cyrilzakka/clinical-trials huggingface dataset:
Study on the Effectiveness and Differential Usability of the UP in Spanish University Students

The present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the blended online group for the treatment of emotional disorders in university students in Spain.

Introduction: Emotional Disorders (EDs) are the most common disorders among the young population. Despite their high prevalence in university students, data suggest that only 16.4% of students suffering from a mental health disorder receive treatment. Therefore, the present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the Blended online group.

Method: The study population will be university students who meet diagnostic criteria for EDs. We estimate a sample of 70 students, 35 per condition. The intervention will consist of the application of the 8 modules of the UP in two formats: online group format of 8 weekly sessions of 2 hours duration and Blended format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the UP + autonomous work through the UP-APP). The variables evaluated will be collected before the intervention, in the post-treatment and in the follow-ups at one month and 3 months.

This study responds to the need to implement services that improve the availability and access to the treatment of EDs in the university context in Spain, and in this particular case, through the formats offered by a transdiagnostic intervention such as the UP.

Eligibility Criteria:
Inclusion Criteria:

* Be enrolled at the University of Cordoba (Spain), in any of the degrees
* Have a diagnosis of anxiety or mood disorder from the Structured Interview for Anxiety and Related Disorders, according to the DSM-5 (ADIS-5)\*
* Be at least 18 years old
* Be fluent in the Spanish language
* Have a technological device (Computer, Tablet, cell phone) with internet connection
* Have a smartphone device with Android operating system
* In the case of taking pharmacological treatment for the treatment of their ED, maintenance of the same doses and medications for at least 3 months before starting their participation in the study and throughout the treatment
* Signature of the informed consent

Exclusion Criteria:

* Have a diagnosis of Obsessive Compulsive Disorder or Post Traumatic Stress Disorder
* Have a severe condition that requires priority for treatment will not be able to participate in the study. This includes a serious mental disorder (personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance abuse within the past three months.
Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.

Eligibility Criteria:
Inclusion Criteria:

* candidate for primary CRS
* histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer

Exclusion Criteria:

* history of previous malignancies within 5 years prior to inclusion
* FIGO stage IV disease
* complete primary cytoreduction is impossible
* prior treatment for the current malignancy
The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study

Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices.

Purpose: This is a pilot study to verify in humans the results obtained from two animal models exposed to ionizing gamma-radiation. The classification of patients results from the treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer undergoing high-dose radiotherapy are selected and compared to control group of age matched healthy women.

Background

Humans are exposed to ionizing radiation from several sources. Gamma-radiation exposure induces thereby both short- and long-term adverse effects. The radiation injuries to be expected in humans in the acute stage (days to some weeks after radiation exposure) correlate with the radiation dose that the individual has received. With very high doses gastrointestinal syndrome leads to death within a few days. The survival of the individual in the acute stage is therefore dramatically dependent on the rapid application of suitable therapies. It is decisive here to identify in the shortest possible time those persons who have been exposed to a critical radiation dose and to estimate the dose received in order to apply an adequate therapy. There are no satisfying test methods available today, which would enable the mass screening for radiation injury.

Furthermore to identify changes in the local or systemic human metabolic fingerprint, which are useful for the prediction of the individual sensitivity of patients to radiotherapy and / or lead to a better understanding of the molecular mechanisms involved in radiotherapy.

Objective

Primary: The primary endpoint is to affirm the results from the animal model in radiation metabolomics in human radiotherapy treatment.

Secondary: The secondary endpoints are to find new potential biomarkers for radiation biodosimetry in humans and to identify changes in the different sequences in measuring from local (sebum) and systemic (blood, saliva and urine) material.

Methods

Gas chromatographic separation and mass spectrometric detection of the metabolites present in a given matrix (urine, saliva, plasma, sebum).

Eligibility Criteria:
Radiotherapy: cancer treatment with total doses of more than 30 Gy, single fraction dose of at least 1.8 Gy/die. Big treatment/target volume. Age over 50 years, according to postmenopausal status. No simultaneous chemotherapy in breast cancer patients. For the control group: healthy volunteers (women), age over 50 years, according to postmenopausal status; no previous chemo - and cancer therapy.
Exploring the Application of 3D Bioprinting for Personalized Treatment in Pancreatic Ductal Adenocarcinoma

The goal of this observational study is to test the application value of 3D bioprinting technology in personalized treatment of pancreatic cancer.

The main questions it aims to answer are:

* Can 3D bioprinting technology be successfully applied to establish preclinical models of pancreatic cancer?
* Can 3D bioprinted preclinical models of pancreatic cancer be applied to personalized treatment of pancreatic cancer?

Participants will have tumor tissue collected to extract primary tumor cells for the establishment of in vitro preclinical models, which will be used for drug sensitivity testing.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Diagnosed as colorectal cancer with or without liver metastases before
* Pathologically proven colorectal cancer after surgery

Exclusion Criteria:

* History of other malignancies or serious medical conditions
* Inability to provide independent informed consent
Energy Expenditure Responses to Acute Exercise in Older Women (Calorie Expenditure and Exercise)

In older, normal-weight women (60-75 yrs, BMI=18-28 kg/m2), an acute bout of higher-intensity (60% of maximum effort) aerobic exercise, in comparison to an isocaloric bout of lower-intensity (45% of maximum effort) exercise (caloric expenditure of 3.5 kcal/kg body weight for both), will result in differential:

1. decline in non-exercise activity calorie expenditure in the subsequent 48 hours after exercise;
2. increase in resting metabolic rate 48 hours after exercise;
3. increase in serum free triiodo-L-thyronine (free T3) concentrations immediately following exercise;
4. decline from pre-exercise in plasma leptin and serum free T3 concentrations 48 hours after exercise.


Eligibility Criteria:
Inclusion Criteria:

1. Women
2. Age 60-75 years
3. normal weight
4. Weight-stable (± 5%) within the previous 3 months
5. Non-smoking for last year
6. Able to provide own transportation to study visits
7. Not currently involved in any other research study
8. Willing and able to participate in all aspects of the trial including research testing
9. Willing to give informed consent to participate

Exclusion Criteria:

1. Self-reported significant cardiovascular disease
2. Other self-reported medical conditions such as diabetes, chronic or recurrent respiratory conditions, active cancer, musculoskeletal disease
3. Medications known to affect exercise performance or metabolism
4. Excess caffeine use (\> 500mg/day)
5. Any self-reported contraindications to exercise
6. Clinical depression
7. Abnormal cognitive function -
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.

OBJECTIVES: I. Determine whether active specific immunization comprising tyrosinase and gp100:209-217 (gp100) peptides fused with OVA BiP peptide and heat shock protein 70 (HSP70) induces immunity against tyrosinase and gp100 in HLA-A2 positive patients with stage III or IV melanoma. II. Determine the lowest optimally immunogenic dose of tyrosinase and gp100 in these patients. III. Determine the tolerability of this regimen in these patients.

OUTLINE: This is a dose escalation study of tyrosinase and gp100:209-217 antigen (gp100). Patients receive vaccination comprising tyrosinase and gp100 fused with OVA BiP peptide and heat shock protein 70 (HSP70) subcutaneously on weeks 0, 1, 2, 6, and 18 for a total of 5 vaccinations in the absence of disease progression or unacceptable toxicity. Cohorts of 9 patients receive escalating doses of tyrosinase and gp100 until the lowest optimally immunogenic dose is determined. The lowest optimally immunogenic dose is defined as the dose at which 4 or more of 9 patients demonstrate T-cell responses.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage III or IV melanoma that is in remission for 2-52 weeks after surgical resection OR minimally resectable HLA-A2 positive Patients who are candidates for potentially curative surgery not eligible until after surgery

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.5 mg/dL AST less than 74 Units/L LDH less than 400 Units/L Alkaline phosphatase no greater than 1.5 times upper limit of normal Renal: Not specified Pulmonary: No evidence of disease by chest x-ray or chest CT scan If pulmonary function tests are abnormal, then abdominal CT scan must be performed Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other high risk malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other medical condition that would preclude compliance or immunologic response No new metastasis during study that requires chemotherapy or radiotherapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: No corticosteroids during the interval between 1 week prior to each immunization through 2 weeks after each immunization Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No antiinflammatory agents (e.g., aspirin) or other nonsteroidal antiinflammatory drugs during the interval between 1 week prior to each immunization through 2 weeks after each immunization
An mHealth Exercise Intervention for Sedentary Adults

This pilot trial examines the feasibility and acceptability of a web-based, social networking exercise intervention in improving physical activity behavior in adults who do not perform regular exercise.

Primary Objective To determine the feasibility and acceptability of an 8-week remotely-delivered exercise intervention by conducting a randomized controlled study comparing 3 levels of behavioral engagement.

Secondary Objectives

To compare the effectiveness of 3 levels of web-based interaction on physical activity behavior, physiological training dose, motivation and quality of life. Participants are randomly assigned to 1 of 3 groups:

Level 1 (attention control): Participants receive health educational materials through email and the web portal.

Level 2 (videos): Participants receive health education materials + access to 24 pre-recorded exercise videos.

Level 3 (livestream classes): Participant receive health education materials + livestream exercise classes 3 days/week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Not exceeding 60 total minutes of physical activity per week
* Access to computer or mobile device with high speed internet connection

Exclusion Criteria:

* History of myocardial infarction, angioplasty, coronary artery bypass, cerebrovascular ischemia/stroke, symptomatic congestive heart failure, atrial flutter, unstable angina, or unstable pulmonary disease; pacemaker; history of alcoholism, drug abuse or other psychiatric problems; current use of tricyclic antidepressant or clozapine medications; type 1 diabetes; orthopedic or rheumatologic problems that could impair the ability to walk.
Electrical Phrenic Nerve Stimulation in Patients With VIDD

This study aims to examine efficacy of transcutaneous electrical phrenic nerve stimulation (TEPNS) in ventilator-induced diaphragmatic dysfunction (VIDD). The investigators recruit VIDD patients, and randomly assign the patients into TEPNS group and control group. TEPNS group receives TEPNS twice a day for consecutive 5 days. Control group only receives usual care. The investigators collect diaphragm function indicators and outcomes to evaluate the efficacy.

Ventilator-induced diaphragmatic dysfunction (VIDD) is common in intensive care unit (ICU). There is a need of measurements to improve VIDD. The investigators hypothesize that transcutaneous electrical phrenic nerve stimulation (TEPNS) will increase diaphragmatic function. This study is a single centre, randomized controlled trial with control or treatment group in a 1:1 ratio. Eligible patients include aged ≥ 18 years, ventilated for at least 48 h with an expected stay of more than 7 days in the ICU, and diaphragm thickening fraction (DTF)\< 25%. The patients are randomly allocated to either receiveTEPNS and usual care (TEPNS group) or usual care only (control group). Blind is not used. TEPNS is conducted twice a day for consecutive 5 days. Electrodes are applied to bilateral neck skin which phrenic nerve runs underneath. Clinical data are collected, including baseline characteristics, airway pressure, esophageal pressure, gastric pressure, ventilation days, ICU length of stay, 28-day mortality, etc.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years
* ventilated for at least 48 h with an expected stay of more than 7 days in the ICU
* diaphragm thickening fraction (DTF)\< 25%

Exclusion Criteria:

* having a pacemaker
* cutaneous lesion that could interfere with probes
* previous diaphragmatic nerve paralysis
* body mass index \> 35 kg/m2
* severe chronic obstructive pulmonary disease (FEV1/FVC\<30%)
* pregnancy or lactation
* decision to withhold life-sustaining treatment
UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling

: Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.

A blood sample of approximately 30 cc will be collected prior to the patients standard of care radical prostatectomy surgery. This blood will be used for the SELDI analysis. The remainder of the blood sample will be stored and may be used for the PSA test at a later date. The patient will have a final blood draw 3 months to 1 year following surgery.

Eligibility Criteria:
Inclusion Criteria:

* For all subjects:

  * Men 50 years of age or older.
  * Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist.
  * It has been determined by the treating physician that a prostate biopsy is clinically indicated.
  * Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy.

For study on treatment effect

* Men with clinically localized prostate cancer (total PSA \< 20 ng/ml and clinical T2b or less).
* Men with organ confined prostate cancer as determined by final pathologic diagnosis.

Exclusion Criteria:

* Exclusion criteria for all subjects:

  * Known prostate cancer or prior treatment for prostate cancer.
  * Acute prostatitis.
  * Untreated urinary tract infection.
  * Presence of Foley catheter or any urethral instrumentation in the previous 48 hours.
  * Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months.

Exclusion Criteria (for study on treatment effect)

* Men with non-organ confined prostate cancer.
* Men with detectable serum PSA levels more than 1 months following radical prostatectomy.
Acute Effects of Cold Exposure on Cognitive Function

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on cognitive function and the underlying mechanisms.

The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include cognitive function tests and magnetic resonance imaging. Investigators plan to collect blood and urine samples.

Eligibility Criteria:
Inclusion Criteria:

* Living in Shanghai during the study period;
* Body mass index \> 18.5 and ≤ 28;
* right-handed;
* receiving or having received higher education;
* with the ability to read and understand Chinese smoothly.

Exclusion Criteria:

* Smoking and alcohol abuse;
* Current drug and dietary supplements intake;
* Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases;
* Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
* Subjects with color vision disabilities.
Behavior of Infants Fed Formula Supplemented With Prebiotics

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.


Eligibility Criteria:
Inclusion Criteria:

* Subject is judged to be in good health.
* Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
* Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
* Infant was identified by parents as very fussy or extremely fussy.
* Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria:

* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
* Subject participates in another study that has not been approved as a concomitant study.
* Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment.
* Subject has been treated with oral antibiotics within 7 days prior to study enrollment.
* Mother intends to use a combination of breast and formula feeding.
Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

Investigator initiated controlled multi-centre trial in a Prospective, Randomised, Open, Blinded Endpoint (PROBE) design.

Patients will be randomised in a 1:1 ratio either to treatment with tolvaptan for six weeks followed by six weeks observation without trial medication or no tolvaptan treatment, but following the same visit and investigation plan as the subjects taking tolvaptan.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic kidney disease and the fourth leading cause of end-stage renal disease in adults Worldwide.

The tolvaptan tablet has been approved by EMA (European Medicines Agency) with the indication of slowing the progression of cysts development and renal insufficiency in adults with ADPKD. It is the newest and only possible treatment for this patient group and could be initiated in patients with evidence for rapidly progressive disease Development.

There is however in Denmark and other countries both scientific and financial reluctance to initiate this expensive treatment for several reasons e.g. selection of patients who might benefit, effect on progression of kidney disease, side effects and tolerability.

Before deciding on implementation in Denmark, more knowledge is needed. The results of the PoCKET trial will contribute with guidance on this decision.

Foremost the trial is designed to address not only the change in kidney volume, but the change in kidney function, which is what matters to the patients and their prognosis in terms of postponing time to end stage renal disease. Furthermore, important data on side effects and tolerability will be generated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 18 and 65 years
* Diagnosis of typical ADPKD
* tKV above or equal to 750 ml by MRI scanning
* Estimated GFR (e-GFR) by CKD-EPI formula of above or equal to 45 mL/min/1.73 m2

Exclusion Criteria:

* Kidney transplant recipient
* Known liver disease except for liver cysts relating to ADPKD
* ASAT and ALAT above upper normal level
* Current treatment with thiazide and thiazide-line diuretics, mineral corticoid receptor antagonists, amiloride or loop diuretics
* Evidence of urinary tract obstruction
* Current treatment with CYP3A4 inhibitors
* Active malignant disease
* Current or previous treatment with tolvaptan