cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of [177Lu]Lu-BQ7876 for Targeting of Prostate-Specific Membrane Antigen

The study should evaluate the biological distribution of \[177Lu\]Lu-BQ7876 in patients with prostate cancer.

The objective are:

1. To evaluate the content of \[177Lu\]Lu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration.
2. To assess the distribution of \[177Lu\]Lu-BQ7876 in normal tissues and tumors at different time points.
3. To evaluate dosimetry of \[177Lu\]Lu-BQ7876.
4. To study the safety and tolerability of the drug \[177Lu\]Lu-BQ7876 after a single injection.

The overall goal is to study the effectiveness of prostate-specific membrane antigen targeting using Lutetium-177 - labeled BQ7876.

Phase I of the study:

Biodistribution, dosimetry, safety and tolerability of \[177Lu\]Lu-BQ7876 in patients with prostate cancer.

The main objectives of the study:

1. To evaluate the content of \[177Lu\]Lu-BQ7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration.
2. To evaluate the distribution of \[177Lu\]Lu-BQ7876 in normal tissues and tumors in patients with prostate cancer at different time points after a single intravenous administration.
3. To evaluate dosimetry of \[177Lu\]Lu-BQ7876 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
4. To study the safety of use and tolerability of the drug \[177Lu\]Lu-BQ7876 after a single intravenous administration in a diagnostic dosage.

Methodology:

Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age
* Clinical and radiological diagnosis of prostate cancer with histological verification.
* White blood cell count: \> 2.0 x 10\^9/L
* Haemoglobin: \> 80 g/L
* Platelets: \> 50.0 x 10\^9/L
* Bilirubin =\< 2.0 times Upper Limit of Normal
* Serum creatinine: Within Normal Limits
* Blood glucose level not more than 5.9 mmol/L
* Subject is capable to undergo the diagnostic investigations to be performed in the study
* Informed consent

Exclusion Criteria:

* Active current autoimmune disease or history of autoimmune disease
* Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
* Known HIV positive or chronically active hepatitis B or C
* Administration of other investigational medicinal product within 30 days of screening
* Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)

The study will measure the improvement in lung function in subjects with asthma after inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA (hydrofluoroalkane), metered dose inhaler.

The study objective is to compare the efficacy and safety of albuterol in a dry powder inhaler (DPI) and albuterol in an HFA metered dose inhaler (MDI) after a cumulative dose of 1440mcg administered as 1+1+2+4+8 inhalations (90mcg per inhalation). Another study objective is to compare the pharmacokinetics (metabolism) of albuterol with the two inhalers. The pharmacokinetics of albuterol will be examined in half (24) of the study subjects. To participate in the study, patients must provide written informed consent, washout any prohibited medications and pass all the screen criteria. Once this is done, there will be two treatment visits. At each visit the subject will inhale with both types of inhalers. At each visit, one inhaler will have active drug (albuterol) and one inhaler will have placebo (dummy). The inhaler with the active drug will be switched at the two visits in a random manner. At each visit the subject will inhale with each inhaler a total of 16 times by a specific schedule. The subject will inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler twice (2), wait 30 minutes, inhale from each inhaler four times (4), wait 30 minutes, and then inhale from each inhaler eight times (8). The total time to complete the inhalations should be about 2 hours. Following that, there will be a series of assessments taken at regular times with vital signs measured up to 6 hours, ECG (electrocardiogram) assessed up to 4 hours, blood taken to measure potassium and glucose up to 4 hours, lung function evaluated with spirometry up to 6 hours, and for those subjects participating in the pharmacokinetic evaluation blood will be drawn up to 12 hours. The two study treatment visits will be 3 to 14 days apart. Following these visits, there will be a study concluding visit 1 to 5 days later.

Eligibility Criteria:
Inclusion Criteria:

* Must provide written informed consent,
* Must be between 18-45 years of age,
* Male or Female, females of non-child bearing potential or using reliable contraception
* Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180mcg albuterol
* Stable low dose of Inhaled Corticosteroids
* Non-smoker
* Otherwise healthy
* Other criteria apply

Exclusion Criteria:

* Pregnant
* Allergic to albuterol or severe milk protein allergy
* ONLY for subject participating in PK assessments, must not have donated blood within 30 days.
* Other criteria apply
Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain

Intervention study with uncontrolled design investigating the effects of smartphone delivered Acceptance and Commitment Therapy for longstanding pain in adolescents. Primary outcome is pain interference. Internet-based parental support will be offered to the adolescents' caregivers.


Eligibility Criteria:
Inclusion Criteria:

* pain duration of ≥ 3 months;
* the pain condition has been examined by a medical doctor
* able to communicate in Swedish
* access to a smartphone and internet connection on a daily basis
* stable medication use since 2 months time, with no planned changes

Exclusion Criteria:

* previous ACT or CBT treatment during the past 6 months
* severe psychiatric co-morbidity (e.g. psychosis or high risk of suicide) as assessed by the psychologist in a semi-structured interview
Mechanisms of Insulin Resistance in Critical Illness: Role of Systemic Inflammation and GLP-1

The purpose of this study is to determine the role of inflammation and the insulin regulating hormone GLP-1 during critical illness.

Critically ill patients often exhibit hyperglycaemia. Although the cause of this hyperglycaemia is probably multifactorial, peripheral insulin resistance is a major contributor, similar to type 2 diabetes mellitus (T2D). There are several similarities between critical illness and T2D, including the presence of systemic inflammation and increased plasma free fatty acids (FFA), all of which may induce insulin resistance in healthy volunteers. In critical illness, elevated catecholamines, cortisol, growth hormone and glucagon may also contribute to insulin resistance.

The degree of hyperglycaemia correlates with mortality in ICU patients. van den Berghe et al. found that IV infusion of insulin to obtain strict normoglycaemia reduced mortality as well as morbidity in critically ill surgical patients and in some medical ICU patients.

However, insulin increases the risk of hypoglycaemia; this is a major obstacle to strict euglycaemia in ICU patients and may explain the inability of others to reproduce the benefits reported by van den Berghe et al. Thus, alternatives to insulin for controlling plasma glucose (PG) in ICU patients are warranted.

Aim:

To study the role of the incretin hormone, glucagon-like peptide (GLP)-1 for glycaemic, metabolic, hormonal and inflammatory profile in

* critically ill patients in the intensive care unit (ICU) and
* healthy volunteers exposed to a standardised systemic inflammation

Eligibility Criteria:
Inclusion Criteria healthy subjects:

* Healthy (assessed by medical history and clinical examination)
* Age 18-40years
* BMI \< 30kg/m2

Exclusion Criteria healthy subjects:

* Previous resection of the small intestine (not including the appendix)
* presence of any inflammatory illness during the fortnight preceding the study

Inclusion Criteria critically ill patients:

* Age\>18 years
* HbA1C\<6,5%
* Admission to the ICU within the last 72 hours
Montefiore Opioid and Pain Study

This study will determine pain and opioid outcomes 3 \& 6 months after an emergency department visit for acute pain. This is an observational study. Patients are enrolled during an ED visit and followed by telephone 3 \& 6 months later. Opioid databases will also be reviewed.


Eligibility Criteria:
Inclusion Criteria:

* Adults seen in the emergency department for acute, new-onset pain, defined as: 1)localized pain duration \< 10 days and 2) prior to the acute episode, the patient has not had this type of pain in the preceding six months
* Upon emergency department discharge, the patients is prescribed an opioid for pain

Exclusion Criteria:

* Any prescribed opioid use within the previous six months including methadone and buprenorphine

  * Frequent use of any analgesic medication (Use of any analgesic \>10 days per month prior to the onset of acute pain)
  * Not available for follow-up
Use of Long-acting Bupivacaine In Lower Extremity Amputation

The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended for use in long-acting local anesthesia. It has been shown in randomized trials to be effective in reducing post-operative pain while reducing opioid narcotic use and length of hospital stay following several surgical procedures, particularly after total knee arthroplasty. Extremity amputation is a painful operation often performed in seriously ill or debilitated patients, often related to infection, trauma or malignancy. Application of liposomal bupivacaine in extremity amputation is not well described. The investigators intend to enroll adults greater than age 18 years of age who are to undergo major extremity amputation. Patients will receive targeted injections of liposomal bupivacaine during their procedure. Patient pain scores, total opioid use, and length of hospital stay will be tracked. Patients receiving liposomal bupivicaine will be compared to similarly matched subjects who received standard anesthesia regimens without liposomal bupivicaine. The investigators hypothesize that liposomal bupivicaine used during major amputation decreases opioid use, hospital stay, and in-hospital costs.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients who underwent unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral \[1 year retrospective analysis\]
* Patients who meet clinical indication for unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral

Exclusion Criteria:

* Minor amputations
* Liver dysfunction (impaired metabolism of Amides)
* Concomitant psychiatric or chronic pain disorders
* Pregnancy
* Amide anesthetic allergy
* Presence of perioperative sepsis or acute organ dysfunction
* Need for ICU admission at any point
* Polytrauma
* Quadriplegic/Paraplegic/Insensate
On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication

The purpose of this study is to investigate several aspects of chronic use of acid suppressing medication: dependence on maintenance therapy, the possibilities for on-demand use, and predictors (patient characteristics) for daily need, for on-demand use and for termination of chronic use.

2-5% of the general population is chronic user of acid suppressing medication (proton pump inhibitors, H2 receptor antagonists), mostly because of gastro-oesophageal reflux disease (GORD). Prescription data from health insurances show that the number of chronic users increases every year, which has large economic consequences.

There are indications however that on-demand and intermittent therapy can be as effective as daily use. No evidence exists regarding patients who are likely to benefit from intermittent, on-demand therapy or even termination.

In this study several aspects of chronic use of acid suppressive therapy are investigated in family practice patients.

Chronic users are transferred to pantoprazole 20 mg for 4 weeks. Patients with adequate relief of symptoms are randomized in two groups for a period of 13 weeks.

group 1: daily pantoprazole 20 mg, placebo on-demand (indicative for placebo-dependency) group 2: daily placebo, pantoprazole 20 mg on-demand (indicative for pharmacological dependency) Patients visit the research nurse at the beginning of the study and at week 4, 5, 10 and 17.

In this study we are looking for patient characteristics indicative for the dependency on acid suppressive drugs and for possibilities to reduce the dose of these drugs.

Furthermore, aspects described in "secondary outcomes" will be addressed.

Eligibility Criteria:
Inclusion Criteria:

* male and female (non-pregnant, non-lactating)out-patients between 18-75
* chronic users of acid suppressive therapy for at least 180 days over the last year

Exclusion Criteria:

* stage 3, 4 oesophagitis, Barrett's oesophagus, acute peptic ulcer
* gastric hypersecretory condition, predominantly IBS symptoms, previous gastric/oesophageal surgery, pyloric stenosis
* severe, unstable comorbidities
* alarm symptoms
* malignancies in the past 5 years
* use of NSAID, systemic glucocorticoids, Cox-2 inhibitors, acetylsalicylic acid more than 150 mg daily, drugs with pH-dependent absorption, anticholinergics
Tylenol Levels in Bariatric Patients

The current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population.

This will be a descriptive study carried out by study staff from the anesthesiology department. The patient population will include obese patients scheduled for robot-assisted or laparoscopic bariatric surgery. There will be no change in our usual anesthetic care for these patients. Volume of distribution and elimination half-life of acetaminophen in serum samples are the primary measurements of the study. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 12, but younger than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery
* American Society of Anesthesiologists Physical Status Classification System (ASA) I, II or III
* Parent/guardian willing and able to give consent
* Patient willing to give assent, or consent
* Patients that are otherwise healthy at the discretion of the study staff
* Patients with BMI \>95th percentile

Exclusion Criteria:

* Patients with severe right heart failure or severe asthma
* Patients with deficient hepatic function that can affect drug metabolism
* Systemic steroid use within the last 3 months
* Patients who have taken acetaminophen containing medications within 24 hours of surgery date
* Patients younger than 12, but older than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery
* Patients having other procedures in addition to robotic assisted or laparoscopic bariatric surgery
* American Society of Anesthesiologists Physical Status Classification System (ASA) IV and above
* Females testing positive for pregnancy
* Parent/guardian not willing and able to give assent, or consent
* Patient not willing to give assent, or consent
* Patients with BMI \< 95th percentile
Health-Related Quality of Life in Patients With Dupuytren's Disease

Main Research Questions:

We want to measure the change in quality of life in Dupuytren's disease patients who do and do not undergo surgery. Also, we want to test the validity of health related quality of life measurements in patients with Dupuytren's disease.

Why is this research important? Some patients with Dupuytren's contracture require excision surgery or palmar fasciectomy. Other patient's with Dupuytren's contracture do not require surgery; however, these patients may need surgery in the future. No studies have reported the health-related quality of life of patients with Dupuytren's disease whether related to surgical intervention or not.

What is being studied? We are studying the difference and change in health-related quality of life in patients suffering from Dupuytren's disease who require excision surgery and do not require surgery.

Previous research on Dupuytren's disease has not reported the health-related quality of life (HRQL) of patients' whether related to surgical intervention or not. The primary objective of this study is to measure the change in HRQL in Dupuytren's contracture patients who do and do not undergo palmar fasciectomy. Health related quality of life will be measured using the 1) Health Utilities Index Mark III (HUI3); 2) Short Form-36 (SF-36); and the 3) Michigan Hand Outcomes Questionnaire (MHQ). The secondary objective is to look at the measurement properties, including the reliability and responsiveness, of each of the three HRQL instruments when they are used in patients with Dupuytren's contracture. We will also assess the concurrent validity of each of the HRQL instruments.

Eligibility Criteria:
Inclusion Criteria:

* patients who have the diagnosis of Dupuytren's disease
* able to comprehend English to complete the self-reported questionnaires
* willing to provide informed consent.

Exclusion Criteria:

* patients who have had previous Dupuytren's contracture surgery on the same hand
* patients who have carpal tunnel syndrome, rheumatoid arthritis, connective tissue disorder, tenosynovitis, or another condition that could affect quality of life
* patients who are under the age of 18 years.
TAP Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following TAH

This randomized controlled clinical trial designed to evaluate the efficacy of transversus abdominis plane (TAP) block, intrathecal morphine, or their combination in postoperative pain relief, as assessed by time to first analgesic request, pain scores, total postoperative analgesic consumption, time of ambulation, complications and hemodynamics following total abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 30 to 70 years.
* Elective total abdominal hysterectomy.
* ASA physical status I or II.
* Willingness to provide informed consent.

Exclusion Criteria:

* Refusal of the block.
* Allergy to study medications.
* Preexisting coagulation disorders.
* Local infection at the site of needle insertion.
* Uncontrolled respiratory or cardiac disorders.
* Impaired kidney or liver function.
Collaborative Wilms Tumour Africa Project

Significant progress has been made in the treatment of Wilms tumor in high income countries, where survival is now around 85% - 90%. Survival in low income countries is much lower; specific challenges include late presentation, malnutrition, less intense supportive care facilities and failure to complete treatment.

A comprehensive treatment guideline was introduced in Malawi in 2006 which included nutritional support and social support to enable parents to complete treatment. Survival has increased to around 50%; 95% of children completed their treatment. A multi-disciplinary group of African clinicians and 'state of the art' experts produced a consensus treatment guideline for children with Wilms tumor in sub-Saharan Africa. This guideline will be implemented as a multi-center prospective clinical trial in 2014 in six - eight institutes, expecting about 200 new patients per year.

The hypothesis is that 2 year event free survival will be 50%, with \<10% failure to complete treatment and \<10% treatment related mortality. Other research questions include efficacy and toxicity of preoperative chemotherapy and the comparison of surgical staging, local pathology and central review pathology in stratifying postoperative chemotherapy.

Patients are treated according to standard care. Data are documented on presentation at diagnosis, response of the tumor, findings at surgery and pathology, treatment given and outcome of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years
* Diagnosis Wilms tumour

Exclusion Criteria:

\* None
Treatment of Dermatofibrosarcoma Protuberans in Patients 10 Years and Younger

The purpose of this proposed study is to assess effectiveness of MOHS micrographic surgery as a form of treatment for dermatofibrosarcoma protuberans in patients who are 10 years of age or younger through review of the patients at Mayo Clinic treated from 1988-2017, and to explore the challenges that providers face which may prevent them performing this potentially superior treatment. This study will provide a comparison of outcomes and recurrence rates in pediatric patients treated by MOHS versus traditional excision.


Eligibility Criteria:
Must be 10 years of age or younger. Must have biopsy proven dermatofibrosarcoma protuberans.
ASPET Study: An Observational Study of Tarceva (Erlotinib) in First Line in Patients With Advanced Non-Small Cell Lung Cancer Harbouring EGFR Activating Mutations

This observational study will evaluate the patterns of disease progression in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring EGFR activating mutations receiving Tarceva (erlotinib) as first-line treatment. Patients will be followed for up to 12 months after progression of disease.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC) which is routinely evaluated in clinical practice according to RECIST criteria
* EGFR mutation-positive disease according to local laboratory testing
* Patients on treatment with Tarceva monotherapy as first-line treatment according to the physician's usual practice

Exclusion Criteria:

* Prior systemic therapy for advanced NSCLC. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it was finalized \>6 months prior to receiving Tarceva
* Participation in another clinical study
* Patients could have received radiotherapy as long as the irradiated lesion was not the only lesion for evaluating response and a long as the radiotherapy was completed before initiating Tarceva treatment