMI) range 18.5 to 35 kilograms per square meter (kg/m2)
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;
* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the principal investigators (PIs)
* Females of non-childbearing potential only

Exclusion Criteria

* History or clinical manifestation of any significant medical condition as determined by the PI (or designee)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the PI (or designee)
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Use of any prescription medications/products within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
* Use of oral antibiotics within 4 weeks or intravenous antibiotics within 8 weeks prior to the Screening evaluation and during the entire study duration
* Use of any over-the-counter, non-prescription preparations within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
* Use of acid reducing medications (proton pump inhibitors \[PPIs\], histamine H2-receptor antagonists \[H2RAs\]) within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration. As an alternative, antacids may be allowed at least 4 hours before or after dose
* Use of any vaccines (including seasonal flu and H1N1 vaccines) within 14 days prior to Check-in (Day -1) for their first treatment period
* Use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day -1) for their first treatment period and during the entire study
* Any acute or chronic condition or any other reason that, in the opinion of the PI, would limit the subject's ability to complete and/or participate in this clinical study
VTE and the Related Factors Associated With Higher Rates of PE After a DVT in Southwestern China

Little is known about the current management status of venous thromboembolism (VTE) in Southwestern China. We aimed to investigate the status of anticoagulant administration in VTE in Southwestern China and assess the potential predictors of deep vein thrombosis (DVT) complicated pulmonary embolism (PE). We extracted data from YiduCloud database from December 2006 to November 2018 and performed a cross-sectional survey of VTE. The demographics, laboratory tests, and anticoagulants were collected and analyzed in the logistic regression model, classification tree and Random Forest model.

We established a collaborative epidemiological work of southwestern China for our cross-sectional survey sample, which included hospitalized patients in the seven main medical centers who met the inclusion criteria. The Human Research Committee of Chongqing Medical University approved this study and waived the need for informed consent. Patients were eligible to be included in the study if they are admitted or discharged with a diagnosis of DVT or/and PE and if they ever received treatment in the seven medical centers between December 2006 to November 2018.

Eligibility Criteria:
Inclusion Criteria:

- In the Chinese VTE guidelines, the diagnosis of VTE depends on a series of tests. D-dimer was used to screen for thrombosis, and limb venous ultrasound was used to diagnose DVT. CT pulmonary angiography (CTPA) or pulmonary ventilation perfusion scan was used for the diagnosis of pulmonary embolism. Through the retrieval of patient diagnosis in the database, we retrieved the basic data of all patients diagnosed as VTE during the study period.

Exclusion Criteria:

-
Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation

This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence of systemic inflammation. Half of participants will receive NP001 and the other half will receive placebo.

This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS and evidence of elevated systemic inflammation. Subjects will be allocated (1:1) to NP001 and placebo. Drug or placebo will be given intravenously.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of clinically possible, clinically probable (with or without laboratory support), or clinically definite ALS (using the revised El Escorial Criteria)
* Forced vital capacity greater than or equal to 65% of that predicted for age and height
* Onset of ALS-related weakness less than 3 years prior to first dose of study drug
* Plasma high sensitivity C-reactive protein (hs-CRP) concentration of greater than or equal to 0.113 mg/dL at pre-screening/screening
* Stable dose (greater than 30 days) of riluzole if undergoing treatment with this agent
* For females: Not be of childbearing potential or agree to use adequate birth control during the study

Key Exclusion Criteria:

* Life expectancy of less than 6 months
* Tracheotomy or be using ventilatory assistance, including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)
* Active pulmonary disease
* Gastrostomy
* Stem cell therapy
* Immune modulator therapy or participation in studies of other agents within 12 weeks of pre-screening/screening
* Unstable medical condition other than ALS
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).


Eligibility Criteria:
Inclusion Criteria

* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* Has adequate organ function

Exclusion Criteria

* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
* Has ampullary cancer
* Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
* Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
* Has had an allogenic tissue/solid organ transplant
Delayed Secondary Reconstruction of Alveolar Clefts Using Autogenous Symphyseal Particulate Bone Versus Iliac Cancellous Bone: A Randomized Clinical Trial

Patients with alveolar clefts whose ages are after 12 years (after eruption of all permanent dentition) were recruited and treated either by particulate bone grafting from the symphysis or from the anterior iliac crest


Eligibility Criteria:
Inclusion Criteria:

* cleft alveolus patients of both genders after eruption of all permanent dentition

Exclusion Criteria:

* previous failed repairs of alveolar clefts and bone metabolic diseases
The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma

The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolescents with asthma in a hospital outpatient clinic.

Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire. The prevalence of dysfunctional breathing defined as NQ score \>= 23 is calculated, and demographics are compared between children with and without dysfunctional breathing.

The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolecents with asthma in a hospital outpatient clinic.

Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire, during appointments at the outpatient clinic. For this study purpose, each participant only takes the questionnairres once.

Patient data regarding age, sex, asthma medication, lung function, allergic sensitization, method of asthma diagnose, Height, weight and Body mass index is registered from the electronical patient journal.

The prevalence of dysfunctional breathing in the cohort is calculated as the fraction of children with a NQ score \>= 23.

The group of children and adolescents with dysfunctional breathing is characterized and compared to the group without dysfunctional breathing, regarding the descriptives mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosed by lung function tests and/or typical symptoms.
* Treatment with inhaled corticosteroids in minimum 3 months.

Exclusion Criteria:

• Other significant cardiopulmonary or muscoluskeletal conditions.
A Multinational Phase III Study of CS-8958 (MARVEL)

The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.

In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of influenza
* Axillary temperature of \> or = to 37.5 degrees C

Exclusion Criteria:

* Infection by bacteria species and/or virus other than influenza virus
* Chronic respiratory disease
* Renal dysfunction
A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)

This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.


Eligibility Criteria:
Inclusion Criteria:

Hepatic Participants:

* Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
* Apart from hepatic insufficiency, is in good general health
* Has a diagnosis of chronic stable hepatic insufficiency
* Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). Moderate and Severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit.

Healthy Matched Participants:

* Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
* Is in good health

Exclusion Criteria:

* Female is pregnant, lactating, expecting to become pregnant or donate eggs
* Has a history of stroke or seizures
* Has a history of cancer
* Is unable to refrain from the use of any prescription or non-prescription medication
* Consumes excessive amounts of alcohol or caffeinated beverages daily
* Has had surgery, donated blood or participated in another investigational study with in the last 4 weeks
* Is a regular user or past abuser of any illicit drug including alcohol
Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

The purpose of this study is to compare two short-acting local anesthetics, articaine and lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and motor block, recovery time until discharge and complications will be studied.

The ideal spinal anesthesia in day-case surgery is characterized by a short onset of sensory and motor blockade, and a rapid recovery after the operation. Short-acting local-anesthetics are used frequently in this setting.

Lidocaine is one of the agents that is used most frequently. It has been associated with an increased incidence of Transient Neurological Symptoms (TNS). Articaine is another agent that is being used more often and is said to act faster and shorter than lidocaine.

We will compare spinal anesthesia with lidocaine and articaine in a randomized double-blind clinical trial. Endpoint are:

* onset of sensory and motor block
* recovery from sensory and motor block
* time to micturition
* patient satisfaction
* complications

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* ASA I-III
* Patients planned for a short surgical procedure on lower extremities or lower abdomen.
* Procedure in day-case setting
* Procedure under spinal anesthesia
* Informed consent

Exclusion Criteria:

* Contra-indications spinal anesthesia
* History of allergic reactions on amide-type local anesthetics
* Pregnancy
Effect of Laser Puncture on Rheumatoid Arthritis Patients

Studying the effect of laser puncture on rheumatoid arthritis patients


Eligibility Criteria:
Inclusion Criteria:

* Meeting the criteria of ACR classification for rheumatoid arthritis
* Meeting the criteria of EULAR classification for rheumatoid arthritis

Exclusion Criteria:

* Having malignancy
* Having connective tissue disease
* Smokers
Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction

It's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS can be discriminated by the level of certain VOCs than there would also be a potential to actually predict the development at an early stage and would enable an earlier intervention.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient bilateral lung transplant recipients including combined transplants

Exclusion Criteria:

* Active Smoking Oxygen therapy Infection with multi or pan-resistant bacteria
Anonymous Treatment on the Internet for Alcohol Dependence: A Randomised, Controlled Trial

Internet based self help program with or without support of a counselor is tested among anonymous Internet help seekers at an open access website.

A 5 module Internet based self help program based on motivational interviewing and cognitive behavioral therapy is tested among anonymous Internet help seekers.The design is a three armed randomized controlled study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 2400 participants are recruited entirely online from an open access website. Consenting participants will be randomized into one of three groups: 1.Internet based self help program with counselor support, 2.Internet based self help program without counselor support or 3. Information about the open access websites resources: information on alcohol and health, where you can find treatment and a online discussion forum. Follow-up will be conducted online after 3, 6, 12 and 24 months in all three groups.

Eligibility Criteria:
Inclusion Criteria:

AUDIT-score \>16 points and/or at least 3 criteria of alcohol dependence (ICD-10)

Exclusion Criteria:

Inadequate Swedish language skills No Internet access