louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01682343: Effect of High-calcium Intake on Appetite, Insulinemia and Incretins
Official title: Effect of High-calcium Intake on Appetite, Insulinemia and Incretins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 10
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the appetite, insulin and incretin hormone responses to a high-calcium meal.

Detailed description: Participants will be provided with control and high-calcium meals. Insulin, appetite, glucagon-like peptide-1 and glucose-dependent insulinotropic peptide responses will be assessed, along with rates of substrate oxidation.

Eligibility criteria: Inclusion Criteria:

* recreationally active
* male

Exclusion Criteria:

* food intolerances/allergies

Primary outcomes:
measure: Subjective appetite ratings
timeFrame: 3 hour
Secondary outcomes:
measure: Serum insulin concentration
timeFrame: 2 hour
measure: Plasma glucose-dependent insulinotropic peptide concentration
timeFrame: 2 hour
measure: Plasma glucagon-like peptide-1 concentration
timeFrame: 2 hour
Other outcomes:
measure: Total fat oxidised during 60 min of exercise (g)
timeFrame: 1 hour
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne on Wear
Study officials:
affiliation: Northumbria University
name: Javier T Gonzalez, MRes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03478943: The Real World Study of Apatinib for Gastric Cancer Treatment in Henan Province
Official title: The Real World Study of Apatinib for Gastric Cancer Treatment in Henan Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of gastric cancer in Henan province

Brief summary: The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .


Eligibility criteria: Inclusion Criteria:

1. Male or female patients .
2. Confirmed by Pathology or histology of Gastric cancer.
3. Patients should be voluntary to the trial and provide with signed informed consent.
4. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
2. Pregnant or lactating women.
3. Patients with Apatinib contraindications.
4. Patients of doctors considered unsuitable for the trial.

Primary outcomes:
measure: Progress free survival
timeFrame: 1 year
measure: Disease-free surviva
timeFrame: 1 year
Secondary outcomes:
measure: overall survival
timeFrame: 3 year
measure: Objective Response Rate
timeFrame: 1 year
measure: Disease Control Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Suxia Luo
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Peichun Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01093443: Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days
Official title: Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: IVF
ICSI
GnRH antagonist
pretreatment
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.

Detailed description: A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.

Eligibility criteria: Inclusion Criteria:

* \< 39 years old on day of randomisation
* FSH \< 12 (in the early follicular phase)
* Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
* Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
* BMI between 18 and 29 (both inclusive)
* 1st or 2nd trial
* IVF or ICSI
* Randomisation at out-patient clinic

Exclusion Criteria:

* ≥ 39 years old on day of randomisation
* Endometriosis ≥ grade 3
* PCOS

Primary outcomes:
measure: Endocrine profile
timeFrame: up to 9 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References:
Clinical trial NCT05763043: Monoferric for Prenatal Iron Deficiency
Official title: Monoferric for Prenatal Iron Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Obstetric Labor Complications
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

Detailed description: Intravenous therapy (IV) Monoferric (ferric derisomaltose), is a single-dose, rapid infusion formulation that has the potential to reduce both time and cost barriers, though its efficacy and safety in pregnant women has not been well studied. Thus, we propose to study the safety and efficacy of single dose, monoferric 1,000 mg IV in a cohort of pregnant participants with iron deficiency.

Eligibility criteria: Inclusion Criteria:

* Participants 18 years of age or older between 14 to 42 weeks gestation who are deemed appropriate for IV iron by their treating provider as part of their standard of care treatment.
* Iron deficiency anemia, defined as second or third trimester (14 weeks or more) hemoglobin less than or equal to 10.5 g/dL or less than or equal to11 g/dL, respectively, and ferritin less than 50 μg/L
* Experience intolerance to oral iron or are greater than 28 weeks gestation
* Willing to participate in the study

Exclusion Criteria:

* Known infectious, inflammatory, or malignant conditions that may confound iron repletion and outcome analysis
* Prior IV iron intolerance or hypersensitivity reaction

Primary outcomes:
measure: The proportion of participants who experienced a resolution of iron deficiency anemia
timeFrame: From enrollment to 6 weeks post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science Univerity
state: Oregon
Study officials:
References:
Clinical trial NCT01352143: Thrombin Generation in Neonatal Plasma After Cardiopulmonary Bypass
Official title: Measurements of Thrombin Generation in Response to Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Neonatal Plasma After Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Bypass
Keywords: Neonates
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Research Oversight Committee Funds
First posted: 2011-05-11
Enrollment: 24
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates (less than 30 days of age) undergoing complex congenital cardiac surgery requiring cardiopulmonary bypass

Brief summary: The primary goal of this investigation is to determine the ability of recombinant activated factor VII (rFVIIa) and prothrombin complex concentrate (PCC) to improve thrombin generation in neonatal plasma after CPB.

Detailed description: In this investigation, the investigators propose a comparison in vitro of the ability of rFVIIa with that of PCC to increase thrombin generation in neonatal plasma after CPB. A pre-cardiopulmonary bypass (CPB) baseline blood sample will be obtained. After the termination of CPB and the administration of one round of protamine, platelets and fibrinogen (standard of care), a second blood sample will be drawn. All samples will be centrifuged to yield platelet rich plasma and stored until processing. In the pre-CPB sample, baseline thrombin generation will be measured. The post-CPB sample will be divided into three aliquots to measure thrombin generation under three different circumstances: the first will serve as a control, the second will include rFVIIa and the third PCC.

Eligibility criteria: Inclusion Criteria:

1. Full-term neonates (36-42 weeks gestational age)
2. Apgar score of 7 or more at 5 minutes after delivery
3. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta at Egleston
4. Parents willing to participate, and able to understand and sign the provided informed consent

Exclusion criteria:

1. Preterm neonates (less than 36 weeks gestation)
2. Apgar score of less than 6 at 5 minutes after birth
3. Emergent procedure
4. Patients undergoing cardiac surgery not requiring CPB
5. Neonates with a known coagulation defect or coagulopathy
6. Mother with a known coagulation defect or coagulopathy
7. Parents unwilling to participate or unable to understand and sign the provided informed consent

Primary outcomes:
measure: Peak thrombin Generation
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Nina A Guzzetta, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023243: Natural Language Processing and Quality Assessment in Primary Care
Official title: Novel Use of Natural Language Processing and Targeted Patient Education Information Regarding the Process for Completion of the Foot Examination in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: foot exam
health services
practice improvement
quality
preventive services
Natural Language Processing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 389
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to use a Natural Language Processing System (NLP) to provide an initial baseline report for primary care patients at risk for diabetes and cardiovascular complications that will include: a) evidence of foot exam documentation in the previous year; b) use of aspirin for cardiovascular risk reduction; and c) tobacco use. As part of a randomized trial, we plan to use a previously validated mailed survey (NCQA Provider Recognition Program) that requests information on the last foot exam, use of aspirin and tobacco. Patients who have been identified by NLP as not having had a foot exam will be randomized into treatment and control arms. Both arms will receive an informational letter; with a second mailing to nonresponders after one month, describing the key strategies for effective patient-physician communication during the clinical encounter. The treatment arm will also receive an informational letter and patient education brochure containing key messages about the importance of regular foot examinations. NLP will be repeated after 6 months to compare the impact of the patient education materials.


Eligibility criteria: Inclusion Criteria:

* primary care patients with diagnosis of diabetes

Exclusion Criteria:

* unwilling to give informed consent

Primary outcomes:
measure: Completion of foot exam
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Patient report in validation of Natural Language Processing
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gregory a Bartel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Steven A Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pakhomov S, Bjornsen S, Hanson P, Smith S. Quality performance measurement using the text of electronic medical records. Med Decis Making. 2008 Jul-Aug;28(4):462-70. doi: 10.1177/0272989X08315253. Epub 2008 May 13.
Clinical trial NCT03294343: Risk-Reducing Surgeries for Hereditary Ovarian Cancer
Official title: Risk-Reducing Surgeries of Salpingo-oophorectomy With/Without Hysterectomy for Carriers With Mutation Genes of Hereditary Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis
Ovariectomy
Hysterectomy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 600
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Based on studies of "Inherited Susceptible Genes Among Epithelial Ovarian Cancer" (NCT03015376, clinicaltrials.gov) and "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov), we provide risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer with relevant pathogenic mutations.


Eligibility criteria: Inclusion Criteria:

* Carriers with known and definite mutation genes of hereditary ovarian cancer.
* With children and without further requirement of pregnancy.
* No less than 35 years for carriers with mutation gene of BRCA1.
* No less than 40 years for carriers with mutation gene of BRCA2.
* No less than 45 years for carriers with mutation genes of BRIP1, RAD51C, RAD51D and RAD51.
* No less than 50 years for carriers with mutation genes of ATM, MSH2, MLH1, SH6, PMS2, EPCAM and STK11.

Exclusion Criteria:

* Without children.
* Not reaching appreciate ages.
* With contraindications of laparoscopy.
* Refusal of risk-reducing surgeries.

Primary outcomes:
measure: Occult cancer or precancerous lesion in histological specimen
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 10 years
measure: Incidence of primary peritoneal carcinoma
timeFrame: 10 years
measure: Incidence of primary uterine cancer
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: China/Beiing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213343: Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration
Official title: Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Velopharyngeal Insufficiency
Keywords: aspiration
phrenic nerve
magnetic stimulation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients

Brief summary: the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration

Detailed description: phrenic nerve stimulation during swallowing

Eligibility criteria: Inclusion Criteria:

stroke with aspiration

Exclusion Criteria:

obstructive rhinitis bronchial obstruction pace maker phrenic nerve paralysis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: eric verin, MD -PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01168843: Computer Program for Evaluation of the Symmetry Between the Primary Sulci of the Two Fetal Brain Hemispheres and Midsagittal Fetal Head Biometry Using 3-dimensional Ultrasound Planes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Fetal Brain Sulcation
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: normal pregnancies in 2nd and 3rd trimester

Brief summary: Computer Program for Evaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes

This retrospective study is based on the computerized analysis of the orthogonal fetal brain planes.

The images are obtained from the digital archive of the fetal sonographic examinations done in Bnai Zion Medical Center.

In addition, midsagittal measurements of fetal head will be obtained from this archive of 3-dimensional images.

Study measurements will provide the quantitative parameters of normal fetal brain sulcation. Normal fetal head growth in midsagittal plane will be studied also.


Eligibility criteria: Inclusion Criteria:

* normal pregnancies
* proper dating

Exclusion Criteria:

* complications of pregnancy
* fetal malformations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
References:
Clinical trial NCT07025343: Does Intralipid Infusion Can Reverse the Spinal Anesthesia Effect in Day Case Surgery?
Official title: Does Intralipid Infusion Can Reverse the Spinal Anesthesia Effect in Day Case Surgery?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intralipid Infusion
Spinal Anesthesia
Day Case Surgery
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 50
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: This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery.

Detailed description: The increasing demand for day-case surgery has led to a growing interest in developing strategies to provide patients with a more convenient, cost-effective, and less invasive alternative to traditional inpatient procedures.

Spinal anesthesia, in particular, is a widely used technique in day-case surgery due to its ability to provide excellent analgesia with minimal side effects.

Intravenous lipid emulsion therapy is commonly used to treat local anesthetic systemic toxicity (LAST) and has demonstrated some efficacy in treating other drug toxicities, particularly cardiotoxicity from lipophilic drugs.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for day-case surgery under spinal anesthesia.
* Time of surgery less than 90 min.

Exclusion Criteria:

* Patients with contraindications for outpatient surgery or spinal anesthesia.
* Local anaesthetic (LA) allergy.
* Those receiving anticoagulant therapy.
* Emergency cases.
* Pregnant cases.

Primary outcomes:
measure: Time from the end of surgery till movement
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Duration of motor block
timeFrame: Intraoperatively
measure: Time till home readiness
timeFrame: 24 hours postoperatively
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Total tramadol consumption
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University
state: Banha
Study officials:
References: