cyrilzakka/clinical-trials huggingface dataset:
Comparison of Physical and Psychosocial Characteristics of Pectus Excavatum and Carinatum Patients With Healthy Controls

Chest wall deformities are the development of ribs, cartilage and sternum that form the chest wall together with isolated or abnormalities of the musculoskeletal system. Pectus excavatum and carinatum deformities are most common. It is reported that individuals with this problem have posture and physical impairments, difficulty in psychosocial relations and decreased quality of life.Therefore, in this study, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

Pectus excavatum (PE) and pectus carinatum (PC) are the most common anterior chest-wall deformities. Both of these malformations predominantly affect males. They often coincide with the vulnerable life phase of puberty, a period characterized by great physical, social, and emotional changes. Outer appearance becomes a major issue for adolescents, and those who display a visible disfigurement may be put at a disadvantage, having to come to terms with a difference in their looks and having to face the risk of harassment by their peers. Patients with pectus deformities often experience feelings of shame and try to hide their chests. This can be reflected in the choice of clothing or poor body posture. Many patients even avoid social activities and sports. They are aware of the fact that their deformity is generally not considered attractive, and some regard it as an obstacle in future relationships. Reduced self-confidence and selfesteem appear to be rather common characteristics of PE patients. Recently, several authors have assessed the improvement of quality of life and body image following surgical repair of PE. Yet, little is known about the degree to which patients, differ from healthy individuals within the same age group. Steinmann et al observed reduced disease-specific and general health related quality in patients with a chest malformation. Body image was highly impaired in both PE and PC patients. However, the number of patients (71 PE, 19, PC, 82 healthy individuals) was not matched and was not evaluated physical function. Also, they evaluated patients with a high degree of preoperative deformity in this study. Therefore, the investigators aimed to evaluated the physical and psychosocial characteristics of patients with pectus excavatum and carinatum compared with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chest wall deformity by doctor
* Not having any chronic systemic and musculoskeletal diseases and injuries for healthy individuals

Exclusion Criteria:

* Having chronic systemic disease
* Genetic disease
* Being psychologically diagnosed
* Having additional musculoskeletal diseases
Testing a Digital Tool to Support Healthy Pregnancies

The delivery of preventive care for modifiable health risks (smoking, nutrition, alcohol, physical activity and gestational weight gain) is a critical part of antenatal care. Clinical guidelines recommend that preventive care is delivered using three elements: Ask, Advise, and Help (AAH). Unfortunately, the AAH model for modifiable risk factors is not routinely delivered to all pregnant people in face-to-face antenatal visits. We will test if adding a digital support tool to usual antenatal care increases the provision of guideline-recommended preventive care for smoking, nutrition, alcohol, physical activity and gestational weight gain, compared to usual antenatal care at two maternity services based at Maitland Hospital and Manning Base Hospital in New South Wales, Australia. The digital support tool will provide the opportunity for pregnant people to self-assess smoking, nutrition, alcohol, physical activity and gestational weight gain risk prior to their antenatal visits, while also being provided with tailored guideline-based information and the opportunity to self-refer to support services. Use of the digital support tool may also prompt pregnant people and/or their antenatal clinicians to have discussions around smoking, nutrition, alcohol, physical activity and gestational weight gain risks at antenatal appointments. As well as assessing impact on receipt of care for smoking, nutrition, alcohol, physical activity and gestational weight gain, we will also explore the feasibility, acceptability, barriers/enablers to use and content and functional preferences of the digital support tool for pregnant people.


Eligibility Criteria:
Inclusion Criteria:

* Any pregnant person (aged 18 years and over) with a scheduled first antenatal appointment at one of the two participating maternity services
* Sufficient level of English language proficiency to access and use the digital support tool and complete follow-up surveys.

Exclusion Criteria:

* Any pregnant person who has had an adverse pregnancy outcome. As per previous studies undertaken by the research team, this criterion will be assessed by review of relevant medical record fields and anyone who meets this criterion will be flagged to exclude from invitation to the study or from being included in any trial related data collection or contacts.
* No registered mobile phone number
CBT Texts for PTSD & Hazardous Drinking (Project Better)

The research study seeks to refine and test a brief, self-directed, intervention for individuals from the general public with PTSD and co-occurring HD that can be delivered via text-messaging. This application seeks to refine the intervention further by testing whether theoretically-driven, evidence-based strategies from basic cognitive psychology (message framing) and social psychology (facilitating growth mindsets) result in better outcomes for PTSD symptoms and HD by addressing pilot participant feedback related to avoidance and motivation.

This study will refine a previously piloted text message intervention by integrating and testing the efficacy of behavioral nudge and psychologically-wise intervention techniques when added to CBT text messages for reducing hazardous drinking (HD) and PTSD symptoms.The enhancements will be tested in a fully crossed 3 (message framing: avoid losses vs. maximize gains vs. no framing) x 2 (mindsets: facilitate growth mindset reminder vs. simple reminder to use skills) factorial design to identify the most effective combination of text messages. A sample of 500 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, immediate post-, 1-, and 3-month assessments will capture change in primary outcomes (PTSD, hazardous drinking).

Trauma exposure and PTSD symptoms will be assessed using the Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 with the Life Events Checklist (PCL-5 and LEC).

HD will be assessed via a set of measures that provide a detailed picture of drinking patterns. First, two questions will ask about heavy episodic drinking (HED: 4/5 or more drinks per single occasion for men/women) episodes, assessing both frequency over the lifetime and frequency over the last month. Typical weekly alcohol consumption will also be assessed using the Daily Drinking Questionnaire (DDQ). Negative alcohol-related consequences will be assessed via the Short Index of Problems (SIP).

Eligibility Criteria:
Inclusion Criteria:

1. 18+ years of age
2. Currently resides in WA State
3. Fluent in English
4. Reports at least one DSM-5 traumatic event that occurred 1+ months ago
5. Current PTSD severity of 33+ on the PCL-5
6. Current hazardous alcohol use (2+ heavy episodic drinking occasions \[4+ drinks on one occasion for women, 5+ drinks on one occasion for men\] in past month, 1+ negative consequences related to alcohol use)
7. Owns a functioning cellular phone
8. Is willing to receive weekly study text messages for 4 consecutive weeks
9. Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)

Exclusion Criteria:

-
Iron Absorption From Iron Fortified Extruded Rice Co-fortified With Various Solubilizing Agents

Food fortification is regarded as a safe and cost-effective approach to counteract and prevent iron deficiency. Rice is a staple food for millions of people living in regions where iron-deficiency anaemia is a significant public health problem. Therefore, rice may be a promising fortification vehicle. Ferric pyrophosphate (FePP) is an acceptable iron compound for rice fortification, due to its white colour and low reactivity with the rice matrix. However, iron from FePP generally has a low bioavailability. To increase the low iron bioavailability of FePP in fortified rice, ligands acting as solubilizing agents have been suggested, such as citric acid/trisodium citrate (CA/TSC), ethylenediaminetetraacetic acid (EDTA) and sodium pyrophosphate (NaPP).

It is however unclear to which extent CA/TSC would enhance iron bioavailability in presence of phytic acid, a common inhibitor of iron absorption found in whole grains and legumes. Zinc oxide reduces iron bioavailability from FePP with and without CA/TSC, in contrast to Zinc sulphate. It is however unclear if this decrease would be also expected in presence of EDTA as solubilizing agent. Further, NaPP has been suggested as a solubilizing agent, enhancing the bioavailability from FePP in bouillon cubes. This study aim to test its effect in rice. Meals containing a high (bean sauce) and low (mixed vegetable) phytic acid level sauce will be used to simulated varying dietary backgrounds, allowing to answer the question which solubilizing agent is viable in enhancing iron bioavailability.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 40 years old
* Normal body Mass Index (18.5 - 25 kg/m2)
* Body weight ≤ 65 kg
* Signed informed consent

Exclusion Criteria:

* Pregnancy (assessed by self-declaration)
* Lactating up to 6 weeks before study initiation
* Anaemia (Hb \< 12.0 g/dL)
* Elevate CRP (\>5.0 mg/L)
* Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
* Continuous/long-term use of medication during the whole study (except for contraceptives)
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
* Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
* Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments)
* Smokers (\> 1 cigarette per week)
* Difficulties with blood sampling
* Male gender
* Do not understand English
Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients

A multi-center, open-label, phase Ib study to evaluate the safety and tolerability of the administration of tisagenlecleucel in combination with ibrutinib in patients with r/r DLBCL who have received two or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy, and who have progressed after or are not candidates for ASCT.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed DLBCL as per the local histopathological assessment.
2. Relapsed or refractory disease having received 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being ineligible for or not consenting to ASCT.
3. Measurable disease at time of enrollment.
4. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
5. Adequate renal, liver, and bone marrow, organ function, and minimum level of pulmonary reserve.

Exclusion Criteria:

1. Patients with Richter's transformation, Burkitt's lymphoma, and primary DLBCL of the CNS.
2. Prior anti-CD19 directed therapy.
3. Prior gene therapy.
4. Prior adoptive T cell therapy.
5. Prior ibrutinib therapy within the 30 days prior to screening.
6. Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was \> 4 weeks before enrollment.
7. Prior allogeneic HSCT
8. . Significant cardiac abnormality including history of myocardial infarction within 6 months prior to screening as detailed in the study protocol.

Other eligibility criteria may apply.
Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy

Objectives: Chest tubes are routinely inserted after thoracic surgery procedures in different size and numbers. The aim of this study is to assess the efficacy of Smart Drain Coaxial drainage compared with two standard chest tubes in patients undergoing thoracotomy for pulmonary lobectomy. 98 patients (57 males and 41 females, mean age 68.3±7.4 years) with lung cancer undergoing open pulmonary lobectomy were randomized in two groups: 50 received one upper 28-Fr and one lower 32-Fr standard chest tube (ST group) and 48 received one 28-Fr Smart Drain Coaxial tube (CT group). Hospitalization data, quantity of fluid output, air leaks, radiograph findings, pain control and costs were assessed.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years
* patients scheduled for pulmonary lobectomy

Exclusion Criteria:

* middle lobectomy,
* extended resections, minimally invasive lobectomies,
* previous ipsilateral thoracic surgery,
* induction chemo and/or radiotherapy
* patients who did not give consent to participate.
A Study to Evaluate Nivolumab in the Treatment of Early Stage Esophageal or Gastroesophageal Cancer

The purpose of this study is to describe the effectiveness and use of nivolumab after surgery in participants with early stage (Stage II/III) Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC).


Eligibility Criteria:
Inclusion criteria:

1. Must provide voluntary informed consent to participate in the study before inclusion in the study
2. Must have confirmed diagnosis of resected early stage (Stage II/III) EC or GEJC (histologically or cytologically confirmed stage)
3. Physician decision to treat the participant with adjuvant nivolumab (according to the local label as per country-specific regulations) must be made prior to and independently of participation in the study

Exclusion criteria:

1. Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days (Participants who have completed their participation in an interventional trial and who are only followed-up for OS can be enrolled.)
2. Prior treatment with immuno-oncologic agents, including nivolumab, for any indication
3. Participants with a current primary diagnosis of a cancer other than EC or GEJC that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Patients With COVID19

Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.

Several interactions by pre-existing therapies for chronic diseases, therapies used by SARS-CoV2 infection generate doubts about risks and benefits. Among these situations in which the current data indicate a situation of equipoise would be about the maintenance or suspension of ACEI / BRA in patients with SARS-CoV2 infection. Increasing the expression of ECA-2 could increase the binding to the virus, however, there are studies that indicate this increase in ECA-2 could be protective. So far, there is no clinical evidence to confirm any of the theories, and this question can only be clarified through a randomized clinical trial.

The objective is to evaluate the impact of the suspension of the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (BRA) on the length of hospital stay and on the mortality of patients with SARS-CoV2 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with COVID-19 diagnosis using ACE inhibitors or blockers of angiotensin receptor;
* Patients ≥ 18 years old;
* Maximum use of 3 antihypertensive drugs;
* Sign the consent form.

Exclusion Criteria:

* Severe evolution with orotracheal intubation, use of mechanical ventilation and / or hemodynamic instability in the first 24 hours until COVID-19 diagnosis confirmation;
* Patients hospitalized per decompensated congestive heart failure in the last 12 months;
* Use of Sacubitril/Valsartan
* Pregnancy
* Recent acute renal failure and shock
Oral Supplementation of Gangliosides to Treat a Rare Metabolic Disorder

The purpose of this pilot project is to see if a supplemental form of dietary gangliosides can serve as a potential treatment for the rare metabolic condition called ganglioside GM3 synthase deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of GM3 synthase deficiency

Exclusion Criteria:

-
Creatine Augmentation Treatment in Major Depressive Disorder Subjects

Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its potential usefulness in improving brain energy metabolism, 3) the reported abnormality in brain energy metabolism in MDD subjects, and 4) plausible association between depression and inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in MDD patients as well as normalize a deficit in brain energy metabolism and that improvement of MDD and brain energy metabolism will be correlated with inflammatory mediators changes.

In this study, we plan to conduct an randomized, double-blind, placebo-controlled augmentation study with creatine in addition to escitalopram. We will assess the efficacy and safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and inflammatory mediators.


Eligibility Criteria:
Inclusion Criteria:

* 19-65 year-old male or female
* Major depressive disorder diagnosed by SCID-IV
* Hamilton depression rating scale score \>= 16 at screening
* Written informed consent

Exclusion Criteria:

* Suicidal idea that needs hospitalization
* Any other axis I psychiatric disorder
* Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
* IQ below 80
* Inflammatory disease including autoimmune disease
* Taking anti-inflammatory medication
* Serious physical disease
* Substance abuse or dependence history in recent 6 months
* Pregnant or having plan to be pregnant
Assessment of Tremor Using SNUMAP Motion Sensing System

The purpose of this study is to record and measure tremor using portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system.

SNUMAP system is portable, finger-worn, battery powered device that contains MEMS (micro-electro-mechanical system) hybrid motion sensor (three-axis accelerometer and three-axis gyroscope). The SNUMAP device consists of a wrist module and finger module, which attaches to an patients's finger and transmits three dimensional motions to a wrist module for storage and further analysis. The aims of this study is to assess tremor severity using tri-axial accelerometry and gyroscope to determine the reliability and the correlation with clinical measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-80 years
* Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body part)
* Subject who signed an informed consent

Exclusion Criteria:

* Pregnant or nursing woman.
* Comorbid neurologic illnesses that impact the ability to perform the study tasks.
* Subjects with medical condition that in the opinion of the investigator would affect his/her ability to participate in this study.
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing abdominoplasty (Cohort 2).


Eligibility Criteria:
Inclusion Criteria:

* Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
* Is scheduled to undergo abdominoplasty.

Exclusion Criteria:

* Is undergoing a revision surgery.
* Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
* History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
* Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
* Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
* Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery.
* Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer).
* Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years.
* Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy).
* Has a body mass index (BMI) \>40 kg/m2.
* Had undergone prior abdominoplasty or major abdominal wall surgery.
Foot Controlled Robotic Endoscope Enabled Robot FESS

To evaluate the safety and feasibility of a Foot Controlled Robotic Endoscope Enabled Robot (FREE) in performing functional endoscopic sinus surgery to answer the two key questions:

1. Is the FREE robot feasible to use in patients for endoscopic sinus surgery?
2. Is the FREE robot safe to use in patients for endoscopic sinus surgery?

Through previous cadaver experiments we have demonstrated and experimentally validated a new foot-controlled robotic endoscope holder prototype that allows the surgeon to directly manipulate surgical instruments with both hands at all times. The conducted ex-vivo cadaver test, corroborated the feasibility of the robotic prototype. However the next step requires further clinical trials to evaluate its use in endoscopic sinus surgery in patients that is the purpose of this study

Eligibility Criteria:
Inclusion Criteria:

* Undergoing FESS surgery for benign pathology

Exclusion Criteria:

* Pregnant/ lactating female patients
* Younger than 18 years of age
* Cognitive impairment or unable to provide informed consent
* Malignant sinus pathologies
* Previous endoscopic sinus surgery
* Contraindication to general anaesthesia
* Untreated active infection
* Non-correctable coagulopathy
* Emergency Surgery
Evaluation of the ProstaPlant Prostate Stent Insertion in Ex Vivo Human Prostate

The purpose of this ex-vivo study is to evaluate the insertion procedure for the ProstaPlant implant in human prostates and the support that it supplies to the prostate.


Eligibility Criteria:
Inclusion Criteria:

* Males,
* 18 years old and up,
* Suffer from BPH,
* Candidate for radical prostatectomies

Exclusion Criteria:

* According to the physician's decision