cyrilzakka/clinical-trials huggingface dataset:
Effect of Kinesio Tape on Back Pain, Breastfeeding Success and Breastfeeding Self-Efficacy

Back pain caused by posture changes and increased weight on the breasts during breastfeeding may negatively affect breastfeeding success and self-efficacy. Kinesio tape application, which is an effective and cost-effective method, can provide a more comfortable breastfeeding experience by controlling this pain.

Despite the universality of these globally valid recommendations for the promotion of breastfeeding, the frequency and prevalence of breastfeeding rates vary from country to country and even between regions within certain countries. Planning and successful implementation of interventions to promote breast milk is possible by controlling both positive and negative factors that affect the success and duration of breastfeeding. In order to control the physical problems associated with breastfeeding, existing approaches in the literature for pain management such as fullness of the breasts due to increased lactation, poor positioning during breastfeeding, backaches. Kinesio taping is one of these methods, and since it does not have any pharmacological content, it is a practice that does not have side effects on breastfeeding and lactation.

Eligibility Criteria:
Inclusion Criteria:

* Mothers who have babies between 0-6 months and are actively breastfeeding
* Primiparous mothers
* Mothers who complain of back pain due to breastfeeding (Getting 6 points or more on VAS in the mothers' own evaluation)

Exclusion Criteria:

* Mothers with premature babies or babies with congenital anomalies
* Mothers taking painkillers
* Mothers diagnosed with posture disorders or skeletal system disorders
* Mothers whose breastfeeding is contraindicated
* Mothers whose breast milk has stopped
* Mothers who have other pain complaints in addition to back pain (such as nipple cracks, mastitis pain, etc.)
Incidence of Postoperative Hypothermia and Associated Factors in Adult Patients Undergoing Surgery in Siriraj Hospital

Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature \<36C (96.8F) immediately following an operation, caused by multiple factors, and had lead to negative outcomes. In our institute, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%). After that, various interventions aimed to prevent perioperative hypothermia were implemented. This study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at Siriraj hospital.

Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature \<36C (96.8F) immediately following an operation, which is a common problem in post anesthesia care unit (PACU). It has been implicated in negative outcomes in surgical patients, including prolonged effects of intraoperative anesthetic medication, increased insulin resistance, postoperative morbidity, delayed surgical wound healing; and prolonged stay in the recovery room and hospital1-7.

In the operating room (OR), patients have to expose to a low ambient temperature with little or no clothing, evaporation from the surgical area, an irrigated fluid in surgical area; and an administration of intravenous fluids. Moreover, many anesthetic agents have an influence on the autonomic thermoregulatory mechanism which causes vasodilatation. All these factors promote patients' unintentional loss of heat and cause hypothermia.

Even of a lot of efforts to keep patients warm intraoperatively and minimize hypothermia including optimizing ambient OR temperature and using of various warming devices, the incidences of postoperative hypothermia in PACU are still high with the reported magnitude ranges from 50%- 90%7. In Siriraj hospital, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%)8. After that, various interventions aimed to prevent perioperative hypothermia were implemented such as maintaining the ambient room temperature of an OR; warming intravenous fluids, blood products, and irrigants; heated, humidified anesthetic gases; and using warming blankets, forced-air warming, layering drapes and head wraps. This study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at Siriraj hospital.

Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years undergoing surgery with anesthesia service
* Stay at Postanesthetic care unit of Syamindra building, fifth floor, Siriraj hospital

Exclusion Criteria:

* Procedure performed under local anesthesia
* Patients with missing data of temperature
Body Composition and Fatty Liver Disease

This study investigates relationship between fatty liver prognosis and body composition analysis result based on non-contrast low dose CT in patients with fatty liver disease.


Eligibility Criteria:
Inclusion Criteria:

* metabolic dysfunction-associated fatty liver disease (fatty liver with overweight/obesity, or type II DM or other metabolic dysfunction)
* or non-alcoholic fatty liver disease with liver function test abnormality
* signed informed consent

Exclusion Criteria:

* chronic hepatitis B or C
* other disease related to fatty liver such as glycogen storage disease, lipodystrophy, familial combined hyperlipidemia, hypobetalipoproteinemia, Weber-Christian syndrome or abetalipoproteinemia
* on medication related to hepatic steatosis (tamoxifen, steroid, valproic acid, methotrexate, amiodarone)
* diabetes after pancreatectomy
* history of total parenteral nutrition in 6 months
* pregnancy or nursing mother
Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338)(COMPLETED)

The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.

This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or metformin.

Part 2 (to be conducted in India): this part of the study will be conducted after completion of Part 1 and an analysis indicates a clinically significant decrease in blood glucose in participants with type 2 diabetes mellitus (T2DM) compared to placebo. The same procedures conducted in Part 1 will be conducted in Part 2.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants)
* Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)
* Type 2 diabetes mellitus

Exclusion Criteria:

* Female participants who are premenopausal or are not surgically sterilized. Participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.
* Participants who have received insulin therapy within 6 months, prior to Day 1/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.
Clinical Performance of Extended All-Ceramic Fixed Partial Dentures Based on Zircon-Oxide Ceramics.

Fixed-partial dentures fabricated of zircon-oxide ceramics were introduced in dentistry some time ago. However, the survival rate of all-ceramic extended (up to 47mm) fixed-partial dentures is unknown.

The hypothesis was that long FDPs fabricated of zirkon-oxide withstand masticatory forces in the posterior and anterior regio of the jaw.

30 patients with at least 2 missing posterior or anterior teeth will be included in the study. All patients will receive all-ceramic fixed partial dentures.

Eligibility Criteria:
Inclusion Criteria:

* All patients older 18 years
* At least two missing posterior teeth
* Tooth wear\<3

Exclusion Criteria:

* Bruxism
* Mental disorders
* Pregnancy
* Tooth mobility\>1
Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets

This is a controlled, randomized, single-blinded, multicenter, prospective clinical study.

In addition to the standard periodontal treatment procedure on all teeth that need to be treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.

The pocket depth will be measured at six sites around each tooth, and only the deepest pocket sites of each tooth will be taken into account.

This is a controlled, randomized, single-blinded (independent Blinded Evaluator), multicenter, prospective clinical study.

Each subject will receive the standard periodontal treatment procedure on all teeth that need to be treated. The usual cares are scaling and root planing (SRP), and chlorhexidine, and instructions to oral hygiene (proper brushing techniques twice a day, proper flossing technique daily, and prevention : sugar intake, alcohol consumption, fluoride level).

Two other optional treatment sessions with SRP could be performed, if deemed necessary by the Treating Investigator. Those optional SRP session could only be performed after all study-related clinical assessement.

The pocket depth of every teeth will be measured at six sites around each tooth, and only the deepest pocket sites will be taken into account. The 4 teeth with the deepest pockets will be included in the study and randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.

Eligibility Criteria:
Inclusion Criteria:

* Men or women, aged between 25 and 60 years
* Patients with at least 20 natural teeth
* Patient with periodontitis confirmed by a X-ray diagnosis, and having at least 4 teeth with periodontal pockets with probing depth between 4 and 6 mm
* Willing to understand and comply with study requirements and to sign informed consent

Exclusion Criteria:

* Patient with an active smoking status
* Patient with an antibiotic therapy within the previous 4 weeks
* Need for continuous medical treatment within 2 weeks prior to enrollment
* Ongoing inflammatory state or a systemic illness that may affect the oral cavity
* Patient with hypofunction in saliva productions (e.g. Sjögren Syndrome with Xerostomia)
* History of active chronic debiliating systemic disease, including insulin or non-insulin dependent diabetes
* Patients with bleeding disorders
* History of allergies to gram positive bacterial proteins
* History of hypersensitivity and/or idiosyncrasies to any of the test compounds, e.g. hyaluronic acid or other device compounds
* History of multiple severe allergies, history of anaphylactic shock
* History of connective tissue disease (rheumatoid arthritis, scleroderma, systemic lupus erythematosus) or of any other autoimmunity disease
* History of herpetic lesion or lichen planus
* Pregnant or breast feeding women, or female subjects of childbearing potential who did not intend to practice medically acceptable method of contraception
* Participation in another clinical study in the previous 3 months
Confidential IPV Screening Tool

Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care.

The objective of this study was to develop and evaluate an integrated suite of electronic health record (EHR) tools that automates "best practices" from Northern California Kaiser Permanente for screening and intervention for IPV identified within clinical settings. The goal of the intervention goes beyond mere screening of patients for IPV and includes tools for assessment of IPV risk, for documentation of IPV care, and support for a warm hand-off during the primary care visit to a national IPV hotline resource. Importantly, the study includes work to keep notes documenting IPV and billing for IPV care confidential, segmenting this care in a secure segment of the electronic health record.

Eligibility Criteria:
Inclusion Criteria:

* Being an Medical University of South Carolina patient at primary care clinics (family medicine)
* Women 18-49 years of age inclusive
* Reported yes to wanting to be contacted for a follow-up research study
* English-speaking

Exclusion Criteria:

* No exclusion criteria
Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer

GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B NSCLC or limited stage SCLC
2. Treatment plan for subjects show that 5 cm of the esophagus for at least one surface, is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose exposure meet V38\>30% and/or V60\>20%
3. Age 18 years or older
4. ECOG performance status ≤ 2
5. Adequate hematologic, renal and liver function
6. Use of highly effective contraception

Exclusion Criteria:

1. Metastatic disease
2. Prior radiation therapy to the region of the study cancer
3. Subjects not receiving chemotherapy
4. Grade 2 or greater esophagitis at baseline
5. Inability to provide information in the electronic symptom-reporting device
6. Receiving any approved or investigational immunotherapy, targeted therapy, hormone therapy, or biologic therapy
7. Participation in another clinical trial or use of another investigational agent within 30 days of first does of GC4419
8. Malignant tumors other than the current lung cancer within the last 5 years
9. Previous diagnosis of pneumonitis
10. Untreated, active infectious disease requiring systemic anti-infective therapy
11. Untreated HIV or active hepatitis B/C
12. Females who are pregnant or breastfeeding
13. Known allergies or intolerance to chemotherapy and similar platinum-containing compounds
14. Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
15. Clinically significant heart disease
Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic clear cell renal cell carcinoma (RCC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with histologically confirmed metastatic clear cell RCC
* Measurable disease according to Response Criteria for Solid Tumors (RECIST)
* No prior systemic cytotoxic chemotherapy
* Subjects who have received either no prior therapy for RCC, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting VEGF or a VEGFR (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
* ECOG performance status of 0 or 1
* Life expectancy ≥3 months
* Adequate organ and marrow function
* No other malignancies within 5 years
* Signed informed consent

Exclusion Criteria:

* Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
* Subjects who have received systemic anticancer therapy within 30 days of XL999 treatment
* Subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to medications administered \>30 days prior to study enrollment
* History of or known brain metastases, current spinal cord compression or carcinomatous meningitis
* Uncontrolled and/or intercurrent illness
* Pregnant or breastfeeding females
* Known HIV
Hearing Impairment, Strategies, and Outcomes in Emergency Departments

Aim 1: Establish the feasibility of screening for hearing loss in the ED Aim 2: Determine the acceptability of the screening procedure (among the ED population) Aim 3: Derive a preliminary estimate of the effect size of primary outcomes Aim 4: Identify the evidence that decision makers in Veteran Affair Medical Centers, ED and Audiology Services need to commit to this approach

The goal of this study is to test whether providing hearing assistance devices to older age hearing impaired patients in the ED setting will improve in-ED understanding and preparation for discharge. The proposed intervention, the Hearing Impairment, Strategies and Outcomes in VA Emergency Departments (HearVA-ED) will be conducted in the Emergency Departments of the Manhattan and Brooklyn VAs of the New York Harbor Healthcare System and will recruit hearing impaired ED patients who are 60 years and older and have been admitted to the ED with a low acuity triage score indicating a high likelihood of discharge home. The investigators will identify hearing impairment by using the Hearing Handicap Inventory for the Elderly survey (HHIE-S). The investigators will randomize consenting patients who fail the screening to either receipt of a simple hearing assistance device (a "PockeTalkerTM") during their ED stay or usual care. The investigators will test whether the provision of a PockeTalkerTM is feasible in this environment (by measuring the amount of device use), whether providing the device improves self-reported quality of hearing and understanding during the ED stay, and whether use of the device improves the quality of preparation for post-discharge care. If this randomized controlled trial demonstrates beneficial effects for in-ED use of a simple hearing assistance device for hearing impaired patients, this strategy can be disseminated throughout the VA healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Emergency severity index criterion of 4 or 5 (low acuity)
* Hearing Handicap Impairment Evaluation Screen greater than or equal to 24
* Capacity to consent to participate in research

Exclusion Criteria:

* Inability to consent to participate in research
* Emergency severity index criterion of 1-3 (high acuity)
* Hearing Handicap Impairment Evaluation Screen less than 24
* Inability to speak English or Spanish
External Oblique Intercostal Block Versus Paravertebral Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Patients

To compare external oblique intercostal block versus paravertebral block for post operative analgesia in patients undergoing laparoscopic cholecystectomy to decease post operative opioid consumption and use the least dose of local anesthesia.

Paravertebral Block (PVB) involve injection of local anesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.

The external oblique intercostal block is a novel motor- and opioid-sparing technique which blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves which innervate the upper abdominal quadrant.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 20-60 years old
* Patients with ASA clinical status I\\II
* Patients schedule for laparoscopic cholecystectomy

Exclusion Criteria:

* Patients refusal
* Coagulopathy
* Infection at site of injection
* Allergy of local anesthesia
* Sever cardiac disease
* Patients with chest wall deformities
Renal Recovery After PEEP Weaning in ARDS (RE2SDRA)

The purpose of the study is to investigate renal recovery in ARDS after PEEP weaning. The primary outcome was the variation of the hourly urine output (HUO), 48 h after PEEP weaning. Secondary outcomes were the need for RRT and mortality. Two groups were defined depending wether hourly urine output was greater or lower than 0.35 mL/kg/h.


Eligibility Criteria:
Inclusion Criteria:

* intubated for more than 48 hours, exposed to a PEEP≥ 8 cmH20

Exclusion Criteria:

* chronic end-stage renal disease on admission
* refusal to participate
* non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity
* under legal protection.
AR Vs VR in Burns Dressing Changes

For children with burn injuries, changing their dressings can be one of the most traumatising experiences of their treatment journey. This process is not only distressing for the children but also for their parents and the healthcare professionals involved. Current methods to reduce this trauma include the use of play therapists, but such resources are often limited. There is good evidence that Augmented Reality (AR) and Virtual Reality (VR) can help by providing a distracting and immersive environment that eases pain and fear. However, no studies have yet compared these two modern technologies to see which is more effective


Eligibility Criteria:
Inclusion Criteria:

* • Participants presenting with guardians with parental responsibility, who are willing and able to consent to recruitment.

  * Aged 4-17 years
  * Presenting with burns requiring a dressing change, on their first attendance to the burns clinic.
  * Participating child is able to complete the FACES Pain Scale

Exclusion Criteria:

* • Children aged 4 or below

  * Those with severe cognitive impairment, visual disorders, facial burns or other conditions preventing the safe use of VR/AR technology.
  * Previous 'cybersickness' symptoms (nausea, dizziness).