louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02691559: The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
Official title: The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Transient Tachypnea of Newborn
Intrauterine Growth Retardation
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 184
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as PPROM, prematurity or fetal distress. It is known that fetal urine is the major content of AF since 20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract, umbilical cord and fetal side of placenta are important sources for AF. Bombesin-like peptides, 8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin, sphingomyelin, lamellar body in FAF are molecules acting on fetal lung maturation. Varying levels of these molecules relevant to the stage of lung maturation may constitute an association to AF pHTo detect the possible effect of AF pH on neonatal respiratory morbidities 1 milliliters of AF is aspirated during C-section before incision of membranes. pH value of AFs were analyzed by the blood gas machine (Siemens RAPIDLab®1200 Systems) of NICU. Maternal and neonatal demographic features and clinical outcomes, incidences of morbidities such as respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN) are all recorded.


Eligibility criteria: Inclusion Criteria:

Inflammation/infection associated pregnancies Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

Primary outcomes:
measure: A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
timeFrame: through study completion, an average of 8 months
measure: A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
measure: A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
timeFrame: through study completion, an average of 8 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
affiliation: Postdoctoral Fellow of Neonatology
name: Seda Yilmaz Semerci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05225259: Expanded Access for LOXO-260 in Participants With Cancer Caused by an Abnormal RET Gene That Did Not Respond/is no Longer Responding to Treatment With a Type of Drug Called a RET Inhibitor
Official title: Expanded Access of LOXO-260 in Participants With RET Mutant or RET Fusion Tumors Refractory to Prior RET Selective TKI Treatment
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms
Keywords: Solid tumors
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2022-02-04
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access for participants with cancer caused by an abnormal RET gene that did not respond/is no longer responding to treatment with a type of drug called a RET inhibitor.

The treating physician/investigator contacts Loxo Oncology, Inc. when, based on their medical opinion, a patient meets the criteria for expanded access.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer with RET mutant (medullary thyroid cancer \[MTC\] or multiple endocrine neoplasia type 2 \[MEN2\] tumors) or RET fusion (solid tumors) advanced/metastatic tumors that have become refractory to RET selective tyrosine kinase inhibitor (TKI) treatment, who are not eligible or able to participate in an ongoing LOXO-260 clinical trial and are medically suitable for treatment with LOXO-260.
* Patients tumor must have developed RET solvent front mutations (eg G810X) after RET selective treatment.
* Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
* Have adequate organ function
* Patients must reside in a country where the LOXO-NGR-21001 study (NCT05241834) is not open or recruiting.

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study of LOXO-260 or another second generation RET inhibitor
* Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds
* Clinically significant malabsorption syndrome
* Pregnant or lactating
* Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4
* Patients harboring known activating bypass alterations outside RET (eg. EGFR, ALK, RAS etc) that may confer resistance to LOXO-260

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loxo Oncology, Inc.
name: Emin Avsar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01063959: Sleeve Gastrectomy Versus Gastric Bypass for Private Pay Patients Seeking Obesity Surgery
Official title: Advantages of Sleeve Gastrectomy Over Gastric Bypass for Private Pay Patients Seeking Obesity Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Morbid Obesity
Keywords: Laparoscopic Sleeve Gastrectomy
Laparoscopic Gastric Bypass
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2010-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery than the gastric bypass, gives similar weight losses and that the safety of gastric in private pay patients versus insurance patients will be similar. This is a retrospective chart review of intervention charts.

Detailed description: This study is a retrospective chart review of 800 intervention charts each for consecutive laparoscopic sleeve gastrectomies compared to consecutive laparoscopic gastric bypasses performed by two surgeons in a Louisiana private practice. This retrospective chart review will evaluate the safety of the two procedures during the operative and 6-week post-operative periods, compare the insurance patients to the private pay patients having the gastric bypass, and comparative weight loss in subjects with a follow-up of at least 18 months. This offers the unique opportunity to compare any differences in surgical complications in subjects paying by insurance versus those paying personally for the gastric bypass operation.

Eligibility criteria: Inclusion Criteria:

* The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic sleeve gastrectomy.
* The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic gastric bypass.

Exclusion Criteria:

* Subjects having any other obesity surgical procedure

Primary outcomes:
measure: Comparison of the incidence of weight loss and complications operatively and in the first 6 weeks post-operatively after gastric bypass compared to sleeve gastrectomy.
timeFrame: 18 Months
Secondary outcomes:
measure: Comparison of the incidence of complications in gastric bypass patients covered by insurance vs. private pay patients during surgery, in the hospital and during the first 6 weeks post-operatively.
timeFrame: 18 Months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedial Research Center
name: Drake Bellanger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01413659: Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Postoperative Wound Infection
Keywords: Colorectal surgery
Surgical site infection
Symbiotic
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.


Eligibility criteria: Inclusion Criteria:

1. Both genders
2. More than 14 years old
3. Candidate for elective colorectal surgery

Exclusion Criteria:

1. Denied written informed consent,
2. Severe neutropenia, and
3. Critically ill condition
4. Not meeting inclusion criteria

Primary outcomes:
measure: Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.
timeFrame: 15 months
Secondary outcomes:
measure: The incidence of postoperative infection including surgical site infections (SSIs) and distant-site infections after elective colorectal surgery in patients whether or not receiving pre-operative symbiotic conditioning.
timeFrame: 15 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04833959: Pilot Study of 89-Zr Panitumumab in Pancreas Cancer
Official title: Pilot Study of 89Zr Panitumumab in Pancreas Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pancreas Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of pancreatic cancer.

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
* History of infusion reactions to monoclonal antibody therapies.
* Pregnant or breastfeeding.
* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
* Severe renal disease or anuria.
* Known hypersensitivity to deferoxamine or any of its components.

Primary outcomes:
measure: Incidence of treatment emergent adverse events assessed by CTCAE v5
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Universiy
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04219059: MR Radiomic Features in Prostate Cancer
Official title: MR Radiomic Features in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: cancer
prostate
radiomics
MRI
prognostic factors
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: IBFM-CNR (Istituto di Bioimmagini e Fisiologia Molecolare, National Research Council, Segrate, Italy
First posted: 2020-01-06
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 male patients who have a pre-intervention prostate MRI with contrast agent from December 2015 to August 30, 2019 and biopsy proven Pca diagnosis, followed by radical prostatectomy will be evaluated.

Brief summary: A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Detailed description: Quantitative approaches to medical image analysis have been developed in recent years with the aim to overcome the limitation of qualitative image interpretation, and provide biomarkers for disease characterization. In particular, the new paradigm, "radiomics", is emerging as the high-throughput extraction of quantitative features from imaging which can aid in characterizing phenotype as in vivo expression of tumoral genotype. The goal of radiomics is to extract accurate and reliable quantitative biomarkers which enhance diagnostic confidence in oncology. A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* In house MRI with contrast medium
* PCa (prostate cancer) biopsy proven diagnosis
* In house radical prostatectomy

Exclusion Criteria:

* \< 18 years of age
* MRI without contrast medium
* Radical prostatectomy executed not in Institution

Primary outcomes:
measure: Number of surrogate bioimaging markers of histological characteristics in MR images
timeFrame: 0-2 years
Secondary outcomes:
measure: Radiomic features from MRI
timeFrame: 0-2 years
measure: Extract radiomic features
timeFrame: 0-2 years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT04566159: Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention
Official title: Computer Delivered and Community Health Worker Supported Smoking Cessation Intervention for Hospitalized Persons With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Keywords: HIV
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of tobacco smoking is high among persons with HIV (PWH). The investigators are piloting a two session computer-delivered intervention (CBI) with linkage to a community health worker (CHW) among hospitalized PWH with tobacco use 1a) To determine feasibility and acceptability of delivering this intervention and 2a) To determine intervention effect on 1) readiness to quit smoking and confidence in ability to quit smoking 2) uptake of smoking cessation therapy


Eligibility criteria: Inclusion Criteria:

* Age \>=18,
* A patient admitted to the Johns Hopkins Hospital
* Smoked \>100 cigarettes in their lifetime
* Current smoker
* English speaking

Exclusion Criteria:

* Contraindication to nicotine replacement therapy including unstable angina and acute coronary syndrome

Primary outcomes:
measure: Intervention Feasibility as assessed by the Feasibility of Intervention Measure
timeFrame: 3 months
measure: Intervention Acceptability as assessed by the Acceptability of an Intervention Measure
timeFrame: 3 months
Secondary outcomes:
measure: Readiness to quit smoking as assessed by a Visual analog scale
timeFrame: immediately post intervention
measure: Uptake of nicotine replacement therapy
timeFrame: immediately post intervention
measure: Continued use of nicotine replacement therapy 1 month post intervention
timeFrame: 30 days post intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Geetanjali Chander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02366559: Electrocautery vs Q-switch for Seborrheic Keratosis
Official title: Comparing the Efficacy and Risk of Adverse Events of Electrocautery Versus 532 nm Qswitched Neodymium-doped Yttrium Aluminium Garnet Laser for the Treatment of Flat Seborrheic Keratoses: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Keratosis, Seborrheic
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy and risk of adverse events of electrocautery versus 532 nm Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) laser for the treatment of flat seborrheic keratoses.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility criteria: Inclusion Criteria:

1. Subjects are Caucasian or Asian.
2. Subjects who are between 18-65 year olds.
3. Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy.
4. Subjects have Fitzpatrick skin type I-III.
5. Subjects are in good health.
6. Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

1. History of keloids or hypertrophic scars.
2. Pregnant or lactating or intends to become pregnant in the next 3 months.
3. Active skin disease or skin infection in the treatment area.
4. Previous history of lidocaine allergy.
5. History of methemoglobinemia
6. Unable to understand the protocol or to give informed consent.
7. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject.

Primary outcomes:
measure: Change in Pigmentation from baseline to week 18
timeFrame: Baseline and 18 weeks
measure: Change in lesion texture from baseline to week 18
timeFrame: Baseline and 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06799559: Study on the Efficacy and Safety of QLM1016 in Schizophrenia
Official title: A Multicenter, Randomized, Double-blind, Parallel Controlled Study on the Efficacy and Safety of QLM1016 in the Treatment of Schizophrenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the antipsychotic efficacy of QLM1016 in a multicenter, randomized, double-blind, parallel controlled study in patients diagnosed with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* male or female subjects, ages 18-65 inclusive, with a clinical diagnosis of schizophrenia
* PANSS total score ≥ 70 and ≤ 120，Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behavior, conceptual disorganization, and unusual thought content
* CGI-S score ≥ 4

Exclusion Criteria:

* Currently, meet DSM-5 diagnostic criteria for other psychiatric disorders ( for example schizoaffective disorder, schizophreniform disorder, bipolar I and II disorder; pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders；
* known or suspected borderline or antisocial personality disorder or other psychiatric disorders of sufficient severity to interfere with participation in the study

Primary outcomes:
measure: change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: Time Frame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01192659: Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes
Official title: Identification of Risk Factors for Low Lymphocyte Count in Patients With Type 2 Diabetes: An Analysis of Data From the SAVOR Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-09-01
Enrollment: 16492
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in the Saxagliptin Assessment of Vascular Outcomes Recorded in Diabetes Mellitus study, which is a randomized, placebo-controlled phase 4 study of cardiovascular outcomes). 12,000 patients with type 2 diabetes and either a history of a cardiovascular event or multiple risk factors for vascular disease. Patients will be distributed as follows: at least 30% in North America, approximately 30% in Europe, and the remainder in South America, Asia, Australia, and South Africa.

Brief summary: The purpose of this study is to identify risk factors for low lymphocyte count among patients with type 2 diabetes who are treated with oral antidiabetic drugs.

Detailed description: Involving a secondary analysis of data collected prospectively from a defined cohort, for the SAVOR trial.

Eligibility criteria: Inclusion Criteria:

* Enrolled in SAVOR
* Diagnosed with T2DM
* Baseline HbA1c ≥6.5% (based on the last measured and documented laboratory measurement within 6 months)
* Age 40 or older
* High risk for a cardiovascular event

Exclusion Criteria:

* Not enrolled in SAVOR
* Current or previous treatment with DPP4 inhibitors and/or GLP-1 or incretin mimetics.
* Acute vascular event
* Pregnancy
* HIV/AIDS
* Severe autoimmune disease
* Current chronic steroid use

Primary outcomes:
measure: To identify risk factors for lymphopenia, defined as an absolute lymphocyte count < 500 cells/μl, or investigator reported lymphopenia, in the SAVOR study population.
timeFrame: 60 months
Secondary outcomes:
measure: To identify risk factors for absolute lymphocyte count <750 cells/µl or investigator reported lymphopenia.
timeFrame: 60 months
measure: To identify risk factors for decreased lymphocyte count (>=30% decrease from baseline.
timeFrame: 60 months
measure: To evaluate whether risk factors for low lymphocyte counts or decreasing lymphocyte count differ between saxagliptin users and non-users.
timeFrame: 60 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: