louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237314: The Impact of Food on Blood Sugar in People With Type 2 Diabetes
Official title: Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
metformin
glargine
exenatide
glycemic impact of food
continuous glucose monitoring
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Sanofi
First posted: 2010-11-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in Clinical Trials Study NCT01089569

Brief summary: This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM).

The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.


Eligibility criteria: Inclusion Criteria:

* Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0.

Exclusion Criteria:

* Study participants who are unable to complete the baseline CGM data collection at week -2-0.
* Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal

Primary outcomes:
measure: 4-hour glycemic response at 3 time points
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Maggie Powers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Alice Shapiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05389514: Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors
Official title: Intermediate-size Patient Population IND for Treatment of KRAS G12V-mutant Tumors With Gene-engineered KRAS G12V-reactive T Cells
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: KRAS G12V Mutant Advanced Epithelial Cancers
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
First posted: 2022-05-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1\*07:01).

Detailed description: This study will treat two identified patients with metastatic pancreatic adenocarcinoma and metastatic pancreatic cancer who have both been treated with standard of care therapies and found to have disease progression. Both of these patients have KRAS G12V mutations in their cancers and express the HLA-DRB1\*07:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB1\*07:01-restricted KRAS G12V reactive T-cell receptors (TCR).

Adoptive T-cell therapy is a type of immunotherapy which involves isolation of T cells from a patient, followed by an amplification of those T cells in the lab to large numbers, and reinfusion of the T cells back to the patient.

In addition to the two identified patients, the protocol will remain open for additional participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (DRB1\*07:01).

Eligibility criteria: Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1\*07:01)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Providence Health & Services
name: Matthew Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06347614: Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study
Official title: Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Low- to intermediate-risk localized prostate patient with enlarged prostate and severe benign prostatic hyperplasia

Brief summary: The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?


Eligibility criteria: Inclusion Criteria:

Diagnosed as prostate cancer pathologically by prostate biopsy Evaluated as localized prostate cancer by imaging studies Prostate volume\>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging Gleason score≤ 4+3=7 Preoperative PSA\<20ng/mL Estimated survival\> 10 years； Informed consent is obtained from the patient

Exclusion Criteria:

The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.

Any contraindication of surgery or anaesthesia

Primary outcomes:
measure: Biochemical Recurrence-free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Surgical time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Hospital stay
timeFrame: From date of surgery until the date of discharge, an average of 7 days
measure: Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence
timeFrame: 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery
measure: Lower urinary tract symptoms
timeFrame: 1 months, 3 months, 6 months, 12 months after surgery
measure: Erectile function
timeFrame: 6 months, 12 months and 24 months after surgery
measure: Positive surgical margin rate
timeFrame: Through study completion, an average of 5 year
measure: Complication
timeFrame: Through study completion, an average of 5 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06497114: Validity and Reliability of the Egyptian-Arabic Version of ABILHAND-Kids
Official title: Validity and Reliability of the Egyptian-Arabic Version of ABILHAND-Kids in a Sample of Egyptian Children With Cerebral Palsy.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Keywords: hand function
Lead sponsor: Horus University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cerebral palsy

Brief summary: HYPOTHESES It is hypothesized that the Egyptian-Arabic ABILHAND-Kids 21-item will be psychometrically appropriate to be used with Egyptian children with cerebral palsy.

Detailed description: BACKGROUND Upper extremity functional impairment is a common problem in children with cerebral palsy. This has a significant impact on the children's manual ability which leads to activity limitation and participation restriction. The ABILHAND-Kids is a parent-reported outcome measure that quantifies the manual ability of children with CP. ABILHAND-Kids measures a child's ability to manage 21 daily activities that require the use of the upper limbs. The ABILHAND-Kids demonstrated very good measurement properties and is currently available in English, French, Dutch, Sweden, and Polish. It was also translated and adapted into the classic Arabic language in Saudi Arabia; in their study removal of two items resulted in a 19-item, valid, and reliable unidimensional scale meeting the requirement of the Rasch model without establishing measurement invariance between cultures. A linguistic adaptation is not sufficient to prove cross-cultural validity as item difficulties may vary across countries due to translation errors or cultural differences.

Eligibility criteria: Inclusion Criteria:

- Parents of 100 children with CP will be recruited.

Exclusion Criteria:

* mental retardation

Primary outcomes:
measure: ABILHAND-Kids
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Horus University
Study officials:
References:
Clinical trial NCT06166914: Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment
Official title: Evaluation of 5-fluorouracil and Low Molecular Weight Heparin Intraoperative Infusion in Preventing Proliferative Vitreoretinopathy in High Risk Pediatric Rhegmatogenous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Proliferative Vitreoretinopathy
Keywords: pediatric retinal detachment
proliferative vitreoretinopathy
5-Fluorouracil
Low molecular weight heparin
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 42
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized clinical trial of patients enrolled sequentially into group A (treatment) and group B (control)
Primary purpose: PREVENTION

Brief summary: EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT

Detailed description: After informed consent, children under 14 years of age with high-risk PRRD underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. Group A received intraoperative infusion of 5-FU (200 µg/ml) and LMWH (5 IU/ml), group B received infusion of normal saline. Primary outcome was occurrence of recurrent PRRD within 12 weeks, secondary outcomes were occurrence of PVR, best corrected visual acuity (BCVA), number and timing of secondary procedures within 12 weeks.

Eligibility criteria: Inclusion Criteria:

Children under 14 years of age with RRD undergoing primary repair Preoperative PVR grade B or higher High risk RRD: uveitis; large, giant, or multiple tears; vitreous hemorrhage; preoperative choroidal detachments; aphakia; and large detachments involving greater than two quadrants of the eye

Exclusion Criteria:

Children with RRD related to penetrating ocular trauma involving the posterior segment Previous RD repair surgery Uncontrolled glaucoma or other concomitant ocular morbidities Patients with bleeding diathesis, hepatic and renal failure Corneal opacity sufficient to impair surgical view No light perception vision Inability to complete follow-up

Primary outcomes:
measure: Recurrent RD due to PVR
timeFrame: 12 weeks post operative
Secondary outcomes:
measure: Post operative PVR
timeFrame: 12 weeks post operative
measure: Best corrected visual acuity
timeFrame: 12 weeks post operative
measure: Secondary procedures
timeFrame: 12 weeks post operative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University
Study officials:
References:
Clinical trial NCT01934114: NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo
Official title: NIR (Near Infrared Spectral Tomography)Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 8
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with locally advanced breast cancer defined as being clinically appropriate for neoadjuvant therapy and healthy volunteers

Brief summary: The purpose of this study is to determine whether an experimental alternative imaging method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory system to examine the breasts for cancer. The NIR system uses light beams to produce an image or picture of the inside of the breast. The respiratory system will help researchers get more information about the breast tissue by changing the amount of oxygen the tissue receives during NIR imaging.


Eligibility criteria: Inclusion Criteria:

* NORMAL cohort

  1. Breast size and epithelial integrity adequate to allow NIR imaging exams
  2. No serious associated psychiatric illnesses
  3. Female, ≥25 and \<76 years old
  4. Written informed consent
* UNDER TREATMENT cohort

  1. Locally advanced breast cancer, with or without metastatic disease, defined as being clinically appropriate for neoadjuvant therapy
  2. Breast size and epithelial integrity adequate to allow NIR imaging exams
  3. No serious associated psychiatric illnesses
  4. Female, ≥25 and \<76 years old
  5. Written informed consent

Exclusion Criteria:

* both cohorts

  1. Pre-existing respiratory conditions:

     1. severe chronic obstructive pulmonary disease (including chronic bronchitis and/or emphysema)
     2. Other respiratory or lung conditions which would place the patient at risk
     3. presence of any other significant cardiac or pulmonary symptoms, such as moderate or severe dyspnea on exertion, orthopnea, or paroxysmal nocturnal dyspnea
  2. Congestive heart failure
  3. Intolerance of hyperoxia or hypercarbia as delivered by the RespirAct breathing circuit
  4. Pregnancy

Primary outcomes:
measure: Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor.
timeFrame: 18 weeks approximately
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT04434014: Proper Nutrition And Its Relation To Oral Diseases In Covid -19 Era
Official title: Proper Nutrition and Its Relationship to Oral Diseases in the Era of Corona
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diet, Healthy
Keywords: Proper Diet
Taste
Oral Health
Corona
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * the participants will answer a questionnaire then a diet will be sent to the participants
* the participants will follow the sent diet for 2 weeks then another questionnaire will be sent to the participants

Brief summary: effect of proper diet and vitamins on the oral health and the regeneration of the taste and smell in Covid 19 patients

Detailed description: effect of proper diet and vitamins on the oral health ( bleeding gums, ulcers, bad breath) also the effect of proper diet on the regeneration of the taste and smell in Covid 19 patients A diet will be followed for 2 weeks then the progress will be evaluated by making another questionnaire

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* chronic diseases

Primary outcomes:
measure: regeneration of taste
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October university of modern sciences and arts
Study officials:
References:
Clinical trial NCT06780514: Cardiopulmonary Exercise Testing in Girls (8-18y) with Turner Sydrome.
Official title: Cardiopulmonary Exercise Testing in Girls (8-18y) with Turner Sydrome.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Turner Syndrome
Keywords: Cardiopulmonary exercise test
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to have a beter insight in the exercise tolerance in girls with Turner Syndrome aged 8-18 years . The main question it aims to answer is:

Is there a difference in VO2 max comparing Turner syndrome girls with standard values? How do cardiovascular parameters change during exercise (heart rate, bloodpressure, ...)

