cyrilzakka/clinical-trials huggingface dataset:
Glutamine PET Imaging Colorectal Cancer

The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning.

PRIMARY OBJECTIVES:

I. To establish and validate a 11C-glutamine (11C-Gln) and fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) PET image guided gene signature to predict response to EGFR-targeted therapy in patients with advanced wild-type RAS colorectal cancer (CRC).

OUTLINE:

Patients receive 11C-glutamine intravenously (IV) and undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 IV and also undergo PET imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* Pathologically or cytologically confirmed diagnosis of metastatic (Stage IV) RAS wildtype CRC;
* Eligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC), either as a single agent or in combination with approved SOC therapies or investigational agents as part of IRB-approved clinical trials;
* Archived tissue from the CRC primary tumor in sufficient amounts to allow RNA-seq gene analysis; specimen from metastatic sites are not required but highly preferred;
* Documented results from (or scheduled to undergo) CT or MRI of the chest, abdomen and pelvis as a standard-of-care procedure within 28 days of baseline investigational 11C-Gln PET/CT and 18F-FSPG PET/CT;
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
* At least one lesion \>2 cm in diameter and thus will be measurable according to PET Response Criteria in Solid Tumors (PERCIST) v1.0 to avoid PET partial volume effects;
* Ability to provide written informed consent in accordance with institutional policies.

Exclusion Criteria:

* Any other current or previous malignancy within the past 5 years
* Previous EGFR-directed therapy
* Body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
* Pregnant or lactating females
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2008) and:

  1. Smoking history of at least 10 pack-years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion criteria:

* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.
Acute Heart Failure Study in Patients Admitted to Emergency Department for Dyspnea

No studies have analyzed the predictive value of different anamnestic and clinical signs for the diagnosis of acute heart failure (AHF) in patients admitted to emergency department. That's why the expert group of the AHF of South West of France mobilizes to conduct this study to evaluate the diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF to emergencies.

There is no recommendation of the French Society of Emergency Medicine (SFMU) on the management of the acute heart failure in the emergency department.

The present study hypothesizes that identifying anamnestic and clinical criteria of AHF in patients admitted to emergency department for acute dyspnea would optimize the management of these patients upon arrival to the emergency department and to implement rapidly the appropriate therapeutic strategies.

All patients admitted for dyspnea will be enrolled by the emergency physicians (after verification of inclusion and exclusion criteria) in the 3 participating centers.

Then, all files will be analyzed retrospectively from information collected by a committee of experts cardiologists and emergency physicians of each center.

The primary objective is the evaluation of diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF in emergency department for the construction of a clinical prediction score of acute heart failure. The secondary objective is the description of the diagnostic and therapeutic management of patients admitted to the emergency for acute dyspnea.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years
* Admitted to emergency department for acute dyspnea

Exclusion Criteria:

* Traumatic dyspnea
* shock / Systolic blood pressure \<90 mmHg
Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)

The goal of the redePHine study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO-101 in participants with primary hyperoxaluria type 1 (PH1). The trial will consist of 2 Study Periods. During the first Study Period, there will be 2 parts. In Part A, adult participants will be treated with a single ascending dose to identify a recommended dose. In Part B, pediatric participants will be treated with the recommended dose. Following the first Study Period, participants will start Study Period 2, a long-term monitoring program to comply with local and national requirements.


Eligibility Criteria:
Key Inclusion Criteria for Parts A and B

* Documentation of PH1 as determined by genetic analysis confirming pathogenic mutations in the alanine-glyoxylate aminotransferase (AGXT) gene (valid historical laboratory data will be reviewed and approved by the Sponsor)
* Age at time of signing the informed consent/assent form:

  * Part A: ≥18 years to ≤64 years
  * Part B: ≥6 years to \<18 years
* 24-hour UOx ≥0.7 mmol/24 hours/1.73 m²
* eGFR ≥30 mL/min/1.73m²
* Weight ≤90 kg

Key Exclusion Criteria for Parts A and B

* Confirmed diagnosis of primary hyperoxaluria type 2 or type 3
* History of a liver, kidney or combined liver/kidney transplant
* Currently on dialysis
* Participant has previously used (within past 24 months) or is currently receiving an approved or investigational urinary oxalate lowering RNA interference (RNAi) or siRNA therapy
* Female participants who are pregnant or breastfeeding (or are planning either during the first 12 months)
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia.
* Life expectancy of at least 3 months.
* Baseline chest X-ray and EKG (electrocardiogram).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Known hypersensitivity to interferons or other exogenous lymphokine.
* History of cardiac abnormality or disease.
* History of hypertension.

Patients with the following are excluded:

* Known hypersensitivity to interferons or other exogenous lymphokine.
* History of cardiac abnormality or disease.
* History of hypertension.

Prior Medication:

Excluded within 4 weeks of study entry:

* Corticosteroids.
* Anti-inflammatory medication (except aspirin).
* Changes in the dose of anti-mycobacterial drugs.
* Immune agents.

Prior Treatment:

Excluded within 4 weeks of study entry:

* Radiotherapy.

Risk Behavior:

Excluded:

* Intravenous drug abuse.
Application of GeneXpert on Bronchoscopic Samples in the Clinical Management of Patients Suspicious of TB

This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years old suspected of TB clinically.
2. Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
3. BAL samples obtained following standard investigation procedure
4. CXR or CT imaging available.

Exclusion Criteria:

1. Bronchoscopy is not planned as a necessary procedure for investigation.
2. Diagnosis of active TB has been made by other means.
Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health

The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). We selected a sub-sample of infants to assess their IQ, emotional and behavioral problem, and language development status. The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history. Other interesting exposure includes breast feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.

The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). We selected 1200 \<30 months infants to assess their IQ with Bayley scale, emotional and behavioral problem with CBCL scale, and language development status with LDS scale. We also selected 1500 \>30 months children to measure their emotional and behavioral problem with CBCL scale. The exposure groups include intrauterine nutritional exposure and cesarean delivery exposure as well as CDMR. The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history. Other interesting exposure includes breast feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.

Eligibility Criteria:
Inclusion Criteria:

* all livebirths

Exclusion Criteria:

* died
* moved out
* refused to participate
* being incapable of participation
Effect of Post-Activation Potentiation

This study investigated the acute effect of post-activation performance enhancement (PAPE) on snatch performance to exhaustion in elite weightlifters.

Background This study investigated the acute effect of post-activation performance enhancement (PAPE) on snatch performance to exhaustion in elite weightlifters.

Methods The study was designed according to a randomized crossover experimental design. Twelve male elite athletes (age; 18.45 ± 0.52 years; height; 1.73 ± 0.03m, body mass; 71.36 ± 11.36kg) voluntarily participated in the study. The participants performed a general warm-up for five minutes, followed by a weightlifting-specific warm-up for five minutes, and rested for two minutes. Then, the athletes performed three different PAPE protocols on different days and performed the snatch performance to exhaustion. Shapiro-Wilk test was applied for the normality test, and the Levene test was applied for the homogeneity test. Repeated measures of two-way analysis of variance (2x3) were applied to analyze the differences between treatments. Greenhouse-Geiser correction test was used for measurements where the sphericity assumption was not met.

Eligibility Criteria:
Inclusion Criteria:

* no recent injury
* no medication or supplements
* being a volunteer

Exclusion Criteria:

* doping or chronic drug use
* neuromuscular disease, metabolic, hormonal, or cardiovascular disorders,
* and orthopedic limitation
Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising

Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. The aim of this study is to assess the predictability of PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥20
2. atrial fibrillation patients who underwent elective valvular heart surgery

Exclusion Criteria:

1. age \< 20
2. LV ejection fraction \< 40%
3. any pulmonary disease
4. end stage renal disease
5. high intrabdominal pressure patient
6. contraindication of passive leg raising
7. deep vein thrombosis
The Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects

This study was conducted as a randomized, open-label, single-dose, crossover study design. All participants were randomly allocated for group A (Period 1: Individual components (ICs), period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg, AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim, Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the washout period, the participants received the opposite treatment (Group A: IN-C009; Group B: dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of T2DM currently.

On the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.


Eligibility Criteria:
Inclusion Criteria:

* age between 19 to 45 years;
* body weight more than 50 kg

Exclusion Criteria:

* a history or evidence of hepatic, renal, gastrointestinal, or hematological abnormality;
* hepatitis B, hepatitis C, syphilis, or HIV infection;
* a history of hypersensitivity to dapagliflozin and/or linagliptin;
* clinically significant allergic disease; alcohol or drug abuse;
* heavy smoker (more than ten cigarettes per day);
* use of any medication within 30 days before the start of the study that may affect the study results.
Estimation of the Burden of Rotavirus Gastroenteritis (RV GE) in Children Less Than 5 Years in Greece

The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* A male or female child \< 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday).
* Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation.
* Written informed consent obtained from the parent/guardian of the subject.
* Children with RV positive stool sample will be enrolled in the study.

Exclusion Criteria:

• Not applicable.
Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia

Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.


Eligibility Criteria:
Inclusion Criteria:

1. - Male;
2. - Ages 25 and 60;
3. - Diagnosis of oligospermia;
4. - With sexual partner;
5. - Indication of drug treatment with steroid hormones, precursors or analogues.

Exclusion Criteria:

1. - Severe oligospermia
2. - Anatomical change
3. - Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues;
4. - BMI 35;
5. - Participant who presents liver enzyme and creatinine values above the upper limit of normality;
6. - History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone;
7. - Hypersensitivity to any ingredient present in the formulation;
8. - Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety;
9. - Proven infertility of the partner;
10. - History of genetic disorder;
11. - History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk;
12. - Active cancer at the discretion of the Investigator;
13. - Participants with pregnant and breastfeeding partners;
14. - Cycling and horse riding more than 3 hours per week;
15. - Alcoholism characterized by the inability to control alcohol consumption according to WHO "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". Source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism;
16. - Smoking greater than half a pack per day or equivalent.
Charcot-Marie-Tooth Disease (CMT) Infant Scale (INC-6611)

The purpose of this study is to develop and validate a clinical outcome measure to evaluate disability and disease progression of children 3 years of age and younger (infants and toddlers) with various types of Charcot-Marie-Tooth disease (CMT).

Most forms of CMT begin in childhood and progress throughout a person's lifetime. Current research suggests that treatment to slow disease progression may be most effective if introduced early in a patient's life before muscle weakness and sensation loss develop, as it may be easier to slow disease progression than to reverse disability that is already in place. Clinical outcome measures have been developed for adults (CMT Neuropathy Score) and for children 3 years of age and older (CMT Pediatric Scale). However, no CMT-specific clinical outcome measure currently exists to measure disease severity or progression in children from birth to 3 years of age. It is the goal of this study to develop and validate the CMT Infant Scale (CMTInfS) to meet this need.

Eligibility Criteria:
Inclusion Criteria (patients with CMT):

* Patient is ≤4 years of age
* Parent(s) or guardians have agreed for the child to take part in the study and have signed an informed consent form.
* Patient has known or probable inherited neuropathy
* Patient participates in the INC Natural History Study (INC 6601)

Inclusion Criteria (controls):

* Participant is ≤4 years of age
* Parent(s) or guardians have agreed for the child to take part in the study and have signed an informed consent form.
* Participant does NOT have an inherited neuropathy as determined by the investigator
* Participant is an unaffected friend or family member of a patient with CMT (patient does not have to be included in the study)

Exclusion Criteria (patients with CMT):

* Patient has a known condition of acquired neuropathy including toxic (e.g. medication related), metabolic (e.g. diabetic), immune mediated or inflammatory (AIDP or CIDP) neuropathies, a neuropathy related to leukodystrophy, or a congenital muscular dystrophy.
* Patient has a severe general medical condition, as determined by the site Principal Investigator.
* Patient has known normal nerve conductions of upper and lower limbs. This will be considered as exclusion criteria because it documents that the child does not have a large-fibre neuropathy. However, patients will not be required to have nerve conduction studies (NCS) or electromyography (EMG).
Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome

There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.

The gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the H.pylori infection. We hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.

Eligibility Criteria:
Inclusion criteria:

* Patients scheduled for gastroendoscopy examination
* Aged between 18 and 80 years old

Exclusion criteria:

* Antibiotic, probiotic or prebiotic usage within 2months
* Esophageal, gastric or duodenal cancer or other malignancy
* History of upper GI tract surgery
* Coagulopathy or bleeding disorders
* Allergy to fluorescein sodium
* Pregnant or breast-feeding (for females)
* Impaired renal function