cyrilzakka/clinical-trials huggingface dataset:
Surgery Versus Stereotactic Radiosurgery in the Treatment of Single Brain Metastasis: A Randomized Trial

Study Objectives:

* To compare the survival (overall, systemic, and neurological) of patients with single cerebral metastases treated with either conventional surgical resection or stereotactic radiosurgery.
* To compare their rates of recurrence, complications, and their cognitive ability, functional status, and quality of life.

Although surgical resection is a proven and effective treatment for brain metastases in patients with systemic cancer, stereotactic radiosurgery has been suggested to be equally effective and less morbid. Nonrandomized retrospective comparisons have been unable to resolve whether stereotactic radiosurgery is as effective as conventional surgery because of the complexity and variability of the population of patients with cancer and brain metastases. This controversy can only be resolved by a prospective randomized trial comparing these treatment modalities. Patients not randomized will be analyzed as a separate group.

Eligible patients will be randomized to either conventional surgery or stereotactic radiosurgery, or participate as a separate group of the study, if they refuse randomization. At the time of diagnosis, patients may be given dexamethasone which will be continued throughout treatment then discontinued in a tapered fashion. Patients with supratentorial tumors and a history of seizures may be treated with anticonvulsants. For patients in the surgical group, surgery will be performed using standard techniques and any necessary intraoperative adjuncts. For patients in the stereotactic radiosurgery group, stereotactic radiosurgery will be delivered using the modified linear accelerator and multiple non-coplanar converging arcs. The dose prescribed will be dependent on the volume treated. Changes in patients' clinical courses will be treated as medically necessary. Should metastases recur or progress at the primary intracerebral site or at a distant intracerebral site, patients who received radiosurgery remain eligible for surgical resection and patients who received conventional surgery may undergo repeat resection or radiosurgery. Whole brain radiotherapy may be given to patients who demonstrate local or distant recurrence and can be given as the primary therapy or as adjunctive therapy. The WBRT dose will be 30 Gy delivered in ten fractions.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 years and older;
* Documented diagnosis of cancer within 5 years (except for patients with unknown primary);
* Newly diagnosed single brain metastases as determined by MRI;
* Candidacy for both conventional surgical resection as well as stereotactic radiosurgery;
* Karnofsky Performance Score \> 70;
* Life expectancy of at least 4 months;
* Signature of the approved consent form.

Exclusion Criteria:

* Prior radiation therapy to the brain;
* Evidence of leptomeningeal disease;
* Need for immediate treatment to prevent neurological deterioration;
* Extremely radiosensitive primary tumor;
* Prior radioiodine (for thyroid metastases);
* Pregnancy or lactation.
Understanding Patient Experience Among Asians at MD Anderson

The purpose of this research study is to understand barriers to and facilitators of a positive patient experience for Asian patients.

Primary Objective:

a. Identify critical aspects of inpatient experience among former Asian/Asian American patients at MD Anderson.

Secondary Objectives:

a. Determine MD Anderson health care providers' perceptions of Asian/Asian American inpatient experience.

Eligibility Criteria:
Inclusion criteria for former patients:

* Self-identify as Asian/Asian American
* Are 18 years or older
* Have been diagnosed with cancer, any type
* Received inpatient care at MD Anderson between 2019 and 2022
* Have a U.S. address
* Can read and write in English or simplified Chinese

Exclusion criteria for former patients:

• None

Inclusion criteria for healthcare providers:

* Self-report as a practicing inpatient provider (advanced practice provider, hospitalist, physician, nurse) at MD Anderson
* Treated patients diagnosed with breast, colon, prostate, thyroid, or lymphatic cancer
* Provided treatment services to Asian/Asian American patients between 2019 and 2022

Exclusion criteria for healthcare providers:

• None
The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair

Inguinal hernia is one of the most-common surgical conditions. Incidence is about 27% in males and 3% in females.The treatment of this condition is inguinal hernia repair operation which can be approached with several techniques; open hernia repair, laparoscopic hernia repair and robotic hernia repair. The current guidelines recommend the hernia repair operation with mesh placement either Lichtenstenstein operation or laparoscopic technique; transabdominal preperitoneal technique (TAPP) and totally extraperitoneal technique (TEP). In the laparoscopic approach, one of the complications that can occur is post-operative pain from the mesh fixator. So the self-gripping mesh becomes another option to decrease this incidence.However the adhesive property of the mesh is still challenging for many surgeons. Several techniques of self-gripping mesh placement were introduced. One of the popular techniques is bilateral vertical folding of self-gripping mesh which still causes some adhesive problems when introduced to the target area. This research's aim is to present a new technique of the self-gripping mesh placement which is more effective, more convenient, and decreases the time taken to place the mesh at the surgery site.

A randomized control trail comparing the duration of mesh placement and surgeon satisfaction of self-gripping mesh with plastic sheath and with non-plastic sheath covering mesh. Patients with groin hernia who planned for elective laparoscopically repair hernia with self-gripping mesh at Ramathibodi Hospital, Faculty of Medicine, Mahidol University will are informed of the details of research at the outpatient department before admission. 1:1 open label randomization trail was designed dividing the patients into two groups by the study number. The operation will be done with the standard laparoscopic hernia repair technique by experienced surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic inguinal hernia repair

Exclusion Criteria:

* Rejected or withdrawn consent
Effects of Topical Insulin on Levels of Tear Inflammatory Mediators

60 samples are take to determine the effects of topical insulin on tear inflammatory mediators interleukin 1a, interleukin 6 and matrix metalloprotenase 9 in diabetics with dry eye disease.

Tear samples are taken to compare the levels of inflammatory markers (IL 1a, IL6 and MMP 9) pre-and post treatment with topical insulin in normal saline compared to standard therapy and normal saline in diabetics with dry eyes and also to correlate the IL 1a, IL6 and MMP 9 levels with clinical outcomes in diabetics with dry eyes treated with topical insulin in normal saline, standard therapy and normal saline

Eligibility Criteria:
Inclusion Criteria:

* all diabetics aged 18 - 50 years of age with at least mild OSDI scores

Exclusion Criteria:

* Diabetics on contact lenses
* Diabetic with history of ocular surgery in the preceding 3 months
* Post menopausal women
* Known mild dry eye with prior usage of topical therapy who are unable to discontinue
* Known case of allergic eye disease
* Sjogren's syndrome patients
* Unwilling or unable to attend 6 follow up and sampling sessions
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia

Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic use of aspirin on the recurrence of placental insufficiency and its complications, mainly preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity in medical practice in Canada and around the world in terms of the dose of aspirin used.

The objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is associated with greater improvement in placental function assessed by biochemistry (sFlt-1 and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by a test used in several Canadian centers (PFA-100).

Many studies suggest that aspirin (acetylsalicylic acid) at low dose significantly reduces the incidence of preeclampsia. More recent data have shown that, when administered before 16 weeks of pregnancy, aspirin can prevent over 50% of preeclampsia, severe preeclampsia, and IUGR but also a significant proportion of the rate of preterm births. Current data also demonstrate a beneficial effect of prophylactic use of aspirin when started early in pregnancy in populations composed of high-risk patients with a history of preeclampsia and / or other pregnancy complications related to poor placental function.

Beside, many clinicians are already using aspirin in the context of a proven benefit. However, the usual dose prescribed in Canada today is 80 mg while the most favorable studies have used a slightly higher dose of aspirin (100 mg).

Moreover, it has been demonstrated that the time of day during which aspirin was administered was also a very important factor regarding the effect on blood pressure and adverse outcomes of the majority of pregnancy. Yet the majority of studies in this context have not specified the time of day at which aspirin was or had been taken, possibly underestimating the effect thereof.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 10 0 / 7 and 13 6 / 7 weeks
* History of preeclampsia (as defined by The Society of Obstetricians and Gynaecologists of Canada) confirmed by medical records

Exclusion Criteria:

* Negative Fetal Heart
* Multiple pregnancy
* Anaphylactic allergy to lactose
* Kown coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C)
* Use of heparin or other anticoagulants.
* Contraindications to aspirin
* Severe fetal abnormality (cystic hygroma, nuchal translucency\> 95th percentile, anencephaly, etc.)
* History or active peptic ulcer
Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

The intestine is the most vulnerable target organ in septic patients and is the first to be damaged organ in multiple organ dysfunction syndrome(MODS).Therefore, improving intestinal motility and mucosal barrier function is critical to the treatment of sepsis. Many studies have shown that, early enteral nutrition(EN) in patients with sepsis helps prevent and treat intestinal dysfunction, reducing ICU mortality and length of stay in ICU. However, there is little research on feeding methods. In this study the investigators will compare the outcomes of different feeding methods: continuously-pumped in 24 hours, continuouslypumped in 16 hours and intermittently-pumped through the stomach tube. The aim of this study is to investigate the effects of different feeding methods on intestinal function in septic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Septic patients in Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine;
2. APACHE-Ⅱ score greater than 15 points;
3. Signing the informed consent.

Exclusion Criteria:

1. Fasting patients in the clinical, such as digestive tract perforation, bleeding or postoperative patients with gastrointestinal tract;
2. Allergic to enteral nutrition preparations;
3. Don't want to attend the test or not with the healer.
Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans

This randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans.

PRIMARY OBJECTIVES:

I. Evaluate the efficacy of lay health worker (LHWs) outreach on colorectal cancer (CRC) screening among 3 Asian American groups (Filipinos, Hmong, and Koreans) in a cluster randomized controlled trial (RCT) comparing CRC education delivered by LHWs (intervention) to a CRC brochure and nutrition education (control).

II. Examine the processes through which LHWs communicate with, connect to, and convince community members from 3 Asian American cultures of the importance of CRC screening using mixed methods.

OUTLINE: Lay health workers (LHWs) are randomized to 1 of 2 groups.

GROUP I (CRC EDUCATION): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a CRC educational session conducted by an LHW over 90 minutes at month 1 and 3. Participants receive phone calls from the LHW at months 2 and 4 reminding them about CRC screening.

GROUP II (CRC BROCHURE): LHWs undergo training over 3 days and recruit 15 participants from their social network. Participants attend a lecture on healthy nutrition for cardiovascular health presented by a professional health educator at months 1 and 3. After the first meeting, participants receive a brochure on CRC screening. Participants receive phone calls from the LHW at months 2 and 4 regarding changes in their nutritional behavior. Participants may attend an optional post-intervention LHW outreach session on CRC screening.

After completion of the study, patients are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* LHW: self-identified as Filipino, Hmong, or Korean Americans
* LHW: age 18 or older
* LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English
* LHW: Live in the relevant area and intend to stay there for the next 12 months
* PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans
* PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong, Korean, or English
* PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months
* PARTICIPANTS: Are willing to participate in a study about health behaviors involving nutrition or CRC screening

Exclusion Criteria:

* Personal history of CRC
* Medical problems which may prevent them from attending 2 educational sessions
Effect of Lower Extremity Traction on the Popliteal Angle After Percutaneous Needle Tenotomy of the Knee Flexor Muscles.

People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of neuro-orthopaedic disorders. Microinvasive percutaneous needle tenotomy is a frequent use alternative to open surgery to treat limb deformities. A lower extremity traction is performed in our unit during 2 to 7 days after surgery of the knee flexor muscles.

The aim of this study is to describe the efficiency of lower extremity traction on the popliteal angle after percutaneous needle tenotomy of the knee flexor muscles.

This is a prospective, monocentric, cohort study of neurological disabled inpatients subjects treated in the perioperative disability unit (UPOH) of our university hospital for limb deformities by percutaneous needle tenotomy of the knee flexor muscles.

All eligible inpatient subjects with neuromotor disability and admitted for the treatment of limb deformities by percutaneous needle tenotomy of the knee flexor muscles will be consecutively included.

Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological, and physiological examinations.

This is a routine care study; no procedures are added for research purposes. It is an ancillary study to the NO-AGING study.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years old ;
* Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;
* Admitted for the treatment of limb deformities by percutaneous needle tenotomy of the knee flexor muscles ;
* Having a neuromotor disability;
* No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;
* Affiliation to a social security scheme.

Exclusion Criteria:

* Associated open surgery ;
* Associated bone surgery ;
* Under court protection.
IP-coated Revision Hip Implants

The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic infection.

The clinical investigation will include patients indicated for revision hip arthroplasty due to chronic periprosthetic infection. Subjects will either receive standard CE-marked revision hip implants or the newly developed IP (Infection prevention)- coated revision hip implants. The primary clinical benefit of the IP hip implant components remains the functional restoration of the hip joint and pain relief, as successfully shown for the uncoated predecessor devices, but additionally the IP coating is regarded ancillary to the intended purpose of the implant. Periprosthetic infections are one of the major complications in revision hip arthroplasty, leading to implant re-revision. A clinical investigation to evaluate additional measures to reduce this complication rate in revision total hip arthroplasty therefore has high clinical relevance.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS definition): single-stage or two-stage surgical procedure according to clinical standard at the clinical investigation site
* According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits
* ASA physical status I - III
* Patient's signed written informed consent is available

Exclusion Criteria:

* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
* The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect
* Patients with an already implanted silver-coated device
* Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
* Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy
* Severe soft tissue defects that require local or free flap procedure
* Periprosthetic joint infections with evidence of fungal infection
* Antibiotic suppression therapy
* BMI \> 40 kg/m2
* Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions
* Known or patient reported hypersensitivity to silver or titanium
* Patients with contraindication for the investigational and comparator devices:

  * in case of secondary diseases influencing the function of the joint implant
  * in case of severe osteoporosis or osteomalacia
  * in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage
  * in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union
  * when use of prosthesis heads with neck length XXL is indicated
Study of CS-3150 in Patients With Essential Hypertension

To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.

Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension satisfying the following blood pressure criteria;

  * Sitting SBP: ≥ 140 mmHg and \< 180 mmHg
  * Sitting DBP: ≥ 90 mmHg and \< 110 mmHg
  * Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetic nephropathy or diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L
* Reversed day-night life cycle including overnight workers
* eGFR \< 60 mL/min/1.73 m\^2
Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders

The FIBOBS study is a multi-centered, observational, prospective study carried out within specialized chronic pain structures (CPS) in France. It will estimate the prevalence of sleep disorders, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with Fibromyalgia Syndrome (FMS) consulting within a CPS. The interaction between these sleep disorders and other symptoms of FMS will also be analyzed using self-administered questionnaires. Based on the hypothesis that sleep disorders associated with FMS are only imperfectly assessed and/or treated in CPS, the FIBOBS study will also interview pain physician in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of FMS. In addition, this study will provide a better understanding of the symptoms of FMS, their impact and how patients feel.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Read, write and understand the French language
* Patient with a diagnosis of Fibromyalgia Syndrome according to ACR 2010 criteria: Painful symptoms present at the same intensity for at least 3 months, WPI ≥ 7 and SSS ≥ 5 OR 3 ≤ WPI ≤ 6 and SSS ≥ 9, Any other cause responsible for chronic osteoarticular pain must be excluded.Primary or secondary fibromyalgia is eligible, at the discretion of the investigator.
* Patient seen in consultation for the first time or for a follow-up visit if the patient has already been followed up in the specialized chronic pain structure for less than a year.
* Have access to an internet connection (for the realization of the "patient questionnaire")
* Patient affiliated to a social security system
* Written and signed informed consent

Exclusion Criteria:

* Patient undergoing anti-cancer treatment or having completed treatment less than 2 years ago
* Patient under guardianship, deprived of liberty, safeguard of justice
* Pregnant or breastfeeding women
* Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
* Refusal to participate in research