louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00532753: Evaluating the Hunger Project in Ghana
Official title: Evaluating the Hunger Project's Scaling-up of Epicenter Strategy in Ghana
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: To Better Understand How Epicenter's (Which House Education, Health and Finance Centers in Ghana) Increase Individual's Sense of Empowerment.
Keywords: empowerment
health
education
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: The Robertson Foundation
First posted: 2007-09-20
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Hunger Project/Epicenter strategy is a community based development strategy that will positively affect health, education, empowerment, and consumption.

Detailed description: The investigators propose a randomized controlled design that will measure how The Hunger Projects' intervention affects the lives of Ghanaians. A pre-intervention baseline survey of approximately 4,000 households with over 20,000 individuals and two follow-up surveys of the same households will be conducted over the ten year experimental period.

Eligibility criteria: Inclusion Criteria:

* The subject population will be individuals and households from communities in the Eastern Region of Ghana.

Exclusion Criteria:

* Only exclusion criteria is that households outside of the Eastern region of Ghana will not be surveyed

Primary outcomes:
measure: Increased sense of empowerment
Secondary outcomes:
measure: Increased health, education, and consumption outcomes and increase in the number of public goods
Other outcomes:
Locations:
city: Several
country: Ghana
facility: Ghana Hunger Project
state: Eastern
Study officials:
affiliation: University of California at Berkeley
name: David Levine, PhD Econ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05011253: Electronic Triggers: Microhematuria Trigger
Official title: Electronic Trigger for Microhematuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematuria
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders.

Detailed description: The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders. The message will notify users that a patient has clinically significant microscopic hematuria and is at high risk for underlying malignancy and will include the official recommendations (imaging with a CT urogram, urology evaluation with cystoscopy).

Eligibility criteria: Inclusion Criteria:

* 35 years of age or older
* 3+ RBC on Urinalysis
* Urinalysis sent during an outpatient encounter
* any of the following: 60 years of age or older; RBC \> 25; current or prior tobacco use; Gross Hematuria

Exclusion Criteria:

* Under 35 years of age
* Cystoscopy within 1 year prior to Urinalysis
* Nitrite positive AND Leukocyte Esterase positive
* Nitrite positive AND \>100 WBC
* Leukocyte Esterase positive AND \>100 WBC
* Know GU cancer diagnosis
* Urinalysis ordered by urology provider

Primary outcomes:
measure: Evaluation rate
timeFrame: 180 days of alert
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone Health
name: Saul Blecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01938053: Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
Official title: Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infections
Keywords: STI, STD
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2013-09-10
Enrollment: 609
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary goal of this project is to improve the process for contacting patients that test positive for a sexually transmitted infection (STI) in the emergency department by using text messaging. We believe patients that are contacted by both a phone call and a text message will be reached more often and they will be reached sooner than those that only receive a phone call or only a text message. In addition, patients will be given reminder cards at the time of testing to remind them that they will be contacted within 7 days if they test positive. Half of the reminder cards will have a number to call for test results. We believe patients that receive a card with a number are more likely to be contacted within 7 days.

Detailed description: Aim 1: To improve the results notification system among all female adolescents who test positive for STIs in the ED using mobile phone texting technology.

Hypothesis 1: We will increase our contact rate for STI positive adolescents in the ED from 65-82%.

Hypothesis 2: We will decrease the time interval between testing and appropriate STI treatment by the ED.

Hypothesis 3: We will decrease the recidivism rates for STI positive patients diagnosed in the ED.

Aim 2: To explore qualitatively the barriers to and preferences for partner notification and treatment among 14-21 year-old females and males being tested for STIs in the ED.

Aim 3: To determine baseline rates of partner notification and preferences around partner notification among STI-positive females in the ED, and to explore the feasibility of ED personnel notifying their sexual partners.

Eligibility criteria: Inclusion Criteria:

* 14 to 21 years old
* Seen in the emergency department at Cincinnati Children's Hospital Medical Center
* Test positive for an STI

Exclusion Criteria:

* Seen for a psychiatric evaluation
* Seen for sexual assault or abuse

Primary outcomes:
measure: Contact rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jennifer Reed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05091853: Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
Official title: Laparscopic Inguinal Hernia Repair - Does the Choice of Self-fixated Mesh Matter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Surgery
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 174
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: Self-fixed mesh and postoperative pain after laparoscopic inguinal hernia surgery, a randomized clinical trial

Detailed description: Pain after inguinal hernia surgery is a major problem for the patient and results in lower quality of life. In this randomized clinical trial we examine if the choice of self-fixed mesh affects post-operative inguinal pain in laparoscopic hernia surgery. 164 patients are randomized and followed up for 1 year.

Eligibility criteria: Inclusion Criteria:

* patients with a clinical inguinal hernia, who are operated with laparoscopic surgery in day case surgery

Exclusion Criteria:

* scrotal or incarcerated hernia
* previous laparotomy
* ASA \>3
* BMI \<18 or \>35
* Liver cirrhosis
* No hernia in clinical examination

Primary outcomes:
measure: Pain during the first post-operative week
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki ja uudenmaan sairaalhoitopiiri
Study officials:
References:
Clinical trial NCT02880553: Disability, Perceived Social Support and Quality of Life in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with all forms of multiple sclerosis

Brief summary: The World Health Organization International Classification of Functioning, Disability and Health has shown that the environment can play a major role in patients' disability, and hence in their quality of life. This study considers social dimensions of quality of life, particularly family as well as social and professional networks.


Eligibility criteria: Inclusion Criteria:

* multiples sclerosis, according to McDonald's criteria

Exclusion Criteria:

* lack of French language proficiency
* severe cognitive impairment
* severe aphasia
* substance addiction
* psychiatric troubles (except for treated major depression)
* other severe neurologic or somatic disease
* pregnant or breast feeding patient

Primary outcomes:
measure: statistical association between perceived social support and quality of life
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: San Pellegrino
country: Italy
facility: casa di cura de San Pellegrino
Study officials:
affiliation: Directrice du laboratoire de psychopathologie et neuropsychologie (LPN EA 2027), Université Paris 8
name: Michèle MONTREUIL, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05913453: Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
Official title: Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Full Thickness Resection (EFTR)
Residual /Recurrent Colorectal Lesion
Full-thickness Resection Device (FTRD)
Colorectal Adenoma
Non-lifting Colorectal Lesions
Intraprocedural Complication
Lead sponsor: Azienda Unità Sanitaria Locale della Romagna
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing colorectal EFTR with occurrence of technical failure.

Brief summary: Among advanced resection techniques, endoscopic full thickness resection (EFTR) allows closure and full-thickness resection by the use of the non-exposed full thickness resection device (FTRD). The study is a retrospective analysis of technical failure occurring during colorectal full-thickness resection. Full thickness resection is a safe and effective procedure for "difficult" colorectal lesions. However, technical failure can occur and to date there is no evidence about type and clinical consequences in this setting.

Detailed description: The study is a multicentre retrospective study involving centres with experience in advanced colorectal resections.

Each centre is invited to submit information about the Centre and to report alle the consecutive cases corresponding to technical failure.

Eligibility criteria: Inclusion Criteria:

* Consecutive colorectal EFTR procedures with technical failure by using OVESCO Full Thickness Resection Device

Exclusion Criteria:

* EFTR performed by exposed techniques and/or devices different from FTRD
* Patients not able to give informed consent for data collection

Primary outcomes:
measure: Technical failure rate and classification
timeFrame: 2014 - 2022
Secondary outcomes:
measure: Conservative Management of technical failure
timeFrame: 2014-2022
measure: Clinical success (R0 resection)
timeFrame: 2014-2022
measure: Complication rate
timeFrame: 2014-2022
Other outcomes:
Locations:
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni
state: Forlì-Cesena
Study officials:
References:
Clinical trial NCT02194153: Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Early Inhospital Thrombolysis With Metalyse
Official title: Surveillance of Patients With Suspected Acute Myocardial Infarction That Receive Prehospital or Early Inhospital (Emergency Department) Thrombolysis With Metalyse ®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 351
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: prehospital or emergency room patients

Brief summary: Obtaining data on efficacy (e.g. complete ST-segment resolution) depending on the time of treatment initiation and safety of prehospital and early hospital thrombolysis with Metalyse® in a real life setting outside clinical trials.


Eligibility criteria: Inclusion criteria:

* Male and female patient with suspected myocardial infarction, e.g. during transportation to the hospital by ambulance. No patient younger than 18 years.
* Possibility of obtaining relevant information concerning indication or contraindication of thrombolysis in each patient
* Typical chest pain with a duration of more than 30 minutes
* Definite infarction signs in a 12-lead-ECG with ST-elevation \> 0.1 millivolt (mV) in \> 2 leads or recent left bundle branch block with typical clinical signs
* Symptom onset \<= 6 hours

Exclusion criteria:

* Patients older than 75 years (exception: patients appear much younger)
* Low body weight
* No persons under 18
* contraindications according to summary of product characteristics (SPC) for Metalyse

Primary outcomes:
measure: Complete ST-segment resolution
timeFrame: up to 30 days
measure: Pain relief
timeFrame: 90 min, 120 min, up to 30 days after treatment initiation
measure: Change in creatine kinase (CK)
timeFrame: up to 24 hours
measure: Change in creatine kinase-MB (CK-MB)
timeFrame: up to 24 hours
measure: Change in troponin
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03067753: Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Radiation Necrosis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Detailed description: A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis

Eligibility criteria: Inclusion Criteria:

* Undergone only one course of definitive radiotherapy for histologically confirmed nasopharyngeal carcinoma years before;
* At least two consecutive MRI study supporting the diagnosis of cerebral radiation necrosis(CRN) with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI;
* Progressive neurologic symptoms or signs;
* Mini-mental status examination(MMSE) score must be ≤27;
* Karnofsky performance status≥70 ;
* Supposed to live more than 6 months.

Exclusion Criteria:

* After the second course of radiotherapy for recurrent nasopharyngeal carcinoma;
* Local or regional relapse,or with distant metastasis;
* Cerebrovascular disease;
* Second primary malignancy;
* Diabetes.

Primary outcomes:
measure: Objective response rate
timeFrame: From the first day of treatment, to 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
Study officials:
References:
Clinical trial NCT02968251: Designing and Evaluating a School-based Hand Washing Program in Malawi
Official title: Designing and Evaluating a School-based Hand Washing Program in Malawi
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: School-based, Hand-washing, Program, Malawi
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 360
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to design and evaluate a school-based hand washing program for children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT), so as to improve proper hand washing, increase knowledge level and also reduce school absenteeism.

Detailed description: A cluster randomized controlled trial (CRCT) design with pre-, mid- and post-interventions and follow-up measures will be randomized into intervention or control groups. A simplified 5-steps hand washing program will be implemented in the intervention group while the control group will continue with their usual practice where schoolchildren do not follow any standard recommended handwashing technique.

Eligibility criteria: Inclusion Criteria:

* Schools that have piped tap water source situated in Mzuzu City,
* Private primary schools,
* Children in elementary one and six,
* Written parental consent allowing their child to participate in the study.

Exclusion Criteria:

* Schools without piped tap water source,
* Government primary schools,
* Children whose parents will not give consent.

Primary outcomes:
measure: Proper hand washing
timeFrame: 9 month
Secondary outcomes:
measure: Knowledge gain
timeFrame: 9 month
Other outcomes:
Locations:
city: Mzuzu
country: Malawi
facility: St John's College of Nursing and Midwifery
state: Northern
Study officials:
References:
Clinical trial NCT00582751: Volumetric Analysis in the Assessment of Therapy Response by CT
Official title: Volumetric Analysis in the Assessment of Therapy Response by CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Diseases
Keywords: Volumetric Analysis
Multiple Diseases
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 26
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: 90 patients from 3 different sections will be accrued (30 liver lesions, 30 lung lesions, 30 lymph node lesions).

Brief summary: To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

Detailed description: To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

Eligibility criteria: Inclusion Criteria:

* Registered and being treated on one of the following therapeutic protocols:

06-043, 07-052, 07-057, 07-112, 07-116, 08-093, and 08-054

* Have at least one measurable lesion\* as per RECIST criteria situated in lung, liver or lymph node meeting RECIST criteria noted on a baseline CT scan.
* Baseline\*\* and at least one follow-up CT scan to likely to be obtained at an MSKCC facility
* All patients must be \> or = to 18 years old

  * The measurable lesions are metastatic in the liver, lung and lymph nodes. The algorithms do not distinguish between primary and metastatic disease, therefore, in selected cases, a primary lesion such as in the liver or lung may also be assessed.

    * Baseline CT are prefer but if not able to obtain for volumetric reconstructions follow up studies will still be use for other objectives if the study.

Exclusion Criteria:

* Pregnant or lactating women

Primary outcomes:
measure: To compare volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.
timeFrame: 1 year
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: Robert Lefkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00537251: 32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus
Official title: 32-Week, Open, Randomized, Cross-Over, Local, Multicenter Clinical Trial Comparing Insulin Glargine in Combination With Insulin Analogue (Insulin Lispro) to NPH Insulin in Combination With Regular Insulin in Type 1 Diabetes Mellitus Patients in an Intensified Insulin Regimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.

Detailed description: Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:

* Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)
* Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)

Eligibility criteria: Inclusion Criteria:

* Subjects with type 1 diabetes mellitus
* 18-65 years of age
* C-Peptide negative
* Treated at least for 6 months with multiple daily doses of insulin and with HbA1c greater than or equal to 7.0% and less than or equal to 9.5% and a BMI less than or equal to 35 kg/m².
* Women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.

Primary outcomes:
measure: Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c .
timeFrame: after 16 weeks of treatment with each treatment regime
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Jose Taboada Mosquera
role: STUDY_DIRECTOR
References: