cyrilzakka/clinical-trials huggingface dataset:
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.

Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.

If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.

The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center.

If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.

Eligibility Criteria:
To qualify for this trial, you must have ALL of the following:

* Histologically documented adenocarcinoma of the prostate
* Cancer that has progressed while on adequate hormone therapy. This state of the disease is androgen independent prostate cancer (AIPC).
* Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone. Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you are not eligible for the study.
* The absence of or minimal current cancer-related pain

Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.

Study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.
Thermal Therapy for the Treatment of Depression in Cancer Survivors, the S-WARM Study

This early phase I trial evaluates the effect of thermal therapy on depression with or without sleep disturbance in cancer survivors. Thermal therapy may help improve quality of life, physical capacity, fatigue, and enhance positive mood and sleep quality. The purpose of this study is to evaluate the potential of thermal therapy to improve patient's quality of life by reducing symptoms of depression, sleep disruption, fatigue and anxiety in cancer survivors.

PRIMARY OBJECTIVE:

I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of depression in cancer survivors.

SECONDARY OBJECTIVE:

I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of sleep disruption in cancer survivors.

EXPLORATORY OBJECTIVE:

I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of fatigue, anxiety and other generally debilitating aspects of increased stress in cancer survivors.

OUTLINE:

Patients undergo thermal therapy over 2.5 hours.

After completion of study treatment, patients are followed up at weeks 1 or 2, 3 or 4, and then monthly for months 2-4.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had therapy for malignancy
* Age \>= 18 years
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Patient denies current pregnancy
* Patients who screen positive on the depression/anxiety domain will be given the Hamilton Depression Rating Scale. Those with a score of 16 or more on this scale will be eligible for intervention

Exclusion Criteria:

* History of prior myocardial infarction. These patients may be allowed with clearance from a cardiologist
* History of any condition deemed by the principal investigator to be a contraindication to S-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc.)
* All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc.)
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive S-WARM
* Received an investigational agent within 30 days prior to enrollment
* Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients on dialysis
Arabic Gum-Absorption Study

Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but its taste is not appreciated by the Western society. For this reason, the active biological compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy affecting a minimum of 2-3% of infants. The investigators will therefore compare this protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides). To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators will also test the efficacy of enriched linseed oil.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged between 20 and 40 y
* Normal body weight and height (BMI \<30 kg/m2)
* Stable body weight (weight gain or loss \<3 kg in past 3 mo)
* Caucasian race
* Written consent to take part in the study
* Low vitamin K status

Exclusion Criteria:

* (A history of) metabolic or gastrointestinal diseases
* Chronic degenerative and/or inflammatory diseases
* Abuse of drugs and/or alcohol
* Use of corticosteroids
* Use of oral anticoagulants
* (A history of) soy allergy
* Use of vitamin K-containing multivitamins or vitamin K supplements
* Anaemia
* Blood donation or participation in another study within one month before the study
Comparative Study Between Duct to Mucosa and Invagination Pancreaticojejunostomy After Pancreaticoduodenectomy:

Postoperative pancreatic fistula (POPF) remains a challenge even at specialized centers, and also affect significantly the surgical outcomes . The incidence of POPF after pancreaticoduodenectomy among different studies, ranging from 5 to 30%.Morbidity and mortality after pancreaticoduodenectomy are usually related to surgical management of the pancreatic stump. The safe pancreatic reconstruction after pancreaticoduodenectomy continues to be a challenge at high volume centers. The variety of reconstruction is a reflection of the lack of ideal one.Duct to mucosa and invagination are two classic PJ techniques. Many studies compared both techniques, but their surgical outcomes still unclear.The aim of the study was to assess the effectiveness and surgical outcomes of both techniques of PJ after pancreaticoduodenectomy.

Consecutive patients who were treated by pancreaticoduodenectomy at Gastroenterology Surgical Center, Mansoura, Egypt Exclusion criteria included any patients with locally advanced periampullary tumour, metastases, patients received neoadjuvant chemoradiotherapy, patients underwent pancreaticogastrostomy (PG), patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy.

All patients were subjected to careful history taking, clinical examination, routine laboratory investigation abdominal ultrasound, magnetic resonance cholangiopancreatography , and abdominal computerized tomography .

The patients were randomized into two groups: Group I: patients underwent duct to mucosa PJ. Group II: patients underwent invagination PJ.

The primary outcome was POPF rate.Secondary outcomes were operative time, operative time needed for reconstruction, length of postoperative hospital stay, postoperative morbidities

Eligibility Criteria:
Inclusion Criteria:

-Consecutive patients who were treated by pancreaticoduodenectomy

Exclusion Criteria:

* Any patients with locally advanced periampullary tumour, metastases
* Patients received neoadjuvant chemoradiotherapy
* Patients underwent pancreaticogastrostomy (PG)
* Patients with advanced liver cirrhosis (Child B or C)
* Malnutrition
* Coagulopathy
Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. However, calcitriol, the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently, paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment at present.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years
* biopsy-confirmed IgA nephropathy
* proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (e.g. ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
* estimated glomerular filtration rate \> 60 ml/min/1.73m2
* corrected serum calcium level \> or = 2.45 mmol/l
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* Pregnancy, lactating or childbearing potential without effective method of birth control
* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
* History of malignancy, including leukemia and lymphoma within the past 2 years
* Systemic infection requiring therapy at study entry
* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* History of drug or alcohol abuse within past 2 years
* Participation in any previous trial on paricalcitol
* Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
* Patients receiving treatment of corticosteroid
* On other investigational drugs within last 30 days
* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
* History of non-compliance
* Known history of sensitivity or allergy to paricalcitol or other vitamin D analogs
Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not.

To be able to find out , we need to divided babies into 2 groups;

group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant

Then we need to compare heart rate during intubation and duration of intubation between the 2 groups.

We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine.

In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.

Eligibility Criteria:
Inclusion Criteria:

* Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
* IV access is obtained
* Informed parental consent

Exclusion Criteria:

* Emergent intubation or need for resuscitation
* Congenital cyanotic heart disease
* Obvious airway abnormalities
* History of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency
Proof of Concept (POC) Study of the Soliton's Acoustic Scar Reduction (ASR) Treatment for the Treatment of Keloid Scar

To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids.

To evaluate the safety, and efficacy of the ASR device for the temporary improvement in the appearance of a keloids. To demonstrate improvement in the keloid scars, without unexpected adverse events (UAEs) and serious adverse events (SAEs) directly attributable to the ASR device or treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female older than 18 at the screening visit;
* The participant is healthy, as determined by the investigator based on a medical evaluation including medical history;
* The participant has a keloid that is easily delineated photographically located on the chest, back, trunk or upper arms and legs.
* Keloid size greater than 1 cm and less than 8 cm in length, with a height of at least 2 mm.
* Keloids less than 5 years old
* Body Mass Index (B.M.I.) is \> 20
* Participant is willing to not undergo any other keloid treatments for a period of 12 months following ASR treatment.
* Participant is willing to participate in study and adhere to follow-up schedule.
* Participant is able to read and comprehend English or Spanish.
* Participant has completed the Informed Consent Form.

Exclusion Criteria:

* Participant had treatments, including topical steroids, to the keloid being treated in the study in the prior 12 months.
* Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
* Participant is unwilling to have ASR treatment provided in the presence of Sponsor's researchers.
* Participant is pregnant or planning to become pregnant during the duration of the study.
* Metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, elbows, knees, etc.).
* Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
* Medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.).
* History of coagulopathy(ies) and/or on anticoagulant medication.
* Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
* Current smoker.
* Any surgical procedure in the prior 3 months, or planned during the duration of the study.
Prospective Evaluation of Taste Function In Multiple Myeloma Patients Undergoing Autologous Hematopoietic Cell Transplantation

The purpose of this study is to study taste disturbances on patients with myeloma who received high dose melphalan.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 or above with diagnosis of multiple myeloma (myeloma is almost unheard of in patients less than 21 years of age).
* Scheduled to receive conditioning chemotherapy with melphalan followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation
* English or Spanish speaking
* Calculated creatinine clearance \> 40 mL/min

Exclusion Criteria:

* Prior head and neck radiation.
* Severe periodontal infection. Poor oral hygiene and dentition as determined by pre HCT dental assessment.
* Pregnancy
* Patients with pre-existing moderate-severe dysgeusia
Glucagon Like Peptide 1 Receptor (GLP1R) Expression and Beta-cell Mass in Patients With Type 2 Diabetes

Validation of the exendin-based beta cell imaging technique in patients with type 2 diabetes

Rationale: Reliable imaging biomarkers for non-invasive characterisation of beta-cell mass (BCM) are needed to aid understanding regarding the relationship between beta-cell mass and function during the course of type 2 diabetes (T2D). This study will provide critical information necessary to validate the applicability of exendin-based imaging techniques in patients with T2D. The characterization of beta-cells is currently limited to pancreatic specimens available at autopsy, as in vivo pancreatic biopsy is associated with complications unacceptable in clinical studies. To date, only measurements of circulating C-peptide and insulin levels can be obtained, but these measures do not reflect beta-cell mass, only total beta-cell function. Reliable imaging biomarkers for non-invasive characterisation of beta cell mass are therefore needed. These biomarkers could also be used to validate novel therapeutic strategies aimed to increase or preserve BCM or identify whether patients are eligible for a certain therapeutic strategy (e.g. when certain amount of beta-cells is required). One can also think of identifying early responders to therapies, to avoid unnecessary drug use and the accompanying costs.

The objective of this study is to determine the specificity of Exendin-4 during the course of T2D and to examine the role of glycemic control on the correlation between pancreatic Exendin-4 uptake, BCM and GLP-1R expression in patients with T2D undergoing (partial) pancreatectomy. This will allow examination of the role of glycemic control on exendin uptake in humans, but also implementation of clinical guidelines for the interpretation of clinical exendin-based scans in patients with T2D to avoid false interpretation of the scans.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for partial or complete pancreatectomy at Radboudumc

Exclusion Criteria:

* Previous treatment with synthetic exendin or dipeptidyl-peptidase IV inhibitors within the past 3 months
* Breast feeding
* Pregnancy or the wist to become pregnant within 6 months
* Creatinine clearance below 40ml/min
* Liver disease defined as aspartate aminotransferase of alanine aminotransferase level of more than three times the upper limit of normal range
Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients

The investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.

This study is designed as a population-based prospective, double blind cohort study. A prospective cohort of patients admitted to laparoscopic gastric banding due to morbid obesity

STUDY GOALS

* To evaluate the morphine-sparing effect of paracetamol IV in obese patients undergoing bariatric surgery.
* To identify potential ability of paracetamol IV to attenuate or relief postoperative pain in obesity patient undergoing bariatric surgery
* To determine effectiveness of paracetamol IV to reduce postoperative complication rate.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients admitted for laparoscopic gastric banding
* Elective surgery
* BMI \> 40
* ASA (American Society Anesthesiologists perioperative risk stratification) class 1-2

Exclusion Criteria:

* Patients' refusal to participate in the study
* Patients unable to give an informed consent
* Pregnancy
* Emergent surgery
* Patient with known allergy to morphine or paracetamol
* Patient with hepatic failure (based on history or elevated liver enzymes).
* ASA class \>2.
WEST-KOaST Study: WES Analysis of Testicular Cancer Patientsand Their First-degree Family Members

The project aims to identify the possible risk factors regarding the onset of the disease and to evaluate genes and gene modifications responsible for the onset od testicular cancer.

Testicular tumor represents a relatively rare disease that hit young-adults men. It represents 1% of all male cancers and 5% of all urological male tumors. Its incidence grow year by year. In the field of the oncological research, the lack of knowledge about genes related to this disease represent a very relevant clinical question. For this reason this project aims to collect biological samples of saliva from testicular cancer patients and from their first-degree family members; demographic-clinical variables will be also collected in order to draft a comprehensive panel of genes and gene modifications related to the testicular cancer, combining this survey with a very detailed description of this cohort of patient in terms of clinical features and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Male testicular cancer patients with an age \> 18 and \< 90
* First degree family members of Male testicular cancer patients with an age \> 18 and \< 90
* Ability to read and sign the informed consent
* Diagnosis of testicular cancer for the experimental group

Exclusion Criteria:

* Female for the experimental group
* Second degree family members of Male testicular cancer patients
* People with an age \< 18 and \> 90
* Diagnosis different from testicular cancer for the experimental group Incapacity to read and sign the informed consent
15 Year Follow-up of New Beginnings Program for Divorced Families

The project is a 15-year follow-up of 240 young adults whose families participated in an experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for divorced families. The NBP was provided in late childhood; the follow-up occurred in young adulthood. Families were randomly assigned to one of three conditions: mother program (MP), dual-component mother and child program (MPCP), or literature-control (LC) condition. Programs were designed to change several putative mediators of children's post-divorce mental health problems using empirically-supported change strategies. The investigators expected that the NBP would have either main or risk by program interactive effects on mental health and substance use problems and disorders, developmental tasks, parent-young adult relationships, physical health problems, and competencies, such that YAs who participated in NBP will have better functioning than YAs in the control condition. The investigators expected that the NBP will have either main or risk by program interactive effects on mothers' mental health; those in the NBP are expected to have fewer mental health problems than those in the control condition.


Eligibility Criteria:
Inclusion Criteria:

* Divorced in past two years
* Female residential parent
* At least one 9-12 year-old child resided (at least 50%) with the mother
* Neither mother nor any child was currently in treatment for mental health problems
* Mother had not remarried nor planned to remarry during the program, and did not have a live-in boyfriend
* Custody was expected to remain stable
* Family resided within an hour drive of program site
* Mother and child could complete assessments in English
* Child was not learning disabled nor in special education
* If diagnosed with attention deficit disorder, child was taking medication

Exclusion Criteria:

* Child scored above 17 on the Children's Depression Inventory (CDI, endorsed an item indicating that s/he wanted to kill her/himself, or scored above the 97th percentile on the Externalizing Subscale (Child Behavior Checklist \[CBCL\])