cyrilzakka/clinical-trials huggingface dataset:
Acute Effect of Chromatic Environment During Chemotherapy

The primary objective is to examine the acute effect of color, room orientation (affecting amount of luminosity) on perceived health status and stress levels in oncologic patients during chemotherapy sessions at outpatient clinic. The secondary objectives will be to study the effect on vital signs (body temperature, heart rate, systolic blood pressure). Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South) for each session. For the next session, patients will be assigned a new condition. Assignment of sequences will be randomized for each patient.

20 patients will be randomly assigned to one of the four groups, after having signed the Free and Informed Consent Form and agreed to participate in the project, will respond to the evaluation form and will be submitted to physical examination. Patients will be treated per standard of care.


Eligibility Criteria:
Inclusion criteria:

* Age 18-89 years
* Diagnosed with breast cancer that required chemotherapy
* Followed in outpatient clinic

Exclusion criteria:

* Diagnosed color blindness
* Undergoing treatment with antidepressants
Glycaemic Response Testing

The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).


Eligibility Criteria:
Inclusion Criteria:

* Male or female (not less than 40% males or females
* Non-smoker
* Aged 18 to 55 years
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Having a fasting plasma glucose (finger stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent
Mobile App for Eating Disorders in Adolescents

This study aims to evaluate the effectiveness of GGTCA-AD to decrease the maladaptive beliefs associated with eating disorders (ED) in non-clinical adolescent population. Specifically, a randomized controlled trial with parallel design and two groups (experimental and control) will be carried out in adolescents aged 13-15 years to assess the changes pre and post use of the app. It is expected that after the use of the GGTCA-AD app for 14 days, at the primary level, a: decrease in the degree of ascription to dysfunctional beliefs associated with ED; and at the secondary level: increase in body satisfaction and self-esteem; decrease in eating symptomatology; and no changes in emotional symptomatology. These results are also expected to be maintained in subsequent follow-up at 1 month.

There is a digital platform called GGtude, which is composed of different modules, each of them aimed at working with different mental health problems. The goal is to provide an easy-to-use tool as a CBT complement to work on the self-dialogue that relates to the core beliefs associated with the psychological problem in particular. To achieve this target, a cognitive training exercise is performed: different sentences appear in the form of beliefs, and the person must identify and accept those beliefs that are functional, adaptive and positive, dragging them to the lower part of the screen; and reject those that are dysfunctional, maladaptive and negative dragging them to the upper part of the screen.

The GGTCA app is a module of GGtude that was developed to work on dysfunctional beliefs associated with eating disorders. Previous research showed that the app produced a statistically significant decrease of mean scores in maladaptive beliefs associated with ED and a statistically significant increase in self-esteem in adult population.

Furthermore, adolescence is a developmental stage vulnerable to the development of these disorders, so it's relevant to adapt the GGTCA application to the adolescent population (GGTCA-AD) and to evaluate its effectiveness.

Eligibility Criteria:
Inclusion Criteria:

(1) ages between 13 and 16; (2) that the parents or guardians of the adolescents and the participants have signed the informed consent form; (3) have a dispositive with Internet access.

Exclusion Criteria:

(1) have inadequately answered control questions, for example "please check the option every day in this sentence".
Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Patients Following Groin-Hernia Repair.

Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.

Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.

In the present study, investigators hypothesize that a high-dose target-controlled naloxone infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a unilateral primary open groin hernia repair procedure. Investigators aim to show that latent sensitization is present in humans and is modulated by endogenous opioids.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 65 years
* Signed informed consent
* Patients submitted to unilateral, primary inguinal, open herniotomy 6-8 weeks prior to study start.
* Open operating procedure a.m. Lichtenstein.
* Urin sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphine, dextromethorphan)
* ASA I-II
* Body mass index (BMI): 18 \< BMI \< 30

Exclusion Criteria:

* Volunteers , who do not speak or understand Danish
* Patients, who cannot cooperate with the investigation
* Patients who have had previous surgery in the groin region
* Patients with pain at rest \> 3 (NRS)
* Activity-related pain in the surgical field \> 5
* Allergic reaction against morphine or other opioids (including naloxone),
* Abuse of alcohol or drugs - according to investigator's evaluation
* Use of psychotropic drugs (exception of SSRI)
* Neurologic or psychiatric disease
* Chronic pain condition
* Regular use of analgesic drugs
* Skin lesions and tattoos in the assessment areas
* Nerve lesions in the assessment sites (for instance, after trauma, disc herniation, etc.)
* Use of prescription drugs 1 week before the trial
* Use of over-the-counter drugs 48 hours before the trial
Nitrocamptothecin in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic melanoma.

OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with metastatic melanoma.

OUTLINE: Patients are stratified according to disease (choroidal vs nonchoroidal). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly for at least 8 weeks (2 courses) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic melanoma Choroidal (no prior chemotherapy required) OR Nonchoroidal No more than 3 chemotherapy regimens Bidimensionally measurable disease No symptomatic uncontrolled CNS involvement including extensive brain metastases, spinal cord compression, or meningeal carcinomatosis Not eligible for treatment protocol of higher priority

PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Zubrod 0-2 Life expectancy: Greater than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study No serious concurrent illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single IV doses of ERB-257 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women of non-childbearing potential between the ages of 18 and 50.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg2.
3. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)

Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation.

Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased.

The goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI.

Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.

A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing.

Before the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure.

Documentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires.

Finally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).

Eligibility Criteria:
Inclusion Criteria:

* suffering from drug-refractory paroxysmal atrial fibrillation
* scheduled for first ablation procedure

Exclusion Criteria:

* contra-indications for DW-MRI
* previous AF-ablation
* minors
* any patient unable to undergo neuropsychological testing due to mental retardation
Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term Infants With Birth Asphyxia

Birth/Perinatal asphyxia in Pakistan continues to be a leading cause of neonatal mortality and morbidity. It is estimated that around 80 to 120,000 neonates either suffer from or die from birth/perinatal asphyxia every year. In addition to the large number of deaths a larger number of babies who survive suffer from neuro-developmental disorders adding to the health burden to the society and the nation.

To date other than prevention (which requires global efforts to improve maternal education and health care) the therapies available to treat infants who have suffered from birth asphyxia have been either technically too complex or extremely expensive.

Birth/Perinatal asphyxia in Pakistan continues to be a leading cause of neonatal mortality and morbidity. It is estimated that around 80 to 120,000 neonates either suffer from or die from birth/perinatal asphyxia every year. In addition to the large number of deaths a larger number of babies who survive suffer from neuro-developmental disorders adding to the health burden to the society and the nation.

To date other than prevention (which requires global efforts to improve maternal education and health care) the therapies available to treat infants who have suffered from birth asphyxia have been either technically too complex or extremely expensive.

Recent evidence from animal studies and small human studies it has become clear that giving Magnesium Sulphate to term or nearterm babies with moderate to severe birth/perinatal asphyxia reduces both mortality and morbidity.

Magnesium Sulphate as a drug has been in clinical use for decades; its pharmacokinetics, safety profile and mode of action are well known. It is cheap and readily available in Pakistan thus providing an opportunity to confirm or refute the efficacy of Magnesium Sulphate in birth/perinatal asphyxia.

With this in mind the following pragmatic study has been designed using the current practices and available resources:

Eligibility Criteria:
Inclusion Criteria:

* Term and near term infants (≥35 weeks gestation) with moderate to severe birth asphyxia Age at admission \< 24 hours

Exclusion Criteria:

* Babies who could not be given first injection before 24 hours of age

Infants with major congenital malformations, sepsis, congenital heart defects, Intracranial hemorrhage and surgical problems

Babies received intubated in emergency

Babies receiving therapeutic hypothermia

Infants with disorders of metabolism

Infants in whom cause other than asphyxia is established as the reason for not initiating or sustaining breathing at birth.
Retrospective Study of Immediate Hypersensitivity (IHS) Reactions to Platinum Salts in the University Hospital of Nancy

To assess the efficacy of skin tests with platinum salts in patients suspects with immediate hypersensitivity reactions.

