cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma

Low-grade glioma (LGG) represent typically slowly growing primary brain tumors with world health organization (WHO) grade I or II who affect young adults around their fourth decade. Radiological feature on MRI is a predominantly T2 hyperintense signal, LGG show typically no contrast uptake. Radiotherapy plays an important role in the treatment of LGG. However, not least because of the good prognosis with long term survivorship the timing of radiotherapy has been discussed controversially. In order to avoid long term sequelae such as neurocognitive impairment, malignant transformation or secondary neoplasms initiation was often postponed as long as possible

Since patients with low grade glioma are expected to become long-term survivors, the prevention of long-term sequelae is particularly important. In addition to disease progression, also treatment related side effects such as decline of neurocognitive function, endocrine impairment or sensorineural deficits can have a negative impact on patient's quality of life.

Owing to the biophysical properties of protons with an inverse depth dose profile compared to photons and a steep dose fall of to the normal tissue, there is a strong rationale for the use of PRT in the treatment of patients with low-grade glioma. Although data from large randomized trials are still missing there is increasing evidence from smaller prospective trials and retrospective analyses that the expected advantages indeed transform into clinical advantages.

However, in about 20 % of all patients, late contrast-enhancing brain lesions (CEBL) appear on follow-up MR images 6 - 24 months after treatment. At HIT in Heidelberg and at OncoRay in Dresden, CEBLs have been observed to occur at very distinct locations in the brain and relative to the treatment field. Retrospective analysis has elucidated potential key factors that lead to CEBL occurrence. However, avoidance of CEBLs is hardly feasible using conventional treatment planning strategies. Model-aided risk avoidance denotes the use of model-based CEBL risk calculations as an auxiliary tool for clinical treatment planning: Model-based risk calculations and risk reduction via software-based optimization help the clinician to minimize risk of CEBL occurrence during treatment planning.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* histologically proven low-grade glioma
* indication for definitive or adjuvant radiotherapy
* ability to understand character and personal consequences of the clinical trial
* written informed consent

Exclusion Criteria:

* previous cerebral irradiation
* contraindication for contrast-enhanced MRI
* neurofibromatosis
* participation in another clinical trial with competing objectives
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation

We, the investigators at Queen's University, propose to conduct a randomized, double-blind, feasibility trial comparing low-dose ketamine versus fentanyl as adjuncts to Emergency Department procedural sedation with propofol. The outcomes of interest will be safety, with respect to hemodynamic and respiratory adverse effects, as well as efficacy, with respect to adequacy of sedation and analgesia, recovery profiles and patient/physician satisfaction. Our hypothesis, based on a review of existing anesthesia literature, is that low-dose ketamine may be a safer and more efficacious alternative to fentanyl when used as an adjunct to propofol-assisted procedural sedation.

This initial, single-centre feasibility study will have the following specific objectives:

* Comparison of low-dose ketamine with fentanyl as adjunct to propofol-assisted emergency department procedural sedation, with respect to safety and efficacy parameters;
* Pilot of a blinded emergency department sedation and analgesia protocol, including drug doses, concealment techniques, and data collection tools, to determine the feasibility of a subsequent larger, multi-centre trial;
* Determination of the true incidence of the primary outcome measures in the study population, using the study drug administration doses and protocol, such that an accurate sample size may be estimated for a future, adequately-powered, multi-centre trial;
* Validation of a newly-developed ordered, categorical rating scale for the reporting of respiratory and hemodynamic adverse events occurring during emergency department procedural sedation and analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting or referred to the Emergency Department at Kingston General Hospital with a fracture or dislocation requiring manipulation under procedural sedation; or abscess requiring incision and drainage under procedural sedation.
* Ability to provide informed consent according to institutional requirements.
* Ability to comprehend and communicate in English.

Exclusion Criteria:

* Age \< 14 or \> 65 years
* Any history of significant active cardiac, pulmonary, hepatic or renal disease, as determined by patient history, chart review, or emergency physician.
* American Society of Anesthesiology (ASA) classification greater than class II.
* Body mass \> 130 kg.
* A history of physician-diagnosed obstructive sleep apnea.
* Chronic use of opioids including methadone and buprenorphine.
* A self-reported history of recent substance abuse or prior opioid dependence.
* Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
* A history of psychotic disorders, as reported by subjects or identified on review of the medical records.
* A known history of allergy or sensitivity to any study medication.
A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma

Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
* Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin \> 9 g/dL
* Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
* Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, \> 50 ml/min calculated by the C-G equation
* Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
* ECOG status ≤ 1 at screening

Exclusion Criteria:

* Subjects will be eligible for the study if they meet all inclusion criteria
"REACT-FM" Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia

The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.


Eligibility Criteria:
Key Inclusion Criteria:

1. Participant is 22 years of age or older
2. Participant has a diagnosis of fibromyalgia based on self-reported responses to 2016 ACR criteria for fibromyalgia diagnosis
3. Participant is capable of reading and understanding English and has provided written informed consent to participate (signed electronically).

Key Exclusion Criteria:

1. Participant is not a resident of the United States
2. In the opinion of the Investigator or Sponsor, the participant suffers from a severe psychiatric condition
3. Participant has a diagnosis of, or is being treated for any type of Dementia (Parkinson's disease, Alzheimer's Disease, Huntington's Disease, Lewy Body Dementia, Creuztfeldt-Jacob Disease, Frontotemporal Dementia, Korsakoff Syndrome, Vascular Dementia) or a current diagnosis of cancer or recurrence in the past 3 years (other than basal or squamous cell skin cancer)
Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement

The purpose of this study is to analyze how common stress hyperglycaemia (abnormally high blood glucose) is in primary hip and knee replacement surgeries and which factors predispose to hyperglycaemia.

Postoperative infections remain one of the most frequent reasons of failure of hip and knee prostheses. Diabetes increases the risk of infections. In other fields of surgery, hyperglycemia induced by surgical stress (stress/perioperative hyperglycemia) has been associated with higher rates of postoperative infections and complications. Such studies have not yet been performed in the field of joint replacement surgery. Unlike several other risk factors of infected joint replacements, hyperglycemia is potentially modifiable and therefore its prevalence, predisposing factors and association with postoperative infections are of interest.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of osteoarthritis
* Scheduled for primary hip or knee replacement

Exclusion Criteria:

* Arthritis other than osteoarthritis
* Medication affecting glucose metabolism (excl. antidiabetic agents)
* Not undergoing hip or knee replacement
Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).

Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI).

Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.

Eligibility Criteria:
Inclusion Criteria:

* 6 month to 7 years
* ASA physical status I or II
* undergoing unilateral hernia repair

Exclusion Criteria:

* history of developmental delay or mental retardation
* type I diabetes
* known or suspected coagulopathy
* known allergy to any local anesthetic
* known congenital anomaly of the spine
* signs of spinal anomaly or infection at the sacral or inguinal region
Synera™ for Epidural Needle Insertion

We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years, body mass index less than 45 kg•m-2, requesting a labor epidural

Exclusion Criteria:

* hypersensitivity to any study medications
Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study

Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement


Eligibility Criteria:
Inclusion Criteria:

* Persons with PsA diagnosed by a consultant Rheumatologist with disease duration of \> 3 months but \< 10 years with or without IBP.

  * Adults between the ages 18 and 80 years, with joint disease onset after 16 years of age
  * Patients able to understand and complete consent procedures
  * Study participants must have PsA, meet CASPAR criteria, and must have active disease as defined by the treating rheumatologist, including an evaluable psoriatic skin lesion amenable to 6mm punch skin biopsy.

    o Psoriasis should be diagnosed by a consultant rheumatologist or dermatologist.
  * Study participants must have been on consistent therapy for their PsA for the past 90 days
  * Study participants must be naïve to biological treatment and targeted synthetic DMARD treatment (examples: JAK inhibitors, apremilast)

Exclusion Criteria:

* • Persons with musculoskeletal (peripheral or axial) symptoms for \>10 years

  * Persons with planned major surgery (e.g., joint replacement) within the duration of the collection of data for the study
  * Persons with a history of chemotherapy, radiation therapy or immunotherapy for cancer in the preceding 5 years.
  * Persons with ongoing cancer (not excluding non-melanoma skin, cervical/breast in-situ carcinoma) but those fully recovered from an episode of cancer (in remission for more than 5 years) may be included at the discretion of the patient's treating rheumatologist.
  * Persons with an active severe or serious infection
  * Patients with non-severe infection at the discretion of the Investigator
  * Persons with other concomitant disorders incompatible with study (at discretion of Investigator).
Time-Restricted Feeding in Children and Adolescents With Obesity

This study will evaluate the effectiveness of a 2-month time-restricted feeding (TRF) intervention in children and adolescents with obesity. The investigators will determine whether the potential beneficial effects of the intervention in this population are maintained over time. Furthermore, potential mechanisms mediating TRF effects will be explored, specifically focusing on the potential role of the gut microbiome and the circadian rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI z score \> 2)

Exclusion Criteria:

* Bariatric surgery
* Spontaneous time-restricted feeding for \> 12 hours
* Diabetes with insulin treatment
* Pregnancy
* Intellectual disability
* Under drug treatment with a prescription change in the last 3 months
Stress-Reducing Interventions in HIV+ Patients: Pilot

The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (QOL) in HIV+ patients.

HIV+ patients will be randomized to receive either PE therapy (up to 18 possible sessions) or weekly symptom monitoring (described below) and will complete measures of PTSD, adherence, and QOL pre- and post-intervention and at 3- and 6-month follow-up assessments. Secondary analyses will examine the impact of the intervention on disorders commonly comorbid with PTSD (i.e., anxiety, mood, and substance abuse/dependence disorders).

Eligibility Criteria:
Inclusion Criteria:

* Must be HIV+
* Must meet PTSD diagnostic criteria
* Must be taking HIV medications
* Must be able to read and write in English

Exclusion Criteria:

* Current or previous diagnosis of schizophrenia, any current diagnosis with psychotic features, or current suicidal ideation
* Being in a current abusive relationship or ongoing intimate relationship with one's assailant
* Mental retardation
Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis

The purpose of this study is to determine whether Lactobacillus reuteri-containing lozenges (Prodentis) are effective in treatment of halitosis in patients with chronic periodontitis.

Bad breath (oral malodor, lat. halitosis) is amongst most common patients' complaints in the dental office. Ironically, available literature and research done on this topic thus far are relatively scarce. Oral malodor is most commonly caused by oral bacteria (87%), yet it can also be sourced from ear, nose and throat region and in a small percentage from distant parts of the body or is of unknown origin. Periodontal pathogens and other Gram(-) anaerobic microorganisms such as Porphyromonas gingivalis, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Enterobacter cloacae, Prevotella loescheii and Porphyromonas endodontalis are regarded as producers of malodorous gases. Namely, these bacterial species and periodontal pathogens particularly produce so called volatile sulfur compounds (VSC) which give mouth air its malodorness. Methylmercaptan, hydrogen sulfide and dimethyl sulfide are waste products of bacterial metabolism, specifically degradation of sulfur-, methionine- and cysteine-containing aminoacids. Offensive smells also stem from other compounds which do not contain sulfur, diamines and polyamines such as cadaverine, putrescine and skatole.

Probiotics are defined as living microorganisms which are considered to have beneficial health effect on their host when consumed in adequate amount. Regarding their advantageous role in periodontal disease, inhibition of specific periodontal pathogens and alteration of host immune response through multifactorial causes are thought to be their main working mechanisms. Reuterin and reutericyclin are two bacteriocins produced by Lactobacillus reuteri that inhibit growth of pathogenic bacteria, while bacterium also exhibits strong capacity of host tissue adherence and subsequent competition with pathogens.

Based on this data, research on efficacy of probiotic lozenges on halitosis in patients with chronic periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, above age of 30
* Non-smokers or ex-smokers (not smoking in the past year)
* Moderate to advanced untreated chronic periodontitis
* Good compliance and following of oral hygiene instructions
* Halitosis in active phase and patient's subjective complaint
* Informed consent by the patient

Exclusion Criteria

* Aggressive periodontitis
* Antibiotics administered up to 3 months prior to this study
* Pregnancy and breastfeeding
* Immunosuppressive therapy
* Oral neoplasms (including radiation or chemotherapy)
* Diabetes mellitus
* Acute oral inflammation or infection
* Poor, unsatisfactory oral hygiene and lack of compliance
* Use of dietary supplements containing probiotics within 2 weeks prior to study start
Evaluation of the Coping Long Term With Active Suicide Program

The purpose of this study is to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior.


Eligibility Criteria:
Inclusion Criteria:

1. Current patient at Butler Hospital
2. Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS
3. Age \> 18 years
4. Have a reliable telephone
5. Ability to speak, read, and understand English well to complete the procedures of the study

Exclusion Criteria:

1. Current psychotic symptoms severe enough to impair study participation
2. Participation in a treatment program with established efficacy in preventing suicidal behavior
3. Cognitive impairment which would interfere with adequate participation in the project (MMSE\< 20).

4. Currently in state custody or pending legal action 5. Already enrolled current or previous CLASP trial
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.

Exclusion Criteria:

* BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
* More than 2 prevalent vertebral fractures (Genant et al, 15).
* If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
* Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
* BMD T-score \> -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.

Other protocol defined inclusion/exclusion criteria may apply
Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution Formulation

This study will assess the relative bioavailability of a capsule formulation of PF-04958242, relative to a oral solution formulation of PF-04958242 in healthy adult subjects.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (of non childbearing potential) subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any condition possibly affecting drug absorption (eg, gastrectomy).
Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis

Periodontitis is a multifactorial disease that can lead to the destruction of supporting tissues of the teeth resulting in pocket formation, recession or both. Since the primary etiological factors for periodontal disease are bacteria in supra and sub gingival biofilm, efforts for disease prevention and treatment are mainly focused on pathogen reduction and strengthening of epithelial barrier, thus contributing to decreased susceptibility to infection. Due to emergence of antibiotic resistance and frequent recolonization of treated sites with pathogenic bacteria, there was need for a new treatment paradigm to be introduced to periodontal disease. The need was fulfilled by the introduction of Probiotics and Bacterial Replacement Therapy. The term probiotic is derived from the Greek, meaning "for life" are microorganisms proven to exert health promoting influences in humans and animals. Food and Agriculture Organization and WHO have stated that there is potential for probiotic foods to provide health benefits and that specific strains are safe for human use.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects in both sexes
2. Age 25 - 60 yrs
3. Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths ≥ 5mm in \> 30 % of the probing sites
4. Subjects in good general health

Exclusion Criteria:

1. Antibiotic therapy in the past 2 months
2. Allergic to doxycycline or probiotics
3. Subjects with diabetic mellitus, hypertension and psychiatric disorders
4. Subjects who are pregnant/ lactating
5. Smokers and/or alcoholics
6. Subjects who have undergone any periodontal therapy within last 6 months.