cyrilzakka/clinical-trials huggingface dataset:
The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer

Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

Biliary tract cancer (BTC) compromises a heterogenous group of tumors with poor prognoses. Curative surgery remains the first choice for localized disease; however, most BTC patients had unresectable or metastatic disease. The gold standard therapy for these patients is chemotherapy with gemcitabine and cisplatin. There are no consensus guidelines for standard treatment in a second-line setting, although the data of the ABC-06 trial showed a slight survival benefit from oxaliplatin and 5-fluorouracil combination chemotherapy.

Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 20 and above.
2. Pathological reported showed adenocarcinoma or adenosquamous carcinoma for patients with BTC (include IHCC, EHCC, GBC or AVC) or hepatocholangiocarcinoma as locally advanced or metastatic status.
3. Willingness to provide the residual biopsy/operative slides.
4. Life expectancy more than 3 months.
5. Patients fully understand the protocol with the willingness to have regular follow-up.
6. Patients are ready to have 1st systemic treatment or under 1st line therapy
7. Total bilirubin ≦5 mg/dL, and ECOG≦2

Exclusion Criteria:

1. Inability to cooperate by providing a complete medical history.
2. No available tumor tissues for genetic testing.
3. Undesirable compliance.
4. Other malignancy within the past 1 years except adequately treated basal or squamous cell skin cancer or cervical cancer in situ.
A Study on the Pathogenesis and Determinants of Intravenous Leiomyomatosis

The goal of this observational study is to learn about the impact of HPV infection in women with intravenous leiomyomatosis(IVL). The main question it aims to answer is:

Does HPV infection promote the development of IVL from uterine leiomyoma? Surgical sections and HPV-DNA test results will be collected in participants diagnosed with IVL or uterine leiomyoma.

Previous proteomic studies have demonstrated that HPV infection-related proteins are more highly expressed in intravenous leiomyomatosis (IVL) compared to uterine leiomyoma (uML). Consequently, we conducted a case-control study to investigate the association between HPV and the development of IVL. We recruited adult patients diagnosed with either IVL or uML, collected their medical histories, surgical specimens from various sites, and HPV-DNA test results from cervical exfoliated cells, and performed subsequent statistical analyses and mechanistic investigations.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients with suspected IVL or uterine leiomyoma who receive surgery at PUMCH
* Be able to understand and sign the informed consent

Exclusion Criteria:

* Patients with other concurrent malignant tumors
* Pregnant or lactating female
* Postoperative pathology do not include IVL or uterine leiomyoma
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetic peripheral neuropathic pain
* Chronic daily pain present for at least 2 months
* On stable analgesic regimen for one month
* Baseline pain score greater than 40mm on a visual analog scale

Exclusion Criteria:

* Hypersensitivity to compounds in study drug or similar drugs
* Pregnant or lactating females
* Drug or alcohol abuse
* Unstable medical condition
The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation

The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).


Eligibility Criteria:
Inclusion Criteria:

1. Age\>=18Y;
2. Good Organ Function;
3. Expected survival time ≥ 3 months;
4. Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;
5. At least one measurable lesion as per RECIST v1.1;
6. ECOG score 0-1.

Exclusion Criteria:

1. Previous treatment with BRAF inhibitors or MEK inhibitors
2. Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
3. Active clinical severe infection;
4. A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the effectiveness of nutrition therapy in combination with education in diabetes using a multimedia application for improving indicators of metabolic control in patients with type 2 diabetes.

Randomized clinical trial. Subjects with type 2 diabetes from three Family Medicine Units (primary care), with HbA1c \>6.5% and \<13.0%, without advanced macro or microvascular complications of diabetes.

Two arms: the experimental group with nutrition therapy plus education in diabetes through a multimedia application. The application had seven modules: Introduction, nutrition, physical exercise in diabetes, myths and truths on diabetes, metabolic control parameters, knowing diabetes, complications of diabetes. The control group received only usual nutrition therapy.

A monthly follow up during the first 7 months and then bimonthly, until 21 months of total follow up, with reinforcement in each visit of nutrition and other non-pharmacological therapy, with control on weight and blood pressure. Laboratory studies included HbA1c, lipids profile, creatinine and albuminuria, performed at 7, 14 and 21 months. Results were provided to both the patient and his family physician, so modification in drug treatment if needed, were performed.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of type 2 diabetes, following ADA \& WHO criteria
* Without severe marco or microvascular complications of diabetes
* HbA1c \> 6.5% and \<13.0%

Exclusion criteria:

* Inability to or unwillnigness to access the multimedia or to follow dietary recommendations
Treatment With Pirfenidone for COVID-19 Related Severe ARDS

A randomized, open label, two arm, pilot trial of Pirfenidone 2,403 mg administered per nasogastric tube or orally as 801mg TID for 4 weeks in addition to Standard of Care (SoC), compared to SoC alone, in a population of COVID-19 induced severe ARDS. Patients will be randomized according to 1:1 ratio to one of the trial arms: Pirfenidone (intervention arm) or SoC (control arm).

The objective of the trial is to evaluate the safety and efficacy of treatment with Pirfenidone vs SoC in COVID-19 induced severe Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation.

Following initial diagnosis of COVID-19, severe ARDS patient will be admitted to a dedicated intensive care unit (ICU) at Soroka University Medical Center (Day 0). Upon admission, patients will be randomized according to 1:1 ratio to one of the trial arms and receive either Pirfenidone 2,403mg administered through nasogastric tube as 801mg TID (intervention arm) plus SoC or only SoC treatment (control arm).

Patients' vital signs (temperature, blood pressure, pulse rate per minute, breath rate per minute, oxygen saturation) urine output, ventilation settings, and respiratory parameters will be monitored according to SoC. Symptom will be captured daily from patients as well as adverse events (AEs) assessment and recording of the need for any supportive care during the period of ICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages 18-80 years
* Diagnosis of COVID19 with severe ARDS (PaO2/FIO2 \<150mmHg)
* Admission to the ICU and in need of mechanical ventilation
* Able to give informed consent according to local regulations. If the patient is unable to give written informed consent, the form will be read to them and their verbal consent will be documented. If the patient is sedated, an impartial ICU physician will approve eligibility.

Exclusion Criteria:

* Previous use of nintedanib or pirfenidone
* Administration of fluvoxamine 7 days prior to admission to ICU
* Severe hepatic impairment (liver enzymes and bilirubin\>2 of normal upper limit, at day 0) or end stage liver disease
* Severe renal impairment (CrCl \<30 ml/min) or end stage renal disease requiring dialysis
* Pregnancy
* Participation in any other clinical trial 30 days prior to enrollment
Virtual Reality and Pain

Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Ages 8 - 18 years
* Able to read, understand and speak English
* Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service

Exclusion Criteria:

* Outside the age range (\< 8 or \> 18 years)
* History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
* History of vertigo, dizziness, and/or seizure disorder
* Conditions that would preclude the application of the VR headset, such as surgeries of the head and neck
Effects of Bracing on Knee Osteoarthritis (OA)

Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness that commonly alter the way one will climb stairs and walk reducing an individual's function and the activities they may perform on a day-to-day basis. Providing a person with a knee brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain and lead to improved function. The purpose of this study is to determine if use of the Rebel Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve strength and balance, and enhance functional activities such as stair and level gait, and ultimately lead to increased participation in the community.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged between 35 and 70
* Present with diagnosed unicompartment osteoarthritis of the knee

Exclusion Criteria:

* Severe cardiac or pulmonary disease that limits ability to walk.
* Presence of hip, ankle or foot OA or other lower limb pathology that limits ability to walk.
* Bilateral knee OA
* Previous use of an OA knee brace
* Surgical procedure in either leg within the past 6-months
* Anthropometrics that are incongruent with manufacturer's specifications for the Rebel Reliever
R3 Delta Ceramic Acetabular System PAS U.S.

R3 Delta Post-Approval Study U.S.

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic Acetabular System is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the study is a total of approximately 5 years: 6 months for site initiation, 12 months for subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up interval.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18-75 years old and he/she is skeletally mature
* Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
* Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
* Patient is willing and able to participate in required follow-up visits and to complete study procedures and questionnaires
* Patient has consented to participating in the study by signing the IRB/EC approved informed consent form

Exclusion Criteria:

* Patients with insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis
* Patients with neurological or muscular conditions that would place extreme load or instability upon the hip joint
* Patients with active joint infections or chronic systemic infection
* Obese patients where obesity is defined as BMI ≥ 40
* Skeletal immaturity
* Known allergy to implant materials
Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol

The purpose of this study is to modify the opioid titration order sheet to meet the needs of the outpatient hospice population and to conduct a pilot trial to assess feasibility, utility, and derive preliminary efficacy data.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligibility includes:

  * Alive Hospice outpatient
  * Diagnosis of carcinoma
  * Pain requiring fixed dose opioids
  * Age \> 21 years
  * Not pregnant or lactating
  * Willing and able to sign informed consent
  * Able to speak/comprehend English

Caregiver eligibility will include:

* Caregiver for an Alive Hospice patient
* Willing and able to sign informed consent
* Able to speak/comprehend English

Hospice Staff eligibility will include:

* Currently on staff at Alive Hospice
* Willing and able to sign informed consent
* Able to read/speak English.

Referring Physician eligibility will include:

* Having recently referred patients to Alive Hospice
* Willing and able to sign informed consent and able to read/speak English.

Exclusion Criteria:

* patients \< 21 years of age
* pregnant or lactating
* patients, caregiver and or Hospice staff that does not speak/comprehend English
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. All consecutive patients aged ≥18 years who underwent pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed) at participating centers from January 2010 to December 2013 were enrolled in the registry. During follow-up the occurrence of the first syncopal relapse after pacemaker implantation is recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing pacemaker implantation for bradyarrhythmic syncope

Exclusion Criteria:

* age \<18 years
Detection of Aggressive Breast Tumors Using Tc-99m-NC100692

The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.


Eligibility Criteria:
Inclusion Criteria:

* Have a lesion on mammogram, ultrasound or breast MRI that measured \< 15 mm in diameter, is considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4b, 4c or 5), and is scheduled for biopsy (needle biopsy and/or surgical biopsy).

OR

* Have a lesion on mammogram, ultrasound or breast MRI that measured \> 15 mm in diameter, is known to be malignant and is scheduled for surgery.
* Patient age \> 18 years of age.
* Have a negative pregnancy test on the first day of the study, or must be postmenopausal or surgically sterilized.

Exclusion Criteria:

* Patients will be excluded if they have a small lesion (\< 15 mm) and have undergone prior needle biopsy of the lesion (such biopsy may effectively remove all or part of the lesion and angiogenesis associated with wound healing might confound imaging results with 99mTc-NC100692).
* Patient's pregnancy is not negative on the first day of the study, or the patient is unable to complete the pregnancy test
* Patient is unable to sit on a chair for 40 minutes
The Effects of Two Different Ventilation Strategies on Lung Ventilation: An Ultrasonographic Evaluation.

This study will be performed in robotic assisted laparoscopic radical prostatectomy patients in Cerrahpasa Medical Faculty Monoblock Operating Room. Since robot-assisted laparoscopic radical prostatectomy is a surgical procedure which requires long-term mechanical ventilation, excessive trendelenburg position (30-45 °) and pneumoperitoneum; these interventions may lead to respiratory complications such as ventilation difficulty and aeration loss in patients. Nowadays, lung ultrasonography has been used in anesthesia practice and intensive care units in order to determine lung aeration loss. In this study, the investigators aimed to compare the possible aeration loss in lung parenchyma during pressure controlled ventilation and volume controlled ventilation which are frequently used in anesthesia practice in patients undergoing robotic radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria: 18-75 age

* Patient who will be undergo robot assisted laparoscopic prostatectomy surgery
* Patient with ASA (American Society of Anesthesiologists) Score 1-3

Exclusion Criteria:

* Patients with ASA Score above 3
* Patients with obstructive (FEV1\<%60) or restrictive pulmonary disease (FVC\<%60)
* Patients with intrathoracic operation history
* Heavy smokers (\>25 cigarettes/day)
The Effect of Plantar Vibration Stimuli on the Balance of Older Women

The objective of the present study was to identify the effect of direct vibration at a frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or older. The hypothesis is that the place improves body balance.


Eligibility Criteria:
Inclusion Criteria:

* women aged 60 or older, static balance deficit verified by the One-Leg Stance test with eyes open (OLSeo) (inability to maintain position for 30 seconds with eyes open, which is associated with the risk of falling17), independent gait without the use of walking aids.

Exclusion Criteria:

* individuals undergoing treatment to improve balance, inability to understand verbal commands, pathologies that affect balance and gait, use of medication that may affect balance, lower limb surgery in the past 12 months or participation in a physical activity program.
Measurement of Tracheobronchial Tree Using 3D CT

Anatomical variations of right main bronchus have been discouraged anesthesiologists' use of right-sided double lumen tubes to facilitate one-lung anesthesia. However, there are absolute indications of right-sided DLTs surgically, such as left pneumonectomy or in cases with left main endobronchial lesions.

With recent advances of 3-dimensional spiral CT reconstruction technique, the investigators conducted this retrospective study to measure accurate length of right and left main bronchus and the angle between the center of the right main bronchus and right upper lobe orifice in axial image to help choosing and further manufacturing right-sided double-lumen tubes.

All CT images will be reviewed using the image measurement software with a slice thickness of 1 mm. A level of -450 Hounsfield units and a width of 1000 Hounsfield units were used for bronchial window settings.

The length of right and left main bronchus will be measured from the tracheal bifurcation to the point of their first branches, respectively, in both 2D- and 3D-CT images. The anteroposterior angulation of right upper lobar bronchus will be measured from the axial 2D-images by the angle between the horizontal midline of the right main bronchus and the center of the RUL orifice which indicates the origin of the RUL bronchus in which the right upper lobar bronchus shows maximal diameter.

Eligibility Criteria:
Inclusion Criteria:

* 3D- thoracic CT scan images obtained between March 1st and October 31th, 2016

Exclusion Criteria:

* younger than 18
* with intraluminal lesions in main bronchus
* with abnormalities of tracheobronchial tree
* with history of tracheobronchial injury or surgery
* diagnosed musculoskeletal deformity.
Knee Aspiration and High Definition MRI for ACL Injury

The aim of this pilot study is to understand the biological changes that occur within the knee joint following injury to the anterior cruciate ligament (ACL). This will be achieved through aspiration and analysis of the haemarthrosis which fills the knee following injury. The study will look at inflammatory and healing responses using DNA, RNA and protein analysis.

This, combined with high resolution imaging of the knee and surrounding soft tissue structures, may enable a more patient specific approach to treatment of ACL injury.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ACL injury confirmed by MRI
* All participants must have the capacity to provide informed consent to participate
* Participants must be able to comply with required study visit

Exclusion Criteria:

* Participants outside of the specified age range
* Participants who do not have the mental capacity to make informed decisions
* Participants who have meniscal pathology or other injuries requiring urgent surgery