cyrilzakka/clinical-trials huggingface dataset:
Bilateral Thoracoscopic Splanchnicectomy for Pain Relief in Patients With Unresectable Pancreatic Cancer

This study aims to compare the efficacy of bilateral thoracoscopic splanchnicectomy (BTS) to conventional narcotic analgesia for control of abdominal pain in patients with pancreatic ductal adenocarcinoma not amenable to surgical resection.

All patients with unresectable pancreatic cancer will be considered for participation in this study. Patients with locally advanced or metastatic cancer that meet inclusion criteria will be randomized into one of two arms, treatment with BTS and narcotic analgesia or treatment with narcotic analgesia alone. After randomization a baseline pain score will be assessed using the visual analog pain scale. Narcotic dosage and frequency will be evaluated at the time of enrollment. A pre-treatment quality of life score will be recorded using the SF-12® Patient Questionnaire. Patients will also be queried about the presence of nausea and reflux.

After all baseline assessments are complete patients will be taken to the OR to undergo their assigned procedure. BTS and infusaport placement will be performed on patients randomly selected for treatment with BTS and narcotic analgesia. BTS will be performed as described in the study procedure. Patients chosen to be treated with narcotic analgesia alone will undergo infusaport placement only. An evaluation will be completed postoperatively in which the length of stay, post-op complications, and chest X-ray results will be recorded. Follow-up assessments will be conducted 24-48 hours post-procedure and at the time of discharge. Further follow-up assessments will be conducted 14 days, 30 days, and 90 days post-procedure during an office visit with the clinical research team or medical oncology.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 years of age
2. Diagnosed with stage III/IV pancreatic cancer
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study

Exclusion Criteria:

1. Participating in another clinical trial for the treatment of cancer at the time of screening
2. Pregnant or currently breast feeding
A Bioequivalence Study of Hetrombopag in Healthy Subjects

This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. History of deep vein thrombosis, or any other thromboembolic event;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RO7790121 (RVT-3101) in adult participants with moderate to severe active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
* Elevated very soft or liquid stool frequency and/or abdominal pain
* Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy

Exclusion Criteria:

* Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
* Short gut syndrome
* Presence of an ostomy or ileoanal pouch
* Bowel resection or diversion with \~6-months
Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.

Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

* Patients with a known systemic disease
* Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group
* On systemic ALN/ bisphosphonates or ATV/statin group
* With aggressive periodontitis
* Who used tobacco in any form
* Alcoholics
* Immunocompromised patients
* And pregnant or lactating females were excluded from the study
Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy

Ear acupuncture can be used as a treatment for pregnancy induced low back pain.

Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low back pain can be debilitating for pregnant women but there is lack of effective treatment. Owing to the unique circulation system between mother and fetus, prenatal care providers and gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal of this clinical investigation is to determine whether ear acupuncture can be used as treatment for this special clinical entity. The participants are randomized into one of the three interventions based on a computer generated randomization table. These three interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture. All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest and topical warm/cold compress. The participants in group 1 \& 2 received a total of three continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand in preselected ear acupuncture points for one week then after day 7. All participants are followed/observed for a total 2 weeks after the initiation of the study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking, healthy pregnant women in at least 25 weeks of gestational age who suffered from low back pain related to pregnancy.
* No obstetric complications during pregnancy or neurological complications that require immediate medical/surgical intervention.

Exclusion Criteria:

* Non-English speaking
* Mentally challenged
* State of pregnancy less than 25 weeks but suffer from pregnancy related low back pain
* Pregnant women without low back pain
* The pregnancy is complicated by obstetrical problems, or low back pain requiring immediate surgical/medical intervention.
Evaluation of BIomarkers for POstoperative Complications in Non-cardiac Surgery Patients

Aim of this study is to evaluate whether the periopertive course is able to predict postoperative complications. Several approaches will be choosed to optimize perioperative risk stratification predicting postoperative complications in patients undergoing elective non-cardiac surgery.

The aim of this secondary analysis of the SUPERADD study is to use the perioperative data from the prospective SUPERADD study ("SUbstitution of PERioperative Albumin Deficiency Disorders") (Eudra-CT 2016-001313-24; Clinical Trials NCT03167645; DOI: 10.1097) to identify risk factors for the occurrence of postoperative complications, based on the Clavien-Dindo classification in the nine domains of the Postoperative Morbidity Survey.

Multivariate Analyses, Decision trees, time series analysis and Machine Learning methods will be applied to distinguish risk factors for postoperative complikations and mortality in a high-risk group (see publication of the statistical analysis plan and its enhancement).

Patients participating in the SUPERADD study (NCT03167656) and who had at least two perioperative high sensitive Troponin T (hsTnT) values in order to detect myocardial injury were included in this secondary analysis as hsTnT is associated with major adverse cardiovascular events (MACE), myocardial injury after noncardiac surgery and mortality.

The secondary analysis uses data obtained at the pre-anaesthesia visit like ASA, preoperative comorbidities measured by the POSPOM, CCI, intraoperative parameters like vitals, medication, estimated blood loss and postoperative data obtained from PACU records and discharge letter. Primary Endpoint are postoperative complications assessed with the Cavien-Dindo classification \> 2.

Eligibility Criteria:
Inclusion Criteria:

* written informed consense
* Age \> 18 years
* ASA Score 3 or 4
* elective non-cardiac high risk surgery

Exclusion Criteria:

* emergency surgery
* need for dialysis
* liver cirrhosis child C
* intolerance of albumin
* participation in other AMG (medicines law) study
* pregnancy or breastfeeding
* patients with attendants concerning medical matters
* ASA V patients
* patients with BMI \> 35 kg/m2
The Measurement of Chemicals in Exhaled Breath Can Identify If a Person is Infected with COVID-19

The type and number of chemicals in exhaled breath are different in people with infection as compared to those without infection. In this study, the breath of people with and without COVID infection will be measured. Changes in the amount and type of chemicals in breath will be used to determine if an individual does or does not have COVID infection. If the measurements of breath are a reliable measure of COVID infection, this device may be used to rapidly screen people who are attending large public events (for example, music concert or baseball game) to minimize the spread of COVID at the event.

N5 Sensors has developed a device that can measure chemical concentrations at parts-per-billion levels (for example, 10 molecules in one-billion molecules is 10 parts-per-billion). This device will be used to measure a variety of chemicals in the exhaled breath of human volunteers. The measured chemicals have been selected based on their presence in the breath of subjects with COVID infection. In addition to measuring breath, samples of mucus from the nose of these same subjects will be collected. These nasal samples will be evaluated to determine the presence of the COVID virus and of COVID infection. Changes in chemicals in the breath will be compared to the presence of COVID or to infection with COVID. This comparison will determine if measurement of breath can be used as a quick and simple measure of COVID infection.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must complete the consent process
2. Subjects of both sexes must be ≥ 18 and ≤ 70 years old
3. Control subjects must have negative RT-PCR and antigen test
4. COVID subjects must have a positive RT-PCR and/or antigen test.

Exclusion Criteria:

1. Subjects with severe lung disease which would prevent them from providing a breath sample through a large bore tube (e.g., large drinking straw)
2. Subjects with uncontrolled diabetes (e.g., ketoacidosis)
3. Subjects who are routinely exposed to paints, paint thinners, gasoline, varnishes, glues, dry cleaning solvents, or industrial cleaning products
4. Subjects who are daily smokers of cigarettes, e-cigarettes, tobacco products, or marijuana
5. Subjects who have consumed alcohol in the previous 24 hours
6. Have not consumed large amounts of garlic (38 grams) over the prior 24 hours. This amount of garlic can come from approximately 6 garlic cloves or garlic supplement capsules,
7. Subjects who are experiencing respiratory failure
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects


Eligibility Criteria:
Key Inclusion Criteria:

* Males and females volunteers of 65 years of age or older
* Mentally competent
* Willing and able to give written informed consent prior to study entry.
* Able to comply with all the study requirements.
* In general good health

Key Exclusion Criteria:

* Any serious chronic or acute disease
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
* Known or suspected impairment/alteration of immune function
* Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
* Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
* Fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination
* Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines
Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

One aim of this study was to find out if the bronchial allergen provocation (BAP) is an appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The investigators had one group of children receiving SIT and one group of patients who denied a SIT although they had an indication for it. Retrospectively the investigators analysed the data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November 2008 till February 2010). Prospectively The investigators analysed the lung parameters and allergic labor parameters that we got in the course of the second BAP. The investigators mean parameter was PD20FEV1-mite. Another aim of The investigators study was to find specific immunological differences between children who improved because of SIT and those who showed no improvement. Thus, The investigators compared the levels of total IgE, cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite after SIT.

One aim of this study was to find out if the bronchial allergen provocation(BAP) is an appropriate method to appraise the efficacy of a specific immunotherapy (SIT). We had one group of children receiving SIT and one group of patients who denied a SIT although they had an indication for it. Retrospectively we analysed the data of the first BAP (PD20FEV1, VC, FEV1, FEV1/VC (%), eNO) and allergic blood parameters like specific IgE-mite, total IgE, cumulative IgE before SIT (November 2008 till February 2010). Prospectively we analysed the lung parameters and allergic labor parameters that we got in the course of the second BAP. Our mean parameter was PD20FEV1-mite. Another aim of our study was to find specific immunological differences between children who improved because of SIT and those who showed no improvement. Thus, we compared the levels of total IgE, cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite after SIT. Additionally all patients answered a questionnaire according to ISAAC about their clinical symptoms, their quality of life and their medication score.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* between 5 and 18 years of age
* diagnosis of a moderate Asthma bronchiale (I-II) in the last 12 months or rhino conjunctivitis
* no exacerbation \> 4 weeks before Visit

Exclusion Criteria:

* age \< 5 years \> 18 years,
* FEV1 \< 75%
* no cooperation to undergo the BAP,
* exacerbation within the last 28 days before Visit
* other serious illnesses
* taking part in other clinical trials \< 30 days
Focus Groups in Ethnically and Racially Diverse Families

Focus groups to identify treatment needs and barriers to participation in the planned multinutrient study among racially and ethnically diverse (Black and Hispanic) communities.

Focus group purpose is to understand parents' priorities regarding their child's mental health, and facilitators or barriers to research participation generally, with inquiry about CIH intervention use, and the multinutrient feasibility study specifically. Researchers will engage Black and Hispanic families in focus groups to discuss mental health priorities related to their children, and real or perceived barriers to engagement in research studies. The feedback will inform the final design and recruitment for the multinutrient feasibility study in Black and Hispanic populations. One group will comprise individuals who self-identify as Hispanic, another, as Black, in order to create space to hear perspectives that may differ between broadly defined groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult parents/caregivers self-identified as Black or Hispanic/Latino
* With a family member 6-18 years old with suspected ADHD and/or emotional dysregulation, or provide care for, or teach someone who meets these criteria
* Who have sought or are interested in treatment
* Willing to discuss child's mental health care needs and provide feedback regarding feasibility study
* Able to attend focus groups in person
* Able to communicate in English or Spanish
* Agree to focus group session audio recording

Exclusion Criteria:

* Unwilling to be recorded
A Novel Smartphone Application for "Smart" Trials

The overarching goal is to develop a mHealth App that can use smartphone embedded sensors to objectively collect physical function data in healthy individuals in the context of daily life.

The goal is to develop a mHealth App using smartphone embedded sensors to objectively collect physical function data in healthy individuals in the context of daily life. The investigators will perform technical development of an internet-interactive App to collect, analyze and transfer the subjects' data. As a proof-of-concept, the mHealth App will execute algorithms that automate deployment of three well-established physical function tests. In a laboratory setting, it will be evaluated usability, acceptability and reliability of the mHealth App compared with traditional performance tests among focus groups. The investigators will then evaluate its usability and acceptability when used in the participants' home environments.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 50 years old with symptomatic knee osteoarthritis
* English Speaker
* Be able to walk 20 meters without an assistive device, such as a cane, walker or crutches.
* Have an iPhone 6 or higher with internet connection.

Exclusion Criteria:

* Prior surgery on either knee within 6 months of enrollment
* Received corticosteroid injection in the knee within 3 months of enrollment
* Evidence or history of knee disease or trauma
Low-dose Maximal-intent Versus Controlled-tempo Resistance Training on Quality-of-life in Adults

The aims of this study were to:

1. Compare the effects of low-dose Maximal Intent and Controlled Tempo Resistance Training on untrained healthy adults' quality-of-life, functional capacity, and strength.
2. Qualitatively explore perceptions of Maximal Intent and Controlled Tempo Resistance Training.


Eligibility Criteria:
Inclusion Criteria:

* Participants were eligible if they were between 30-60 years old
* Uninjured
* Had no cardiovascular or neuromuscular conditions
* Had not participated in lower-limb RT in the previous six months.

Exclusion Criteria:

* Participants were excluded if they had either taken part in any lower-limb RT in the last six months
* Had underlying health condition(s) that prevented them from participating in RT
* Regularly met or exceeded the UK recommended PA guideline of 150-minutes of moderate to intense PA per week.
Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery

The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.

Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured before and after abdominal insufflation in the supine position. After insufflation the head-up position (30°) was made and cuff pressure was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Participants who were underwent laparoscopic cholecystectomy with American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* history with respiratory disease, difficult intubation, and morbid obesity (body mass index more than 35 kg/m2).