cyrilzakka/clinical-trials huggingface dataset:
Using Digitalized Incentive Spirometers to Assist Postoperative Rehabilitation of Abdominal Surgery Patients

The purpose of this clinical trial is to use a digital recording device integrated with an incentive spirometer to record a patient's deep breathing lung training following abdominal surgery. Through this digital recording, it will be possible to effectively assess the daily frequency, duration, depth of deep breaths, and the volume of inhalation performed by the patient during their breathing exercises. This will transform the previously difficult-to-describe deep breathing training into a digital record, allowing healthcare professionals to quickly evaluate the patient's condition. Patients can also monitor their own respiratory function changes, leading to positive health promotion benefits, accelerating their postoperative recovery, and simultaneously reducing healthcare costs and improving medical quality.

After thoracoabdominal and neurosurgery procedures, an incentive spirometer is commonly employed for deep breathing exercises to prevent or improve potential postoperative pulmonary atelectasis, increase lung capacity, promote the clearance of respiratory secretions, and maintain chest mobility to reduce postoperative complications related to lung collapse. This medical device and the respiratory training process are essential components of Enhanced Recovery After Surgery (ERAS) protocols, which integrate postoperative care processes to enhance recovery, reduce hospitalization times, and minimize postoperative complications. Currently, clinical guidelines typically recommend patients to perform 200-600 deep inhalations per day after surgery. Despite the simplicity and effectiveness of using an incentive spirometer for deep breathing exercises, the observation of patients' usage, recording of the number and duration of exercises, and tracking of their deep inhalation volumes have become crucial tasks for respiratory therapists, nurses, and physicians in the postoperative setting, consuming significant time and resources.

Generally, using an incentive spirometer requires patients to perform 200-600 deep breaths a day. According to a 2018 medical literature estimate in the United States, approximately 9.7 million surgical procedures annually involve the use of incentive spirometers, with human resource costs for assisting patients in their use and assessing the effectiveness of their pulmonary rehabilitation reaching approximately one billion US dollars.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients undergoing bariatric surgery
* 2. Patients could cooperate with conducting incentive spirometry before and after the operation.

Exclusion Criteria:

* 1. Patients with contra-indication for incentive spirometry.
* 2. Patients could not deeply breathe with pulmonary vital capacity less than 10mL/kg.
* 3. Patients could not cooperate with conducting incentive spirometry before and after the operation.
* 4. Other causes judged by the Principal Investigator
The Effects of Traditional Massage on Spasticity and Activity of Children(2 to 10 Years) With Cerebral Palsy

The study has been conducted to see the effects of traditional massage on spasticity and activity of children with cerebral palsy (CP). It is a randomized controlled trial having two groups, control and intervention. Both groups received routine physical therapy treatment comprising stretching of tight muscles, strengthening of weak muscles, positioning and handling. Intervention group also received traditional massage in addition to routine physical therapy. Caregivers were trained to perform routine physical therapy treatment and traditional massage at home. Data was collected using a structured questionnaire, Modified Ashworth Scale (MAS), Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM) and CPChild Caregiver Priorities \& Child Health Index of Life with Disabilities at baseline, after 06 weeks and 12 weeks of intervention.

Physical therapy is an important component of rehabilitation regimen which is commonly used in the management of children with CP. Massage is also used as a complimentary alternative medicine (CAM). It has many types being practiced across the globe. Traditional massage is a type of massage being practiced in a specific society and has its own way of execution. It does not need professional education, training and certification so do not have any financial burden on the caregivers. As Pakistan is a poor country with low socio-economic status, so such measures of management which involve less financial burden on caregivers need to be investigated.

In this RCT, traditional massage was performed on the participants in the supine lying position. Each upper and lower limb was massaged for five minutes with gentle rubbing in proximal to distal direction. Five minutes massage was also provided at front and back of trunk area each in center to periphery direction. This type of traditional massage is practiced in Pakistan population which is somewhat different to Swedish massage. In few previous studies effect of Swedish massage on spastic CP has been investigated with conflicting level of evidence. However no study has been conducted in Pakistan to see the effects of traditional massage on children with cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Child should have diagnosis of spastic cerebral palsy (hemiplegic and diplegic types only).

Exclusion Criteria:

* Children having moderate to severe contractures.
* Children having moderate to severe mental retardation and with multiple disabilities.
* Children with Attention Deficit Hyperactive Disorder (ADHD), uncontrolled seizures and behavioral disorders
Effects of Proprioceptive Focal Stimulation (EQUISTASI) on Freezing of Gait in Parkinson's Disease

Freezing of gait (FOG) is a common disabling condition in Parkinson's disease (PD), causes falls, and impairs quality of life. Therapeutic options for this symptom are limited and of limited efficacy. Besides, the pathophysiology has been not clarified yet. Proprioceptive sensitivity is likely to play a role and recent studies have reported that high-frequency microfocal vibratory stimulation exert a modulatory effect of proprioceptive reflex circuits and could be considered a valuable treatment strategy. However, evidence is not available. The present study was designed to collect preliminary evidence of efficacy of a vibrotactile device (Equistasi) for the treatment of FOG.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Parkinson's Disease
* Stable drug therapy response without any change in the 3 months before the study.
* written informed consent

Exclusion Criteria:

* Hoehn-Yahr stage ≥ 4
* Cognitive decline (Mini Mental State Examination \<26)
* Systemic illness involving the nervous system
* Diabetes
* Presence of cardiac pacemaker
* Presence of deep brain stimulation
* Presence of severe dysautonomia with marked hypotension
* History or active neoplasia
* Pregnancy
Analysis of Volatile Organic Compounds in Exhaled Air and Sweat: Interest in Rapid Screening for COVID-19 Infection.

In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.

The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.

Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).

Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Subject included in the Foch Hospital :
* Patients managed at the Foch Hospital with RT-PCR screening for SARS-CoV-2 infection
* Healthy volunteers among the hospital staff, asymptomatic, for whom an RT-PCR SARS-CoV-2 is indicated or recommended.
* Healthy hospital volunteers vaccinated against COVID (full vaccination schedule completed)
* At least 18 years of age;
* Fluency in the French language;
* Have signed a consent form;
* Be affiliated with a health insurance plan.

Exclusion Criteria:

* Pregnant woman
* Patient deprived of liberty by judicial or administrative decision
Measurement of Cardiac Output and Blood Volumes

Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (older than 18 years of age)
* Should have both arterial and central venous catheters already in place

Exclusion Criteria:

* Patients who do not have either the arterial or central venous catheters.
The MOM Program at the Children's Hospital of Philadelphia

The purpose of the MOM Program is to promote child development by helping families become more competent in accessing and using available resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The hypothsis is that children receiving the intervention will participate in more of the public services and primary healthcare activities which have been shown to be effective in improving their development.

The MOM Program is a 3 year randomized controlled trial of mothers and newborns. At enrollment subjects are given a questionnaire to assess self efficacy and a non-verbal test of intelligence. Program personnel are blind to the results of this testing. Test results will be used in data analysis at the end of the study to compare outcomes of the intervention and control groups and to assess how mothers with impaired cognitive ability have benefited from participation in the study.The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. At 33 months of age all children receive a developmental assessment.

Eligibility Criteria:
Inclusion Criteria: mothers from West and South Philadelphia who have given birth on the post-partum unit at the Hospital of the University of Pennsylvania during the six month enrollment period from July, 2001 to Jan, 2002..

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Exclusion Criteria: women or infants who are critically ill, those involving multiple births (ie twins), and women who are solely non-English speaking.

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Functional Outcomes Comparison in Patients Using Knee Brace Post ACL Reconstruction With Autograft Bone Quadricep Tendon

This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy.

This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy.

The research will be conducted at the National Central General Hospital dr. Cipto Mangunkusumo, Jakarta Police Hospital and Gatot Soebroto Army Hospital in Jakarta, Indonesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with age more than equal to 18 years
* Patients with ACL rupture without other ligament ruptures undergoing ACL reconstruction
* Patients undergoing ACL reconstruction using Quadricep Tendon Autograft

Exclusion Criteria:

* Patients with hyperlaxity
* Patients with previous history of ACL reconstruction
* Patients with recurrent rupture during the observation period
Safety and Clinical Performance of the Protecta ICD and CRT-D

The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated.

The PainFree SST study was a prospective, multicenter clinical trial, which was conducted in two consecutive phases. Phase I assessed safety as determined by assessment of delays in ventricular fibrillation (VF) arrhythmia detection time using new algorithms. Phase II assessed the influence of new algorithms on inappropriate and unnecessary shocks at 1 year of follow-up. Subjects enrolled in Phase I continued in Phase II of the study and data from all enrolled subjects contributed to the analysis of Phase II objectives. A sub-study of Phase II randomized secondary prevention subjects to either 18/24 NID or 30/40 NID in order to assess the safety of prolonged detection in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting one of the following criteria can be included in Phase I of the study:

  * Patients indicated (per local indications) for a dual chamber implantable cardioverter defibrillator (DR-ICD)/cardiac resynchronization therapy defibrillator (CRT-D)
  * Patients undergoing a device replacement or upgrade to DR-ICD or CRT-D and with the protocol required leads (patients must be enrolled prior to implant)
* Patients meeting one of the following criteria can be included in Phase II of the study:

  * Patients indicated for a DR-ICD/VR-ICD/CRT-D device and intended to receive a Protecta device
  * Patients undergoing a DR-ICD/VR-ICD/CRT-D device replacement or an upgrade to a Protecta DR-ICD/VR-ICD or CRT-D
  * Patients indicated for a DR-ICD/VR-ICD/CRT-D already implanted with a Protecta device and the protocol required leads, who have not yet been discharged after implant

Exclusion Criteria:

* Patients with a mechanical tricuspid heart valve
* Patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
* Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
* Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc)
* Patients anticipated not being able to complete the study
* Patients unwilling to provide written informed consent
Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients

This retrospective study aims to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022

This is a multicenter, retrospective study to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022.

This study will be divided into two parts： The first part will include 200 subjects who were pathologically diagnosed with breast cancer at FUSCC between Jan 2015 and Dec 2015 (PART 1).This part will collect rescored HER2 expression level results based on the archived HER2 IHC slides and re-staining and re-scoring HER-2 IHC while relative demographic, treatment, and clinicopathologic data will be extracted from the FUSCC Breast Cancer Single Disease Database.

The second part will include 3000 patients from all sites in China who were pathologically diagnosed with breast cancer between July 2021 and July 2022 (PART 2). This part will collect re-assessed HER2 expression level results based on the archived HER2 IHC slides. The general information of patients, diagnosis, clinicopathological information were collected from medical records, Hospital Information System (HIS) and Laboratory Information Management System (LIS).

In PART 2, among 3000 patients, 270 from all participating sites except FUSCC should have enough tumor tissue for re-staining and re-scoring HER-2 IHC at FUSCC to analyse the concordance between leading site and other centers.

In PART 2, among 3000 patients, 800 HER-2 IHC samples will be selected for the validation through AI-assisted HER2 assessment system

Eligibility Criteria:
Inclusion Criteria:

Patients fulfilling all of the following criteria will be eligible for this study:

* Male and female patients must have a histological confirmed diagnosis of BC
* The patients must be ≥18 years old at the diagnosis.
* In PART 1, all patients should be diagnosed at FUSCC between Jan 2015 and Dec 2015.
* In PART 2, all patients should be diagnosed at all participating sites between July 2021 and July 2022.
* Provision of at least 1 archived HER2 IHC slides associated with confirmed diagnosis of BC, which are in good condition for rescoring.
* FISH result is available for HER2 IHC2+ in primary scoring.

Exclusion Criteria:

Patients who meet any of the following criteria will be disqualified from entering the study:

* Absence of all demographic, histopathologic, clinicopathologic information .
* Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
Retrospective CT Imaging of BioComposite Interference Screw With BTB

The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-50
* Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago
* Isolated ACL tear
* Type of graft used was bone-patellar tendon-bone autograft
* Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.)
* No degenerative joint disease on preoperative X-rays (\> 50% joint space loss, presence of osteophytes)

Exclusion Criteria:

* Revision ACL reconstructions
* Types of grafts other than bone-patellar tendon-bone autograft were used
* ACL tear with concomitant pathology
* Degenerative joint disease on preoperative X-ray (\> 50% joint space loss, presence of osteophytes)
* Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used
* ACL reconstruction performed less than 5 years ago
* Pregnancy
* Greater than Grade 2 laxity of other ligaments
* No additional fixation
Ultrasound-guided Blood Sampling Drawing for Microbiological Analysis in the Critically Ill

This study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. The aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult venous access and requiring more than one venipuncture attempt in general clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 year-old)
* admitted to intensive care unit
* suspected sepsis requiring blood cultrure

Exclusion Criteria:

* pregnancy
* infections requiring respiratory isolation
* burns or skin disease involving arms and/or more than 60% of body surface
Nerve Coaptation in LTP Flap Breast Reconstruction

The sensory recovery of the breast remains an undervalued aspect of breast reconstruction and surgical reinnervation is not regarded as a priority by most reconstructive surgeons. A prospective study was conducted of all patients who underwent either innervated or non-innervated lateral thigh perforator (LTP) flap breast reconstruction in Maastricht University Medical Center and returned for follow-up between February 2016 and April 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years or older
* Unilateral or bilateral LTP flap breast reconstruction
* Returned for follow-up between February 2016 and April 2019
* Informed consent

Exclusion Criteria:

* In case of a total flap loss
* Flaps that required a take-back
* Follow-up less than six months postoperatively
Study to Obtain Full Thickness Bladder Tissue From Subjects Undergoing Cystectomy Surgery

The objective of this study is to obtain bladder tissue specimens from patients otherwise undergoing cystectomy for use in research and training of personnel at Tengion, Inc.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 to 90 years and undergoing a cystectomy surgery
* Willing and able to give signed informed consent

Exclusion Criteria:

* Known active infection
* Known colonization with MRSA or VRE
* Receipt of blood or blood products for transfusion during the previous 3 months