All patients adressed in consultation to the Allergy Department of university hospital of nancy for an immediate hypersensitivity reaction to platinum salts between 2015 and 2021 were retrospectively recruited.


Eligibility Criteria:
Inclusion Criteria:

* adult
* suspected immediate hypersensitivity reaction to platinum salts

Exclusion Criteria:

* skin tests not achievable
The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation

This is a long-term intervention study on the effects of marine n-3 PUFAs in renal transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation will have less decline in kidney transplant function compared to patients treated with placebo.

The study is designed as a randomized, double blind, placebo controlled, multi-center trial of 174 renal transplant recipients. Patients will be randomized to oral supplementation of marine n-3 PUFA 2.5 g / day or control in a 1:1 fashion.

The primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the treatment group compared with the control group. Secondary endpoints include the following variables: proteinuria, plasma inflammatory biomarkers, blood pressure, resting heart rate, fasting serum glucose / HbA1c, lipid and lipoprotein concentrations, number of graft rejections and graft losses, and number of cardiovascular events and deaths.

Patients from Akershus University Hospital will also participate in a sub-study, where renal graft biopsies will be performed to assess the degree of fibrosis and chronic allograft damage index (CADI) and markers of fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients over 18 years of age.
* Stable renal graft function, defined as eGFR \>30 ml/min at the last 2 visits.
* 6-60 months post-transplantation at randomization.
* Signed informed consent.

Exclusion Criteria:

* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug.
* Women who are pregnant or breastfeeding.
* Patients who participate in a clinical trial with other investigational drugs.
* Patients with a history of an allergic reaction or significant sensitivity to fish, seafood and the study drug Omacor or drugs or dietary supplements similar to the study drug.
* Any reason why, in the opinion of the Principal Investigator, the patient should not participate - E.g. history of repeated non-adherence to prescribed treatment, repeated non-attendance to clinic visits, cognitive impairment that prevents understanding the nature of this study, etc.
Dietary Cholesterol and Defects in Cholesterol Synthesis in Mevalonate Kinase Deficiency

Participants wanted for study of mevalonate kinase deficiency (MKD), mevalonic aciduria, or hyperimmunoglobulinemia with periodic fever syndrome (HIDS).

Patients with MKD (mevalonic aciduria or hyperimmunoglobulinemia with periodic fever syndrome (HIDS)) may be eligible for a research study conducted at Oregon Health \& Science University (OHSU) in Portland, Oregon USA. The purpose of the study is to find out more about how these diseases affect body chemistry and health. The researchers also want to find out how cholesterol in the diet affect blood cholesterol and how the body handles cholesterol. This is a short-term and long-term dietary study. The long-term goal of this research is to see if controlling dietary cholesterol can decrease any of the symptoms of the diseases.

The study could involve up to 12 one-week admissions to OHSU over the course of 5 years.

Participants are admitted to the clinical research center for up to a week per visit. Additional visits at least yearly encouraged. During the week we measure such things as cholesterol absorption, sterol and bile acid synthesis, mevalonate and mevalonate shunt products, isoprenoids, fatty acids, leukotrienes, plasma cholesterol and other sterol levels. Also, the effects of altering dietary cholesterol on plasma 24-S OH-cholesterol, a measure of brain cholesterol turnover, will be evaluated. Studies of body composition/ metabolism/ growth, development, behavior, sleep, feeding, hearing and vision will be carried out to document the phenotype and determine if dietary intervention may be helpful.

The objective of the study is to characterize the metabolic and phenotypic consequences of MKD and study the effects of altering dietary cholesterol in MKD. We hypothesize that some of the phenotypic effects of MKD are due to altered cholesterol metabolism, but that the phenotype is predominantly due to derangements in isoprenoid metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Must have documented mevalonate kinase deficiency, mevalonic aciduria, or HIDS
* Must be willing to participate in most research procedures

Exclusion Criteria:

* Unable or unwilling to participate in most research procedures
Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges

BACKGROUND: The literature has shown that simplified methods for complete denture fabrication can be as effective as the traditional techniques, but with less expenditure of time and resources, without prejudice to the patients. However, the effectiveness of these simplified methods for patients with more complex medical conditions haven't been deeply explored.

OBJECTIVES: To evaluate the effectiveness of a proposed simplified method for complete dentures fabrication for patients with severely resorbed mandibular alveolar bones.

METHOD: edentulous patients requesting treatment with bimaxillary complete dentures in a university clinic will be rehabilitated following a simplified technical proposal, being divided randomly into two groups according to the mandibular arch molding technique. In group A, a single impression with alginate through pre-fabricated trays will be performed, while patients allocated in group B will receive a second molding with a more complex technique. After 3 and 6 months, besides important clinical parameters, it will be investigated aspects related to patient's perceptions about the success of treatment. The study will be conducted with a minimum of 30 participants per group, and comparisons between the two groups will be made by means of tests suitable for distribution of data.


Eligibility Criteria:
Inclusion Criteria:

* complete edentulism for at least one year;
* desire to receive a pair of new conventional complete dentures
* mental receptiveness;
* good understanding of spoken Portuguese

Exclusion Criteria:

* disorders of the masticatory system;
* pathological changes of residual ridges;
* debilitating systemic diseases.
Investigation Of Receptivity Markers For Endometrial Cancer Treatment Development

Hyaluronan is an extracellular matrix protein that is involved in cell-cell and cell-matrix interactions. Hyaluronan performs this activity through hyaladherins, which are intracellular and extracellular receptors.

The purpose of this study was to compare the distributions of Hyaluronan Synthetase 2 (HAS2) and CD44s in healthy endometrial tissue samples obtained during the proliferative phase endometrium (PPE) and secretory phase endometrium (SPE), as well as pathologic samples diagnosed with benign endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN), early stage of endometrial carcinoma (EC) (stage I/II) and advanced stage of endometrial carcinoma (stage III/IV) (n:5, each).

By using the avidin-biotin-peroxidase method, tissue samples that had been fixed with formalin passed through a regular paraffin follow-up protocol, and subsequently embedded in paraffin were stained indirectly with anti-CD44s and anti-HAS2 primary antibodies. Immunostaining intensity was graded as 0: negative, 1: weak, 2: moderate, 3: strong, and 4: very strong using a semiquantitative technique. The ANOVA test was used to assess the statistical significance of the findings. Statistical significance was defined as (p) values less than 0.05.

While weak HAS2 and weak/moderate CD44s immunoreactivity was observed on the surface epithelium (SE)/glandular epithelium (GE) and stroma of the tissue samples acquired during PPE; weak/moderate HAS2 and moderate CD44s immunoreactivity were observed in SPE and EH groups; moderate/strong HAS2, strong CD44s immunoreactivity was observed in EIN; strong/very strong HAS2 and very strong CD44s immunoreactivity were observed in early-stage EC and advanced stage EC. It was determined that the immunoreactivity intensity increased at a statistically significant level in both early and advanced stage EC.

The fact that HAS2 and CD44s, two intracellular receptors, have increased in endometrial carcinoma leads us to believe that they are likely to play a role in tumor development, invasion, migration, metastasis and that they may be useful in developing future treatment protocols targeting hyaluronan receptors.


Eligibility Criteria:
Inclusion Criteria:

- All patients with endometrial carcinoma underwent surgery.

Exclusion Criteria:

* No patient was subject to chemotherapy or radiotherapy prior to surgery.