louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03276091: Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test
Official title: Evaluation of a Motivational Phone Call Strategy to Improve Colonoscopy Participation, for Patients With a Positive Immunochemical Fecal Test : Colofit + Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: colonoscopy
immunochemical fecal test
screening
Lead sponsor: Association pour le Dépistage Organisé des Cancers dans le Rhône
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 127
Sex: ALL
Minimum age (years): 51
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. And try to understand why this patients don't want to make this examination.


Eligibility criteria: Inclusion Criteria:

* immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters)

Exclusion Criteria:

* colonoscopy done

Primary outcomes:
measure: Participation to the colonoscopy
timeFrame: From date of phone call until the date of first documented colonoscopy assessed up to 6 months
Secondary outcomes:
measure: reasons for rejecting colonoscopy
timeFrame: Reasons for rejecting colonoscopy will be assessed during the phone call only, and assessed until the end of this phone call
measure: cancer and adenoma detected
timeFrame: From date of phone call until the date of first documented colonoscopy result assessed up to 6 months after phone call
Other outcomes:
Locations:
city: Lyon
country: France
facility: Ademas-69
Study officials:
affiliation: Hopital Edouard Herriot
name: Thierry Ponchon, PHD
role: STUDY_DIRECTOR
References:
citation: Gandilhon C, Soler-Michel P, Vecchiato L, Chaunier C, Fay I, Walter T, Rivory J, Saurin JC, Ponchon T, Pioche M. A motivational phone call improves participation to screening colonoscopy for those with a positive FIT in a national screening programme (NCT 03276091). Dig Liver Dis. 2018 Dec;50(12):1309-1314. doi: 10.1016/j.dld.2018.08.007. Epub 2018 Aug 17.
Clinical trial NCT00197691: Botswana Pediatric Respiratory Disease and Bloodstream Infection Study
Official title: Botswana Pediatric Respiratory Disease and Bloodstream Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Respiratory Tract Diseases
Sepsis
Keywords: HIV infected mothers
Infants at risk of HIV-infection
Infant lower respiratory tract disease
Infant bloodstream infection
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: LIVEBORN INFANT IN THE MASHI PMTCT TRIAL

Brief summary: The purpose of this study is to learn about lower respiratory tract and bloodstream diseases among infants born to HIV positive mothers in Botswana. Study factors include how commonly infants get these diseases, the causes, and outcomes. The study will also try to measure the protective effect, if any, of breast feeding on respiratory disease illness and deaths.


Eligibility criteria: Inclusion Criteria:

* Participation in parent study, "Mashi" HIV vertical transmission prevention study for pregnant Botswana women and their infants

Primary outcomes:
measure: OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
timeFrame: Between birth and 2 years of life
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Shahin Lockman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shapiro RL, Smeaton L, Lockman S, Thior I, Rossenkhan R, Wester C, Stevens L, Moffat C, Arimi P, Ndase P, Asmelash A, Leidner J, Novitsky V, Makhema J, Essex M. Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana. J Infect Dis. 2009 Feb 1;199(3):414-8. doi: 10.1086/596034.
citation: Shapiro RL, Lockman S, Kim S, Smeaton L, Rahkola JT, Thior I, Wester C, Moffat C, Arimi P, Ndase P, Asmelash A, Stevens L, Montano M, Makhema J, Essex M, Janoff EN. Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana. J Infect Dis. 2007 Aug 15;196(4):562-9. doi: 10.1086/519847. Epub 2007 Jul 9.
Clinical trial NCT03402191: L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Official title: Comparative Clinical Study Evaluating the Effect of L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thalassemia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

Detailed description: This study focuses on different lines of treatment for pulmonary hypertension in children with thalassemia as this study discusses the Effect of L-arginine Versus Sildenafil in Children with Beta Thalassemia Associated with Pulmonary Hypertension

Eligibility criteria: Inclusion Criteria:

* Children with thalassemia and pulmonary hypertension.

Exclusion Criteria:

* Rheumatic heart diseases.
* Other comorbid disease

Primary outcomes:
measure: Number of patients with improvement of pulmonary hypertension
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Pharmacy
name: Sahar El-Haggar, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University Pediatrics Department
name: Mohamed El-Shanshoury, Prof
role: STUDY_DIRECTOR
affiliation: Tanta University Pediatrics Department
name: Osama Abd-rab El-Rasol, Prof
role: STUDY_CHAIR
affiliation: Tanta University-Faculty of pharmacy
name: Tarek Mostafa, Ass Prof
role: STUDY_CHAIR
affiliation: Tanta University-Faculty of pharmacy
name: Eman El-Khateeb, Msc
role: STUDY_CHAIR
References:
Clinical trial NCT00755391: Cognitive Behavioral Therapy for Adolescents With Bulimia
Official title: Cognitive Behavioral Therapy for Adolescents With Bulimia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Keywords: BN and subthreshold BN
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.

Detailed description: Patients will be randomized to have an equal chance of either receiving CBT or SP. Participants will include both individuals with DSM-IV bulimia nervosa (BN), and patients with sub-threshold BN. Adolescent patients will be treated at the New York State Psychiatric Institute, with a target recruitment of 20 patients completing the study. Participants in both conditions will be assessed prior to treatment and at the end of treatment. This trial is intended to serve as a pilot investigation to determine the feasibility and utility of a larger controlled study in this population.

Eligibility criteria: Inclusion Criteria:

1. Age between 12 and 18
2. DSM-IV diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (binge eating and/or purging at least once per week)

Exclusion Criteria:

1. Diagnosis of bipolar disorder
2. Current psychosis
3. Drug or alcohol abuse in the past 3 months
4. Acute Suicidal Risk
5. Major depression producing significant functional impairment
6. Significant medical illness
7. Weight outside of normal weight range (between 85% and 120% of the 50th percentile for age as measured by standard growth charts)

Primary outcomes:
measure: Eating Disorder Examination scores
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Robyn Sysko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05947591: Influence of Gait and Running on Foot Posture
Official title: Influence of Gait and Running on Foot Posture Index and Navicular Drop Modifications for Non-athletes.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Foot Pronation in Healthy Adult
Keywords: run
pronation
adult
sport
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy non atletes subjects

Brief summary: Objective: To evaluate in a sample of healthy non-athlete subjects, if the foot tends to a pronated position during a period of running compared to walking, evaluated during and after one hour after performing said activity.

Design: Quasi-experimental study, experimental and control group. Setting: Subjects who attend the Podiatry Clinical Area of the University of Seville.

Participants: N=72 healthy non-athlete volunteer adults who regularly run.

Detailed description: Interventions: The volunteers will participate in the research on three occasions, the day of data collection, one day when they will carry out a one-hour walking period and on another occasion where they will carry out an hour of running. Changes in foot posture \[FPI\] or foot pronation position (navicular drop \[ND\]) were identified in various periods of time at the time of the initial assessment and examination (p1), after 30 minutes of walking or running ( p2), 45 minutes of walking or running (p3) and 60 minutes of walking or running (p4) of the activity elapsed.

Main outcome measures: Foot position will be measured using the Foot Posture Index (FPI) and navicular height using the navicular drop test (ND) at p1, p2, p3 and p4.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria are: healthy adults, of both sexes, who come to the center on the indicated date and who are professional athletes but who do practice some regular physical activity, understood as running for one hour three times a week as minimum.

-

Exclusion Criteria:

a congenital or traumatic foot deformity, wearing plantar supports, pregnancy or being in current rehabilitation treatment or serious illness.

-

Primary outcomes:
measure: Foot posture index
timeFrame: 15 minutes
measure: navicular drop test
timeFrame: 15 minutes
Secondary outcomes:
measure: Foot posture index
timeFrame: 60 minutes
measure: Navicular drop test
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Aurora Castro Mendez
Study officials:
References:
Clinical trial NCT05540691: Effect of Noise Blocking During General Anesthesia on Postoperative Pain
Official title: Effect of Noise Blocking During General Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: noise blocking
Postoperative Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）
Primary purpose: TREATMENT

Brief summary: To investigate the effect of noise blocking during general anesthesia on postoperative pain in patients undergoing laparoscopic abdominal surgery. The aim of this study was to determine whether noise blocking can reduce postoperative pain, analgesic use, and its possible effects on intraoperative electrocorticogram.


Eligibility criteria: Inclusion Criteria:

* ASA Classification ⅰ-ⅲ
* Patients undergoing elective laparoscopic abdominal surgery under general anesthesia
* Voluntarily accept PCIA and signed informed consent

Exclusion Criteria:

* Patients with previous severe disease
* Patients with hearing abnormalities
* Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
* Patients with chronic preoperative pain and/or long-term analgesic use
* Patients who could not cooperate with the study for any reason

Primary outcomes:
measure: Maximum pain score (NRS score) at 0-24 hours postoperatively
timeFrame: From ending of the surgery to 24 hours postoperatively
measure: Pain score (NRS score) at 0-6 hours postoperatively
timeFrame: From ending of the surgery to 6 hours postoperatively
measure: Pain score (NRS score) at 6-12 hours postoperatively
timeFrame: From 6 hours postoperatively to 12 hours postoperatively
measure: Pain score (NRS score) at 12-24 hours postoperatively
timeFrame: From 12 hours postoperatively to 24 hours postoperatively
Secondary outcomes:
measure: Patient controlled analgesia pump analgesic consumption
timeFrame: From the time when the surgery was completed until to 24 hours after surgery
measure: Postoperative hyperalgesia after surgery
timeFrame: from the 30 minutes before the surgery until to 30 minutes after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
name: Huang He, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04838691: Premenstrual Syndrome and Interpersonal Counseling
Official title: The Effect of Interpersonal Counseling in Symptoms Management of Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: premenstrual syndrome
interpersonal counseling
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to test the effectiveness of interpersonal counseling in PMS symptom management in university students experiencing PMS symptoms.

Detailed description: People diagnosed with Premestrual Syndrome were identified through an online questionnaire. 80 people who were identified and accepted to study were divided into two groups as experiment and control. Initially, pre-menstrual screening tool, interpersonal relationship dimensions scale and perceived stress scale were applied to all groups. Then, 8 sessions of interpersonal counseling, each lasting 40 minutes, were applied to the experimental group for 2 months. Scales were repeated for both groups after the application was completed. Repeated measurements were made 3 months later.

Eligibility criteria: Inclusion Criteria:

1. According to the Pre-menstrual Symptom Screening Instrument, which is located in the group living with AES (Pre-Mental Syndrome)
2. between the ages of 18-30
3. Menstruating at regular intervals for at least 2 years (21-35 days)
4. Those who have never given birth
5. Speak and understand Turkish
6. It will consist of people who have not received antidepressant, oral contraceptive or hormone therapy for any reason.

Exclusion Criteria:

1. Having a known gynecological disease (endometriosis, polycystic ovary, ...)
2. A known, ongoing physical health problem (diabetes, rheumatic disease, ...)
3. Any psychiatric disease diagnosed (psychotic disorder, mood disorder, anxiety disorder ...)
4. People who use cigarettes, alcohol or substances

Primary outcomes:
measure: Premenstrual Symptom Screening Tool
timeFrame: Baseline (beginning), Change from Baseline PMDD or PMS after 2 months, Change from Baseline PMDD or PMS after 5 months,
Secondary outcomes:
measure: Scale Of Interpersonal Relatıonshıps Dımensıons
timeFrame: Baseline (beginning), Change from Baseline Sub-dimensions of Interpersonal Relationships Scale after 2 months, Change from Baseline Sub-dimensions of Interpersonal Relationships Scale after 5 months
measure: Perceived stress scale
timeFrame: Baseline (beginning), 2 months after beginning, 3 months after beginning
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Neslihan Özcan, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00850291: Economisation of Whipple Resection Using Electrosurgical Sealing Device
Official title: Prospective, Controlled, Randomized Study of Economisation of the Preparation in Partial Duodenopancreatectomy Using an Electrosurgical Sealing Device Versus Traditional Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenopancreatectomy
Keywords: Partial duodenopancreatectomy using electrosurgical vessel sealing device
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2009-02-24
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.

Brief summary: Including 89 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an electrosurgical sealing device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.


Eligibility criteria: Inclusion Criteria:

* resectable tumor

Exclusion Criteria:

* palliative resection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: UH Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Jacob R. Izbicki, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. doi: 10.1053/j.seminoncol.2007.05.004.
citation: Uzunoglu FG, Bockhorn M, Fink JA, Reeh M, Vettorazzi E, Gawad KA, Bogoevski D, Vashist YK, Tsui TY, Koenig A, Mann O, Izbicki JR. LigaSure vs. conventional dissection techniques in pancreatic surgery--a prospective randomised single-centre trial. J Gastrointest Surg. 2013 Mar;17(3):494-500. doi: 10.1007/s11605-012-2107-z. Epub 2012 Dec 19.
Clinical trial NCT01708291: HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: youth
Stress
mindfulness
foster care
stress reduction
high risk teens
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 45
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will measure baseline stress among a group of youth in foster and kinship care. The investigators will implement a pilot program to target stress reduction by using an evidence-based group therapy technique teaching mindfulness skills. The investigators hypothesize that the mindfulness skills will help youth to reduce stress, which will be measured using psychological and physiological techniques.


Eligibility criteria: Inclusion Criteria:

* ages 14-21 years at time of intervention being offered, offered to youth in out of home care (e.g. foster and kinship care)

Exclusion Criteria:

* severe developmental delay
* non English speaking, not in age range

Primary outcomes:
measure: Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)
timeFrame: Baseline and week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
citation: Jee SH, Szilagyi M, Conn AM, Nilsen W, Toth S, Baldwin CD, Szilagyi PG. Validating office-based screening for psychosocial strengths and difficulties among youths in foster care. Pediatrics. 2011 May;127(5):904-10. doi: 10.1542/peds.2010-1350. Epub 2011 Apr 18.
citation: Jee SH, Halterman JS, Szilagyi M, Conn AM, Alpert-Gillis L, Szilagyi PG. Use of a brief standardized screening instrument in a primary care setting to enhance detection of social-emotional problems among youth in foster care. Acad Pediatr. 2011 Sep-Oct;11(5):409-13. doi: 10.1016/j.acap.2011.03.001. Epub 2011 Jun 17.
citation: Jee SH, Couderc JP, Swanson D, Gallegos A, Hilliard C, Blumkin A, Cunningham K, Heinert S. A pilot randomized trial teaching mindfulness-based stress reduction to traumatized youth in foster care. Complement Ther Clin Pract. 2015 Aug;21(3):201-9. doi: 10.1016/j.ctcp.2015.06.007. Epub 2015 Jun 20.