louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00799162: Prediction of Post-Cesarean Section Pain
Official title: Prediction of Post-Cesarean Section Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2008-11-27
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a scheduled elective cesarean section

Brief summary: The purpose of this study is to determine if dynamic psychophysical testing along with genetic screening will allow to identify pre-operatively women who will suffer severe acute pain post-operatively and the subset who may experience chronic pain following cesarean section.


Eligibility criteria: Inclusion Criteria:

* Women age 18-50 scheduled for an elective cesarean section (1st or 2nd cesarean section)

Exclusion Criteria:

Women who:

* have taken opioids, acetaminophen, or NSAIDs 48 hrs prior to psychophysical testing
* have had more than two previous cesarean sections
* have a vertical abdominal incision from a prior cesarean section
* are non-English speaking
* have mental health issues
* have a failure of spinal anesthetic and require conversion to general anesthesia
* have a vertical uterine incision performed during ongoing cesarean section
* have a previous vertical uterine scar discovered during ongoing cesarean section

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Brussels
country: Belgium
facility: St. Luc Hospital, University Catholic of Louvain
city: São Paulo
country: Brazil
facility: Hospital e Maternidade Santa Joana
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
citation: Ortner CM, Turk DC, Theodore BR, Siaulys MM, Bollag LA, Landau R. The Short-Form McGill Pain Questionnaire-Revised to evaluate persistent pain and surgery-related symptoms in healthy women undergoing a planned cesarean delivery. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):478-86. doi: 10.1097/AAP.0000000000000158.
Clinical trial NCT00206362: Ability to Cope With Type 1 Diabetes
Official title: Evaluation of Ongoing Management of Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Depression
Socioeconomic status
Type 1 diabetes mellitus
Children
Adolescents
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of diabetes clinic, Texas Children's Hospital.

Brief summary: The purpose of this study is to learn about the relationship that exists between coping skills and blood glucose control. In addition to this, we will study the effect of type 1 diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic groups, and the duration of diabetes.

Detailed description: Coping with type 1 diabetes can be very difficult. Type 1 diabetes is a very unique chronic disease because it requires constant attention to several responsibilities such as daily glucose monitoring, multiple daily insulin doses, and strict diet and exercise. Several studies have shown that increased rates of poorer glucose control are a result of struggling to cope with type 1 diabetes. This may be due to the fact that many type 1 diabetics experience a feeling of exhaustion, or "burnout," after a certain period of time due to an overwhelming amount of responsibility.

In our study we would like to determine how children's ability to cope with diabetes affects glucose control. By completing several questionnaires, we can analyze different kinds of coping skills through a complex scoring system. These scores will then be analyzed in comparison to your glucose control using HbA1c.

Eligibility criteria: Inclusion Criteria:

* Subjects must be type 1 diabetic
* English/spanish speaking
* The legal guardian must be present.

Exclusion Criteria:

* Non-cognitive or mentally ill
* Under the age of 8.0 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Rubina A Heptulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04541862: Adult Intensive Care Units Database of National Taiwan University Hospital
Official title: Adult Intensive Care Units Database of National Taiwan University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 200000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to intensive care units.

Brief summary: Australian and New Zealand Intensive Care Society (ANZICS) has built an Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of intensive care unit (ICU) database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. This database also add expansion of data include hourly vital signs data, more laboratory data, more diagnoses at admission and discharge, data after 24 hours till discharge, and extended information of clinical outcomes more than 30 days after admission to ICU .

This database will retrospectively collect the data of patients discharged from intensive care after March 1, 2019 and will prospectively continue the retrospective collection of data till the patients discharged before June 30, 2043.

The data will be used for the evaluation of quality and resource allocation, quality improvement, education of data science, datathon, and research to predict the clinical outcomes and assist the treatment strategies.


Eligibility criteria: Inclusion Criteria:

* Critically ill patients admitted to intensive care units

Exclusion Criteria:

* Patients aged less than 20 years

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Length of stay in intensive care unit
timeFrame: Time to discharge from intensive care unit, a median of 2-7 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05460962: Effects of Deep Breathing Excercises With and Without PMR on Depression & QOL in Females With Hystrectomy
Official title: Effects of Deep Breathing Excercises With and Without Progressive Muscle Relaxation Technique on Depression and Quality of Life in Females With Hystrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Hysterectomy Vaginal Vault Prolapse
Keywords: Depression, Hysterectomy, Progressive muscle relaxation technique
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find out the Effects of deep breathing exercises with and without Progressive Muscle Relaxation Technique on depression and Quality of life in females with hysterotomy


Eligibility criteria: Inclusion Criteria:

* Age 35-55
* Females gone through all types of hysterotomy
* Hysterotomy done due to heavy menstrual bleeding, fibroids, pelvic pain, endometriosis and MAP ( Morbidly adherent placenta ).

