cyrilzakka/clinical-trials huggingface dataset:
Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.

Suicide is a major public health issue. Repeated self-harm may lead to potential future suicide deaths. In addition, it may lead to substantial loss in medical costs. Recently, smartphones have been widely used. Researchers started to apply mobile health to support individuals with self-harm experiences and to combine brief contact interventions which require lower cost to reduce repeated self-harm. However, the research evidence remains sparse. Furthermore, self-harm behaviors might be influenced by different cultural contexts. There is a need to conduct local studies in Taiwan. The aim of this study is to establish a co-design team which includes service users and service providers, to collaboratively develop a text- and web-based brief contact intervention (BCI) to reduce repeated self-harm, and to evaluate the feasibility of the intervention.

Study objectives:

1. To establish a co-design team and develop a brief contact intervention (BCI), including the content, frequency, settings, and outcome measures of the intervention.
2. To evaluate the feasibility of BCI, including the feasibility of recruitment, required resources, the appropriateness of data collection, and the acceptability of the BCI.

Methods:

1. In study 1, we will recruit 4-6 service users and 4-6 service providers respectively, and we will conduct focus groups to discuss the content of the BCI. We will conduct individual interviews with participants to explore their experiences and perspectives regarding their participation in the co-design team.
2. In study 2, we will recruit 30 participants who have self-harm experiences to participate in the BCI. The BCI will be delivered through texts and web pages and will last around 5 months. The content of BCI will include caring messages, reminders of appointments, safety planning, volitional help sheet, and resources information. We will collect user engagement data and compare study outcomes (e.g., suicidal ideation and behaviors, brief symptom rating scale (BSRS), and mental well-being scale) before and after receiving the BCI. We will collect the participants' feedback regarding the BCI and evaluate the required resources to further revise the BCI.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or over
* Mentally and physically stable and able to participate in individual interviews and interventions
* Able to communicate in Mandarin and provide written informed consent
* Willing to be recorded during the interviews
* Received medical treatments or aftercare due to self-harm experiences, including self-harm ideations, self-harm behaviors, suicidal ideations, and suicidal attempts.
* Able to use the smartphone to access the internet

Exclusion Criteria:

* Mental and physical states are unstable (e.g., unconscious, severe psychiatric symptoms, strong suicidal ideations with specific suicide plans) to complete the interviews and interventions according to the health professionals.
Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)

The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented chronic myelogenous leukemia in blast crisis, myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia.
* Life expectancy of 12 weeks or greater.
* ECOG Performance Status less than or equal to 2.
* Meets protocol requirements for specified laboratory values.
* No manifestations of a malabsorption syndrome.

Exclusion Criteria:

* Patients who have received more than three chemotherapy regimens for more than three recurrences of the disease.
* Poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled conditions.
* Patients who have received investigational therapy of any type within 30 days prior to administration.
Awareness of Osteoporosis in HIV Patients

Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with human immunodeficiency virus infection are at increased risk for developing osteoporosis. Identifying whether patients with human immunodeficiency virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with human immunodeficiency virus infection.

Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with human immunodeficiency virus infection are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with human immunodeficiency virus infection.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of human immunodeficiency virus
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent
Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial

Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery. The post-operative pain of this surgery is managed according to recommendation. In the majority of case, femoral nerve block is performed. The femoral nerve block can cause "paralysis" of the quadriceps more or less complete that no allowing a good quadriceps locking. This locking is indispensable to avoid post-operative flexima and to ensure stabilization of the knee during walking.

In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain requires powerful analgesics with their adverse events.

Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in the same time optimal analgesia and optimal quadriceps locking. The main objective of the investigators study is to compare two analgesia techniques : femoral nerve block vs intra articular injection and obturator nerve block in surgery of the anterior cruciate ligament of the knee


Eligibility Criteria:
Inclusion Criteria:

* Physical Status score = 1 or Physical Status score = 2
* Major Patient
* indication of anterior cruciate ligament reconstruction
* informed consent for participation in the study

Exclusion Criteria:

* Contraindication to general analgesia
* Contraindication to peripheral nerve block
* Allergy to analgesic treatment
* Porphyria,
* Neurologic deficit
* Contraindication antiinflammatory drugs
* Simultaneous reconstruction of another ligament or complex gesture intended
* Patient treated with an anti-arrhythmic drug class III
* Patient with severe hepatic impairment
* Pregnant woman
Fecal Transplantation in Ulcerative Colitis

Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.

80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).

The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.

Eligibility Criteria:
Inclusion Criteria:

* • • Diagnosis of CU based on clinical, endoscopic, and histological findings.

  * Remission assessed by Mayo score (0 to 1) and F-Calpro (\<100 ug/g).
  * Availability of consecutive fecal samples during one year after the diagnosis of CU.
  * Availability of blood sample to study the IBD associated genetic background
  * Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
  * 18-75 years

Exclusion Criteria:

* Unable to provide informed consent
* Need for any antibiotic therapy within 3 months
* Use of corticosteroids, immunosuppressive or biological medication at the baseline
* Use of any probiotics
* Pregnancy
Efficacy of Naso-Esophageal Tube Feeding in Patients With High Cervical Spinal Cord Injury.

The goal of this clinical trial is to compare the differences in Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury using Naso-Esophageal Tube Feeding and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Naso-Esophageal Tube Feeding for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in Pneumonia situation and nutritional status of two groups of patients before and after the study to see if Naso-Esophageal Tube Feeding can improve the Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury

Naso-esophageal tube feeding is a medical procedure utilized to provide nutrition directly into the esophagus via a tube inserted through the nose. This method is employed when individuals cannot consume food orally due to various medical conditions, such as dysphagia (difficulty swallowing), neurological disorders, or conditions affecting the upper gastrointestinal tract.

The goal of this clinical trial is to compare the differences in Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury using Naso-Esophageal Tube Feeding and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Naso-Esophageal Tube Feeding for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in Pneumonia situation and nutritional status of two groups of patients before and after the study to see if Naso-Esophageal Tube Feeding can improve the Pneumonia situation and nutritional status between Patients With High Cervical Spinal Cord Injury

Eligibility Criteria:
Inclusion Criteria:

* High Cervical Spinal Cord Injury.
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.

Exclusion Criteria:

* damaged mucosa or incomplete structure in nasopharynx;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Administration of BIIB028 to Subjects With Solid Tumors

Safety and Tolerability of BIIB028


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Age greater than or equal to 18 years at the time of informed consent.
* Subjects with histological or cytological confirmed solid tumors who have failed standard therapies or for which no standard therapy is available.
* Anticipated survival of at least 3 months in the opinion of the Investigator.
* ECOG performance status of less than or equal to 2.
* Lab values consistent with adequate renal hepatic and bone marrow function.
* Must utilize effective contraception.

Exclusion Criteria:

* Pregnant (positive pregnancy test) or nursing women
* Prior treatment with Hsp90 inhibitors at any time.
* Prior antitumor therapies including prior experimental agents, approved antitumor small molecules and biologics, or radiotherapy with in 28 days or \<3 half lives (whichever is longer). In addition,prior to enrollment, all asociated toxicities must have been resolved to eligibility levels.
* Concurrent severe or uncontrolled other medical disease (i.e, diabetes, hypertension, coronary artery disease, congestive heart failure), which in the opinion of the Investigator and/ or the Sponsor could compromise assessment of safety.
* Use of anticoagulants, except low dose warfarin.
* History of seizure, previous significant head trauma (e.g., associated with loss of consciousness for more than 5 minutes), abrupt discontinuation of benzodiazepines, or use of potentially epileptogenic medication
Disrupting SDOH to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions

The study will evaluate the effectiveness of the Just Care for Families program in preventing Oregon Department of Human Services (ODHS)-involved parents in rural communities from escalating opioid and/or methamphetamine use and mental health disorders by disrupting the associated social determinants of health (SDOH). In addition, investigators will examine the impacts of SDOH on Just Care treatment and the associated costs from the perspective of provider clinics delivering Just Care. Just Care is a behavioral intervention for the treatment of parental substance abuse and child neglect for families involved in the child welfare system. Just Care involves treatment components, supported by ongoing purposeful engagement: (1) Substance use treatment; (2) Mental health treatment; (3) Parent management training; (4) Community building; (5) Systems Navigation; and (6) Addressing basic needs.

This study provides multiple tests of the mechanisms by which Just Care for Families disrupts the effects of lifetime social determinants of health (SDOH) on ultimate outcomes of preventing escalation of opioid and/or methamphetamine use and suicide (ideation, intention, attempts). Just Care for Families 's effect on these outcomes is hypothesized to occur through two mechanisms of action: (1) improvement in malleable SDOH (direct targets of intervention) and (2) improvement in substance use and mental health problems (intermediate prevention outcomes). Analyses will examine whether the effects vary as a function of non-malleable external, structural SDOH, such as community poverty and healthcare service availability. Additionally, system dynamics will be used to examine patterns of influence between SDOH and Just Care for Families intervention targets, case outcomes, and associated costs.

Eligibility Criteria:
Inclusion Criteria:

Parents:

* Use or misuse of opioids in the last year, and/or any methamphetamine use in the last year
* Parent of a child, age 0-18
* Current mental health symptoms
* Resident of participating county (Lane, Linn, Benton, Douglas, Lincoln)
* Insured by Oregon Health Plan (Medicaid)
* Access to a computer or smartphone; or wireless/cellular connection if a device were to be provided; or reliable access to a landline to receive a brief weekly phone assessment in place of the digital assessment

Clinical Staff:

* clinician at a participating clinic
* Providing Just Care for Families services to parents in the study at any point during study

Exclusion Criteria:
Navicam for Detection of Barrett's Esophagus

Using a non-invasive capsule system to achieve optimal viewing angles of the esophagus for detection of Barrett's esophagus


Eligibility Criteria:
Inclusion Criteria

* Adults greater than or equal to 22 years of age with or without Barrett's Esophagus
* All Patients:

  o Have had an endoscopy within 1 year of baseline enrollment
* Patients with Barrett's Esophagus:

  * Presence of at least 1cm of salmon colored mucosa with corresponding biopsies showing intestinal metaplasia who are treatment naïve and undergoing surveillance Or
  * Chronic Gastro Esophageal Reflux Disease (GERD) patients with at least 3 additional risk factors that meet Barrett's Esophagus screening criteria per latest clinical guidelines

Exclusion Criteria

* Inability to comprehend or read the consent form
* Have an oropharynx, esophageal, or gastro-esophageal tumor
* Ongoing symptoms of dysphagia
* Presence of active clinically significant stricture
* History of stricture requiring dilation
* Presence of pacemaker or implanted cardiac defibrillator
* History of esophageal surgery with the exception of fundoplication
* Pregnancy
* History of surgery or obstructive process of the small bowel
* BMI \> 38
A PROSPECTIVE, MULTICENTER, SINGLE-ARM TRIAL FOR THE NEW SIZES OF BRIDGE STENTS FOR VERTEBRAL ARTERY STENOSIS: Bridge-MAX

Aprospective, multicentre, single-arm clinical trial in which approximately 36 subjects would be enrolled using the Bridge 4.5 mm and 5.0 mm stent in accordance with the inclusion and exclusion criteria in this protocol. The success rate of immediate post-procedure stent target lesion treatment was recorded for all subjects, and the incidence of in-stent restenosis (≥50% stenosis) was assessed by DSA imaging follow-up at 6 months (±30 days) post-procedure. The subjects were also followed up at 30 days (±7 days), 6 months (±30 days), and 12 months (±60 days) after stent implantation to assess safety events during the follow-up period. .


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above (including 18 years old), 80 years old below (including 80 years old), male or women with pregnancy test (-); 2. Symptomatic vertebral artery stenosis patients who have failed in medical treatment (defined as patients who have suffered from stroke or TIA within 90 days, and are taking at least one antithrombotic drugs as well as interventions in other vascular risks, such as hypertension and hyperlipidemia decompression or lipid reducing); 3. DSA angiography showed target lesion stenosis degree ≥70% (Stenosis degrees are determined according to WASID method); 4. Diameter of normal blood vessels distal to the target lesion ≥3.5mm and the length of target lesion ≤23mm; 5. Modified Rankin score \<3; 6. Patients who are suitable for implantation of rapamycin target eluting vertebral artery stent and are voluntary to

Exclusion Criteria:

* Presence of tandem stenotic lesions (≥50% tandem stenosis) in the target lesion area; (2) TIA or non-disabling stroke due to factors other than vertebral artery stenosis (e.g. atrial fibrillation, etc.); (3) Previous surgical treatment or endovascular intervention in the target lesion area; (4) Comorbid severe systemic systemic diseases or other diseases with a potential risk of sudden death, or subjects with a life expectancy of \<1 year; (5) Subjects with contraindications to heparin, aspirin, clopidogrel, or other antiplatelet drugs and who cannot tolerate anticoagulant and antiplatelet drug therapy; (6) Previous cerebral infarction with residual responsible vascular-related severe neurological deficits (mRS ≥3 points); (7) Previous severe myocardial infarction within 2 weeks; (8) Accompanied by other intracranial lesions such as intracranial haemorrhage, aneurysm, arteriovenous malformation, intracranial tumour, etc (9) Non-atherosclerotic stenosis such as arterial entrapment, smoker's disease, active arteritis, and unknown causes; (10) Severe tortuosity or calcification of the target vessel that precludes implantation of a stent or lesion that cannot be dilated; (11) Severe renal impairment, or those who are allergic or resistant to contrast agents, rapamycin (Rapamycin) and its derivatives, cobalt-based alloys, PDLLA; (12) Pregnant or lactating women; (13) Patients participating in other drug or device studies that have not met endpoints
A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers

It is important to evaluate the accuracy of the pulse oximeter, which is commonly used in clinical practice. The US FDA only allows the use of devices that meet the ISO 80601-2-61:2017 standard in the United States. According to the ISO 80601-2-61:2017 standard, the accuracy of the oxygen saturation (SpO2) of the pulse oximeter should have an error range of less than 4.0% compared to the actual arterial blood oxygen saturation (SaO2) in the range of 70-100%. To prove compliance with this requirement, it is necessary to conduct a clinical trial that induces hypoxemia in healthy adults and compares and evaluates the arterial blood oxygen saturation values of the pulse oximeter's SpO2 and the arterial blood oxygen saturation values of the carbon monoxide-oxygen meter (CO-oximeter).


Eligibility Criteria:
Inclusion Criteria:

* healthy adults between 20 and 50 years
* volunteers who have plasma proportion of carboxyhemoglobin 3%
* volunteers who have plasma proportion of methemoglobin 2%
* volunteers who have total plasma hemoglobin concentration over 10 g/dL

Exclusion Criteria:

* History of respiratory diseases
* History of cardiovascular disease
* Smokers (including ex-smokers)
* Pregnant
* History of fainting
* History of diabetes
* Obesity (BMI\> 30 kg/m2)
* Allen's test results, those who do not recover the color of their fingers and palms within 10 seconds
* History of allergic reaction to lidocaine, a local anesthetic
Comparison of CTI Ablation Prior to or After LA Ablation for AF

This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.


Eligibility Criteria:
Inclusion Criteria:

* continuous/persistent atrial fibrillation

Exclusion Criteria:

* age\<18
* congenital heart disease
* pacemaker or ICD implant
* previous ablation
Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy

Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing conditions, and to investigate whether additional educational information affects satisfaction with treatment as perceived by the patient.

Patients will be identified and monitored during routine clinical practice visits, and will not be specifically selected as this would interfere with the representativeness of the results. The study will be conducted with office-based urologists and office-based general physicians, practitioners and internists (GPs) in Germany, thus representing a wide range of practices and populations. Each urologist or GP may invite patients to participate who have already been diagnosed with overactive bladder and prescribed Toviaz according to their usual standard of care. Study enrollment stopped on December 31, 2011 due to difficulty in recruiting patients. No safety issues were related to the decision to stop patient enrollment.

Eligibility Criteria:
Inclusion Criteria:

Patients with increased urinary frequency and/or imperative urgency and/or urge incontinence, as can occur in patients with overactive bladder syndrome, for whom Toviaz was prescribed for treatment of the symptoms.

Patients will complete the OABv8 questionnaire and will need to meet a minimum score in order to be eligible for the study.

Exclusion Criteria:

Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.