cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Acupuncture for Asthma

What is the trend of changes in asthmatic patients' daily peak expiratory flow (PEF) variability, pulmonary function, and quality of life (QOL) with acupuncture treatment on specific acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1) compared with minimal acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment (waiting list control group)?


Eligibility Criteria:
Inclusion Criteria:

* aged 19-70 years
* at least 12% improvement in forced expiratory volume in one second (FEV1)after the administration of short acting beta2 agonist.
* at least one typical asthmatic symptom
* using more than one routine anti-asthmatic medicine

Exclusion Criteria:

* acupuncture for asthma within 12 months of the study
* emergency department visit within one month of the study
* hospitalization for asthma within three months of the study
* severe upper respiratory tract infections within six weeks of the study
* systemic infections, cancers, autoimmune disorders, cardiac failures, myofacial infarcts,angina pectoris, renal failures or hepato-biliary diseases
* smoke more than ten cigarettes per day
Obese Patient During RARP: the Role of a Preemptive Ventilator Strategy to Contrast Pneumoperitoneum and Trendelenburg Position

Analysis of the specific elastance during general anesthesia in patients treated with RARP (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position.

RARP (robotic assisted radical prostatectomy) requires the induction of pneumoperitoneum and the trendelenburg position, causing increase in the intra-abdominal pressure and cephalic shift of the diaphragm, with consequent airway closure and collapse of the dependent regions of the lung.

Obese subjects present an increased risk of respiratory complications, caused not only by the surgical procedure itself, but also by the respiratory mechanics changes associated with the body mass. In obese patients we can observe higher values of lung and chest wall elastance, with reduction in ventilation-perfusion ratio.

The partitioning between lung and chest wall elastance can improve ventilatory setting and mechanics parameters of ventilation.

In every patient we will place, after anesthesia induction, a catheter to get esophageal and gastric pressure that represent pleural and abdominal pressure.

Ventilation will be conducted with a tidal volume of 8-10 ml/kg (IBW) and a respiratory rate adequate to maintain a physiological level of Pa CO2.

The preemptive strategy involves recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position in the treatment group, while the current procedure provides it afterwards (control group).

Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 30
* Robotic-assisted laparoscopic prostatectomy

Exclusion Criteria:

* Chronic cardiac or pulmonary diseases
Safety of Overnight Corneal Reshaping Lenses

This retrospective chart review study compares the incidence of corneal inflammation due to infection in children vs. adult patients wearing overnight corneal reshaping lenses.


Eligibility Criteria:
Inclusion Criteria:

* Patients completing at least 3 months of wearing corneal reshaping lenses

Exclusion Criteria:

* Less than 3 months of wearing corneal reshaping lenses
Wrist Arthroscopy Study

The purpose of this study is to evaluate the diagnostic efficacy of Arthrex NanoScope compared to conventional arthroscopic instruments. Patients with wrist pathology who are indicated for an arthroscopic procedure will be enrolled pre-operatively after a thorough discussion of the study aims, risks, and benefits. At the time of surgery, under standard conditions, using standard wrist arthroscopy portals, a diagnostic arthroscopy will be performed with the Arthrex Nanoscope. The diagnostic arthroscopy will be performed in a stepwise manner for consistency with notation of pathology and intended intervention. The diagnostic arthroscopy will then be performed with the standard arthroscopic equipment, again noting pathology and final intervention. Post-operatively, diagnostic accuracy, incidence of change in intervention, and surgeon rated ease of use and confidence will be determined.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.
3. Willingness to participate in the study

Exclusion Criteria:

* 1. Age \< 18 years.
Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE

To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.

Objective:

To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.

Method:

All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.

120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG.

MRI will be performed in the same hospital, during hospital stay, within 45 minutes.

Two MRI sequences will be used to measure placental perfusion:

* dynamic sequences using Gd contrast agent.
* " spin tagging ", which do not need any contrast agent. Perfusion will be modelled using compartmental analysis. Reference ranges will be build up by statistical modelling. Gadolinium assays will be performed on amniotic fluid and placental tissue following TOP.

Duration of inclusion: 24 months.

Duration of patient participation: 45 minutes.

Expected results:

* Feasibility in routine practice.
* Reference ranges for placental perfusion.
* Comparison between the two measurements methods.

Adverse outcome measure:

Nausea, vomiting, lack of comfort and other adverse outcome.

Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years,
* Undergoing TOP for fetal reason,
* Informed signed consent.

Exclusion Criteria:

* Placental adhesion anomaly,
* Growth restriction,
* Contrast agent allergy,
* Absent consent,
* Contraindication of MRI or Gadolinium,
* Renal insufficiency,
* Placental abnormality at pathological examination.
Time for Lunch: The Impact of Lunch Time Constraints on Child Eating Behaviors

Recent peer-reviewed observational evidence suggests that school children receive anywhere from 10-33 minutes of seated lunch time and that students with less time to eat discard higher amounts of milk, entrée (i.e. protein items), grains, and vegetables. This waste is a missed nutritional and food security opportunity and also negatively impacts the environment. The purpose of this study is to estimate the impact that lunch time constraints have on child food selection, consumption and waste behaviors using a crossover trial design, where the duration of seated lunch times are randomly allocated to be either 10 minutes or 20 minutes each day.


Eligibility Criteria:
Inclusion Criteria:

* Must be enrolled in local summer camp

Exclusion Criteria:

* None
Surgical and Medical Emergencies on Board of European Aircraft Carriers

The goal of this retrospective study is to describe emergency relevant illnesses occurring in airline passengers.

An epidemiologic database documenting medical and surgical emergencies across European airlines will provide access to data potentially valuable for further flight-epidemiological research. Data on medical emergencies / per rpk (revenue passenger kilometres) are sparse and often based on data from a single airline. While handling the data the regulations of the data protection act of the Ethic commission of the Ruhr-University Bochum are fully respected. As noted, evaluation of the data will be completely anonymized without any information regarding the airline or other details than the passengers illness.

Preview: The results of the study specified above will be submitted for publication in a peer review and Medline listed journal.

Study Design: Retrospective, epidemiological study for the evaluation of medical and surgical emergencies on board airliners.

Patients: In the context of a retrospective study approximately 20,000 patient data from 32 European airlines are collected and statistically evaluated.

Documentation: The direct documentation takes place through project responsible person into an electronic statistical data base.

Eligibility Criteria:
Inclusion Criteria:

* Men, women, adolescent, children and babies who have suffered from an emergency on board an European airline.

Exclusion Criteria:

* None
TacTIC- Trans-disciplinary Chronic Disease Continuity of Care Model

The overall aim of this study is to create a trans-disciplinary chronic disease continuity of care model with health information technology, utilizing mobile devices such as tablets, iPads and smartphones.

This study aims to explore if a trans-disciplinary chronic disease continuity of care model with integrated technology (mobile devices such as tablets, iPads and smartphones) to standard practice (patient-centered, coordinated care model without the integration of technology) will results in a reduction in 30-day readmission rate in adult patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients on a 43 bed medical surgical unit
* Adult patients on 44 bed geriatric unit

Exclusion Criteria:

* Adult patients admitted and not diagnosed with chronic disease
* Patients who are transferred between Intervention and non-Intervention unit
* Patients who refuse
* Patients with delirium, dementia and altered mental status
* Patients who cannot read and write in any language
* Patients in the intervention group who cannot use mobile technology
Virtual Reality Experience in First Trimester D&C

Virtual reality (VR) has been used in health care settings to decrease anxiety and pain. This project is a feasibility study to evaluate whether virtual reality can be used in the setting of a first trimester pregnancy termination by D\&C and whether the use of virtual reality (VR) headsets can help decrease anxiety for patients during this procedure.

The investigators will assess the practicality and qualitative experience of women using VR during first trimester surgical abortion under local anesthesia. Semi-structured interviews will be conducted to understand the patient's experience of using VR. Surveys evaluating anxiety will be administered to women before and after surgical abortion. Investigators plan to enroll 30 patients in order to obtain an effect size for future studies. A group of control patients will be enrolled; these patients will receive standard care and will be compared to the anxiety scores of the group receiving VR. The mean and standard deviation of anxiety scores for each group will be used to calculate power for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Elective surgical abortion under local anesthesia
* English speaker

Exclusion Criteria:

* No psychiatric history
* No history of motion sickness or vertigo
* No history of seizures or epilepsy
* No recent eye surgery or visual impairment
* No claustrophobia.
* No current nausea or vomiting
* Not on seizure-threshold lowering medications
A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)

A Phase 2, multicenter, adaptive 2-part clinical trial designed to evaluate the safety and efficacy of ADX-629 alone and in combination with standard-of-care in adults with atopic dermatitis.

The trial is divided into 2 parts; the first part of the trial (Part 1) is open label, and the second part (Part 2) is randomized, double-blind, and placebo controlled.

In Part 1, approximately 10 subjects will receive open-label ADX-629 twice daily for 90 days.

In Part 2, approximately 40 subjects will be randomized to receive either ADX-629 or matching placebo twice daily for 90 days.

Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* History of atopic dermatitis, according to American Academy of Dermatology criteria, that has been present for at least 6 months
* Mild, moderate, or severe atopic dermatitis, defined as an IGA score of ≥2 at Baseline
* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable

Exclusion Criteria:

* Presence of clinically significant kidney disease or an estimated gloverular filtration rate (eGFR) of less than or equal to 45 milliliters/min/1.73 m2 during screening
* History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial
Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants

This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. Female participants of childbearing potential must have a negative pregnancy test.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of Screening or Day -1.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy- or brady brady-arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure, underlying structural heart disease, Wolff Parkinson-White syndrome).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg,. contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer

The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with Metastatic Castration-Resistant Prostrate Cancer


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written consent
* Screening PSA ≥ 2ng/ml
* Patients must have a diagnosis of mCRPC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Prior surgical or medical castration with testosterone at screening \< 50 ng/dL

Exclusion Criteria:

* Prior chemotherapy for prostate cancer within 6 months prior to screening. (Any prior therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.)
* Documented central nervous system metastases
* Clinically significant heart disease
* Patients who have an abnormal 12-lead ECG result at screening including one or more of the following: QRS\>110 ms, QTcF\>480ms, PR interval\>200 ms
* Patients who have a history of risk factors for TdP including unexplained syncope, known long QT syndrome, heart failure, angina, or clinically significant abnormal laboratory assessments

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.

This study is designed as a randomized, active-controlled, superiority study in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment.

Eligible patients will be randomly assigned (2:1) to receive SYD985 or physician's choice treatment until disease progression, unacceptable toxicity or study termination by the Sponsor. During treatment, patients will have to visit the clinical site to assess efficacy, quality of life (QoL), and safety using standardized criteria.

Eligibility Criteria:
Main Inclusion Criteria:

* Female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;
* Patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease;
* HER2-positive tumor status;
* Patients must have measurable or non-measurable disease that is evaluable per RECIST 1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
* Estimated life expectancy \> 12 weeks at randomization;
* Adequate organ function and blood cell counts.

Main Exclusion Criteria:

* Current or previous use of a prohibited medication as listed in the protocol;
* History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine;
* History of keratitis;
* Severe, uncontrolled systemic disease at screening;
* Left Ventricular Ejection Fraction (LVEF) \< 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;
* Cardiac troponin value above the Upper Limit of Normal (ULN);
* History of clinically significant cardiovascular disease;
* Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Performance of a New Glucose Meter System

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose monitoring system, which includes meter and sensor strip.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes
* Age 18 years or older
* Routinely performs blood glucose self testing at home, at least once per day
* Able to speak, read, and understand English.
* Is willing to complete all study procedures

Exclusion Criteria:

* Currently pregnant
* Hemophilia or any other bleeding disorder
* Taking prescription anticoagulants or has clotting problems that may prolong bleeding. Taking aspirin daily is not excluded
* Subject employee of competitive medical device company
* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Multistate Relative Survival Model

Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57% in men to 60% in women. About one third of patients diagnosed with CRC will develop a metachronous recurrence during the following years. It is of paramount importance to accurately identify factors associated with the increased risk of progression and death, in order to develop effective follow-up and treatment strategies. However, to accurately assess the role of patients' specific characteristics in the progression of cancer several methodological challenges need to be overcome.

One difficulty, common to prognostic studies of cancer, concerns the need to separate the effects of prognostic factors on different clinical endpoints, such as disease recurrence vs recurrence-free death. Another difficulty, encountered in prognostic studies, is that the cause of death is not available or not accurately coded. Yet, some patients are likely to die of causes not related to the disease of primary interest, especially in cancers with longer survival and in those that affect older subjects. Until recently, the existing statistical methodology was not able to simultaneously, deal with both difficulties, i.e. to account for (i) possibly different effects of prognostic factors on death vs recurrence, and (ii) unknown causes of death. However, this challenge has been addressed by the recent development of the Markov relative survival model (MRS) , which extends the Markov multi-state model to incorporate relative survival modelling. Simulations demonstrate that MRS is able to accurately estimate different effects of prognostic factors on the risk of each of several events, including separate effects on disease-specific vs other causes of death. To date, the MRS had not been applied in clinical or epidemiological studies.

The aim of this study was to assess the potential advantages of the new multi-state relative survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To this end, we compared the MRS results with those obtained with two more conventional analyses, based on Cox's proportional hazards model, and the multi-state Markov model proposed by Alioum and Commenges (2001). The three models were applied to explore the impact of prognostic factors on cancer-specific mortality and recurrence, in a large population-based French registry of colorectal cancer, with up to 25 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

patient with primary digestive cancer between 1985 and 2000, TNM I-III, resected for cure, residing in Burgundy or Calvados, France

Exclusion Criteria:

metastatic cancer, non adenocarcinoma, recurrence within 6 month