Exclusion Criteria:

* Females with hormonal replacement therapy
* Any history of cancer
* Diagnosed patient of any psychiatric illness

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 8 weeks
measure: WHOQOL-BREFF
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Neelam Muneeb, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515762: Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling
Official title: Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia
Breast Cancer
Keywords: persistent alopecia
docetaxel
breast cancer
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.

Detailed description: Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. Docetaxel is toxic to skin and skin annexes and can produce nail toxicity and persistent alopecia. Nail toxicity has been successfully prevented by means of hypothermic gloves and slippers (Elasto-gel, Southwest Technologies, Inc, North Kansas City, MO). This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.

Eligibility criteria: Inclusion Criteria:

* age 18-75
* breast cancer stages II-III
* adjuvant or neoadjuvant chemotherapy with docetaxel regimens (TAC or anthracyclines followed by docetaxel 100 mg/m2 x 4)

Exclusion Criteria:

* contraindications for adjuvant docetaxel and or anthracyclines

Primary outcomes:
measure: percentage of patients without persistent alopecia
timeFrame: 2nd year following docetaxel chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: hospital clinico san carlos
name: miguel martin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin M, de la Torre-Montero JC, Lopez-Tarruella S, Pinilla K, Casado A, Fernandez S, Jerez Y, Puente J, Palomero I, Gonzalez Del Val R, Del Monte-Millan M, Massarrah T, Vila C, Garcia-Paredes B, Garcia-Saenz JA, Lluch A. Persistent major alopecia following adjuvant docetaxel for breast cancer: incidence, characteristics, and prevention with scalp cooling. Breast Cancer Res Treat. 2018 Oct;171(3):627-634. doi: 10.1007/s10549-018-4855-2. Epub 2018 Jun 19.
Clinical trial NCT02935062: New Therapeutical Perspectives in Cases of Phonological Disorders
Official title: New Therapeutical Perspectives in Cases of Phonological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech Sound Disorders
Keywords: Speech
Speech Therapy
Speech Sound Disorders
Phonological Disorders
Auditory Perception
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to verify phonological and auditory aspects of children submitted to traditional phonological therapy, phonological therapy using a software and placebo therapy in children with phonological disorders.

Detailed description: The study will provide different therapeutic approaches for cases of phonological disorders, the classical approach would be mediated by Cycles Model, innovated approach is performed by means of an intervention speech software-SIFALA, there will still be the group that does not receive any of the proposals therapies that will be the placebo group.The study will provide 25 sessions for each group, with 30 minutes in each group. At the end of these sessions, the placebo group will receive one of the therapeutic approaches. With these three study groups, the investigators understand in what manner to obtain correct sounds is more effective.

Eligibility criteria: Inclusion Criteria:

* Parents/guardians and child agree to participate and have signed the Informed Consent Form;
* Have age between 4:0 to 8:11 (years:months);
* Present diagnosis of phonological disorders;
* Present hearing thresholds within the normal range

Exclusion Criteria:

* Present neurological impairment, emotional and/or cognitive clearly diagnosed, or have complaint;
* Present any degree of hearing loss is the type conductive, mixed or sensorineural, and middle ear disorders in time of selection, as well as having presented otitis complaints;
* Present language impairment associated with speech sound disorder;
* Present commitment in the stomatognathic system that can interfere in the speech production;
* Have been received speech and language therapy before.

Primary outcomes:
measure: Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument
timeFrame: 10 weeks
measure: P300- Long-latency Auditory Evoked Potential
timeFrame: 10 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria- campus Camobi e centro- Floriano Peixoto 1709.
state: Rio Grande Do Sul
city: Santa Maria
country: Brazil
facility: Federal University of Santa Maria
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Marcia Keske-Soares, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05314062: Effect of Iron Source on the Growth of Enteric Pathogens
Official title: Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Iron Deficiency Anemia Treatment
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically \<10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from children following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome measures will be determined following in vitro fecal fermentation.


Eligibility criteria: Inclusion Criteria:

* Healthy children 5-12 y
* Willing to donate stool sample

Exclusion Criteria:

* Currently taking antibiotics
* Currently taking a vitamin and mineral supplement containing iron
* Wards of the state, including children in foster care

Primary outcomes:
measure: Concentration of iron taken up by enteric pathogens
timeFrame: 0-24 hours
measure: Growth of enteric pathogens measured by optical density
timeFrame: 0-24 hours
Secondary outcomes:
measure: Gut microbiome composition and diversity
timeFrame: 0-24 hours
measure: Individual fecal short chain fatty acid (SCFA) concentration
timeFrame: 0-24 hours
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT06789562: F-18 FDG PET/CT and CT in Initial Staging of Non-small Lung Cancer
Official title: Comparison of F-18 FDG PET/CT and CT in Initial Staging of Non-small Lung Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with non small lung cancer underwent initial F-18FDG PET/CT

Brief summary: Is to compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.

Detailed description: * The optimal treatment of non-small cell lung cancer (NSCLC) relies on accurate disease staging that is based on the TNM system which relies on tumor size, regional nodal involvement, and the presence of metastasis.
* CT is the standard modality used to assess the intra-thoracic spread but false negative CT scans have been reported and were related to the presence of metastasis in normal sized lymph nodes and false positive findings have been related to lymph node enlargement due to benign process.

PET is most widely used in thoracic oncology because of its superiority over other imaging techniques in staging nodal and metastatic disease, however, the poor anatomic details of PET can lead to errors in diagnosis and staging.

• To solve this problem, CT is combined with PET to provide matched morphological and functional data. The diagnostic capability of PET/CT in the preoperative staging of lung cancer is superior to that of CT alone and PET alone as it has the advantage of a more accurate assignment of tumor stage (T stage) and defining the lymph node stage (N stage) as well as reduction of the number of useless thoracotomies

Eligibility criteria: Inclusion Criteria:

* Patients with pathologically proven NSCLC who underwent initial PET/CT images.
* All patients ≥ 18 years.

Exclusion Criteria:

* Patients who had started treatment before initial PET/CT. Patients with glucose level \< 200 mg/dl. Patients with another malignant condition.

Primary outcomes:
measure: compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hadar R, Slonim A, Kuhn J. Role of D-tryptophan oxidase in D-tryptophan utilization by Escherichia coli. J Bacteriol. 1976 Mar;125(3):1096-1104. doi: 10.1128/jb.125.3.1096-1104.1976.
Clinical trial NCT00596362: Treatment With Intravitreal Avastin for Large Uveal Melanomas
Official title: Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveal Melanoma
Keywords: Melanoma
Eye
Avastin
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with large uveal melanomas who elect to undergo enucleation.
* Patients diagnosed with uveal melanomas with tumor thickness \> 10 mm or basal diameter \> 16 mm, as measured by ultrasound examination, funduscopic examination, or transillumination.

Exclusion Criteria:

* Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
* Patients with history of metastatic cancer (other than melanoma).
* Patients not able to provide consent for the study.
* Patients with clinical or radiographic evidence of extraocular extension of the tumor.
* Patients with a previous history of an adverse reaction to intravitreal injection.
* Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
* Patients with intravitreal silicone oil or gas tamponade.
* Patients \< 18 years of age.
* Women known to be pregnant.

Primary outcomes:
measure: The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).
timeFrame: At conclusion of study, up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Abramson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00509262: Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
Official title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 426
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.


Eligibility criteria: Inclusion Criteria:

* Has type 2 diabetes mellitus
* Has moderate or severe renal insufficiency

Exclusion Criteria:

* Has type 1 diabetes mellitus or a history of ketoacidosis
* Is on a new weight loss program
* Has active liver disease
* Is on dialysis or is likely to need dialysis during the study

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
timeFrame: Baseline to Week 54
measure: Percentage of Participants With Hypoglycemic Events
timeFrame: Baseline up to 28 days following the last dose of study therapy
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
timeFrame: Baseline to Week 54
measure: Change From Baseline in Body Weight at Week 54
timeFrame: Baseline to Week 54
Other outcomes:
Locations:
Study officials:
References:
citation: Arjona Ferreira JC, Marre M, Barzilai N, Guo H, Golm GT, Sisk CM, Kaufman KD, Goldstein BJ. Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes and moderate-to-severe chronic renal insufficiency. Diabetes Care. 2013 May;36(5):1067-73. doi: 10.2337/dc12-1365. Epub 2012 Dec 17.