cyrilzakka/clinical-trials huggingface dataset:
PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma

RATIONALE: Diagnostic procedures may improve the ability to detect metastatic melanoma and to determine the extent of disease.

PURPOSE: Phase II trial to evaluate the effectiveness of PET and CT scans to detect metastatic disease in patients who have stage III or stage IV melanoma.

OBJECTIVES: I. Evaluate the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging in detecting metastatic disease in patients with stage III or IV melanoma considered for operative management based on the currently accepted diagnostic work up including CT imaging. II. Determine how often the clinical management of these patients is altered based on FDG PET imaging findings in addition to CT scan results.

OUTLINE: Patients are required to fast for a minimum of 6 hours prior to positron emission tomography (PET) imaging. Fludeoxyglucose F 18 (FDG) is administered IV over 15 minutes followed 50-60 minutes later by whole body PET imaging. Iodinated contrast dye is administered by IV injection and by mouth followed by CT imaging of the chest, abdomen, and pelvis within 2 weeks of PET imaging. Whole body FDG PET imaging and CT imaging of the chest, abdomen, and pelvis are repeated at 6 months. Initial positive PET or CT imaging results are verified based on surgical and/or biopsy findings or clinical follow-up.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven melanoma considered for operative management with 1 of the following: Deep primary melanoma (greater than 4 mm, stage IIIA) Regional nodal disease (stage IIIB) Locally or regionally recurrent disease of an extremity considered for operative resection or isolated limb perfusion with curative intent Systemic disease considered for curative resection (stage IV)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Able to fast for 6 hours Able to lie still for positron emission tomography imaging No second malignancy except previously treated nonmelanomatous skin cancer or carcinoma in situ of the cervix No active infection No inflammatory disease (sarcoidosis or rheumatoid arthritis) No allergy to shellfish or contrast dye used for CT imaging

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness

subjects with severe seasickness, who failed to habituate to sea conditions after at least six month of active sailing, were enrolled to the single-blind randomized control study. The intervention group was treated with rotatory chair stimulation at sinusoidal harmonic acceleration protocol coupled with galvanic vestibular stimulation to the mastoid processes. This unique procedure was hypothesized to promote habituation to seasickness. The control group underwent a sham procedure. All study participants filled out seasickness questionnaires at set time points following the intervention and underwent repeated step testing to determine their vestibular time constant. The number of anti-motion sickness clinic visits and scopolamine prescriptions was also recorded in the three months period following the intervention.


Eligibility Criteria:
Inclusion Criteria:

* maximum score of 7 on the Wiker seasickness questionnaire in moderate sea conditions, with wave height of 0 - 1.5 m
* All had been sailing regularly for at least six months before enrolling in the study

Exclusion Criteria:

* history of hearing loss
* otoscopic findings of ear pathology
* an implanted electrode
* a finding of vestibulopathy on otoneurologic examination
* withdrawal by any subject of his informed consent.
Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care Unit

This study aims to investigate the correlation between pulmonary microbiota dynamics (including bacteria, fungi and viruses) and COPD exacerbation for COPD patients admitted to ICU

Chronic obstructive pulmonary disease (COPD) is a frequent cause of ICU admission. COPD exacerbations are a leading cause of lung function worsening and of morbimortality. Hospitalizations due to COPD exacerbations are highly expensive for health insurance system. Bacterial pulmonary microbiota has been shown to be correlated to the severity of COPD and to exacerbations. Nevertheless fungi and viruses which are full actors of pulmonary microbiota have not yet been investigated.

Our primary outcome will be the assessment of alpha and beta diversity dynamics of the whole pulmonary microbiota (bacteria, fungi and viruses) between COPD exacerbation and steady state.

This study will prospectively include 24 patients at ICU admission for COPD exacerbation with sputum sampling. Steady-state as defined during a 2 months-later visit will be studied with another sputum collection.

Eligibility Criteria:
Inclusion Criteria:

* Patient above 18 admitted in ICU
* Admitted for COPD exacerbation defined by sustained (\> 2 days) worsening of respiratory symptoms considering Anthonisen's criteria with life-threatening condition.
* Needing mechanical ventilation (noninvasive ventilation or oro-tracheal intubation)
* COPD condition will be presumed according to patient's respiratory history or previous lung function testing
* Able to consent or with the patient's family consent
* Affiliated to a social insurance scheme

No inclusion Criteria:

* COPD patient admitted for another cause than respiratory failure
* person under tutorship or curatorship
* living further than 100 kilometers away from the ICU
* expected survival inferior to 1 week

Exclusion Criteria

- Lung function testing not consistent with COPD at steady-state visit
Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination

RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the recent dissemination of a serine carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2003 or biapenem) plus a new beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases, including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics and pharmacodynamics of Intravenous Biapenem and RPX7009, administered alone and in combination in healthy adult subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males and/or females, 18 to 55 years of age
* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
* Medically healthy with clinically insignificant screening results
* Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
* Sexually abstinent or use acceptable methods of birth control

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
* Hypersensitivity or idiosyncratic reaction to beta-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenems, etc.).
* Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
* Plasma donation within 7 days prior to Day 1.
* Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).
Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure

The aim of this study is to examine the effect of dairy proteins (whey and casein) on postprandial appetite regulation and energy expenditure.

Several studies have shown that a high protein intake is associated with a increased loss of body weight and body fat as compared to a diet with a normal or low protein content. The effect seems to be due to a higher diet induced thermogenesis and increase satiety.

Milk has a high content of proteins. It contains two very different types of protein: whey and casein. Whey is a soluble protein whereas casein clots into the stomach, which delays its gastric emptying and thus probably results in a slower release of amino acids. It is therefore very likely that the two types of protein affect the thermogenesis and appetite regulation differently.

The aim of the present study is to examine the effect of dairy proteins (whey and casein) on postprandial energy expenditure, substrate oxidation and appetite regulation.

The study will have a cross-over design including four meals each including a test drink (milk, casein drink, whey drink or water).

Eligibility Criteria:
Inclusion Criteria:

* healthy males
* body mass index (BMI) 25-30 kg/m2
* 18-50 years
* weight stable

Exclusion Criteria:

* smoker
* regular use of medicine
* elitist athletes
* participation in other intervention studies
Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam

To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.

* In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
* In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women of non-childbearing potential between 18-50 years of age
* Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
* In good health, determined by no clinically significant findings from clinical evaluations
* Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

* Women of childbearing potential
* Evidence of clinically significant medical conditions
* History of gastrointestinal disease or surgery that may affect drug absorption
* Positive or indeterminate tuberculosis-spot test at screening
* Any active infection at the time of screening or admission
* Subjects with acute narrow-angle glaucoma
Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients

The purpose of this study is to measure the effect of introducing a patient navigator to guide high and moderate risk patients through the pre-waitlisting phases of the kidney transplant process. Patients identified as being at high and moderate risk of delay to waitlisting will be linked with a patient navigator, who will facilitate their completion of pre-waitlisting requirements. We believe that patients who are randomized to a patient navigator will be more likely to complete the pre-waitlisting process and will complete the process more quickly than high and moderate risk patients who do not receive additional assistance from a patient navigator.

The investigators plan to implement a newly developed risk assessment tool that uses medical and demographic indicators to estimate the probability of waitlisting for all patients beginning the transplant process at the Emory Transplant Center. Medical secretaries will collect information about patients' medical and demographic characteristics during the appointment scheduling phone call. This information will be entered into the REDCap risk assessment tool, which will be used to calculate the probability of waitlisting. A previously defined cut-off will be used to categorize the risk of delay to waitlisting.

A random subset of patients identified as being at high and moderate risk of delay to waitlisting will be connected with a patient navigator, who will be available not only to answer questions, but also to manage clinical information prior to, during, and following transplantation. The navigator will work to identify potential barriers and to ensure that the most up-to-date clinical information has garnered responses at the nurse and physician levels.

The effect of connecting high and moderate risk patients with a patient navigator on time to waitlisting and rate of waitlisting will be analyzed to determine whether such a program is an effective means of increasing access to transplant for patients who are likely to face financial, racial, and demographic barriers.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant candidates older than 18 years of age at Emory Transplant Center

Exclusion Criteria:

* There are no exclusion criteria that would limit subject participation
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) \[Lp(a)\]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women with ages between 18 and 70 years old, inclusive.
* Protocol-defined elevated plasma Lp(a) level.
* Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening.
* Women must be of non-reproductive potential.
* Other Inclusion criteria may apply

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study.
* Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
* History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
* History or clinical evidence of bleeding diathesis or any coagulation disorder.
* History or clinical evidence of peripheral neuropathy.
* Other Exclusion criteria may apply
Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.

In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.


Eligibility Criteria:
Inclusion Criteria:

* Women at first cesarean delivery
* Women who consent to the study

Exclusion Criteria:

* Women who are having a repeat caesarean section
* Refusal to participate in the study
* Urgent or emergent cesarean delivery
Gallstones and Concomitant Gastric Helicobacter Pylori Infection

In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.

Gallstone disease is one of the most common problems affecting the digestive tract where autopsy reports show a prevalence of 11-36% . The prevalence of gallstones is related to many factors including age, gender, and ethnic background. Women are three times more likely to develop gallstones than man and first-degree relatives have a two-fold increased prevalence . However, the etiology of gallstone formation beginning with the change in the composition of bile, leading to stones is not clear.

The association between Helicobacter pylori (H.Pylori) and gallstones has been investigated but not clearly demonstrated. H.Pylori is a gram negative and micro-aerophilic microorganism that can cause chronic gastritis, gastric and duodenal ulcers, gastric adenocarcinoma and lymphoma of gastric mucosa-related lymphoid tissue (MALToma) . Relationship of H.Pylori with diseases of organs other than the stomach and duodenum has also been investigated and reported . H.Pylori have been detected in the gallbladder mucosa of patients with gallstones .

In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute cholecystitis, cholangitis, biliary and hepatic tumors, Crohn's disease, and previous gastric surgery were not considered suitable for evaluation.

Exclusion Criteria:

* Patients undergoing ERCP (endoscopic retrograde cholangio-pancreatography) and patients who have received H.Pylori eradication treatment in the last 6 month were also excluded from the study.
Duration of Adjuvant Chemotherapy for Gastric Cancer Patients at Pathological N3 Stage

The goal of this retrospective study is to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.

Due to a heavy metastatic node burden, pathological stage N3 (pN3) gastric cancer (GC) patients have extremely poor prognoses. Except for surgical resection, postoperative adjuvant chemotherapy is the major treatment strategy to improve survival for these patients. Capecitabine plus oxaliplatin (CapOx) and S-1 plus oxaliplatin (SOX) were considered the effective treatment for stage II and III GC after D2 gastrectomy in the CLASSIC and RESOLVE trials. But N3b (positive lymph nodes ≥16) and T1-3N3 patients were omitted in these two trials, respectively. Moreover, only 66.5% of patients finished 6 months of chemotherapy in the CLASSIC trial, and in the RESOLVE trial, 17-19% of patients required dose reductions and about 19% of patients discontinued chemotherapy due to drug-related toxicity for 6 months of chemotherapy. Particularly, cumulative administration of oxaliplatin led to peripheral sensory neurotoxicity, which caused poor quality of life and treatment compliance. Recently, a prospective analysis of six randomized, phase 3 trials with 12834 participants (IDEA trail) for stage III colon cancer, demonstrated that 3 months of CapOx was as effective as 6 months with relatively lower recurrence risk, no significantly different overall survival, and fewer adverse effects. However, there were no relevant studies to explore the optimal duration of chemotherapy for pN3 GC patients.

This study aims to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old
2. Pathological stage N3 GC (≥7 positive lymph nodes) after curative surgery according to the AJCC TNM staging system, 8th edition
3. Histologically confirmed R0 resection, defined as no macroscopic or microscopic residual tumor
4. Postoperative chemotherapy with CapOX or SOX doublet regimen, initiating within 6 weeks after curative gastrectomy
5. No distant metastases or gastric stump cancer
6. No other malignant tumors

Exclusion Criteria:

1. Patients who had undergone neoadjuvant chemotherapy or radiotherapy
2. Patients who received capecitabine or S-1 alone or combined with biological therapy, radiation therapy, or Immunosuppressive therapy
Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.

The study aims is to find out if people with type 1 diabetes diagnosed in later life (after age 30) have the same rapid loss of insulin secretion (measured using C-peptide) that occurs in younger adults with type 1 diabetes. The investigators will recruit 135 participants aged over 30 years with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. The investigators will also recruit a comparison group of 61 participants aged 18-30 with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. C-peptide will be measured during mixed meal tolerance tests (MMTT) performed at baseline, 6 months and a year.

This study also aims to test a new more practical way of monitoring insulin secretion at home using a finger prick 'blood spot' rather than time consuming tests in a hospital. Finger-prick C-peptide samples will be collected after the MMTT and by the participants at home throughout the year.

The study aims to evaluate progression of type 1 diabetes. Primary analysis will be conducted on those with \>=1 diabetes autoantibody positive (GAD, IA2 ZNT8). Sensitivity analysis will be performed by repeating all analysis defining T1D as a) double antibody positivity and b) single antibody positivity combined with a high genetic risk score for T1D (T1DGRS\>5th centile of a control population).

Further aims will be to evaluate the utility of dried blood spot testing to detect change in C-peptide and the utility of home test results as a marker of hypoglycaemia and glucose variability.

Eligibility Criteria:
Inclusion Criteria:

* Adults with a clinical diagnosis of Type 1 diabetes within the previous 100 days.
* Aged \>30 at the time of Type 1 diabetes diagnosis OR (additional early onset Type 1 diabetes cohort) aged ≥18 and ≤30 at the time of Type 1 diabetes diagnosis.
* Insulin treated at the time of recruitment
* Able and willing to provide informed consent.

Exclusion criteria

* Pregnancy
* Known monogenic diabetes
* Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).