Participants will perform a cyclo-ergometry in a standardised way.


Eligibility criteria: Inclusion Criteria:

* Turner syndrome girls aged 8-18 years old

Exclusion Criteria:

* Severe mental impairement making it impossible to perform an exercise test

Primary outcomes:
measure: VO2 max
timeFrame: Whitin a week after the CPET
Secondary outcomes:
measure: Bloodpressure
timeFrame: Whitin a week after the CPET
measure: Heart rate
timeFrame: Whitin a week after the CPET
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT00999414: UARK 2009-32 Compassionate Use Study of Carfilzomib
Official title: Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Keywords: MM
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Onyx Therapeutics, Inc.
First posted: 2009-10-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.

Detailed description: The protocol has been designed for relapsing or refractory multiple myeloma patients. A maximum of 30 patients may be treated on this protocol.

Since this is a compassionate use study of an investigational agent, the size is determined by agreement with the manufacturer of carfilzomib. Therefore, the time period for enrollment and accrual number will be limited to N=30.

Eligibility criteria: Inclusion Criteria:

* Participants must have histologically documented multiple myeloma which is relapsing or resistant after stem cell transplantation, or when other conventional therapies have failed or are contraindicated
* Serum creatinine \< 3.0 mg/dL OR calculated creatinine clearance \>15 mL/min calculated or measured clearance is ≥15 mL/min
* ANC \> 1000/mm3 (may be supported with growth factors)
* Platelet count \> 30,000/mm3 (may receive transfusion)
* Female participant of child-bearing potential has agreed to use dual methods of contraception for the duration of the study
* Male participant has agreed to use a barrier method of contraception if sexually active with a female of child-bearing potential
* Patients must have signed and IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations

Exclusion Criteria:

* Active infection requiring systemic treatment
* Requires concomitant use of approved or investigative anticancer therapeutic treatment with activity against multiple myeloma, other than dexamethasone
* Concomitant use of other investigative agents (e.g., antibiotics or antiemetics)
* Pregnant or breast-feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Bart Barlogie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03787914: Effect of Community Mobile Outreach Approach Compared to Facility Based Directly Observed Treatment Short Course on Treatment Outcome Among Tuberculosis Patients in Jeddah: A Randomized Controlled Trial
Official title: Community Outreach Mobile Teams Impact on Tuberculosis Treatment Outcome in Jeddah Region: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Ministry of Health, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2018-12-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators conducted a two-arm, parallel design\[1:1\], single blind randomized control trial in 200 newly diagnosed TB patients
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare the effectiveness of the community mobile outreach approach in improving treatment outcomes (success rate) among tuberculosis patients with those being treated with facility based directly observed treatment short course (DOTS) in Jeddah region.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed TB cases

Exclusion Criteria:

* Visitors having TB especially pilgrims

Primary outcomes:
measure: Treatment Success rate
timeFrame: 6 to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Ministry of Health
state: Makkah
Study officials:
affiliation: Director of Public Health
name: Abdullah AlSahafi, MBBS, SBFM
role: STUDY_DIRECTOR
References:
citation: Al-Sahafi A, Al-Sayali MM, Mandoura N, Shah HBU, Al Sharif K, Almohammadi EL, Abdul-Rashid OA, Assiri M, Buksh MF, Alali MM, Al-Garni A, Al-Garni F, Al-Zahrani A, Khalawi A, Alawi M, Moawwad AL, Almalki AIA, Al-Osaimi MM. Treatment outcomes among tuberculosis patients in Jeddah, Saudi Arabia: Results of a community mobile outreach directly observed Treatment, Short-course (DOTS) project, compared to a standard facility-based DOTS: A randomized controlled trial. J Clin Tuberc Other Mycobact Dis. 2020 Dec 31;22:100210. doi: 10.1016/j.jctube.2020.100210. eCollection 2021 Feb.