cyrilzakka/clinical-trials huggingface dataset:
Sodium Selenite as a Cytotoxic Agent in Advanced Carcinoma

In vitro studies have demonstrated that sodium selenite in sufficient concentration and during sufficient time have a high tumoricidal capacity. This is found in many human cell types as leukemia cells, mesothelioma and non-small cell lung cancer cells. A minority of cell lines seem to be resistant. The question from a clinical point of view is: Is it possible with respect to toxicity to administer sodium selenite to patients in sufficient dose and during sufficient time to get responses in patients with cancer? We have performed first part of phase-1 study and found MTD of 10.2 mg/m2 if given as 10 daily infusions during 12 days. We have recorded limited anti-tumor effect in this treatment regimen. However, in vitro data suggest that low concentration of continuous exposure for 51 h is much more effective. Now we are planning to continue the phase-I trial with modified protocol.

More specific:

1. Phase I: Find maximal tolerable dose with continuous infusion
2. Phase II: Use MTD and study responses, if any

* Patients: With advanced malignant disease, any kind, in which all standard treatment has been tried, but still progression. In sufficient good performance status (ps 0-2)to get more treatment: first selenite and immediately afterwards chemotherapy (since an additive or synergistic effect from selenite and chemotherapy has been found).
* Treatment: We have performed the initial study with sodium selenite i.v. daily, 10 treatments during 2 weeks. The week after that response evaluation and then chemotherapy. In each patient, his or her first line chemotherapy treatment is given, since in vitro studies indicate that selenite might reverse resistance. In the modified protocol, a 2 days continuous infusion will be performed.
* Toxicity evaluation (main criteria in phase I): Meeting a doctor once a week during selenite treatment and before each chemotherapy treatment and at End of treatment. Meeting a nurse each treatment day during selenite treatment. Blood samples for liver, kidney, blood and thyroid values. Plasma samples for selenite concentration during treatment.
* Response evaluation (to be: main criteria in phase II and studied also in phase I): CT scan just before and after selenite treatment and after chemotherapy. From May 2011 FDG-PET-CT-scan just before and after selenite treatment. Cytokeratin and cytokeratin fragments evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Advanced malignant tumor disease
* All standard treatments should have been tested, but the disease still progressing.
* In sufficient good performance status to get more treatment
* Informed consent

Exclusion Criteria:

* More than 1 active tumour disease
* Impaired capacity to cooperate
* Serious other disease such as heart or kidney disease that might give extra risk for complications and difficulties to interpret effect of the selenite treatment
* The tumour not possible to evaluate
The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
* Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)

Exclusion Criteria:

* Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
* Non-English speaking
* Allergy to bupivacaine, lidocaine, zinc, silver or menthol
* Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
* History of glucose-6-phosphate deficiency
* Use of anti-arrhythmic drugs such as tocainide or mexiletine
Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy

This is a non-interventional observational, multi-center cohort study to evaluate patient-reported outcomes in Chinese HER2+ early breast cancer patients undergoing (neo) adjuvant anti-HER2 based therapy and describe changes over time, from baseline to 12 months.

This is a non-interventional observational, multi-center cohort study with primary prospective data collection. This study will be conducted at approximately 10 sites in China.

The study population is Chinese HER2+ early breast cancer patients receiving (neo) adjuvant anti-HER2 based therapy.

Patients who are eligible for (neo) adjuvant anti-HER2 based therapy will enroll in this study.

Treatment choice in this non-interventional study will be at the discretion of the treating physician as per CACA-CBCS guidelines.

Participants are longitudinally assessed at baseline (T0, before treatment), during chemotherapy (T1, after 2 cycles), 1-month after completion of chemotherapy (T2) and at 12-month follow-up (T3).

The PRO instruments will be captured by electronic devices through WeChat mini-program which are input by patients, before or after their clinic visit but before administration of anti-HER2 therapy. Paper questionnaires will be available only as a last option if the electronic devices cannot be used for any reason (such as issues with internet access or if the device is not working). Oncology staff provided no assistance with filling in the questionnaires, but a prerecorded video will provide a detailed explanation of the questionnaires before the ePRO questionnaires. The PROs data will be restored centrally at the server of the leading site.

The usage of PROs is considered non-interventional according to local regulation. PRO measures include EORTC QLQ-C30, PDQ-5 (cognitive), PHQ-9 (depression), GAD-7 (anxiety) and Insomnia Severity Index (ISI).

Patient satisfaction for subcutaneous injection will be assessed using TASQ-SC at T3.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years;
2. Women;
3. Have signed the informed consent form as per local regulations;
4. Newly diagnosed with non-metastatic breast cancer (stage I-II-III, HER2+) at the time of starting anti-HER2 therapy;
5. Be able to comply with the follow-up visits, assessments, answering questionnaires.

Exclusion Criteria:

1. Metastatic breast cancer;
2. Prior systemic treatment for any malignancy;
3. Active secondary cancer requiring anti-HER2 therapy;
4. Vulnerable populations \[e.g., decisional impaired (cognitive, psychiatric), terminally ill, prisoners\], or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent;
5. Men.
Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

The purpose of this study is to to demonstrate the feasibility and tolerability of the use of Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal symptoms, craving scores and cannabis consumption during the study period.

This will be a one year pilot/feasibility study, assessing the effects of fixed or self-titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal from cannabis and craving among cannabis dependent subjects. Subjects in this study will undergo an 8-week double-blind, placebo-controlled trial. Subjects will be regular cannabis-users who are not currently seeking treatment for cannabis dependence. Subjects will participate in each of 8 conditions, lasting 5 weekdays each (an ABACADAE study design); four smoke as usual conditions (SAU) and four cannabis abstinence conditions. During each abstinence condition (B, C, D, E conditions), subjects will be allocated to one condition including self-titration of placebo, fixed dose of placebo, self-titration of SATIVEX (up to a max of 40 sprays per day, equal to 108mg THC) or fixed dose of SATIVEX (40 sprays per day). Each medication phase will be followed by a washout period where individuals will be requested to smoke cannabis as usual (A condition). The experimental conditions will be: type of SATIVEX® spray used (active vs placebo), and titration regimen (fixed or self-titrated). This pilot study will allow us to demonstrate the feasibility of our approach and to determine the sample size to use secondarily for a larger study. Our ultimate goal is to determine optimal conditions to use for a subsequent randomized controlled trial assessing the efficacy of SATIVEX® in treatment of Cannabis dependence among treatment-seeking subjects.

Eligibility Criteria:
Inclusion Criteria:

* age 18-50
* current cannabis dependence
* cannabis as primary drug of abuse
* frequent cannabis use (i.e., at least 5 days per week)
* have experienced at least 2 withdrawal symptoms during previous cessation periods
* cannabis use not for medical purposes (i.e., not a government-licensed medical cannabis user)
* not seeking treatment for cannabis dependence
* willingness to participate in study protocol

Exclusion Criteria:

* meet criteria for any psychiatric disorder requiring psychiatric intervention
* have a history of seizures; c)have known sensitivity to Dronabinol, Cannabidiol, Propylene glycole, Ethanol or peppermint oil (used in Sativex buccal spray
* suffer from an unstable medical condition
* currently have physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
* currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
* pregnant or breast-feeding
* hold a job that involves operating heavy machinery
* currently seeking treatment for cannabis-related problems
* family history of psychotic symptoms
Efficacy of AMALS in Treating Language Impairment in Children

The goal of this proposal is to examine the efficacy of a manualized treatment intervention, AMALS: Addressing Multiple Aspects of Language Simultaneously, which is designed to remediate semantic, morphological, and syntactic aspects of language in preschool children with language impairment. This study will target preschool children with language impairment living in a region characterized by nonmainstream dialects.

Questions driving this work are:

1. Will children participating in the AMALS treatment exhibit greater semantic, morphological, and syntactic complexity on multiple outcome measures at the completion of the intervention compared to a Discrete Trial Approach (DTA) group?
2. Will these gains be maintained at one-month follow up?
3. What is the impact of dialect on dependent variables, specifically morphosyntactic abilities?

To answer these questions a randomized clinical trial will be conducted comparing AMALS, an integrated approach to treatment, with DTA, an additive approach to therapy. In this study rather than restrict the ethnic and cultural backgrounds of this population, children's use of dialect will be uniquely identified and examined.


Eligibility Criteria:
Inclusion Criteria:

1. Demonstrate sufficient intelligibility as determined by a score of 85% on percent consonant correct (PCC) measures;
2. Demonstrate sufficient phonological ability to use grammatical morphemes as determined by use of word-final /s, z, t, d/ on sound- in-word subtest from the Goldman-Fristoe Test of Articulation-2 (GFTA; Goldman \& Fristoe, 2000)
3. Nonverbal IQ above 70 as scored on the Columbia Mental Maturity Scale (CMMS; Burgemeister, Blum, \& Lorge, 1972);
4. Below 1SD on the Diagnostic Evaluation of Language Variation: Norm-referenced Test (DELV; Seymour, Roeper \& de Villiers, 2005);
5. Below 1.39SD on the Structured Photographic Expressive Language Test-Preschool (SPELT-P; Werner \& Kresheck, 1983);
6. Documentation from teachers and/or parents of impressions of language status in comparison with peers;
7. More than one standard deviation below the mean on both levels 3 and 4 of the Preschool Language Assessment Instrument (PLAI; Blank, Rose, \& Berlin, 1978).

Exclusion Criteria:

1. English as the primary language
2. No oral-motor impairment
3. No hearing impairment
4. No co-morbid psychiatric or neurological impairments
Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients

The perioperative preservation of functionality and quality of life plays an increasingly important role in older physically limited and frail patients undergoing cardiac surgery. Hereby, impairments of the skeletal muscle system integrity often contributes to a reduced physical performance. Early identification of these high-risk patients could help to initiate appropriate preventive and therapeutic measures. Volatile organic compounds (VOC) represent a non-invasive and real-time measurable approach for recording physiological and pathophysiological processes. Isoprene (2-methyl-1,3-butadiene) is one of the most abundantly exhaled VOCs and has recently been shown to originate from skeletal muscle metabolism. However, the prognostic value of isoprene as a volatile biomarker for skeletal muscle integrity, physical performance and functional outcome in patients undergoing cardiac surgery has not been evaluated before.

This is a single center prospective observational study evaluating exhaled isoprene as a perioperative volatile biomarker of skeletal muscle integrity, physical performance and functional outcome in cardiosurgical patients. All study participants will be assessed by comprehensive clinical examinations, laboratory testing, breath analysis and skeletal muscle ultrasound before, during as well as five and thirty days after surgery. Clinical assessments will be performed using established clinical scores and scales (e.g. the Short Physical Performance Battery and the Fried Frailty Index). Laboratory testing comprises a broad panel of blood-based biomarkers of skeletal muscle integrity and metabolism.

The investigators hypothesize that:

* perioperative exhaled isoprene levels correlate with postoperative measures of physical performance, functional outcome and morbidity
* perioperative exhaled isoprene levels differ between patients with and without physical frailty
* perioperative exhaled isoprene levels correlate with sonographic and laboratory parameters of skeletal muscle integrity

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 65 years
* planned cardiac surgery
* operation duration \>60 min

Exclusion Criteria:

* refusal of study participation
* emergency / urgent surgery
* acute myocardial infarction
* acute or chronic infection
* Pre-existing illness with permanent restriction of mobility
* Pre-existing neuromuscular disease
* current malignant disease
* terminal renal insufficiency
* severe liver cirrhosis
* severe obstructive pulmonary disease
A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery

The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, age 18 years or older.
* Body weight \> or = to 100 pounds and \< or = 300 pounds.
* Women of childbearing potential must have a negative serum pregnancy test result prior to entry into the study.
* Able to provide written informed consent.
* At least moderate pain as determined by a PI score of \> or = to 50 mm on a 100-mm VAS.
* Willing and able to comply with all testing and requirements defined in the protocol.
* Willing and able to complete the posttreatment visit.
* Immediately prior to entering the study, surgical removal of 3 or 4 third molars (at least 1 mandibular partial bony or complete bony impaction).

Exclusion Criteria:

* Allergy or sensitivity to ketorolac or EDTA.
* Allergic reaction to aspirin or other NSAIDs.
* Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (AEs).
* Use of any IN product within 24 hours prior to study entry.
* Clinically significant abnormality on screening laboratory tests.
* History of cocaine use resulting in nasal mucosal damage.
* Active peptic ulcer disease, recent (defined as within 6 months) history of peptic ulcer disease or gastrointestinal bleeding considered by the investigator to be clinically significant.
* Advanced renal impairment (serum creatinine \>1.5 mg/dL) or a risk for renal failure due to volume depletion.
* A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation.
* Participation within 30 days of study entry or within 5 times the half- life, whichever is longer, in another investigational drug study.
* Pregnancy or breastfeeding.
* Extraction of teeth other than third molars during the surgical procedure; exceptions:(1) supernumerary third molars; (2) cases whereby extraction of a third molar requires the removal of an adjacent molar.
* Previous participation in this study.
* Use of any short-acting NSAID (such as aspirin or ibuprofen) or acetaminophen within 12 hours of surgery.
* Use of longer-acting NSAIDs (such as naproxen sodium) within 48 hours of surgery or piroxicam within 7 days of surgery.
* Use of steroids (other than oral contraceptives) within 72 hours of surgery.
* Use of mood-altering drugs, such a cannabis or alcohol, within 12 hours of surgery.
* Surgical anesthesia including narcotic agents except fentanyl. Short-acting anesthetics, both DEA scheduled and unscheduled, were allowed. Naloxone in any form was not permitted.
* Use of any other medication within 24 hours prior to surgery that, in the opinion of the investigator, could confound the subject's efficacy assessments (eg, sedatives, tranquilizers, MAO inhibitors, phenothiazines).
* Consumption of any caffeine-containing products within 4 hours of surgery.
Beetroot Juice Ingestion Effects on Field Hockey Performance.

Scientific evidence supports that only a few dietary supplements have reported good evidence for improving sports performance, between we can mention beetroot juice supplementation with doses \> 5 mmol of NO3-. In this randomized placebo-controlled study, we investigated the effects of BJ acute supplementation in improving neuromuscular performance and match-play demands in female field hockey players.

Beetroot juice supplementation has demonstrated good evidence for improving sports performance, however, benefits in team sports, especially in female athletes, are underrepresented. In this randomized placebo-controlled study, we investigated the effects of beetroot juice acute supplementation in improving neuromuscular performance and match-play demands.Testing sessions will comprise a neuromuscular test battery consisting of a countermovement jump (CMJ), isometric handgrip strength, 20-m sprint and repeated sprint ability test, followed by a 20-minute simulated field hockey Physical match activity (distances, speeds, accelerations and decelerations) will be monitored in real-time using an inertial tracking system

Eligibility Criteria:
Inclusion Criteria:

* Elite female field hockey players (playing in First Field Hockey Division).
* More than 8 years of field hockey training experience.

Exclusion Criteria:

* Concurrently participating in other studies.
* Contraindications associated to beetroot ingestion.
* Health problems or musculoskeletal injuries 6 months previous to study realization
Assessment of Navigation Abilities in Children with Cerebral Palsy and Their Peers

Spatial navigation skills are very important in everyday activities and quality of life but spatial navigation abilities are not part of the standard process of assessment and rehabilitation of patients. Furthermore, it is known that children with cerebral palsy have impaired visuo-spatial competences. The main objective of this study is to evaluate and compare the spatial navigation abilities of typically developing children and of children with cerebral palsy using the "StarMaze" application delivered by means of a Head Mounted Display (HMD). The second aim is to investigate the user experience during the session. A similar application was already developed and tested in a virtual reality large scale platform whose size and cost limit the accessibility. Therefore, the assessment (and future training) of navigation abilities with affordable and easy-to-use technology such as HMD open new perspectives.


Eligibility Criteria:
Inclusion Criteria:

* IQ higher than 70

Exclusion Criteria:

* Subjects with epileptic issues
* Subjects with poor head control
* Visual acuity not correctable with eyeglasses
Measurement of Gemcitabine Metabolites in Blood and Urine as Predictors of Response to GemX Bladder Radiotherapy

The purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of Gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to GemX chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of muscle-invasive transitional cell carcinoma.
* suitable for treatment with radical concurrent chemoradiotherapy with GemX.
* Standard radiological assessments with CT or MR for staging.
* ECOG performance status 0-2
* Adequate pre-treatment haematological and biochemical parameters
* Age greater than or equal to 18 years
* No significant co-morbidity thereby excluding patient from having radical treatment.
* No previous treatment for diagnosis of muscle-invasive bladder cancer or other pelvic radiotherapy.
* Women of child bearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 3 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy
* Patients must have given written informed consent

Exclusion Criteria:

* Patients with a known history of anaphylactic reaction to any other drug.
* Patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix
* Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial.
* Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial Any other serious uncontrolled medical conditions
* Clinical evidence of metastatic disease to brain
* Any pregnant or lactating woman
* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent