cyrilzakka/clinical-trials huggingface dataset:
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer

The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction of any stage now with recurrent disease in the pelvis
* One prior course of radiation therapy to the pelvis for rectal cancer
* ECOG performance status 0-2
* At least 18 years of age
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Patients with pre-existing radiosensitizing conditions, such as connective tissue disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia)
* A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease, basal cell or squamous cell carcinoma of the skin that were treated with local resection only, or carcinoma in situ of the cervix. Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible
* More than one prior course of radiation to the pelvis for rectal cancer
* Prior radiation to the pelvis for disease other than rectal cancer
* Tumor in the rectum/colon requiring radiation therapy to the full circumference of the rectum/colon.
* Current treatment with any investigational agents.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or unstable angina pectoris
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry.
Urine Sample Collection From Non Pregnant Peri and Post-menopausal Women

This is a sample collection study, participants will be required to collect one (if last menstrual period ≥12 months) or two (if last menstrual period \<12 months) urine samples and return them to the study site, together with collection sample information. Participants having a menstrual cycle within the last 6 months will also be required to provide follow-up information on pregnancy status and date of next menstrual bleed.

Each subject will be provided with a urine sample collection container, a transport container, barcode labels, prepaid envelopes and a full set of study instructions, together with the materials required to facilitate the collection of a follow-up urine sample and completion of follow up form, where applicable.

Subjects admitted into the study that are unsure of their pregnancy status will be provided with a marketed Clearblue HPT, to test for pregnancy prior to beginning the study. If a subject informs the trial site that they have become pregnant prior to urine sample collection, they will be withdrawn from the study and no urine sample will be collected. The subject will return their materials to the study site, and the co-ordinator will complete the exit form.

Subjects will be required to collect a urine sample, label their sample (as soon as collected) with the appropriate bar-coded label provided and return this to the study site. Where it is not possible to return the sample as soon as collected, urine samples must be stored in a domestic fridge in the container provided for a maximum of 1 week and then sent to the study site at their earliest convenience.

Subjects will receive follow-up to establish pregnancy status unless ≥ 12 months from their last menstrual period (LMP). On completion of the study, subjects will be reimbursed for their participation.

It is anticipated that sample collection will be carried out remotely (i.e. at the volunteers home) but volunteers may attend the study site for sample collection should they require.

Eligibility Criteria:
Inclusion Criteria:

* Known to be not pregnant,
* Willing to give consent

Exclusion Criteria:

* Pregnant or breastfeeding,
* Pregnant within last 2 months,
* Having treatment for infertility,
* Taken hormonal contraception containing hCG in last month,
* Using hormonal contraception within last month,
* Previously taken part in sample collection study for SDP (providing 1-7 samples).
Gross Myofascial Release in Cervical Radiculopathy Pat

To investigate the Effect of gross Myofascial Release on pain and function in cervical radiculopathy patients. BACKGROUND: cervical radiculopathy is considered serious problems causing neck pain \& radiating pain which affect physical inactivity and function of a patient, thus gross Myofascial Release is a form of manual therapy technique that has a profound effect upon the musculoskeletal system.

HYPOTHESES:

This study hypothesized that:

gross Myofascial Release on pain and function in cervical radiculopathy patients RESEARCH QUESTION: Is there an effect of gross Myofascial Release on pain and function in cervical radiculopathy patients?

Forty patients with cervical radiculopathy will participate in this study. The patients will randomly be divided into two equal groups; the control group which received the conventional selected exercise program and the study group received the same exercise training program in addition to gross Myofascial Release, three times per week for four weeks. The evaluation methods are visual analogue scale (VAS), Electro-goniometer, Quick DASH scale, and Neck disability index

Eligibility Criteria:
Inclusion Criteria:

* 40 cervical radiculopathy patients,
* Age will range as (30:45) years old
* Cervical radiculopathy due to cervical spondylosis
* body mass index (25:29)

Exclusion Criteria:

* difficulty to communicate or to understand program instructions
* any other neurological deficits or orthopaedic abnormalities,
* secondary musculoskeletal complication
* Cervical disc prolapses
* Any other cervical problem
* Spinal stenosis
* Previous spinal surgery
Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors

A randomized controlled trial study is conducted to compare treatment efficacy between psycho-education, anxiolytics drug and proton pump inhibitors in participants who met the criteria of globus.

This is a randomized controlled trial in patients with globus. All participants will be allocated into 3 groups (16 subjects/group) : Proton pump inhibitors (miracid®) , anxiolytics drug (Deanxit®) and psycho-education. The study duration is 4 weeks long.

Data regarding clinical severity and quality of life of all participants will be collected at the beginning and at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Symptoms based on the following criteria: Persistent or intermittent nonpainful sensation of a lump or foreign body in the throat with no structural lesion identified on physical examination, laryngoscopy, or endoscopy.

  1. Occurrence of the sensation between meals.
  2. Absence of dysphagia or odynophagia

Exclusion Criteria:

* Subjects with psychological disease
* Significant heart disease and/or arrhythmia
* Proton Pump inhibitors and/or Histamine 2 Receptor Antagonist use within 2 weeks before randomization
* Mono-amine Oxidase inhibitors or Selective Serotonin Reuptake Inhibitor or Tricyclic antidepressant use within 2 weeks before randomization
* History of drug allergy that use in research
* Pregnancy or breast feeding
* Decline to participate in study
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty

Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty.

There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. The purpose of acromioplasty is to create adequate space for the rotator cuff tendons. Arthroscopic acromioplasty involves the removal of the subacromial bursa, resection of the coracoacromial ligament and anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement. However, acromioplasty without cuff repair has been reported to have both good and poor results, showing that the technique may be suspect in repair of full thickness tears alone.

The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff.

We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or older
* Complete rotator cuff tear up to 4 cm in size
* Persistent pain and functional disability for at least 6 months
* Failure of conservative treatment
* Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability

Exclusion Criteria:

* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of glenohumeral instability including Bankart lesions and labral tears of any type
* Previous surgeries of the shoulder
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Patients with partial thickness tears of the rotator cuff
* Patients unable to provide informed consent due to language barrier or mental status
* Patients with a major medical condition that would affect quality of life and influence the results of the study
* Patients with worker compensation claims
* Patients unwilling to be followed for the duration of the study
Clinical Precise Diagnosis and Treatment in the Kawasaki Disease

The purpose of this project is to explore the differential gene expression profile of Kawasaki disease, and will explore the diagnosis and treatment targets related to coronary artery injury or kawasaki disease susceptibility, vascular damage, IVIG (intravenous immunoglobulin) treatment resistance, incomplete Kawasaki disease, etc.

After being informed about the study and potential risks, all patients giving written informed consent will acquire blood samples with complete clinical data and prognostic information. Using clinicopathology, molecular biology, gene diagnostics and other techniques to verify the expression differences of target genes and proteins and analyze their expression levels; To analyze the role of target genes and proteins in the occurrence and development of Kawasaki disease and their correlation with the risk of coronary artery injury. In vitro and in vivo KD (Kawasaki Disease) model was used to investigate the role of target genes in Kawasaki disease by gene interference and various molecular biological techniques.

Eligibility Criteria:
Inclusion Criteria:

* Individual patient's medical file data confirmed the diagnosis of KD using diagnostic criteria issued by the American Heart Association in 2017;
* Patients were respond to IVIG treatment;
* the patients aged from 2 months to 14 years old;
* All included patients required to sign an informed consent form.

Exclusion Criteria:

* The patients with severe infections;
* The patients with a history of tuberculosis or recent close contact with tuberculosis;
* The patient vaccinated with live vaccine in 6 months;
* The patients with the application of hormone or other immunosuppressive agents;
* The patients didn"t want to signed informed consent.
A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services

The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM and transgender women.

Two community-based sites (LALGBT Center and The OASIS Clinic) will serve as facilities at which participants may present for screening for prevention services. At the sites, eligibility criteria will be assessed, HIV, Sexually Transmitted Disease (STD) and laboratory testing will be performed, and HIV prevention service referrals will be initiated. Follow-up will be on a monthly basis for the first three months, and then de-escalated to an every-3-month interval.

The program stratifies participants into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (LM) and a high-risk cohort (H). Participants in the LM cohort will be provided a customized prevention package (CPP) including access to PEP for emergency HIV prevention in the event of unanticipated HIV exposure. Participants in the H cohort will be provided a CPP including daily Truvada-based PrEP. All participants will be followed for 48 weeks. Participants in the LM cohort who, on longitudinal sexual risk behavior surveillance, report increased levels of sexual risk-taking such that they meet enrollment criteria for the H-cohort will be transitioned to the H-cohort.

At each follow-up visit, a careful safety assessment will be made, including signs/symptoms and laboratory assessments. STD testing will be performed at 3 month intervals. An escalating-intensity adherence intervention will be implemented based on real-time plasma tenofovir levels. A computer-assisted self-interview (CASI) will be used to capture detailed sexual risk, adherence, and substance use behavior.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Able to understand and provide consent in English or Spanish
* Self identified MSM, MSM/W, or Transfemale
* At least one male sex partner for anal intercourse in the prior 12 months
* HIV negative by enzyme immunoassay (EIA) and viral load (VL)
* CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)
* No signs or symptoms suggestive of primary HIV infection (PHI).

Exclusion Criteria:

* Participants \<18 years of age
* Unable to understand and provide consent in English or Spanish
* Known or found on testing to be HIV positive
* Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing
* Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry
* Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
* Signs or symptoms suspicious for PHI.
Does Recurrent Pancreatic Cancer Really Have Similar Outcome Compared With Primary Metastatic Pancreatic Cancer?

The recurrent pancreatic cancer (Rec-PC) after radical surgery is sometimes eligible to clinical trial of chemotherapy for unresectable pancreatic cancer. However, the difference between Rec-PC and primary metastatic pancreatic cancer (PM-PC) did not know well. Thus, whether Rec-PC and PM-PC should be included in the same category when conducting clinical trials evaluating chemotherapy remains controversial. The purpose of this study is to investigate the difference of overall survival (OS) between Rec-PC and PM-PC, and analyze their impact on prognosis.


Eligibility Criteria:
Inclusion Criteria:

* unresectable pancreatic cancer

Exclusion Criteria:

* Patients expected to survive for less than three months
Risk Factors of Postoperative Acute Lung Injury Following Liver Transplantation

Postoperative acute lung injury (ALI) during the first 72 hours after liver transplantation is not uncommon. Injury may occur because liver transplantation is often associated with prolonged operative time, large volumes of fluid administration and transfusion, as well as inflammatory responses related to ischemia-reperfusion injury. For more precise perioperative fluid and hemodynamic management, modern monitoring systems, such as the pulse contour cardiac output (PiCCO) system, have been devised and reported in recent years. The PiCCO system uses the thermodilution technique to determine the cardiac index (CI) and thoracic fluid indices such as the intrathoracic blood volume index (ITBVI), extravascular lung water index (EVLWI), and pulmonary vascular permeability index (PVPI), all of which may reflect pulmonary fluid and injury status. However, perioperative changes in thoracic fluid indices in liver transplantation and their associations with postoperative ALI are not yet clear. In this study, the investigators aimed to determine patterns of change in perioperative thoracic fluid indices and compare these changes in recipients who did or did not develop postoperative ALI. Furthermore, the investigators will also try to determine the potential risk factors following liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* End stage liver disease receiving liver transplantation in NTUH.
* Age: 6 months old to 75 years old

Exclusion Criteria:

* history of pulmonary resection,
* chronic respiratory insufficiency
* cardiac dysfunction
* failure of the surgery.
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF

This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.

Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.

Eligibility Criteria:
Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 12 to 65 years old;
3. Serum total bilirubin level \> 10 times upper limit of normal;
4. Prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5；
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Using glucocorticoid;
8. Patients can not follow-up;
9. Investigator considering inappropriate.
Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis

The aim of this clinical study is to evaluate the success of buccal infiltration (BI) anesthesia + intraligamentary (ILI) anesthesia between inferior alveolar nerve block (IANB) anesthesia + buccal infiltration anesthesia in mandibular molar teeth with acute symptomatic irreversible pulpitis.The main questions it aims to answer are:

* Does the anesthesia techniques adequate to perform root canal treatment painlessly?
* Which technique achieved pulpal anesthesia? Participants were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. Then, root canal treatment was performed.

Researchers were compared the success of anesthesia techniques in different stages of root canal treatment.

A total of 50 patients, aged between 18-65, who were diagnosed with symptomatic irreversible pulpitis of the mandibular molar tooth, were included in this study. The patients were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. After the anesthesia, a rubber dam was placed on the associated tooth of the patient for root canal treatment, the endodontic access cavity was opened, and canal preparation procedures were started. The pain levels felt by the patients during the endodontic treatment stages (starting the treatment, opening the endodontic access cavity and pulp extirpation) were determined by Heft-Parker VAS (HP-VAS) scale. Anesthesia was considered successful in patients who felt no pain (HP-VAS ratio = 0) or mild pain (HP-VAS ratio ≤ 54) during the procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy patients
2. The absence of periapical pathology
3. Not sensitive to articaine or epinephrine
4. No facial paresthesia
5. Not taking any analgesic drug 6 hours before treatment
6. Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers
7. The absence of pathosis in areas planned for injection
8. Not pregnant
9. The absence of pathologic periodontal pockets during probing
10. Patients with a mandibular first molar tooth exhibiting symptomatic irreversible pulpitis

Exclusion Criteria:

-
Trigger Thumb Randomized Controlled Trial

We are conducting this study to determine if administration of local anesthetic to the thumb prior to surgery can reduce the amount of anesthetic gas given during the course of surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, age 0-4 years, presenting to the Children's Hospital of Philadelphia (CHOP) Department of Orthopaedics with unilateral trigger thumb that requires surgical treatment.
2. American Society of Anaesthesiologists (ASA) Classification of 1 or 2.
3. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Males or females over the age of 4.
2. ASA Classification higher than 2.
3. Patients presenting with systemic diseases or significant comorbidities.
4. Patients that received treatment for trigger thumb at an outside institution.