cyrilzakka/clinical-trials huggingface dataset:
Modeling Organ Motion During Abdominal Imaging in Healthy Volunteers

In this study, we plan to systematically analyze the motion of organs and tissues in the abdomen, to understand the physical mechanisms of three-dimensional (3D) motion and interactions of abdominal organs and tissues. This work will allow us to learn how to mathematically model and predict abdominal organ motion.

Specifically, we plan to conduct this study in 3 steps, in an order of increasing complexity, starting with the (intra-fractional) respiratory only motion, then adding intra-fractional GI motility motion, and finally the inter-fractional anatomical variations (adding food intakes and fecal excretion). The research methods described will allow the study team to develop the ability to estimate the motion of both tumor target and critical organs given the patient's MRI, CBCT or x-ray fluoroscopy images on the day of radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* No contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, body habitus, claustrophobia).
* May have pre-existing medical conditions provided they are capable of completing the exam and their condition is not expected to affect the physical tissue properties of the organs that will be imaged.
* Women of child-bearing potential must verbally confirm lack of pregnancy prior to signing consent

Exclusion Criteria:

* None
Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.

Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy
* Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
* No alveolar bone loss
* Identifiable cemento-enamel junction
* Probing depth ≤3mm

Exclusion Criteria:

* Smoking
* Pregnancy
* History of periodontal surgery in last two years
* Mobility
* Excessive occlusal contacts
* Caries
* Loss of vitality
Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain

The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.

Pelvic floor pain may be treated with trigger point injections with medications (steroids and local anesthetics) that are FDA approved for injection into muscles. The alternative is a noninvasive treatment option using pelvic rehabilitation which involves vaginal muscle massage. Both treatment options have been used and reported; however, rapidity of improvement and return to normal sexual function have not been assessed. This study assigns patients to either treatment option randomly and the sexual function is assessed based on standardized sexual function questionnaires as well as pain ratings.

Eligibility Criteria:
Inclusion Criteria:

* pelvic pain
* pelvic floor myalgia
* dyspareunia
* female
* age \> 18 years

Exclusion Criteria:

* interstitial cystitis
* vaginal lesions / ulcerations
* prior trigger point injections in the past 6 months
* prior pelvic rehabilitation in the past 6 months
* laparoscopically documented endometriosis / pelvic adhesions or adhesive disease
* documented pelvic inflammatory disease identified within the past 6 months
* documented sexually transmitted disease within the past 6 months
Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients

This study is a Randomized clinical trial comparing the effectiveness of two different mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and dental models will be taken for each patients pre and post -retraction. Following complete anterior segment retraction, the rate and duration of retraction will be evaluated for both groups as well as patient satisfaction with treatment. Changes in incisors inclination and soft tissue as well as anchorage loss will be also assessed.

Adult patients with Class I bimaxillary dentoalveolar protrusion will be recruited. All the patients need extraction of upper first premolars followed by anterior segment retraction and maximum anchorage.

The patients will be randomly allocated to one of two groups; either Friction or Frictionless group. In friction group, Nickel Titanium coil spring will be used for retraction of anterior segment while in frictionless group, T-loops will be used for retraction. All the patients will receive two miniscrews , one on each side to achieve maximum anchorage during retraction.

The patients will be seen on a monthly basis for follow up visit for activation of the appliance to maintain constant force during the study. An impression will be taken for the patients every visit, poured into stone for fabrication of dental models. The models will be used to monitor the rate of retraction of anterior teeth.

Every patient will be asked for lateral cephalometric radiograph before and after complete retraction. After data collection, two assessors will carry on the measurements blindly and independently. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for en-masse retraction.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult patients with age range 18-30 yrs old.
2. Class I bimaxillary dentoalveolar protrusion .
3. Full permanent dentition.
4. Good oral hygiene.
5. Maximum anchorage is required.
6. Healthy bone between first molars and second premolars is needed.

Exclusion Criteria:

1. Systemic disease.
2. Severe crowding.
3. Extracted or missing upper permanent tooth/teeth (except for third molars).
4. Any signs or symptoms or previous history of temporomandibular disorders (TMD).
5. Previous orthodontic treatment.
Yoga Cancer Rehabilitation Study: A Randomized Trial of Adaptive Yoga for Older Cancer Survivors

With advances in the detection and treatment of cancer, there are now 14 million cancer survivors in the U.S., 500,000 of whom are treated in the Veterans Health Administration. The mental and physical health consequences of cancer and its treatment may affect a Veteran's functioning and re-integration back into family, work, and daily life. Recent studies suggest that yoga may be an effective intervention for improving both the physical and mental health of individuals after cancer, although this has not been studied in Veterans. This study has three components: (1) Determine factors that increase participation in Yoga by Veterans using individual interviews and focus group; (2) Create a Yoga protocol for Veterans adapted from an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and tolerability; (3) Evaluate the efficacy of Yoga for improving fatigue, insomnia, anxiety, and depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.

With a 1 and 2 lifetime risk of diagnosis, cancer is a highly prevalent disease. Cancer and its treatment are associated with long term mental and physical side effects that impair physical, vocational, and social role functioning. In order to provide excellent care for Veterans, rehabilitative strategies to improve mental and physical health after cancer treatment need empirical study. The objective of the proposed pilot project is to create a Veterans' Yoga Rehabilitation Program for cancer survivors who receive care in the Veterans Health Administration, that is based on an existing evidence based protocol which is systemically adapted, marketed, and tested in a Veteran population, with 3 aims:

Aim 1: Enhancing Acceptability To determine factors that will increase participation in Yoga in Veterans after treatment for cancer, who are primarily male and older than age 60.

Aim 2: Adapting to Veterans To create a Yoga protocol by adapting an empirically supported Yoga protocol to the needs of Veterans.

Aim 3: Evaluating Efficacy To evaluate the efficacy of the Yoga protocol for improving health related quality of life in four domains, and, to determine if efficacy varies as a function of patient age or pre-existing Post Traumatic Stress Disorder. The long term goal is to develop an evidence based mind-body Yoga intervention to support healing and restore function in Veterans Health Administration patients for use after treatment for cancer.

Eligibility Criteria:
Inclusion Criteria:

* Cancer treated in the past 3 years

Exclusion Criteria:

* Dementia
* Psychotic Disorder
* In hospice care
Epithelial Damage in GERD

The purpose of this study is to characterize and compare epithelial damage in patients with erosive esophagitis and non-erosive reflux disease.


Eligibility Criteria:
Inclusion Criteria:

* Typical GERD-symptoms lasting for more than 6 months (recurrent episodes of heartburn or acid regurgitation)
* abnormal pH-parameters (pathological acid exposure and/or symptom association)

Exclusion Criteria:

* Age \<18 years
* Previous esophageal or gastric surgery
* Severe esophageal motility disorder on manometry
* Histological evidence of Barrett's mucosa
* Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure)
* Use of anticoagulant or immunosuppressive drugs
* Inability to stop medication that can influence the test results, like PPI, for at least 10 days before tests
* Excessive alcohol consumption (\>20 units per week)
* Patients unable to give informed consent.
Normal Saline Use With Suctioning

A long-standing intervention during tracheostomy tube suctioning in acute care settings is use of saline to loosen and remove respiratory tract secretions, maintain airway patency, and prevent mucus plugs. Controversy exists regarding safely using saline prior to suctioning for head and neck cancer and mechanically ventilated patients. To date, all studies had methodological limitations. In 2013, the clinical consensus statement published by AAO-HNSF identified a research gap based on lack of strong scientific evidence. A single site, randomized controlled pilot study will be conducted to evaluate effects of saline instillation with tracheostomy tube suctioning; test feasibility of proposed methods and procedures; and ensure proposed outcome variables are measurable and not confounded by extraneous variables. Institutional review board approval will be obtained before eligible adult subjects (inpatient and intensive care units) are recruited and consented. Oxygen saturation and heart rate are primary outcome variables; secondary outcome variables are mucus plugs and ventilator-associated pneumonias; other demographic data and patient characteristic variables; and outcome variables on complications and length of stay. Mean, standard deviation, median, and interquartile range will be calculated for continuous variables using t-tests to compare pre- and post-assessment scores. Frequencies and percentages will be calculated for categorical variables using Chi square and Fisher Exact tests to compare pre- and post-assessment scores. Multiple regression analysis will be used to control for confounding variables. This study is innovative as the first to recruit both head and neck cancer patients and mechanically ventilated patients and to measure all major outcomes of interest in one study. Understanding the effects of normal saline instillation will enable development of evidence-based guidelines and standardized protocols for tracheostomy tube suctioning.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients, ages 18 or older, cared for on adult inpatient units/wards.
* Patients who have a tracheostomy tube.
* Tracheostomy tube has been in place at lease for 72 hours (to avoid any late effects of anesthesia that was administered at the time of tracheostomy tube placement).
* Patients must have a physician order to suction the tracheostomy tube at least every 8 hours. This will help us to recruit patients for whom suctioning is already part of standard care. Therefore, patients will not undergo unnecessary suctioning for the purpose of the study.
* Expected hospitalization to be 5 days or greater after consent.

Exclusion Criteria:

* Fresh tracheostomy that still has bleeding from the stoma (\< 72 hours since the surgical placement of a tracheostomy tube).
* Active respiratory distress or hemodynamic changes that warrant a change in the existing treatment plan.
* Patients who are expected to die or undergo withdrawal of treatment within 48 hours.
* Patients who are allergic to latex to avoid a reaction with the red rubber suction catheter that will be used in the study.
REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study

The investigators propose to perform serial detailed cognitive, motor, behavioral, and blood collection follow-up using longitudinal structured telephone interviews of an anticipated 350 ICH survivors enrolled in Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation (MISTIE) III and ENRICH trials to identify specific cognitive and motor impairment and to perform RNA sequencing to evaluate for evidence of chronic inflammation. The investigators' expected sample size in 2022 accounts for mortality attrition of 10%/year.

The REASSESS study will conduct long-term cognitive, functional, and neuropsychiatric performance assessments to determine if evacuation of spontaneous intracerebral hemorrhage (ICH) reduces the risk of later cognitive decline in the ageing brain. This study will compare rates of cognitive decline under two treatment strategies for intracerebral hemorrhage: the use of minimally invasive surgery with two similar techniques as performed in the MISTIE III and ENRICH trials, and the current standard of care using data from controls in MISTIE III and ENRICH and comparative data from The Ethnic/Racial Variations of ICH (ERICH) study (U-01-NS067963) extended into the ERICH-Longitudinal study (R01-NS093870) which followed over 900 of ERICH cases with serial cognitive examinations.

Eligibility Criteria:
Inclusion Criteria:

* Participants in the study must be survivors enrolled in MISTIE III and ENRICH trials at end of each trial's final follow-up (day 365 in MISTIE III and day 180 in ENRICH). Relatives of known survivors that are found to be deceased since the end of each trial will be interviewed to capture relevant data.

Exclusion Criteria:

* None
CT in Diagnosing Patients With Lung Cancer

This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.

PRIMARY OBJECTIVES:

I. Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.

II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.

III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.

OUTLINE:

Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Measurable disease on CT scan
* Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
* Patients must be able to perform ABC procedures

Exclusion Criteria:

* Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
* No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
* Women of childbearing potential will undergo a pregnancy test
A Study About the Operation Efficacy and the Early Stage Safety of Heavy Ion Beam Treatment System in Solid Tumor

The main purpose of this study is to investigate the safety of Hitachi's Heavy Ion Beam Therapy System HyBEAT for treating patients with solid tumor in Taipei Veterans General Hospital, including patients early-stage adverse reactions and the efficacy on tumors, as well as to assess the operation efficacy of the device.


Eligibility Criteria:
Inclusion Criteria:

1. Must be 20 years of age inclusive, male or female
2. Diagnosed with one of the following cancer: head and neck cancer, lung cancer, liver cancer, prostate cancer, osteosarcoma or bone and soft-tissue tumours
3. Having a lesion of less than 12cm
4. Having no metastasis at distant organ sites
5. Having a life expectancy of more than 12 weeks or longer
6. ECOG Performance Status (ECOG PS): 0, 1 or 2
7. Maintain the function of major organs and satisfy the following criteria: WBC≥3,000 / mm3 , Plt

   ≥75,000 / mm3 (assuming no serious bleeding tendency below 100,000), Hb≥9.5 g / dl
8. Able to maintain body position during irradiation
9. Based on his/her free will, agree to participate in the clinical study and sign and date the informed consent form after understanding the clinical study.

Exclusion Criteria:

1. Weigh more than or equal to 135kg
2. Subjects need chemotherapy or immunotherapy as concomitant treatment
3. Have received radiotherapy on the area planned to be irradiated
4. Have received local treatment that might potentially affect endpoint evaluation, 4 weeks prior to the screening process (for instance TACE etc.)
5. Have been treated with targeted therapy, chemotherapy or immunotherapy 4 weeks prior to the screening process
6. Participated in other clinical studies within 12 weeks before screening (studies using questionnaire are exemption)
7. Subjects contraindicated in using radiotherapy
8. Wearing electronic devices, for example implantable cardiac pacemakers, implantable defibrillators, cerebrospinal stimulators, artificial hearts and cochlear implants, where the function and activity may be affected by radiation
9. Have been diagnosed with another active, uncontrolled cancer
10. Subjects whose irradiated area has active or persistent infectious disease
11. Has autoimmune diseases or connective tissue diseases
12. Subjects with other serious complications
13. Pregnant or currently breastfeeding
14. Planning to give birth or unable to take contraception during the screening and treatment period, as well as within 52 weeks after receiving the last treatment, regardless of gender.
15. Subjects who are judged by the investigators as unsuitable
Intermediate IND Severe Illness COVID-19 CP

Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.

Subjects will receive open-label screened plasma from COVID-19+ clinically resolved individuals (≥14 days post-resolution). Dosing of single or double plasma units (weight based \< and \> 90Kg) will be administered on days 0, 2, 4, 6, and 8 (based on plasma availability), or until futility (if either occurs before day 8) is determined by the ICU. Doses can be omitted at the discretion of the treating clinician (e.g., TRALI events are 100% donor-dependent and do not prohibit future transfusions).

The study drug is the investigational product, anti-SARS-CoV-2 convalescent plasma obtained from the American Red Cross or local plasma supply (medicDal center or city/region-wide shared blood bank) from patients identified as having recovered from COVID-19. Donors and samples will be screened for infections transmitted via transfusion (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T.cruzi, ZIKV) both through the use of the uniform donor questionnaire and FDA mandated blood donor screening tests. Plasma will be collected using apheresis technology or whole blood collection in accordance with standard FDA and blood bank protocols.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed COVID-19
* Severe or Immediately life threatening COVID-19
* Dyspnea
* Respiratory frequency \> 30/minute
* Blood oxygen saturation \<93%
* Life-threatening disease is defined as the following
* Respiratory Failure.
* Septic shock, and/or,
* Multiple organ dysfunction or failure.

Exclusion Criteria:

* Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
* Other documented uncontrolled infection.
* Severe DIC needing factor replacement, FFP, cryoprecipitate.
* On dialysis.
* Active intracranial bleeding.
* Clinically significant myocardial ischemia.
System for Ocular Oxygen Measurement

The purpose of this study is to demonstrate the ability of the OcuMetrics system to measure oxygen on the surface of the eye. Oxygen is important to the health of the cornea. The proposed instrument will take advantage of phosphorescent dyes that are sensitive to oxygen concentrations to monitor oxygen concentrations on the surface of the eye. This will have obvious applications in eye research and contact lens testing.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* contact lens wear in last 6 weeks
* Use of topical drugs