louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00627211: Carbon Dioxide Versus Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)
Official title: A Double-blinded, Randomized Trial Comparing Carbondioxide(CO2)and Air Insufflation in Oesophago-gastro-duodenoscopy (OGD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: quality assessment
pain reduction
gastroscopy
carbondioxide insufflation
Patient satisfaction
Lead sponsor: Norwegian Department of Health and Social Affairs
Sponsor class: OTHER_GOV
First posted: 2008-02-29
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison on the effect on patient pain and discomfort by using CO2 instead of air for insufflation during gastroscopy.

Detailed description: To achieve a satisfactory examination of the GI tract it needs to be distended during endoscopic procedures. After the examinations many patients complain of abdominal pain and discomfort. This pain has been substantially reduced by substituting room air with CO2 in both colonoscopies and ERCPs. The use of CO2 during colonoscopy has become routine practice at many endoscopy centers.

In our study we will test the hypothesis that abdominal pain after gastroscopies also can be reduced by substituting room air with CO2.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for OGD at the outpatient clinic of Telemark Hospital

Exclusion Criteria:

* Age \<18
* Inability to give an informed concent
* Unsatisfactory norwegian language skills
* Patients not willing to participate
* COPD with dyspnoea NYHA 3-4

Primary outcomes:
measure: Pain after OGD
timeFrame: 0-48 hours
Secondary outcomes:
measure: Pain during OGD
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05781711: Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
Official title: Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University
First posted: 2023-03-23
Enrollment: 60
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: Parkinson's disease (PD) is one of the most common neurodegenerative diseases characterized by the progressive loss of dopaminergic (DA) neurons in the substantia nigra compacta (SNc) and aggregation of Lewy bodies in neurons. Although aging, oxidative damage and neuroinflammation have been recognized to play crucial roles in the pathogenesis of PD, the precise etiology remains obscure. Emerging evidence suggests PD is a systemic metabolic disease, and metabolic abnormality correlates with functional alternations in PD


Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa

Exclusion Criteria:

Secondary causes of Parkinsonism Diabetic patients Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and/or drugs Known allergy to the studied medications

Primary outcomes:
measure: • The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 3 months
Secondary outcomes:
measure: The secondary endpoint is estimated by changes in serum biomarkers.
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Menoufia University
state: Shebeen El-Kom
Study officials:
References:
Clinical trial NCT02504411: Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy
Official title: Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy Versus Standard Colonoscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing first screening colonoscopy
2. Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.
3. Ability to provide informed consent.

Exclusion Criteria:

1. Previous surgical resection of any part of the colon
2. history of colon cancer
3. history of inflammatory bowel disease
4. use of antiplatelet agents or anti-coagulants that precluded removal of polyps
5. Poor general condition
6. History of polyposis syndrome or hereditary nonpolyposis colorectal cancer
7. Inability to give informed consent.

Primary outcomes:
measure: Adenoma detection rate (ADR) as determined by Colonoscopy
timeFrame: intraoperative
measure: Complete adenoma resection rate (CARE) for adenoma > 10 mm in diameter as determined by Colonoscopy
timeFrame: intraoperative
Secondary outcomes:
measure: Cecal Intubation Rate (CIR)
timeFrame: intraoperative
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nirav Thosani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05294211: Safety and Performance of a Fetal Monitoring System
Official title: Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: antenatal monitoring
fetal monitoring
Lead sponsor: Marani Health
Sponsor class: INDUSTRY
First posted: 2022-03-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent and follow study instructions
* 18 years of age or older
* Pregnant subjects ≥ 32 weeks' gestation
* Singleton pregnancy
* BMI ≥15, pre-pregnancy
* BMI ≤45, pre-pregnancy
* Belly circumference ≥80 cm and ≤ 130 cm

Exclusion Criteria:

* Known major fetal malformation or chromosome abnormality
* Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation
* Participants with implanted electronic devices (pacemakers, defibrillator, etc.)
* Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
* Medical or obstetric problem that in the investigator's opinion would make the participant incapable of taking part in the study
* In the investigator's opinion, the participant is not likely to be available for the minimum 60 minutes of the monitoring session
* History of skin allergies to cosmetics and lotions
* Known allergies to silver, nylon, or polyester

Primary outcomes:
measure: Fetal Heart Rate (FHR)
timeFrame: Up to 120 minutes
measure: Maternal Heart Rate (MHR)
timeFrame: Up to 120 minutes
Secondary outcomes:
measure: Uterine Contractions (UC)
timeFrame: Up to 120 minutes
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
Study officials:
References:
Clinical trial NCT00783328: A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
Official title: A Clinical Phase 1 Safety And Pharmacokinetic/Pharmacodynamic Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: solid tumor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.


Eligibility criteria: Inclusion Criteria:

* Malignant solid tumor with no currently approved treatment
* Adequate functions Bone Marrow, Renal, Liver and Cardiac

Exclusion Criteria:

* Any surgery, radiotherapy within 4 weeks of baseline disease assessments
* Clinically significant abnormalities of the cornea
* Patients with symptomatic brain/central nerve system metastases
* Any clinically significant gastrointestinal abnormalities
* Uncontrolled or significant cardiovascular disease
* Patients with significant interstitial pneumonia or pulmonary fibrosis

Primary outcomes:
measure: Overall safety: type, grade and frequency of all adverse events and laboratory abnormalities
timeFrame: End of study
Secondary outcomes:
measure: To explore PD markers
timeFrame: End of study
measure: To evaluate the plasma pharmacokinetics of PF-00299804 in Japanese patients following single and multiple dosing
timeFrame: End of study
measure: To assess any clinical evidence of anti-tumor activity of PF-00299804 per RECIST
timeFrame: End of study
Other outcomes:
Locations:
city: Sunto-gun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Takahashi T, Boku N, Murakami H, Naito T, Tsuya A, Nakamura Y, Ono A, Machida N, Yamazaki K, Watanabe J, Ruiz-Garcia A, Imai K, Ohki E, Yamamoto N. Phase I and pharmacokinetic study of dacomitinib (PF-00299804), an oral irreversible, small molecule inhibitor of human epidermal growth factor receptor-1, -2, and -4 tyrosine kinases, in Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Dec;30(6):2352-63. doi: 10.1007/s10637-011-9789-z. Epub 2012 Jan 17.
Clinical trial NCT00055328: Treatment for Depression in the Primary Care Setting
Official title: Problem-Solving Treatment for Primary Care Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare a brief form of counseling to usual care for the treatment of minor depression in the primary care setting.

Detailed description: Minor depression is one of the most common types of depressive disorders seen in primary care. The effectiveness and tolerability of antidepressants in patients with minor depression is unclear, and the development of alternative treatments is necessary.

In the first phase of this study, participants are observed for 4 weeks to identify those most in need of depression-specific treatment. Participants are then exposed to the Problem-Solving Treatment for Primary Care (PST-PC), a six-session behavioral treatment for depression. After 4 weeks, patients who do not respond adequately to the treatment are randomly assigned to either continued PST-PC or to usual care for 9 weeks. Participants are followed for 6 months after the study.

Eligibility criteria: Inclusion Criteria:

* Primary care patient at Dartmouth-Hitchcock Medical Center (DHMC)
* Hamilton Depression Score \>= 10 and minor depression at time of entry and after 4 weeks of observation

Exclusion Criteria:

* Psychosis, Obsessive Compulsive Disorder (OCD), or Post Traumatic Stress Disorder (PTSD)
* Active substance abuse
* Receiving treatment for depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT00463528: Women and Children as the Focus for Control of Schistosomiasis Infections in the Irrigations Area of Burkina Faso
Official title: Women and Childres at the Focal Point for the Schistosomiasis Control and Sustainability and Effectiveness in the Hydro Agricultural Zone of Sourou, Burkina Faso
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis
Keywords: schistosomiasis
gender perspectives
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 360
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The purpose of this study is to examine the extent of schistosomasis infections in women and children, their daily activites that encumber contact with water and their knowledge and attitudes towards the prevention of schistosomiasis.

The hypothesis that will be explored is that women and children spent more time with agricultural and household activities which bring them in contact with water and therefore give them an increased risk of being infected by schistosoma. Prevention and control of schistosomiasis has to be focusing on women and children.

Detailed description: The study will be carried out in and irrigation area of Burkina Faso where people relay on water. The study applies several methodes;

1. Parasitological survey: From thre villages 200 women and children are randomly sampled to have their urin and stool examined for parasittes.
2. Observations: At each village sites at the irrigation canals where people meet and have their activities observations of the kind and the duration of watercontact will be observed.
3. Focus group interview: In each village 5 focus group interviews will be conducted with 6 to 12 participants in each group
4. Individual interviews: for the participant in the focus group interview a total of 45 participants will be selected for indept individual interviews
5. Questionnaire: a total of 360 questionnairs will be distributed to participants in the parasitological survey, the focus group interviews and to participants who did not participate in any of the above mentioned.

Participants will be women and children from the three villages.

Eligibility criteria: Inclusion Criteria:

Women and children from three villages

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Health Sciences Research, Burkina Faso
name: Jean N Poda, Ph.d.,M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00765128: Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy
Official title: The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy: a Double Blinded Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Calculus
Kidney Stones
Keywords: Percutaneous
Nephrolithotomy
Kidney stones
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing percutaneous nephrolithotomy for kidney stone disease

Exclusion Criteria:

* History of nonsteroidal antiinflammatory drug allergy
* Asthma
* History of long-term opioid use
* Intraoperative blood loss greater than 300 mL
* Postoperative hemodynamic instability
* Active peptic ulcer disease
* Advanced renal impairment (Creatinine \> 2.0 mg/dL)
* Bleeding diathesis
* Current use of probenecid
* Pregnancy

Primary outcomes:
measure: Pain 'Right Now'
timeFrame: 24 hours after the end of surgery
measure: Morphine Equivalents of Concomitant Pain Medication
timeFrame: 24 hours after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mitchell R. Humphreys, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimsby GM, Andrews PE, Castle EP, Nunez R, Mihalik LA, Chang YH, Humphreys MR. Long-term renal function after donor nephrectomy: secondary follow-up analysis of the randomized trial of ketorolac vs placebo. Urology. 2014 Jul;84(1):78-81. doi: 10.1016/j.urology.2014.04.009.
citation: Grimsby GM, Conley SP, Trentman TL, Castle EP, Andrews PE, Mihalik LA, Hentz JG, Humphreys MR. A double-blind randomized controlled trial of continuous intravenous Ketorolac vs placebo for adjuvant pain control after renal surgery. Mayo Clin Proc. 2012 Nov;87(11):1089-97. doi: 10.1016/j.mayocp.2012.07.018. Epub 2012 Oct 8.
Clinical trial NCT05225428: Video Education With Result Dependent dIsclosure
Official title: Video Education With Result Dependent dIsclosure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genetic Testing
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Colorectal Cancer
Renal Cancer
Melanoma
Sarcoma
Keywords: Genetic Testing
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Colorectal Cancer
Renal Cancer
Melanoma
Sarcoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Human Genome Research Institute (NHGRI)
First posted: 2022-02-04
Enrollment: 1020
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.

Detailed description: This study consists of two parts:

* Qualitative assessment:

  * This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants.
  * The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial.
* Randomized control trial:

  * A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
* Ability to understand spoken or written English or Spanish in a healthcare context
* Ability to understand and the willingness to sign a written informed consent document
* Black or Latinx (qualitative assessment study only)

Exclusion Criteria:

* Prior cancer genetic testing
* Prior germline genetic testing
* Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
* Currently pregnant
* Currently incarcerated

Primary outcomes:
measure: Video Education Acceptability (Qualitative Interview Study)
timeFrame: 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Huma Q. Rana, MD., MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00403728: Ciclosporin A and Acute Myocardial Infarction
Official title: Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Myocardial Infarction
Keywords: Ischemia
Reperfusion
Myocardial infarction
ciclosporin A
acute myocardial infarction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.


Eligibility criteria: Inclusion Criteria:

* Male and female patients, aged more than 18, with suspected first acute myocardial infarction
* Within 12 hours of the onset of chest pain
* With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow \>2 after direct stenting by angioplasty.

Exclusion Criteria:

* Hypersensibility to ciclosporine A
* Cardiac arrest or cardiogenic shock
* Immunosuppressive disease (\< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
* Known renal failure or serum creatinine \> 120 µmole/l at admission
* Liver failure
* Uncontrolled hypertension
* Current pregnancy or women without contraception

Primary outcomes:
measure: Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
Secondary outcomes:
measure: Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
measure: No reflow evaluated by MRI at day 5
measure: Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
Other outcomes:
Locations:
city: Lyon
country: France
facility: Michel Ovize
Study officials:
affiliation: Hospices Civils de Lyon
name: Michel Ovize, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, Andre-Fouet X, Derumeaux G, Piot C, Vernhet H, Revel D, Ovize M. Effect of cyclosporine on left ventricular remodeling after reperfused myocardial infarction. J Am Coll Cardiol. 2010 Mar 23;55(12):1200-1205. doi: 10.1016/j.jacc.2009.10.052.