cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac

The purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator \[Linac\]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed new diagnosis of HPV-positive OPC \[i.e. Base of tongue, tonsil, soft palate, vallecula, and posterior pharyngeal wall\]
* American Joint Committee on Cancer (AJCC) 8th edition Stage I-III planned for definitive chemoradiation.
* Members of all races and ethnic backgrounds
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for duration of study participation.
* Must be able to understand and sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria:

* Prior surgery, chemotherapy, or radiation treatment for head and neck cancer
* Prior history of cancer other than non-melanomatous skin cancer
* Distant metastases (cM1) or (pM1) disease)
* Evidence of a compromised airway
* Medical contraindications to MRIs
* Unable to tolerate MRIs without sedation
* Pregnant patients
* Breastfeeding patients
* Eastern Cooperative Oncology Group (ECOG) performance status \>1
Derivation of Induced Pluripotent Stem Cells From an Existing Collection of Human Somatic Cells

Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation.

The major goal of the project is to develop human iPS cells from various types of cell cultures or lines from existing collections. The IPS cells will be developed for modeling diseases, for developing the technology that may eventually allow the use of IPS cells for transplantation therapy, and for basic research.

The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc.

We will induce the differentiation of the iPS cells towards specific cell lineages and the progeny can be used to study the pathogenesis of diseases. They will be used for developing new therapeutic approaches and for high throughput screening of factors for potential toxic or therapeutic effects.

All samples will be non-identified.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers
* Male and Female

Exclusion Criteria:

* Below the official age of consent
Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease

The trial will test the hypothesis that edible structures within plant cells (ginger) will have clinically important anti-inflammatory effects on the gut lining of patients with inflammable bowel disease.

To evaluate the safety and tolerability of exosomes with and without curcumin in patients with Inflammatory Bowel Disease (IBD); To estimate the effect of ginger exosomes or curcumin alone or combined with curcumin on the symptoms and disease score in patients with refractory IBD describe toxicities associated with ginger exosomes; to evaluate the effect of ginger exosomes on biomarkers of inflammation.

Up to 90 patients with Chronic IBD will be enrolled, with the goal of having three arms of 30 subjects in each group who are eligible for evaluation.

This exploratory trial is designed to estimate the effect of ginger exosomes or curcumin on IBD symptoms compared to ginger exosomes plus curcumin. In this prospective and randomized study the main focus is to compare exosomes alone, curcumin, and exosomes plus curcumin. Three primary stratification factors race (white and black), gender and type of IBD (CD and UC) will be used. plan Zelen's (1974) method will be used to avoid imbalance allocation within each stratum. A block size of 4 will be used. We plan to enroll all eligible patients visiting the clinic, as well as eligible patients referred from other gastroenterologists. All eligible visiting our clinic will be enrolled. By enrolling consecutive patients, we reduce selection bias. A patient will be enrolled only once.

The most important aim of this study is to compare the IBD symptoms in exosomes alone and exosomes plus curcumin groups of patients. The symptomatology will be measured in each group and compared to the self-reported score. We will use the incidence rate of bloody stool to justify the sample size. With the combination treatment (ginger exosomes plus curcumin as compared to curcumin alone) we hope to reduce symptoms by at least 30%. Using a two sample one-sided t test for comparing mean differences in Inflammatory Bowel Disease Questionnaire, with 30 subjects in each group and using alpha=5%, we will have 80% power to detect effect size of 0.65 Standard Deviation, which is a large effect size (Cohen, 1988).. When the reduction in sample size due to missing data or other reasons, we will have reduced power to detect the difference in two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a confirmed diagnosis of IBD (either CD or UC) with moderate disease activity.)
* Ability to independently care for oneself

Exclusion Criteria:

* Pregnancy
* Known HIV
* Patients receiving immunosuppressive drugs, other than for their bowel disease
* Patients must be on stable doses of their medications for the 2 weeks prior to study entry and for the duration of the treatment period, or inform the investigator of any changes in medication
* Active malignancy in the last 5 years
* Patients receiving any other investigational agent(s)
* Ginger allergy
Postoperative Pain After Ultrasonically and Laser-activated Irrigation During Root Canal Treatment

The aim of this prospective, randomized clinical study is to compare the frequency and intensity of post-operative pain after root canal treatment with ultrasonically-activated or laser-activated irrigation.

Patients older than 18 years who require root canal treatment of an asymptomatic tooth with vital or necrotic pulp are included. Those teeth are subjected to root canal treatment using hand and rotating/reciprocating instruments, in combination with irrigation (3% NaOCl, 17% EDTA). After chemomechanical preparation, the teeth are randomly allocated to one of the following groups, according to the final irrigant activation:

* Ultrasonically activated irrigation (UAI), with an Irrisafe file (Satelec Acteon, Mérignac, France) held 1-3mm from working length, driven by an ultrasonic device, activated for 3 x 20 seconds. In between each 20-second cycle, each canal is rinsed with 1 mL NaOCl and finally with 2 mL.
* Laser-activated irrigation (LAI), with the tip of a pulsed Er:YAG laser (2940 nm, Fidelis II, Fotona) held above the canal entrance, activated for 2 x 30s. Settings are 20 Hz, 50 μs, 20 mJ. In between each 30-second cycle, each canal is rinsed with 1 mL NaOCl and finally with 2 mL.

The canals are then dried using paper points and obturated with gutta percha and an epoxy resin sealer using warm vertical condensation. Finally, the endodontic access is sealed with a provisional or permanent filling.

The patient is asked to keep a pain diary after the treatment, indicating postoperative pain on a visual analogue scale at 6, 24, 48 and 72 hours after treatment. Pain medication (Ibuprofen 400mg) is prescribed, and the intake of analgesic tablet is recorded at the same times.

Pre-Treatment Procedure

* Medical + dental history
* Clinical examination: sensibility tests, percussion, palpation, mobility, pockets measurement
* Radiographic examination
* Pulpal and periapical diagnosis
* Intensity of pre-op pain on 100mm VAS scale
* Patient information and informed consent
* Explanation on how to complete the pain diary and how and when to return it

Endodontic Protocol

* Anesthesia
* Rubber dam, disinfection of operative field
* Removal of caries and/or defective restorations
* Access cavity
* Build-up to provide a reservoir for the irrigation if necessary
* Crown-down preparation
* Length determination
* Apical enlargement

Irrigation protocol

* 3% NaOCl
* 17% EDTA when shaping completed
* Irrigation throughout the whole procedure with 27G notched-end needle 2 - 3 mm from WL

Eligibility Criteria:
Inclusion Criteria:

* subject has an asymptomatic (VAS 0-0,4mm) tooth requiring primary endodontic treatment
* subject must be able to undergo primary endodontic treatment

Exclusion Criteria:

* analgesic intake over the last 12h
* immunocompromised patients
* pregnant women
* tooth with incompletely formed apex/apices
* subjects with more than one tooth in need of RCT
* previously root canal treated teeth
* subjects with intolerance on NSAID's
The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis.

Substudy of the RECOVER trial (a randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery) investigating innate immune homeostasis after laparoscopic colorectal surgery.

Rationale: increased intra-abdominal pressure can cause peritoneal mesothelial cell injury either directly or by compression of the capillary vessels, causing a variable degree of ischemia reperfusion injury. The immune system can identify damage to host cells by recognising Danger-Associated Molecular Patterns (DAMPs) that are released upon cell death in an uncontrolled fashion, such as during surgical trauma. DAMPs elicit an immune response similar to the response to invading pathogens and induce an anti-inflammatory immune response strongly related to postoperative recovery, infectious complications and mortality. Low pressure PNP is associated with lower levels of serum pro- and anti-inflammatory cytokines and better preservation of innate immune function.

Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and innate immune function after laparoscopic colorectal surgery.

Study design: a multi-center, blinded, randomized controlled clinical trial.

Study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis.

Intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group A): low pressure PNP (8 mmHg) with deep NMB (PTC 1-2) or the control group (group B): normal pressure PNP (12 mmHg) with moderate NMB (TOF count 1-2).

Primary endpoint: mononuclear cell responsiveness ex-vivo as reflected by TNFα release upon LPS stimulation.

Secondary endpoints: mononuclear cell responsiveness ex-vivo as reflected by IL-6, IL-10 and IL-1beta release upon LPS stimulation. Peritoneal mesothelial hypoxia as reflected by peritoneal HIF1α mRNA expression, histological peritoneal mesothelial cell injury and plasma levels of DAMPs and cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for laparoscopic colorectal surgery with a primary anastomosis
* Obtained informed consent
* Age over 18 years

Exclusion Criteria:

* Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
* Primary colostomy
* Neo-adjuvant chemotherapy
* Chronic use of analgesics or psychotropic drugs
* Use of NSAIDs shorter than 5 days before surgery
* Known or suspected allergy to rocuronium of sugammadex
* Neuromuscular disease
* Indication for rapid sequence induction
* Severe liver- or renal disease (creatinine clearance \<30ml/min)
* BMI \>35 kg/m²
* Deficiency of vitamin K dependent clotting factors or coagulopathy
The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT

To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.

A single-center, open-label, dose-escalation study to assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years (inclusive) at screening; gender is not restricted;
* Diagnosed with hematological malignancies to receive sUCBT for the first time;
* No severe organ failure and no active infections
* ECOG performance status of 0-2;
* Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.

Exclusion Criteria:

* Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
* Pregnant patients;
* Patients and/or authorised family members who refuse to receive Coenzyme I for Injection;
* Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at undue risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive impairment;
* Participants in other clinical studies affecting hematopoietic recovery within 3 months;
* Those who are considered by the investigator to be unsuitable for enrolment (e.g., those who anticipate that the patient will not be able to adhere to the examination and treatment due to financial or other issues).
Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial

Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.


Eligibility Criteria:
Inclusion Criteria:

• Bilateral cleft lip and palate

Exclusion Criteria:

Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)
Drug Interaction Study Between AZD3355 and Nexium

The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Females no childbearing potential
* Clinically normal physical findings

Exclusion Criteria:

* Clinically significant illness within 2 weeks prior to the first dose of investigational product
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation

The purpose of this study is to assess the efficacy and safety of three ultrasound assistance techniques for internal jugular venous cannulation, in terms of cannulation success and prevention of complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* Indication for internal jugular venous cannulation, previously established by the doctor responsible for the patient´s hospital diagnosis and treatment
* Informed consent for trial participation has been obtained from the patient

Exclusion Criteria:

* Infection signs at or close to puncture site
* Cutaneous erosions or subcutaneous haematoma at or close to puncture site
* History of internal jugular venous cannulation during the past 72 hours (in the same side in which the present cannulation is taking place)
* History of previous surgical interventions on the cannulation site
* Recent cervical trauma with present neck immobilization and without having ruled out eventual cervical spinal injury
* Severe coagulopathy (altered coagulation parameters and active bleeding) which cannot be promptly corrected by platelet, fresh frozen plasma or pharmacologic intervention
* Subcutaneous emphysema with cervical extension
* Agitated or uncooperative patient (including deep sedation)
* Inability to obtain formal informed consent from the patient or his legally authorized representative (in case the patient is legally incompetent to give informed consent)
* Cannulation being performed outside the surgical area or the post-anesthesia care unit
Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study

The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.


Eligibility Criteria:
Inclusion Criteria:

* 50 to 70 years
* For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:

  1. IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality);
  2. thrombopenia \< 20x10ex9/L:
  3. IPSS intermediate 2 or high
* For CMML: patients can be included if they have at least one of these criteria:

  1. 2 of these criteria: hyperleucocytosis \> 10x10exp9/L, splenomegaly\>18cm, hemoglobin \< 10gr/dl, platelet \< 100x10ex9/L
  2. IPSS intermediate 2 or high

Exclusion Criteria:

* Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including:
* Renal failure with creatinine clearance \< 30ml/min
* Cirrhosis or hepatic failure
* Respiratory disease with vital capacity \< 30%
* Uncontrolled cardiac failure
* Uncontrolled neurological disease
* Poor performance status with karnofsky \< or = 60%
Impact of Apathy on Caregiving in HD. Version 1

Huntington's disease (HD) can affect motivation. People with HD may not wash often, keep their house clean and tidy, or eating healthy food. This loss of motivation, or apathy, can also affect the way they talk to people and how willing they are to be in social situations.

There are thought to be four different subtypes of apathy. These include reduced (1) motivation for planning and organising, (2) emotional reactions, (3) thoughts and actions and (4) social interaction.

It is clear from talking to patients and their families in clinic that apathy has a big impact. It is often a source of distress for the people around the patient, who are trying to support and care for them. We know from previous research, that having good social support helps people with Huntington's disease to live independently for longer. This research aims to understand the ways in which apathy can impact the levels of burden felt by caregivers of people with HD.

Caregivers will be asked to take part in a single interview. They will be asked questions about caring for someone with apathy. There will also be the opportunity to share their own first-hand experiences. These interviews will be analysed for common themes using framework analysis. Attention will be given to the relationship between burden and the different types of apathy.

Understanding the factors that lead to increased caregiver burden is the first step towards finding way to support caregivers of people with HD.


Eligibility Criteria:
Inclusion Criteria:

Participants will be included in the study if:

* They hold significant caring responsibilities for someone with clinically manifest HD
* The person they care for scores above the abnormality cut-off determined for HD on one or more subscale of the Dimensional Apathy Scale - Companion version, or the proposed clinical cut-off for the Apathy Motivational Index - Companion.
* They are 18 years or older and able to give valid, informed consent for study participation.

Exclusion Criteria:

Individuals will be excluded from the study is they:

* Have a lack of spoken English, sufficient to affect their understanding of the interview questions or compromise their ability to express their opinions.
* Did not consent to the interview being recorded.
The Role of Endothelin in Pulmonary Hypertension

The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.

Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers or known diagnosis of pulmonary hypertension

Exclusion Criteria:

* hypertension due to other reasons (not pulmonary)
Protein-rich Diet and NAFLD in Bariatric Surgery

Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese subjects with a BMI \>40 kg/m2 who are eligible for bariatric surgery and have accepted to undergo RYGB
* Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
* Stable medication
* Provision of informed consent

Exclusion Criteria:

* Patients not eligible for laparoscopic RYGB
* Incapacity to give a valid informed consent or unwilling to give the consent
* Pregnancy or lactating
* Type 2-diabetes mellitus
* Significant illness within the two weeks preceding surgery, as judged by the physician.
* Obvious infection (bacteria, virus etc)
* Major cardiovascular disease
* Major gastrointestinal, respiratory, or any hormonal disorders
* History of drug addiction and/or alcohol use
* Suspected or confirmed poor compliance
* Alcohol consumption of \> 20 g per day in the case of women and \> 30 g per day in the case of men for at least 3 consecutive months during the previous 5 years
* Presence of hepatitis C or frank cirrhosis.
Psychiatric Neurosurgery (PNS) for Obsessive Compulsive Disorder (OCD): A Qualitative Analysis of Patient and Family Member Experiences

In this study the investigators will use semi-structured interviews to qualitatively analyse patient and family member experiences with either deep brain stimulation or other forms of psychiatric neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

* (family member of) patient who has previously been treated with deep brain stimulation or anterior capsulotomy

Exclusion Criteria:

* none