louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00191841: Gemcitabine in Combination With Cisplatin as Neoadjuvant NSCLC Chemotherapy
Official title: Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy in Operable Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical response rate of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with operable NSCLC


Eligibility criteria: Inclusion Criteria:

* histologic or cytologic diagnosis of operable non-small cell lung cancer (IB-IIIA)
* no prior chemotherapy
* WHO criteria for disease status assessment

Exclusion Criteria:

* Concurrent administration of any other tumor therapy
* pregnant or breast feeding
* serious concomitant disorders

Primary outcomes:
measure: Antitumor activity
Secondary outcomes:
measure: Duration of response, time to progressive disease, time to treatment failure
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
city: St Petersburg
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
city: Ufa
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Davidov MI, Polotzky BE, Marenich AF, Orlov SV, Lazarev AF, Skryabina LS, Pavlushkov EV, Semenchenya VA, Brichkova OY, Karaseva VV. Gemcitabine combined with cisplatin as neoadjuvant chemotherapy in stage IB-IIIA non-small cell lung cancer. Anticancer Drugs. 2011 Jul;22(6):569-75. doi: 10.1097/CAD.0b013e328342d50a.
Clinical trial NCT00180141: Elidel-Study: Elidel in Patients With Atopic Dermatitis
Official title: Control of Therapy With Elidel vs Placebo in Patients With Atopic Dermatitis Using Bioengineering Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis on both lower arm.
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 24
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: Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective to treat this disease. The research question is, whether the effective component (Elidel) is better than the emollient to improve the skin function.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Atopic dermatitis on both lower arms at least 1% body surface area.
* Atopic Dermatitis Severity Index (ADSI)-Score \>= 6
* Investigator Global Assessment (IGA)-Score \>= 2

Exclusion Criteria:

* Systemic therapy with immunosuppressive drugs within the past 24 weeks
* Phototherapy against atopic dermatitis.
* Antibiotic therapy against atopic dermatitis.
* Allergy against Elidel.
* Pregnancy
* Nursing
* Skin cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Technical University Dresden
state: Sachsen
Study officials:
affiliation: Department of Dermatology. Medical Faculty, Technical University Dresden, Germany
name: Roland Aschoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100241: Effectiveness Analysis of Active Stretching Versus Active Stretching With Low Frequency Currents
Official title: Effectiveness Analysis of Active Stretching Versus Active Stretching With Low Frequency Currents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Diseases
Keywords: Young adult
Muscle Stretching Exercises
Range of Motion, Articular
Lead sponsor: Rodríguez, Francisco Piqueras, M.D.
Sponsor class: INDIV
First posted: 2014-03-31
Enrollment: 62
Sex: MALE
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether active stretching with low frequency currents are more effective than active stretching in the treatment of hamstring shortness syndrome in children.

Detailed description: In 2012 we studied 51 young footballers with Short Hamstring Syndrome in Spain. Three groups were formed:

1. Stretching+Transcutaneous Electrical Nervous Stimulation (TENS);
2. Active stretching;
3. Conventional stretching.

Parameters: straight leg raise test (SLR), popliteal angle with the passive knee extension test (PKE) and the toe-touch test (TT).

The inter-group means were compared and clinically relevant parameters calculated \[relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT)\].

Eligibility criteria: Inclusion Criteria:

* children between 10 to 16.
* children federated belonging to Football School of Jumilla.
* children whose result in the assessment of range of motion is less than 70º in the Straight Leg Raising Test.
* not afraid to present the application of electrotherapy.
* not have low back pain in last three months.
* not to be injured

Exclusion Criteria:

* children who have acute muscle injury or ligamentous.
* children with recent fractures or unconsolidated.
* children with ligamentous laxity.
* functional shortening suffering children

Primary outcomes:
measure: Range of motion
timeFrame: a week
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan de Alicante
country: Spain
facility: Universidad Miguel Hernandez de Elche
state: Alicante
Study officials:
name: Francisco Piqueras, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05984641: Efficacy and Safety of CONAN® Proctological Cream for Treatment of Haemorrhoidal Disease
Official title: Efficacy and Safety of CONAN® Proctological Cream Formulation in the Topical Treatment of Haemorrhoidal Disease and Anal Fissures: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoid Pain
Haemorrhoid Inflammation
Keywords: Haemorrhoids; anal fissures; controlled clinical trial.
Lead sponsor: Omikron Italia S.r.l.
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study population was randomized into two treatment arms: Group A, active treatment (CONAN® Proctological Cream, Medical Device, Omikron Italia Srl) and Group B, the control group (bowel-function regulation).
Primary purpose: TREATMENT

Brief summary: Aim of the study is to assess the efficacy, safety and tolerability of CONAN® (Proctological Cream, Medical Device, Omikron Italia Srl) on most frequent symptoms in grade 1-2 of haemorrhoidal disease and anal fissures.

Detailed description: Background: To evaluate the role of CONAN® Proctological Cream containing escin, hesperidin and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its potential efficacy in reducing related symptoms.

Methods: Forty patients with haemorrhoidal disease and anal fissures were enrolled. Of them, 20 were randomized to receive the medical device CONAN® Cream (Group A) and 20 to the untreated control group (Group B). At each scheduled visit, total symptoms were assessed and recorded by assigning a Numerical Rating Scale score from 0 to 10. The adverse events reported by study subjects were also assessed and recorded.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70 years
* Hemorrhoidal pathology, anal fissures and anitis
* NRS score ≥ 3 for at least one of the symptoms (burning, itching, feeling of heaviness, foreign body)

Exclusion Criteria:

* Known hypersensitivity to study products
* Proctitis
* Current therapy with other local treatments based on phlebotropes and/or anti-inflammatories
* Surgical treatments undergone less than a year after inclusion
* Pregnancy, breastfeeding

Primary outcomes:
measure: Change in the symptom numerical rating scale
timeFrame: 30 days
Secondary outcomes:
measure: Evaluation of potential adverse events and treatment compliance
timeFrame: 30 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Tor Vergata Foundation (PTV)
Study officials:
affiliation: Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
name: Nicola Di Lorenzo, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgical Sciences,University of Tor Vergata, Policlinico Tor Vergata
name: Gabriella Giarratano, Medicine
role: STUDY_CHAIR
References:
Clinical trial NCT00944541: Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
Official title: Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
HIV Infections
Keywords: maraviroc
immune restoration
treatment intensification
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Pfizer
First posted: 2009-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV\< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4\<350 cells/mL and CD4 earning \<100 cells/mL during last 24 months).

The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.


Eligibility criteria: Inclusion Criteria:

* HIV-1 infection
* maraviroc-naives patients
* CD4 less than 350 cells/mm3
* viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months

Exclusion Criteria:

* HIV-2 infection
* X4 tropism at inclusion
* pregnancy and breast feeding
* interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
* hypersensibility of peanut or soya

Primary outcomes:
measure: Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load
timeFrame: immunologic benefit at week 24
Secondary outcomes:
measure: Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36.
timeFrame: immuno-virologic evolution between week 0 and week 36
Other outcomes:
Locations:
city: Paris
country: France
facility: French National Agency for Research on AIDS and Viral Hepatits
Study officials:
affiliation: CHU Purpan - Toulouse (France)
name: Lise CUZIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06582641: Evaluation of Peer Group Connection - Middle School
Official title: Evaluation of Peer Group Connection - Middle School (PGC-MS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Mathematica Policy Research, Inc.
name: Reproductive Health National Training Center
name: Center for Supportive Schools
First posted: 2024-09-03
Enrollment: 1400
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized trial is to learn if the Peer Group Connection - Middle School (PGC-MS) intervention delays initiation of sexual intercourse in middle school-aged youth. The primary research question it aims to answer is:

Sixteen months after being offered the intervention, does PGC-MS impact youth's initiation of sexual intercourse?

Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)).

Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (either 6th or 7th grade). Participants randomized to the control group will be offered class-as-usual.

Detailed description: This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at four time points: baseline (fall semester of 6th or 7th grade); post-intervention (spring semester of 6th or 7th grade); four months post-intervention (fall semester of 7th or 8th grade); and sixteen months post-intervention (fall semester of 8th or 9th grade).

Eligibility criteria: Inclusion Criteria:

* Be enrolled at a middle school participating in the study
* Entering the middle school transition grade for the first time (6th or 7th grade depending on the middle school transition year) at a participating study school
* Provide parental consent and student assent to participate in the study
* Have the ability to complete a self-administered questionnaire in either English or Spanish in a classroom or group setting, unassisted, in 60 minutes or less.

Exclusion Criteria:

- Repeating the middle school transition year (6th or 7th grade)

Primary outcomes:
measure: Initiation of sexual intercourse
timeFrame: Assessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program)
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Policy & Research Group
state: Louisiana
Study officials:
affiliation: The Policy & Research Group
name: Sarah Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230841: Comparing Different Ways of Delivering Humidity to Children With Croup
Official title: Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Croup
Keywords: croup
humidity therapy
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2005-10-03
Enrollment: 129
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).


Eligibility criteria: Inclusion Criteria:

* children aged 3 months - 10 years
* croup score greater than or equal to 2 after a 30 minute waiting period

Exclusion Criteria:

* Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation
* symptoms or signs of alternative causes of stridor
* inability of caregivers to understand or speak English and/or sign for informed consent
* history of chronic pulmonary disease except for asthma, or co-existent systemic disease
* previous history of intubation
* duration of present illness \>1 week
* systemic or inhaled glucocorticoids in previous 48 hours
* epinephrine in previous 4 hours

Primary outcomes:
measure: changes in the croup score from baseline to 30 and 60 minutes
Secondary outcomes:
measure: steroid or epinephrine treatment at 60 minutes
measure: discharge rate at 60 minutes
measure: change in pulse, respiratory rate, and oxygen saturation at 60 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Dennis Scolnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scolnik D, Coates AL, Stephens D, Da Silva Z, Lavine E, Schuh S. Controlled delivery of high vs low humidity vs mist therapy for croup in emergency departments: a randomized controlled trial. JAMA. 2006 Mar 15;295(11):1274-80. doi: 10.1001/jama.295.11.1274.
Clinical trial NCT02923141: Trauma Intervention for Affect Regulation, AIDS, and Substances
Official title: Trauma Intervention for Affect Regulation, AIDS, and Substances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Substance Related Disorder
Post Traumatic Stress Disorder
Keywords: substance use
trauma
HIV
viral load
women
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 16
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: The Purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in HIV care with HIV-positive women.


Eligibility criteria: Inclusion Criteria:

* HIV positive
* woman or trans woman
* substance use
* elevated PTSD symptoms
* HIV care difficulties

Exclusion Criteria:

* not HIV positive
* no substance use
* men
* no HIV care difficulties
* no history of trauma

Primary outcomes:
measure: Reduction in HIV RNA Copies/mL
timeFrame: 6 months
Secondary outcomes:
measure: Increase in T-helper (CD4+) cell count
timeFrame: 6 months
measure: Reduction in HIV transmission risk
timeFrame: 6 months
measure: Decrease in stimulant use
timeFrame: 6 months
measure: Decrease in stimulant use
timeFrame: 6 months
measure: Decrease in post-traumatic stress disorder (PTSD) symptoms
timeFrame: 6 months
measure: Decrease in depressive symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Research Building
state: Florida
Study officials:
affiliation: University of Miami
name: Adam Carrico, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jemison D, Jackson S, Oni O, Cats-Baril D, Thomas-Smith S, Batchelder A, Rodriguez A, Dilworth SE, Metsch LR, Jones D, Feaster DJ, O'Cleirigh C, Ironson G, Carrico AW. Pilot Randomized Controlled Trial of a Syndemics Intervention with HIV-Positive, Cocaine-Using Women. AIDS Behav. 2019 Sep;23(9):2467-2476. doi: 10.1007/s10461-019-02625-2.
Clinical trial NCT04425941: Polyp Artificial Intelligence Study
Official title: Artificial Intelligence Based Colorectal Polyp Histology Prediction by Using Narrow-band Imaging Magnifying Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Software Analysis on Polyp Histology Prediction
Lead sponsor: Petz Aladar County Teaching Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with symptoms of colorectal polypoid laesions, colorectal cancer screening patients

Brief summary: Background We are developing artificial intelligence based polyp histology prediction (AIPHP) method to automatically classify Narrow Band Imaging (NBI) magnifying colonoscopy images to predict the non-neoplastic or neoplastic histology of polyps.

Aim Our aim was to analyse the accuracy of AIPHP and NICE classification based histology predictions and also to compare the results of the two methods.

Methods We examined colorectal polyps obtained from colonoscopy patients who had polypectomy or endoscopic mucosectomy. Polyps detected by white light colonoscopy were observed then by using NBI at the optical maximum magnificent (60x). The obtained and stored NBI magnifying images were analysed by NICE classification and by AIPHP method parallelly. Pathology examinations were performed blinded to the NICE and AIPHP diagnosis, as well. Our AIPHP software is based on a machine learning method. This program measures five geometrical and colour features on the endoscopic image.


Eligibility criteria: Inclusion Criteria:

* endoscopic diagnosis of colorectal polyp

Exclusion Criteria:

* colonoscopy result without polyps or IBD diagnosis

Primary outcomes:
measure: Software accuracy of polyp histology prediction
timeFrame: 2014-2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: