cyrilzakka/clinical-trials huggingface dataset:
Fuzheng Yiliu-1010

Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by using real-world data and gene expression profile data.


Eligibility Criteria:
Inclusion Criteria:

1. The age of the patients was 18-75 years old;
2. Radical resection of colorectal cancer (negative margin) was performed;
3. Patients with stage II high risk and stage III colorectal cancer confirmed by histology;
4. No liver, peritoneal or distant metastasis was found;
5. Patients with colorectal cancer who received standard chemotherapy or radiotherapy after operation and had no recurrence or metastasis at the end of radiotherapy and chemotherapy;
6. ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above;
7. Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was less than 1.5 mg / dl;
8. Renal function: creatinine \< 1.8mg/dl.

Exclusion Criteria:

1. Allergic to the drug of this scheme;
2. Pregnant or lactating women with fertility requirements during the study period;
3. Severe hypertension, coronary heart disease, diabetes and so on, which are under control for half a year due to cardiovascular accident and poor drug control, are accompanied with other uncontrollable benign diseases such as lung, kidney, liver, infection, etc;
4. Participate in other studies before and during treatment;
5. There was a history of other malignant tumors or multi-source tumors within one year;
6. Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or active phase;
7. Patients with tuberculosis or seizures who need to be treated (e.g. steroids or antiepileptic therapy).
Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.

The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).

Eligibility Criteria:
Inclusion Criteria:

* chronic back pain
* opioid addiction
* not successful with abstinence
* at least 18 years old
* able to understand spoken English
* live in Western New York State (Erie or Niagara county)
* have health insurance or ability to pay for health care
* no methadone or buprenorphine treatment within past year
* not member of a vulnerable population (e.g., pregnancy, prisoner)

Exclusion Criteria:

* homelessness
* unable to give consent (e.g., dementia, psychosis)
* serious heart or lung disease
* taking a medication that could interact with methadone or buprenorphine
* pregnancy
Cohort of Prosthetic Joint Infections

Management of prosthetic joint infections (PJI) is a challenging task. These infections include different clinical and microbiological settings calling upon various treatment strategies according to infection type (acute or chronic), bone quality, the involved micro-organism and the patient's general condition and willing.

Treatment of PJI combines surgery and prolonged antibiotic therapy. In some patients with a high operative risk prolonged suppressive antibiotic therapy can be used.

Lack of large prospective studies motivated the conception of this cohort with a long term follow up, regardless to PJI management procedures.

Large prospective cohort study in a French referral center for bone and joint infections.

Population

* all patients who consented to participate in the study with PJI treated with:
* debridement-synovectomy for acute infection
* with one-stage, two-stage exchange arthroplasty for chronic infection
* other procedures (complete removal of the prosthesis) and antibiotic therapy
* patients (non-operated or operated) receiving prolonged suppressive antibiotic therapy

Outcome:

* Follow-up at least 2 years
* Events monitored: reinfection including relapse and new infection, joint revision for mechanical failure, PJI related or non-related death Study duration: 10 years. Recruitment period: 4 years. Maximal duration of data collection: 6 years. Investigator center: monocenter study. Mean patient inclusion per year: 100 patients per year.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:
* According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.

Major Criteria:

* Two positive periprosthetic cultures with phenotypically identical organisms, OR
* A sinus tract communicating with the joint, OR

Minor Criteria:

* Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
* Elevated synovial fluid white blood cell (WBC)
* Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%)
* The presence of pus in the joint without known cause
* Positive histological analysis of periprosthetic tissue
* A single positive culture

Or a PJI which meets the following three criteria:

* Medical story suggesting prosthetic joint infection.
* The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause.
* Germ identification in a single sample of fluid aspiration or tissue culture.

  * Or microbial growth in prosthesis sonication fluid culture greater than 50CFU/ml.

Exclusion Criteria:

* Patient who does not meet eligibility criteria.
* Patient lawfully deprived of his liberty.
* Patient not insured under social security scheme.
The Use of Ultrasound Detection of Lipohypertrophy to Improve Glycemic Control

Lipohypertrophy is swelling of the fatty tissue located below the skin ("subcutaneous tissue") where many patients with diabetes inject their insulin. Lipohypertrophy can sometimes be felt as firm swelling, lumps or small bumps near insulin injection sites. Previous studies have shown that injecting insulin into areas of lipohypertrophy can affect how insulin is absorbed, and can increase insulin requirements in patients. New data suggest that lipohypertrophy can be detected using ultrasound technology. The ultrasonographic presence of changes to the subcutaneous tissue without swelling that can be felt ("subclinical lipohypertrophy") and the effect of injecting insulin into these sites is unknown.

100 people will participate in the Phase 1 of this study. In the second phase of the study, 40 patients identified with subclinical lipohypertrophy in Phase 1 will be asked to participate in the randomized study using crossover design by checking your glucose levels.

Purpose:

In Phase 1: to use computer based technology to detect lipohypertrophy on portable ultrasound images.

In Phase 2: to demonstrate that injecting insulin into areas to be free of lipohypertrophy will have better glucose control as compared to injecting into areas demonstrated to have lipohypertrophy.

Eligibility:

You can participate in this study if:

* You have been diagnosed with Type 1 or Type 2 diabetes
* You are currently using injection of insulin daily or insulin pump for at least 2 years
* You are 19 years of age or older

You should not participate in this study if:

* You are taking a glucagon-like peptide medication
* You are currently using a systemic steroid agent (e.g. prednisone)
* You have history of a non-lipohypertrophic skin disease in the insulin injection area
* You are not fluent in English (unless accompanied by a translator)

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of Type 1 or Type 2 diabetes mellitus
* Current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years

Exclusion Criteria:

* Subjects taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid
* Past history of a non-lipohypertrophic dermatological condition in the insulin injection site area
EGFR-targeted Therapy for Gastric Cancer

Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.

Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Eligibility Criteria:
Key inclusion criteria

1. Histologically-proven gastric and gastroesophageal junction adenocarcinoma
2. Refractory to first-line chemotherapy for metastatic disease
3. Presence of at least 1 measurable lesion according to RECIST version 1.1
4. EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Key exclusion criteria

1.Prior exposure to taxane or EGFR-targeted therapy
Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in PICU

The objective of the study is to evaluate the effects of halogenated gases on sedation and analgesia, to describe the tolerance and to determine the risk factors for failure, in pediatric intensive care patients during prolonged sedation.

This study will be based on the medical records of patients hospitalized between 2015 and 2020.

Sedation is a major therapeutic element in patients in intensive care under artificial ventilation, in order to allow their comfort and patient-ventilator synchronization. The use of benzodiazepines in combination with opioids is common practice. However, during prolonged sedation, the effects wane, then the doses must be increased, responsible for an increase in the incidence of a significant withdrawal syndrome in the recovery phase, a source of delay in extubation or early reintubation.

The use of halogenated anesthetic gases is now possible in pediatric intensive care in these patients on artificial ventilation.

Their efficacy and tolerance in prolonged use must be evaluated. Their use could improve the sedative effects, reduce the doses of benzodiazepines and opioids used, and reduce unwanted effects in terms of withdrawal syndrome.

The objective of the study is to evaluate the effects of halogenated gases on sedation and analgesia, to describe the tolerance and to determine the risk factors for failure, in pediatric intensive care patients during prolonged sedation.

This study will be based on the medical records of patients hospitalized between 2015 and 2020.

Eligibility Criteria:
Inclusion Criteria:

* Minor patient over 1 month old (and over 36 WA of corrected age) and under 18 years old
* Hospitalized in neonatal or pediatric intensive care unit
* Invasive mechanical ventilation over 72 hours
* Prolonged sedation greater than 72 hours

Exclusion Criteria:

- Opposition of the holders of parental authority of the minor patient or the adult patient to the use of the data for the study
BEAM for Weight Loss - a Pilot Study

Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.


Eligibility Criteria:
Inclusion Criteria:

* BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND
* failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination

Exclusion Criteria:

* Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
* Gastroparesis
* Active smoking
* An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
* Previous pyloromyotomy or pyloroplasty
* Gastrointestinal obstruction
* Use of any medication that may interfere with weight loss or gastric emptying
* Severe coagulopathy
* Esophageal or gastric varices and/or portal hypertensive gastropathy
* Underlying uncontrolled endocrine problem that leads to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc.)
* Any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)
* Malignancy
* Pregnant or breast feeding
* Patients not fit for general anesthesia
* ASA grade IV or V
* Mental or psychiatric disorder; Drug or alcohol addiction
* Other cases deemed by the examining physician as unsuitable for safe treatment
* Refusal to participate
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
* Signed ICF (Informed Consent Form)
* Subject-reported history of DED in both eyes
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Early termination of CYS-004
* Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
* Have a history of herpetic keratitis;
* Have an ocular or periocular malignancy;
* Be unwilling to avoid wearing contact lenses during the trial;
* Have any planned ocular or eyelid surgeries during the trial period
* Be a woman who is pregnant, nursing or planning a pregnancy
* Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential
* Women of childbearing potential not using an acceptable means of contraception
* Presence of known allergy and/or sensitivity to the study drug or its components
* Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004
* Have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly
Efficacy of Kinesio Taping on Mutational Falsetto

This study aimed to assess of efficacy of the kinesio-taping on male patients suffering from mutational falsetto

Mutational falsetto is a functional voice disorder involving a failure to transition from the high-pitched voice of childhood to the lower-pitch ed voice of adolescence and adulthood. In the recent years, kinesio taping has begun to be employed for treating dysphonia patients. We hypothesized that, because the kinesio taping relaxes the suprahyoid muscles and pushes the larynx backward, it could also be used as a therapy of mutational falsetto. This study aimed to assess of efficacy of the kinesio taping on male patients suffering from mutational falsetto.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffered from Mutational falsetto
* Patients who were accept to consent form
* Patients who have not open wound on neck

Exclusion Criteria:

* Having mental disorders or major physiatric disorders
* Cognitive limitations
* Contact dermatitis
* history of smoking
* Asthma, chronic pulmonary diseases
* history of allergic reactions against to medical tape applied
* having an other organic vocal disorders
* advanced hearing loss
* Out of BMI\<18.5 or 30\<BMI
* Out of age 16-60 years old patients who were not accept to consent form.
Post-stroke Cognitive Impairment

Present study aims to track the post-stroke cognitive trajectories and to investigate its inter-individual variability.

The study aim is to establish a model capturing patients' inter-individual variability in susceptibility to stroke damage to predict stroke-induced cognitive trajectories. This is a prospective longitudinal observational national monocentric study for 6 years (recruitment during the first 3 years). The investigators perform comprehensive neuropsychological testing in i) acute stroke phase (0-10 days post-stroke), ii) sub-acute stroke phase (3 months post-stroke), and iii) chronic stroke phase (12 months and 3 years post-stroke). At each time point, cognitive performances as well as clinical and functional status will be assessed. Furthermore, the investigators will assess the proxies of cognitive reserve and the level of post-stroke physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* First-ever anterior circulation ischemic stroke confirmed by routine MRI
* Time of enrollment: ≤ 10 days from stroke onset.

Exclusion Criteria:

* Previous stroke anamnestic or based on clinical imaging
* Additional stroke in posterior circulation
* Conditions that preclude the cognitive testing (e.g. delirium, intubation, reduced vigilance
* Neurological or psychiatric conditions that preclude the data interpretation (e.g. pre-stroke dementia, schizophrenia, brain tumor, regular intake of benzodiazepine, depression)
* MRI contraindication
* Native language other than German, French or Italian
A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes

The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.

Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 9 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have no significant body weight change for the 3 months prior to screening

Part A:

* Are considered healthy
* Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at screening

Part B:

* Have a BMI of 27 to 45 kg/m2 at screening

Part C:

* Have a BMI of 25 to 45 kg/m2 at screening

Part D:

* Have type 2 diabetes
* Have hemoglobin A1C (HbA1c) ≥7.0% and ≤10.5% at screening
* Have a BMI of 27 to 45 kg/m2 at screening

Exclusion Criteria:

* Have had an acute cardiovascular condition within the past 6 months prior to screening
* Have liver disease or pancreatitis
* Have used medications for weight loss within the 3 months prior to screening

Parts A, B, C:

* Have any form of diabetes

Part D:

* Have type 1 diabetes
A Theory-based Sleep Intervention in Improving Sleep Quality in Adolescents

Sleep education has been used as a method of primary and secondary prevention of sleep problems in all age groups. An especially vulnerable age group are adolescents who frequently have poor sleep habits and suffer from sleep deprivation. In adolescents, insufficient sleep, inadequate sleep quality, and irregular sleep patterns are associated with daytime sleepiness, negative moods, increased likelihood of stimulant use, higher levels of risk-taking behavior, poor school performance, and increased risk of unintentional injuries. As an US study has shown, sleepiness was the major causal factor in many traffic accidents and more than 50% of sleep-related crashes involved drivers aged 25 or younger. The study was aimed to evaluate the effectiveness of a theory-based sleep hygiene intervention in improving sleep quality in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* They are not involved in any sleep education program
* study at secondary schools in Qazvin city
* Ability to understand Persian language

Exclusion Criteria:

* Does not meet inclusion criteria
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of \< 1 cm2, mean AV gradient of \> 40 mmHg, or AV peak systolic velocity of \> 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)
2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
4. Patients are technical and anatomical eligible for interventions

Exclusion Criteria:

1. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:

   Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
2. Subject refuses a blood transfusion.
3. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
4. Native aortic annulus size \< 20 mm or \> 29 mm per the baseline diagnostic imaging.
5. Life expectancy is less than one year