louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00060762: Effectiveness of Binge Eating Disorder Treatments
Official title: Effectiveness of Psychological Treatments for BED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eating Disorders
Keywords: Weight Loss
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-05-13
Enrollment: 205
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 will evaluate the long-term effectiveness of interpersonal psychotherapy, behavioral weight loss interventions, and guided self help treatments in treating binge eating disorder (BED).

Detailed description: BED is a serious condition that is associated with psychiatric comorbidity, psychosocial impairment, and obesity. Interpersonal psychotherapy (IPT), behavioral weight loss (BWL) interventions, and guided self help (GSH) treatments for BED have been evaluated, but the safest and most effective treatment has not yet been identified. This study will determine which of these three treatments is most effective in treating BED.

Participants are stratified by negative affect subtype and are randomly assigned for 6 months to one of three treatment groups: IPT, BWL, or GSH. IPT focuses on current interpersonal problems which are hypothesized to increase negative affect and lead to binge eating. BWL interventions involve the adoption of weight loss inducing behaviors. GSH is a shortened version of cognitive behavioral therapy that focuses directly on eating behavior. IPT and BWL patients have 20 treatment sessions; those receiving GSH have 10 sessions. Assessments are made pre-treatment, post-treatment, and at 6, 12, 18, and 24 months after treatment is complete.

Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for Binge Eating Disorder
* Body Mass Index (BMI) between 27 and 45

Exclusion criteria:

* Body Mass index \> 45
* Current psychosis
* Current bipolar disorder
* Alcohol or drug dependence within last 6-months

Primary outcomes:
measure: Binge eating
timeFrame: Pre-treatment, 6, 12, and 24-months
Secondary outcomes:
measure: Eating disorder psychopathology
timeFrame: pre-treatment, 6, 12, 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: W. Stewart Agras
state: California
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Piscataway
country: United States
facility: Rutgers University Eating Disorder Clinic
state: New Jersey
Study officials:
affiliation: Stanford University
name: William S Agras, MD
role: STUDY_DIRECTOR
References:
citation: Wilson GT, Wilfley DE, Agras WS, Bryson SW. Psychological treatments of binge eating disorder. Arch Gen Psychiatry. 2010 Jan;67(1):94-101. doi: 10.1001/archgenpsychiatry.2009.170.
Clinical trial NCT03816462: ReNEW Clinic Cohort Study
Official title: Reversing the Negative Cardiovascular Effects of Weight (ReNEW) Clinic Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Prehypertension
Obesity
Overweight
Left Ventricular Hypertrophy
Elevated Blood Pressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-01-25
Enrollment: 200
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between birth and 22 years of age with overweight or obesity referred for evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University

Brief summary: This is an ongoing, prospective cohort study of children and young adults who are evaluated in the Reversing the Negative Effects of Weight on the Heart (ReNEW) Clinic at Johns Hopkins University.

Demographic and clinical data of patients who agree to participate are obtained via chart review and entered into a longitudinal clinic registry.


Eligibility criteria: Inclusion criteria:

* Children and young adults with overweight or obesity referred for evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University are eligible.

Exclusion Criteria:

* Children who are wards of the state or who are non-English speaking without an in-person interpreter accompanying them to the clinic visit.

Primary outcomes:
measure: Demographic and clinical data obtained via chart review
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tammy M Brady
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ducharme-Smith K, Brady TM, Vizthum D, Caulfield LE, Mueller NT, Rosenstock S, Garcia-Larsen V. Diet quality scores associated with improved cardiometabolic measures among African American adolescents. Pediatr Res. 2022 Sep;92(3):853-861. doi: 10.1038/s41390-021-01893-w. Epub 2021 Dec 16.
Clinical trial NCT04142762: A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
Official title: A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate CYP3A4-Mediated, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
2. Cohort 5: naive to the use of oral contraceptives.

Exclusion Criteria:

1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.

Primary outcomes:
measure: Area under the plasma concentration time curve (AUC) of ABI-H2158
timeFrame: before dosing and at pre-specified time points up to Day 17
measure: Maximum observed plasma concentration (Cmax) of ABI-H2158
timeFrame: before dosing and at pre-specified time points up to Day 17
measure: AUC of Midazolam
timeFrame: before dosing and at pre-specified time points up to Day 12
measure: Cmax of Midazolam
timeFrame: before dosing and at pre-specified time points up to Day 17
measure: AUC of ethinyl estradiol and levonorgestrel
timeFrame: before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days
measure: Cmax of ethinyl estradiol and levonorgestrel
timeFrame: before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Assembly Biosciences
name: Clinical Study Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT06857162: Comparison of Maternal Hemodynamics During Spinal Anesthesia with Different Cesarean Delivery Positioning
Official title: Comparison of Maternal Hemodynamics During Spinal Anesthesia with Different Cesarean Delivery Positioning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic Outcomes
Maternal Hemodynamic
Maternal Positioning During CS
Lead sponsor: Aswan University
Sponsor class: OTHER
Collaborators: name: Aswan University Hospital
First posted: 2025-03-04
Enrollment: 216
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean delivery is a common surgical procedure, and maintaining maternal hemodynamic stability during the procedure is crucial for both maternal and fetal outcomes . Hemodynamic instability, such as hypotension following spinal anesthesia, is a frequent complication and can lead to adverse maternal and neonatal outcomes. Traditionally, after spinal anesthesia, women are positioned supine, sometimes with a slight left lateral tilt to mitigate the risk of aortocaval compression . However, recent studies and clinical observations suggest that delayed supine positioning-keeping the patient in a sitting or semi-sitting position for a period following spinal anesthesiamay improve hemodynamic stability. These alternative positions may help to mitigate the abrupt drop in blood pressure commonly seen after spinal anesthesia by allowing for a more gradual redistribution of blood volume . Understanding the optimal positioning strategy could lead to improved clinical protocols that enhance maternal and fetal safety. By comparing immediate supine positioning with delayed supine positioning (in sitting and semi-sitting positions), this study aims to provide evidence on which positioning strategy offers the best hemodynamic outcomes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women scheduled for elective cesarean delivery.
* Age between 18 and 40 years.
* ASA (American Society of Anesthesiologists) physical status II.

Exclusion Criteria:

* Emergency cesarean delivery.
* Pre-existing cardiovascular disease.
* Severe preeclampsia or eclampsia.
* Multiple pregnancies.
* Known fetal anomalies.

Primary outcomes:
measure: To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery.
timeFrame: 9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University
name: Ayman Mohamadi Eldemrdash, MD Of Anesthesia
role: STUDY_CHAIR
References:
Clinical trial NCT03269162: Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection
Official title: The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: NSCLC
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB
2. Accept chemotherapy for the first time 6 weeks after operation
3. Age of 18-75 years old
4. Eastern Cooperative Oncology Group-PS≤2
5. N\>1.5×109/L、PLT\> 100 × 109/L、Hb\>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times
6. Voluntary participation in the prospective study with signed informed consent

Exclusion Criteria:

1. No pathology-confirmed diagnosis patients
2. Patients with overall survival time\<6 months
3. Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time
4. Pregnant or breast feeding patients
5. Patients with uncontrollable mentally disease
6. Patients with diabetes

Primary outcomes:
measure: Disease-free survival Rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Longhua Hospital
name: Hegen Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099462: Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fever
Keywords: fever
Ibuprofen
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children and Infants 3 month to 18 years of age with fever (rectal temperature \>38.0OC or oral temperature \> 37.6 OC)

Brief summary: Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children. There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF). The objective of the current study is to describe concentrations of ibuprofen in the CSF of infants and children after administration of ibuprofen. We will study infants presenting to the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup including sampling of blood and CSF is conducted in cases of suspected meningitis. We will measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will unable us to suggest more accurate dosing guidelines, and to better predict the effects of this commonly used drug.


Eligibility criteria: Inclusion Criteria:

* Age: 3 month-18 years
* Rectal temperature \> 38.0OC or oral temperature \> 37.6 OC measured in the ED or at home.
* A sepsis work up is indicated
* At least one dose of Ibuprofen was given in the last 8 hours prior to lumbar puncture (LP)

Exclusion Criteria:

* Hypersensitivity to Ibuprofen
* Known metabolic disorder
* Known liver or kidney disease
* Hydrocephalus
* Informed consent could not be obtained from a legal guardian

Primary outcomes:
measure: Ibuprofen concentration in the CSF
timeFrame: 30 - 360 minutes after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh
Study officials:
References:
citation: Har-Even R, Stepensky D, Britzi M, Soback S, Chaim AB, Brandriss N, Goldman M, Berkovitch M, Kozer E. Plasma and cerebrospinal fluid concentrations of ibuprofen in pediatric patients and antipyretic effect: Pharmacokinetic-pharmacodynamic modeling analysis. J Clin Pharmacol. 2014 Sep;54(9):1023-30. doi: 10.1002/jcph.307. Epub 2014 Apr 21.
Clinical trial NCT00046462: Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Official title: Substituting Lantus®(Insulin Glargine[rDNAorigin]Inj) for a Thiazolidinedione vs. a 3rd Oral Agent as add-on Therapy in Patients Failing a Thiazolidinedione & Sulfonylurea or Metformin Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-10-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 - 79 years of age
* With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months

Exclusion Criteria:

* Major cardiovascular events

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy
timeFrame: During the Study Conduct
Secondary outcomes:
measure: Occurrence of hypoglycemia
timeFrame: During the study conduct
measure: Change in fasting plasma glucose
timeFrame: During the study conduct
measure: Percentage of patients achieving HbA1C less than or equal to 7%
timeFrame: During the study conduct
measure: Time to glycemic control
timeFrame: During the study conduct
measure: Change in body weight
timeFrame: During the study conduct
measure: Change in serum lipid profile
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Doug Green
role: STUDY_DIRECTOR
References:
citation: Hollander P, Sugimoto D, Vlajnic A, Kilo C. Combination therapy with insulin glargine plus metformin but not insulin glargine plus sulfonylurea provides similar glycemic control to triple oral combination therapy in patients with type 2 diabetes uncontrolled with dual oral agent therapy. J Diabetes Complications. 2015 Nov-Dec;29(8):1266-71. doi: 10.1016/j.jdiacomp.2015.05.022. Epub 2015 Jun 5.
Clinical trial NCT02078362: ADCC Against Gastric Cancer Cells
Official title: Evaluation of Antibody-dependent Cell Cytotoxicity (ADCC) Against Gastric Cancer Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric cancer patients treated at National University Hospital.

Brief summary: Peripheral blood will be taken from the enrolled patients at National University Hospital and from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine candidates.


Eligibility criteria: Inclusion Criteria:

For the gastric cancer patients, patients with 21 years of age and above and younger than 80 years old who have gastric cancer can enroll in this study. For the healthy donors, healthy volunteers with 21 years of age and above and younger than 80 years old can enroll in this study.

Exclusion Criteria:

(A) Age of \<21 and \>80 years old (B) Pregnancy (C) Decision of unsuitableness by Principal Investigator or physician-in-charge

Primary outcomes:
measure: Percentage of cell lysis
timeFrame: within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Wei Peng Yong, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.
Clinical trial NCT00370162: Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene
Official title: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata New Fragrance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-08-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety of the gynaecological formulation in normal and usual usage condition.


Eligibility criteria: Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of antiinflammatory or immunosuppression drugs
* Topical medication use at the tested region
* Active cutaneous gynaecological disease
* Personal history of allergic disease at the area to be treated
* Allergic or atopic history

Primary outcomes:
measure: Adverse Events and its association with the drug in study
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT01980862: Blood Collection From Heart Failure Patients to Evaluate for Galectin-3 Measurement Differences Using Various Collection Tubes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Measure Galectin-3 in Heart Failure Patients on Commercial Platforms
Lead sponsor: Fujirebio Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 matched door serum and plasma. Samples set collected form individual Heart Failure patients for galecin-3 measurements

Brief summary: Single-site blood collection investigation.

Detailed description: 45 Heart Failure patients will be recruited. Patients will provide a one-time blood sample specimen collection. Theses samples will be de-identified and provided for measurement of Galectin-3 on commercial platforms.

Eligibility criteria: Inclusion Criteria:

* Heart Failure patients New York Heart Association class able to provide (4) collection tube types Subjects \> 18 years old All subjects must provide informed consent and associated documentation

Exclusion Criteria:

* Subjects that cannot tolerate blood withdrawal of 4 specimens collection tube tubes (approximately 40 mLs)

Primary outcomes:
measure: Obtain 45 matched donor serum and plasma samples sets collected from Heart Failure patients for galectin-3 measurements
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: Universtiy of Maryland School of Medicine
name: Robert Christenson, MD
role: PRINCIPAL_INVESTIGATOR
References: