cyrilzakka/clinical-trials huggingface dataset:
Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis

This study intends to investigate the three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS). In particular, it will look at the relationship between frontal deformity correction and changes in the sagittal profile and apical vertebral rotation (AVR) during bracing. The investigators hypothesise that if the thoracic frontal deformity can be controlled with bracing, there will be spontaneous correction of the sagittal plane and rotation deformity through coupling.

Scoliosis is a 3D deformity of the spine with curvatures occurring in three planes.

The efficacy of bracing in correcting the frontal deformity is now well-accepted after the Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST). Restoration of the sagittal alignment is one of the fundamental goals in scoliosis treatment. The investigators have previously demonstrated on fulcrum bending radiographs that there is coupling between the frontal deformity, thoracic kyphosis and apical vertebral derotation. The investigators' findings suggest that there may be natural coupling of the frontal and sagittal deformities towards "self-normalisation" during correction of the curves. The effect of bracing on the sagittal alignment and 3D deformity in scoliosis is currently not well-understood. If there is a tendency for the natural curve behaviour to return towards a more normal sagittal alignment, then bracing may exert a similar effect on the 3D profile. Understanding how the 3D deformity is affected by bracing allows further insight into curve progression and brace effectiveness.

Few studies in the literature have addressed the sagittal profile and 3D correction by bracing. Of those, the findings were based on vertebral reconstructions obtained from CT-scan, finite element analysis modelling, or studying the changes in the rib cage rotation. However, the investigators propose to measure the 3D profile using the modern EOS ® system, which allows biplanar radiography and 3D calculations and a more accurate measurement of vertebral wedging.

Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of Lenke type 1 AIS who fulfil the normal criteria for bracing

Exclusion Criteria:

* if the aetiology of the scoliosis is not idiopathic
* does not belong to Lenke type 1
* previous treatment with a brace
* severe presentation requiring surgical intervention
* unavailable for regular follow-up
* parents are unable to give informed consent
Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.

Advanced pancreatic ductal adenocarcinoma is a fatal disease with about 6 months of median overall survival (OS). Gemcitabine is the only approved single agent. Gemcitabine-based chemotherapy did not show benefit in OS during the past decade. The recent phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and OS, with nab-paclitaxel (125 mg/m2 on day 1, 8 and 15 every 28 days) plus gemcitabine (1000 mg/m2 on day 1, 8 and 15 every 28 days) compared to gemcitabine alone. Accordingly the combination of nab-paclitaxel with gemcitabine became one of standard treatments in metastatic pancreatic cancer. A Chinese phase II trial showed the modified dosage of nab-paclitaxel (120 mg/m2 on day 1 and 8 every 21 days) plus gemcitabine (1000 mg/m2 on day 1 and 8 every 21 days) is more suitable for Chinese patients. This study aims to explore the efficacy and safety of the tentative dosage of nab-paclitaxel (125 mg/m2 on day 1 and 8, every 21 days) and gemcitabine (1000 mg/m2 on day 1 and 8, every 21 days) for Chinese patients.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed-consent form.
2. Age no less than 18 years.
3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
5. Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
6. Adequate liver/bone marrow function.
7. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
8. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
2. Serious infection requiring antibiotics intervention during recruitment.
3. Allergic to study drug.
4. More than grade 1 neuropathy.
5. Uncontrolled brain metastasis or mental illness.
6. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
7. Other malignancy within 5 years.
8. Can't be followed up or obey protocol.
9. Ineligible by the discretion of the investigator.
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo

The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.


Eligibility Criteria:
Inclusion Criteria:

* provide written informed consent and signed HIPAA form;
* be able and willing to follow all instructions and attend the study visits;
* if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to use adequate method of birth control
* have a positive history of seasonal allergic rhinitis to ragweed;
* have a positive skin test reaction to ragweed of within the past 24 months;
* manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC

Exclusion Criteria:

* known intolerance or allergy to antihistamines or corticosteroids;
* have a compromised lung function at Visit 1;
* develop a compromised lung function at Visits 2-6
* have any presence of active sinus or nasal infection at any visit;
* have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1;
* have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
* have had any nasal surgical intervention in the past;
* have a known history of glaucoma
* have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
* inability or refusal to discontinue contact lens wear during all visits;
* use disallowed medications during the study or appropriate pre-study washout period
A Study on the Prospective Cohort Library of COVID-19 in Southeran

This is a multi-centre population-based follow-up study for all 504 patients with laboratory-confirmed COVID-19. This study establishes a standardized and structured clinical database to provide complete and multidimensional clinical diagnosis and treatment data of novel coronavirus pneumonia, which also support future epidemiological, infectious disease study and patients' prognosis, by collecting clinical data and the related data of patients with novel coronavirus pneumonia in Southern Zhejiang province.

The follow-up information will be collected in one-month, three-month, six-month and one-year after discharge. Information about symptoms, radiographic and laboratory findings, lung function, SF-36 QUESTIONNAIRE, antibody of COVID19，result of RT-PCR Test and suvival information will be collected through all time frames.

Eligibility Criteria:
Inclusion Criteria:

* All patients with laboratory-confirmed COVID-19 in Wenzhou

Exclusion Criteria:

* Suspected cases of COVID-19
A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)

To describe real-world demographic and clinical characteristics, treatment characteristics, and clinical outcomes among patients in Latin America who were treated with first-line sunitinib for metastatic renal cell carcinoma and switched from the 4/2 to 2/1 administration schedule

Understanding characteristics of patients who switched from a 4/2 to a 2/1 sunitinib schedule or initiated the 2/1 schedule in Brazil, and the resulting clinical outcomes in the real-world setting

• Describing the occurrence of AEs on the 4/2 and 2/1 schedules

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with metastatic RCC with clear cell histology

   a. The patient may have been initially diagnosed with Stage IV or initially diagnosed at an earlier stage and progressed to having disease at distant sites (i.e., metastatic disease)
2. Initiated first-line treatment for metastatic RCC with sunitinib on the 4/2 schedule (all countries) or initiated first-line treatment for metastatic RCC with sunitinib on the 2/1 schedule (Brazil only)
3. Switched to the 2/1 schedule (all countries) or initiated the 2/1 schedule (Brazil only) during the first treatment line between January 1, 2014, and June 30, 2018 a. The final dates defining this selection period will be dependent on country-specific ethics and reporting requirements

Exclusion Criteria:

1. Evidence of other malignant neoplasms (except nonmelanoma skin cancer or carcinoma in situ) within 5 years before switching to the sunitinib 2/1 schedule (all countries) or initiation of the 2/1 schedule (Brazil only)
99Tc-MDP for Thyroid-Associated Ophthalmopathy

To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to Methylprednisolone, in the treatment of participants suffering from active moderate to severe TAO.


Eligibility Criteria:
Inclusion Criteria:

* The patient age 18 Years to 76 Years;
* Fewer than 6 months from onset of TAO;
* Clinical diagnosis of Graves' disease associated with active TAO and a clinical activity score of ≥ 3;
* Moderate to severe TAO;
* No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization.

Exclusion Criteria:

* Optic neuropathy, severe orbital appearance and surgical;
* Extra-thyroid disease;
* Pregnant and children;
* Severe impairment of cardiac, hepatic and renal functions;
* Allergies;
* Other contraindications.
Safe Return to Play After ACL Reconstruction

Recent studies report that as few as 44% of athletes undergoing ACL reconstruction were able to return to their prior level of competitive level of sports. Early return may predispose an individual to re-injury including graft re-tear, meniscal tears, chondral injuries, and contralateral knee injuries. Criteria governing clearance to return to sports after ACL reconstruction has been traditionally defined using time from surgery and one or two objective criteria, often solely isokinetic quad/hamstring strength. Several studies have suggested that historical criteria used to assess readiness to return to play (RTP) are insufficient in identifying individuals at risk of a re-injury. They advocate for additional functional and dynamic testing, which may better reflect the complex kinematics required in high level athletic competition.

We previously developed a "Safe Return to Play Following ACL Reconstruction Checklist" based on a systematic review of the literature and expert survey. Seven objective measures were developed as part of the checklist. The checklist is performed by a certified physical therapist trained in these performance tests.

The purpose of this study is to validate the utility of our "Return to Play Checklist" by evaluating our patients prospectively for return to play following ACL reconstruction by comparing a cohort of patient undergoing testing with the checklist versus "clinical judgement."


Eligibility Criteria:
Inclusion Criteria:

* All patients ages 15-35 undergoing primary ACL reconstruction

Exclusion Criteria:

* patients who are undergoing revision ACL surgery
Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies

The study aims at identifying:

1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk;
3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women;

In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum.

Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health.

Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses.

Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses.

Clinical and psychological data will be collected from women at all timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women of a singleton pregnancy
* Age ≥ 18 years

Exclusion Criteria:

* Uterine anomalies and obstetric complications
* Comorbidity with severe or chronic diseases
* Substance abuse
* Language barrier
Record Voxel Rate Nonlinear Optical Microscope to Unravel Brain Connectome and Signaling

The research aims to develop a novel pathological technology, including rapid whole-mount tissue H\&E \& IHC staining protocol and high-resolution nonlinear optical microscopy imaging system, to intraoperatively assess brain tumor grade, types and other biological parameters.

Brain tumors, especially like glioma, the infiltrative growth pattern resulted in an indistinct margin against normal brain tissues. Surgery is currently the most effective method in prolonging patient's survival, the extent of tumor resection is therefore crucial to the overall outcome. Distinguishing the tumor type and grading can help neurosurgeons plan the intraoperative surgical strategies to cure the suffered patients. Feasible solutions to improve the extent of resections including fluorescence-guided surgery and intraoperative MR imaging are relatively indirect to judge the completeness of tumor resection and its margin; considering means like Moh's surgery performed in the dermatological practice, though it is reasonable to look at the resection proportion by pathological interpretation, it is very time consuming. Besides, many kinds of brain tumors can't be classified only by the outcomes of frozen pathology. There are several related studies trying to solve the problem, but the judgment criteria is not sufficient to meet the standard of modern pathological diagnosis. The research aims to acquire images by optical microscopy from both H\&E and IHC stained tissues, and to compare those images with slides obtained by standard pathological workflow in order to achieve accurate and rapid assessment of tumor categories and grading.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than the age of 20 with diagnosis of brain tumor (both newly-diagnosed or recurrent) who are suitable and willing to receive resection surgery.

Exclusion Criteria:

1. Patients who cannot give consent to participate in the study.
2. The tumor samples failed to give a conclusive pathological diagnosis by standard pathological workflow.
3. Patients who only receives biopsy surgery rather than resection surgery.
4. Significant post-irradiation effect or radiation necrosis reported in the pathological examination.
Comparative Study of Duration of Respiratory Weaning Between Adaptive Support Ventilation and Succession of Controlled Ventilation Then Spontaneous Ventilation for Patients After Surgery

This is a comparative study of duration of respiratory weaning between adaptive support ventilation and succession of controlled ventilation then spontaneous ventilation for patients after surgery.

General anaesthesia is marked by the passage of a stage of controlled ventilation where the patient does not carry out any respiratory work and the stage of spontaneous ventilation, which precedes extubation. Adaptive support ventilation (ASV) is a new protocol of weaning of the tracheal prosthesis after surgery which maintains a preset ventilation by an operator and the activity of the patient. At each breath, a microprocessor allows an optimization of volume and frequency by an adjustment of the inspiratory pressure and frequency. ASV was already validated for fast tracheal extubation after cardiac surgery. Our study proposes to compare the duration of intubation between this mode of weaning and with the traditional way (controlled ventilation then spontaneous ventilation) for faster surgery. The purpose of the study is to check the interest of ASV to limit the duration of intubation compared to the traditional protocol in this kind of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Surgery \< 2 hours
* Anesthesia with thiopental, midazolam, sufentanil and suprane

Exclusion Criteria:

* Patients ASA III or IV (classification of American Sociéty of Anesthésiologist)
Minimal Invasive Surgery for Gastric Subepithelial Tumor

The investigators conducted a retrospective study of those patients with gastric SETs receiving ER or LR at the operative theater in the single institution from January 2013 to December 2021. Medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients with gastric subepithelial tumors
* patients received minimal invasive surgery (endoscopy or laparoscopy) for tumor resection

Exclusion Criteria:

* patients had gastric anatomic changes due to previous surgery
* patients converted open surgery
An Online Evaluation of Work Chat

This study is aiming to see if it is feasible for the intervention Work Chat to be delivered in a completely online setting to adults with autism spectrum disorder.

Nearly 50,000 youth with autism spectrum disorder (ASD) transition from high school to adult life each year, with only 25% of these transition-age youth with ASD (TAY-ASD) getting jobs within 2 years of graduation. TAY-ASD's ability to sustain employment is even more challenging due in part to their social cognitive deficits (e.g., poorly reading social cues) that disrupt communicating with customers, coworkers, and supervisors. Research shows nearly 90% of job dismissals among TAY-ASD are attributed to poor work-based social functioning (e.g., poorly communicating with upset customers). The subsequent unemployment has damaging effects on their mental, physical, and economic health. A critical gap in federally-mandated services to support youth with ASD as they transition from school-to-adult life is the lack of evidence-based practice to enhance their work-based social functioning. Given that TAY-ASD report computerized training tools are highly acceptable and improve their real-world outcomes, the investigators propose to address this critical barrier to sustained employment by developing and evaluating a novel and scalable computerized training tool to enhance their conversations with customers, coworkers and supervisors at work.

The investigators are aiming to see if it is feasible for Work Chat to be delivered in a completely online setting and not within schools or other sites. The investigators are also evaluating the tool specifically with employed adults who have autism spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder
* 18 years or older
* Has 4th grade or higher reading level
* Employed or Unemployed and searching for employment within the next 3 months
* Has access to a computer, laptop, or tablet that has connection to the internet and a camera (not including smartphone)

Exclusion Criteria:

-
Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer

This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography / computed tomography (PET/CT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.

Local recurrences of prostate cancer following radiotherapy often originate from the primary tumor site. Therefore,focal boost to the primary gross tumor has been proposed to increase biochemical disease-free survival (bDFS) without increasing toxicity.

The higher relative biological effectiveness (RBE) and greater cytocidal effect on the intrinsic radiation resistant cancer cells offer carbon ion radiotherapy (CIRT) advantages over conventional radiotherapy. In this study, carbon ion were used to treat localized prostate cancer and simultaneous integrated boost to the gross tumor in the prostate specific membrane antigen (PSMA) PET/CT and multi- parameter MRI.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of prostate
* Stage cT1-3N0M0 localized prostate cancer
* performed PSMA PET/CT and mpMRI before treatment
* No lymph nodes or distant metastasis
* Age ≥ 45 and \< 85 years of age
* Karnofsky Performance Score ≥70
* No previous pelvic radiation therapy (RT)
* No previous prostatectomy
* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

* No pathologically confirmed adenocarcinoma of the prostate
* Pelvic lymph node metastasis (N1)
* Distant metastasis (M1)
* Previous pelvic radiotherapy
* Previous prostatectomy