louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00969358: Evaluation of a Rehabilitation Program After Lung Surgery
Official title: Evaluation of a Rehabilitation Program After Lung Surgery (Prospective Observational Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 100
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: tertiary care clinic

Brief summary: Fast track programs, multimodal therapy strategies, have been introduced in many surgical fields to minimize postoperative morbidity and mortality. This study is intended to evaluate a rehabilitation program in comparison with a historical series.


Eligibility criteria: Inclusion Criteria:

* adult patient
* ASA 1, 2 or 3
* lung surgery (postero-lateral or axillary approach)
* epidural analgesia

Exclusion Criteria:

* preoperative oxygen therapy
* lack of autonomy
* unstable coronary artery disease
* FEV1 \< 50%
* pregnancy

Primary outcomes:
measure: length of postoperative hospital stay
timeFrame: end of hospitalisation
Secondary outcomes:
measure: Program Monitoring
timeFrame: end of hospitalisation
measure: postoperative complications
timeFrame: end of hospitalisation
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Dept of Anesthesiology, Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02290158: Effects of a Finishing Protocol Implementation in Orthodontic Patients
Official title: Effects of a Finishing Protocol Implementation on the American Board of Orthodontics - Objective Grading System Score in Patients of Orthodontic Postgraduate Program: A Quasiexperimental Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: treatment outcomes
Malocclusion/therapy
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of a finishing protocol in orthodontic outcomes using ABO-OGS scores. Patients who finish orthodontic treatment and fulfill the inclusion and exclusion criteria receive a treatment using a finishing protocol and their scores are compare with 40 patients who don't receive a finishing protocol

Detailed description: The phase of finishing is the most demanding and detailed of all phases of the orthodontic treatment. American Board of Orthodontics- Objective Grading system is a detailed and objective method that evaluates the quality of the final outcome of orthodontic treatment. In order to evaluate and compare the effects of a protocol implementation on the ABO-OGS scores, standardize cast models and Pan X-Ray from by convenience patients of Orthodontic Postgraduate Program of University of Antioquia who finish orthodontic treatment and receive the protocol are digitized, eight variables are evaluate and ABO-OGS score is calculate. A comparison with 40 no-protocol ABO-OGS scores by convenience-selected patients is done. The protocol includes an educate residents program about finishing problems , an standardized clinical and X-ray assessment , brackets reposition and frequent clinical evaluation. The percentage of the protocol implementation is calculate in every patient and reliability test is make . The descriptive analysis and the ABO-OGS score comparison is done by Pearson or Spearman correlation.

Eligibility criteria: Inclusion Criteria:

* Patients who finish orthodontic treatment by orthodontic criteria
* Receive finishing protocol
* Accept and sign inform consent
* Records ( Panoramic Xray and cast models) taken immediately or 7 days after orthodontic appliances are remove

Exclusion Criteria:

* Patients who don't accept being at the study
* Bad quality records
* Prosthodontic, periodontic and surgical needs treatment after orthodontic treatment

Primary outcomes:
measure: ABO-OGS Total Score
timeFrame: Until 7 days after orthodontic appliances are removed
Secondary outcomes:
measure: Line Smile
timeFrame: Until 7 days after orthodontic appliances are removed
measure: Arch Smile
timeFrame: Until 7 days after orthodontic appliances are re
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Uniersidad de Antioquia
state: Antioquia
Study officials:
References:
Clinical trial NCT05675358: Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
Official title: Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Pain, Acute
Pediatric Cancer
Keywords: virtual reality
phlebotomy
pain
fear
anxiety
emotional apperance
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Afyonkarahisar Health Sciences University
First posted: 2023-01-09
Enrollment: 69
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.

Detailed description: This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey.

Patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.

Eligibility criteria: Inclusion Criteria:

the age range is between 4-12

to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken

consent of the child and parent to voluntarily participate in the study

The child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.

Exclusion Criteria:

having a fever (\>37.5C) and severe dehydration

Before the invasive procedure, the patient was given anagesics.

Primary outcomes:
measure: Pain assesed by Wong-Baker FACES
timeFrame: procedure - during the phelobotomy
measure: Fear assesed by Child Fear Scale
timeFrame: procedure -during the phelobotomy
measure: Anxiety assesed by Children Anxiety Meter-State
timeFrame: procedure- during the phelobotomy
Secondary outcomes:
measure: emotional apperance assesed by Emotional Appearance Scale for Children
timeFrame: Baseline - before the phelobotomy
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gülçin Özalp Gerçeker, pHD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01820858: The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Official title: A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Endometrial Neoplasms
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Shandong University
name: Huazhong University of Science and Technology
name: Zhejiang University
First posted: 2013-03-29
Enrollment: 300
Sex: FEMALE
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: This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.


Eligibility criteria: Inclusion Criteria:

* FIGO stage: Ⅰ, endometrial carcinoma;
* Female, Chinese women;
* Initial treatment is staging surgery;
* Pathological diagnosis: Endometrial adenocarcinoma;
* Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
* No prior treatment;
* Provide written informed consent.

Exclusion Criteria:

* Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
* Family history of ovarian cancer;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials;
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 3-year DFS
Secondary outcomes:
measure: Side effect of adjuvant chemotherapy
timeFrame: 3-month，6-month，1-year and 3-year
measure: Complications of radiotherapy
timeFrame: 3-month，6-month，1-year and 3-year
measure: Quality of Life
timeFrame: 3-month，6-month，1-year and 3-year
measure: Overall survival (OS)
timeFrame: 3-year OS
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Jinan
country: China
facility: Qilu Hospital，Shandong University
state: Shandong
city: Hangzhou
country: China
facility: Women's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Beihua Kong, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05377658: AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Official title: A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: neoadjuvant and adjuvant therapy
bispecific antibody
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.


Eligibility criteria: Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC.
3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
4. Have adequate organ function.

Key Exclusion Criteria:

1. Mixed NSCLC and small cell lung cancer histology.
2. Patients with other active malignancies within 3 years prior to enrollment.
3. Known active autoimmune diseases.
4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
5. Presence of other uncontrolled serious medical conditions.

Primary outcomes:
measure: Pathological Complete Response (pCR) Rate
timeFrame: At time of surgery
Secondary outcomes:
measure: Major Pathological Response (MPR) Rate
timeFrame: At time of surgery
measure: Incidence of Surgical Complications
timeFrame: Up to approximately 30 days following surgery
measure: Complete (R0) Resection Rate
timeFrame: After surgery (approximately 7 weeks)
measure: Objective Response Rate (ORR)
timeFrame: At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)
measure: Event Free Survival (EFS)
timeFrame: Up to approximately 5 years
measure: Adverse Events (AEs)
timeFrame: From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT00487058: A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors
Official title: A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Gimatecan
topoisomerase I inhibitor
advanced solid tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-06-15
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.


Eligibility criteria: Inclusion criteria

* Patients with histological or cytological confirmed advanced solid tumors, which progressed despite standard therapy or for whom no standard therapy exists
* Life expectancy of at least 3 months
* No dysfunction of bone marrow
* No major impairment of renal and hepatic function

Exclusion criteria

* Gastrointestinal dysfunction, such as gastrectomy or malabsorption syndrome, that could alter absorption of the study drug
* Receipt of any investigational compound within the 28 days prior to the first dose of study drug, or failure to recover from the side effects of such prior therapy
* Receipt of other antineoplastic therapy including chemotherapy, hormone therapy, immunotherapy, radiation therapy within the 28 days
* Patients known to be HIV, or hepatitis B or C viruses positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
* Patients with a history of allergies to the camptothecin family of drugs

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety and tolerability assessed by Adverse Events Characterization of the pharmacokinetic profile of gimatecan Anti-tumor activity assessed by Response Evaluation Criteria in Solid Tumors RECIST)
Secondary outcomes:
Other outcomes:
Locations:
city: Saitama Prefecture
country: Japan
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT00167258: Effectiveness and Costs of Enhanced Cocaine Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effectiveness, economic benefits, and costs of voucher reinforcement for cocaine and alcohol abstinence, additional counseling services, and their combination in a sample of cocaine dependent patients receiving outpatient treatment as usual in a community clinic.


Eligibility criteria: Inclusion Criteria:

* Enrollment in an intensive outpatient program (IOP) for no more than 1 month
* Current DSM-IV diagnosis of cocaine dependence (month prior to IOP treatment)
* 18-65 years of age
* Ability to provide names of informants to help locate subject for follow-up

Exclusion Criteria:

* IV heroin use in last year
* Acute medical/psychiatric diagnosis that precludes outpatient treatment
* Inpatient treatment for 6 weeks or more prior to IOP treatment
* Incarceration for 6 months or more prior to IOP treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James R McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04424758: Testing Video Information About Mammography Screening
Official title: Testing Video Information About Mammography Screening in a Randomized Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: See protocol
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.

Detailed description: This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be randomized to either the intervention group (video information about mammography screening followed by a survey about mammography screening) or the control group (video information about energy systems followed by the same survey). The survey computer programme will randomly assign each respondent to either the intervention arm or the control arm in the beginning of the survey.

The allocation will be concealed from the researchers. The survey computer programme will deliver the intervention right after randomization. Participants will be aware of the allocation. However, they do not know about the study design. Data analysts will be kept blinded to the allocation.

Choice, knowledge and opinions related to mammography screening will be compared between the control group and the intervention group at one timepoint.

Eligibility criteria: Inclusion Criteria:

* Participants eligible for the study includes all men and women age 18-75.

Exclusion Criteria:

* None

Primary outcomes:
measure: Choice: proportion of participants in favor of mammography screening
timeFrame: One month
Secondary outcomes:
measure: Response duration: time
timeFrame: One month
measure: Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.
timeFrame: One month
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Section of General Practice
state: Capital
Study officials:
affiliation: Section of General Practice, University of Copenhagen
name: Manja Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04675658: Stay Active Physical Activity Program
Official title: Stay Active Physical Activity Program for Teachers, Students, and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Sedentary Behavior
Keywords: Physical Activity
Exercise
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The pilot study will create, implement, and evaluate a physical activity program in both the school and home setting during the COVID-19 pandemic.

Detailed description: This study will compare the impact of two physical activity interventions on student's physical activity.

Eligibility criteria: Inclusion Criteria:

Classrooms

* Teacher of a 4th or 5th grade class in the Kansas City area.
* English speaking only

Students

* Any student in the selected classrooms
* A parent or guardian of the student
* English speaking only

Exclusion Criteria:

* Does not meet the required criteria above.

Primary outcomes:
measure: Daily minutes of PA (physical activity)
timeFrame: 3 months
measure: Daily step count
timeFrame: 3 months
Secondary outcomes:
measure: Parent perceptions of interventions
timeFrame: 3 months
measure: Teacher perceptions of interventions
timeFrame: 3 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
Study officials:
affiliation: Research Faculty
name: Jordan Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03750058: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Official title: AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Resynchronisation Therapy
Keywords: quadripolar LV leads
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: MicroPort CRM
First posted: 2018-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing


Eligibility criteria: Inclusion Criteria:

* Male or female patient aged ≥18 years old.
* Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines .
* Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
* Signed and dated informed consent.
* Patient affiliated with, or beneficiary of a social security category.

Exclusion Criteria:

* Class IV of NYHA (ambulatory or not).
* Allergy to contrast media used for imaging during cardiac catheterization.
* Severe Renal Failure (clearance of creatinine \< 30ml/mn/m²).
* Previous failure catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
* Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
* Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
* Known pregnancy, breastfeeding women or in childbearing age without an adequate contraceptive method (failure rate \< 1%).

Primary outcomes:
measure: LV Multizone pacing success rate
timeFrame: 20 min
measure: LV pacing success rate
timeFrame: 20 min
Secondary outcomes:
measure: Implant testing Procedure-related Adverse Events procedure.
timeFrame: 1 month post testing
measure: Electrical performance of device (1)
timeFrame: 20 min
measure: Electrical performance of device (2)
timeFrame: 20 min
measure: Lead Implant Efficiency
timeFrame: 20 min
measure: Lead Implant Efficiency
timeFrame: 20 min
measure: Satisfaction of implanter
timeFrame: 20 min
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Frédéric ANSELME, Pr
role: PRINCIPAL_INVESTIGATOR
References: