louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02132572: Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Official title: Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Implantation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that have undergone a primary breast augmentation for aesthetic reasons with a Natrelle BIOCELL™ textured 410 cohesive implant

Brief summary: Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)


Eligibility criteria: Inclusion Criteria:

* Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 \& 3 only) has been implanted
* Primary breast augmentation 3 to 10 years prior to data collection
* Submuscular/dual plane or subglandular implant placement

Exclusion Criteria:

* Breast augmentation for Poland Syndrome or amastia
* Breast reconstruction following mastectomy
* Revision or secondary breast reconstruction
* Non 410 device at initial breast augmentation
* Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant
* Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions)
* Axillary or peri-areolar approach
* Glandular mastopexy augmentation (skin excision only)

Primary outcomes:
measure: Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant
timeFrame: 3 to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Düsseldorf
country: Germany
city: Tel Aviv
country: Israel
city: Madrid
country: Spain
city: East Grinstead
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05773872: Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
Official title: Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Narcolepsy
Social Cognition
Keywords: Narcolepsy
social cognition
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Narcolepsy is a chronic disabling neurologic disorder mainly characterised by excessive daytime sleepiness. Type 1 narcolepsy is associated with a deficit of hypocretin in the cerebrospinal fluid responsible for the cataplexy symptom while type 2 shows a normal hypocretin level and no cataplexy. While the development of narcolepsy is independent of parental social level, narcolepsy has a significant influence on educational level, grading, social outcome, and welfare consequences. Several studies assessed global cognition efficiency, mood, and attention in narcoleptic patients but only a few specifically measured social cognition and mostly without a control group.

In a population of narcoleptics children, a severe impairment in social cognition is described for 20% of the group, contrary to 2 % for the control group. The literature also depicts some impairments in decision making, somatic and cognitive emotions responses but the emotion recognition seems to be preserved.

A better understanding of the social and cognitive aspects of narcolepsy could lead to a better treatment of the disease in its entirety, including if relevant specific cognitive behavioural therapy.

The protocol consists in a psychometric evaluation including several questionnaires in order to assess social cognition. It will be proposed to patients with type 1 or type 2 narcolepsy and patients with idiopathic hypersomnia.


Eligibility criteria: Inclusion Criteria:

* adult patients (\>/= 18years old)
* diagnosis of type 1 or type 2 narcolepsy or idiopathic hypersomnia
* non opposition

Exclusion Criteria:

* comorbid psychiatric or neurologic disease
* patient under 18 years old
* patient under guardianship, curators or deprived of liberty, refusal of the patient

Primary outcomes:
measure: Mean SART score in the three groups
timeFrame: 2 years
measure: Mean IGT score in the three groups
timeFrame: 2 years
measure: Mean UPPS score in the three groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT01375972: Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma
Official title: Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Biliary Cancer
Keywords: biliary cancer
systemic chemotherapy
S-1
gemcitabine
cisplatin
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 92
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: To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.


Eligibility criteria: Inclusion Criteria:

1. Pathologically proven biliary adenocarinoma
2. Age \> 18
3. Evaluable disease
4. ECOG performance status of 2 or better
5. No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
6. Adequate bone marrow function A. WBCs \> 4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL B. Hemoglobin \>9.0 g/dL C. Platelets \> 100,000/µL
7. Adequate kidney function (creatinine\<1.5 mg/dL)
8. Adequate liver function (bilirubin\<1.5 mg/dL \[\< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction\], transaminases levels\<3 times the upper normal limit, and serum albumin of \>2.5 mg/dL)
9. No serious medical or psychological condition that would preclude study treatment
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

1. Other tumor type than adenocarcinoma
2. Evidence of GI bleeding or GI obstruction
3. Presence or history of CNS metastasis
4. Pregnancy or breastfeeding
5. Other serious illness or medical conditions
6. Axial skeletal radiotherapy within 6 months
7. Neuropathy grade 2 or worse

Primary outcomes:
measure: Progression-free survival rate at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Response rate
timeFrame: 6 months
measure: Toxicities
timeFrame: Up to 24 months
measure: overall survival
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: MJ Kang, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park DH, Lee SS, Seo DW, Lee SK, Kim MH. Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma. Acta Oncol. 2012 Sep;51(7):860-6. doi: 10.3109/0284186X.2012.682628. Epub 2012 May 6.
Clinical trial NCT04360772: Monitoring of Corticosteroids Induced Immunosuppression Using Monocyte Human Leukocyte Antigen-DR (mHLA-DR).
Official title: Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Immunosuppression
Keywords: any pathology
corticosteroids therapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient Diagnosed With Any Pathology Indicating a Treatment by Corticotherapy

Brief summary: Corticotherapy is widely used in auto-immune diseases. If induced immunosuppression by corticosteroids is well admitted, it's currently not possible to determine individual risk of infection. Thus, the development of new biomarkers able to reflect immunological status under immunosuppressive treatments is needed. It would help identifying patients who would benefit from adapted treatment protocols or infectious prophylaxis. In this field, the mHLA-DR (monocyte Human Leukocyte Antigen-DR) has shown encouraging results. However, it has never been used in patients treated by immunosuppressive therapies. The investigators aim to describe changes induced by corticosteroids in mHLA-DR expression in vivo. To achieve this goal, the investigators will measure mHLA-DR before treatment, after 1 months, 3 months and 6 months of treatment. Finally, the investigators will look for correlation between the level of expression of mHLA-DR and the cumulated dose of corticosteroids administered.


Eligibility criteria: Inclusion Criteria:

* Patient aged of 18 years old or more, male or female.
* Patient diagnosed with any pathology indicating a treatment by corticotherapy at 1mg/kg/day.
* Patient who didn't express any opposition to be enrolled in the study after reading the dedicated information letter.
* Patient affiliated to social heath care regimen

Exclusion Criteria:

* Treatment by corticosteroids in the previous 6 months.

  * Immunsuppressive treatment (except for corticosteroids) in the previous 2 years.
  * Patient under judicial protection, guardianship or curators

Primary outcomes:
measure: Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses
timeFrame: Month 1, 3 and 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Service de Médecine Interne
name: ARNAUD HOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03199872: RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Official title: A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostatectomised cancer patients
Lead sponsor: RhoVac APS
Sponsor class: INDUSTRY
Collaborators: name: Dantrials Aps
First posted: 2017-06-27
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer


Eligibility criteria: Inclusion Criteria:

* Patients prostatectomised (PT) due to histologically verified adenocarcinoma of the prostate gland who currently are not being treated, or expected within the next 8 months to be treated, with any anti-cancer treatment.
* ECOG performance status 0 or 1.

Exclusion Criteria:

* Patient has been treated with Androgen Deprivation Therapy (ADT), or expected to receive such treatment within the next 8 months from enrolment.
* Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.

Primary outcomes:
measure: Proportions of Participants With Treatment-related Adverse Events
timeFrame: 8 month
Secondary outcomes:
measure: Immunological Response
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Dantrials Aps
name: Jesper Sonne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuhmacher J, Heidu S, Balchen T, Richardson JR, Schmeltz C, Sonne J, Schweiker J, Rammensee HG, Thor Straten P, Roder MA, Brasso K, Gouttefangeas C. Vaccination against RhoC induces long-lasting immune responses in patients with prostate cancer: results from a phase I/II clinical trial. J Immunother Cancer. 2020 Nov;8(2):e001157. doi: 10.1136/jitc-2020-001157.
Clinical trial NCT01540968: Nutrition and Physical Exercise Study
Official title: Influence of a Combined Intervention by Nutritional Support and Physical Exercise on Quality of Life in Cancer Out-patients Treated in Palliative Intention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Lung Cancer
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effect of a combined treatment of nutritional therapy and physical exercise in palliative cancer out-patients. The investigators hypothesize that this combined intervention consisting of an increased energy- and protein intake and physical exercise level improves quality of life (QoL), functional and clinical status.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed metastatic lung cancer or gastrointestinal cancer
* WHO performance status 0, 1 or 2
* Able to walk at least 100 meters independently without crutches or walking frame assessed by the treating physician on the basis of the patient's history and physical condition
* Receiving palliative treatment

Exclusion Criteria:

* Enteral and/or parenteral nutrition within 1 month previous to study participation
* History of ileus within one month
* Known brain metastases or symptomatic bone metastases
* Psychiatric disorder precluding understanding of information on trial related topics and giving informed consent.
* Any serious underlying medical condition which could impair the ability of the patient to participate in the trial

Primary outcomes:
measure: Quality of life
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Peter E. Ballmer, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06716268: Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students
Official title: Dynamics of Pelvic Floor Muscles With Different Phonation Patterns Among Female Students: An Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pelvic Floor Dyssynergia
Phonation Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty healthy female university students will participate in this study. They will be selected from faculty of physical therapy, Cairo University.

Brief summary: The purpose of the study is to know if there is relation between the dynamics of pelvic floor muscles and different phonation pattern.

Detailed description: Some pelvic floor physical therapists are beginning to experiment with using phonation and vocalization cues to elicit different pelvic floor movements . However, there is a significant gap in the literature about the coordination and movement between the pelvic floor and glottis during speech and phonation, and there is an urgent need to identify the voices accompanied by increasing pelvic floor tone and integrating them into pelvic floor strengthening programs and voices accompanied by lowering pelvic floor tone and integrating them into pelvic floor down-training programs. To date, there has been only one study describing pelvic floor displacement during vocalization tasks. So this study aims to investigate pelvic floor muscle displacement during respiratory and phonatory tasks using trans-abdominal ultrasound to assess respiratory and phonatory tasks that can relax or enhance pelvic floor tone and be integrated into clinical practice.

Eligibility criteria: Inclusion Criteria:

- 1. They should be virgin, healthy female physiotherapy students. 2. They have regular menstruation (3-8 days in duration, with 21-35 days in-between).

3. Their ages will range from 18 to 25 years old. 4. Their body mass index (BMI) will range from 18 to 24.9 Kg/m2. 5. Their waist- hip ratio will be less than (0.8).

Exclusion Criteria:

1. Any urological, gynecological, respiratory, or vocal disorders in the previous 12 weeks.
2. Pelvic floor dysfunction.
3. Professionally trained singers.

   -

Primary outcomes:
measure: Assessment of pelvic floor muscle displacement
timeFrame: 1 month
Secondary outcomes:
measure: Voice pitch classification
timeFrame: 1 month
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy Cairo university
Study officials:
affiliation: Ass. prof.
name: Doaa A Osman, PhD
role: STUDY_DIRECTOR
affiliation: professor
name: Amel M Yousef, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05478668: Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds
Official title: Predictors of Pain Chronicity in Patients With Gunshot and Mine-explosive Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain, Widespread
Keywords: Chronic pain, gunshot wounds, mine-explosive wounds
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 2215
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations.

A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.

Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.

Brief summary: 82.1% of patients with gunshot and mine-explosive wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Identifying predictors of pain chronicity in these patients may improve their treatment outcomes.

Detailed description: The study of predictors of pain chronicity in patients with gunshot and mine-explosive wounds requires in-depth study, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions have their own characteristics. Since pain becomes chronic in 82.1%, the data of our study will play an important role in preventing the chronicity of pain.

Eligibility criteria: Inclusion Criteria:

* the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

* absence of gunshot and mine-explosive injuries

Primary outcomes:
measure: visual analog scale
timeFrame: 1 year
measure: Didier Bouhassiraa DN4
timeFrame: 1 year
measure: The Hospital Anxiety and Depression Scale
timeFrame: 1 year
measure: Chaban Quality of Life Scale
timeFrame: 1 year
measure: Mississippi PTSD scale (military version)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University, Ministry of Health of Ukraine
Study officials:
References:
Clinical trial NCT03726268: Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Official title: Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Pain, Postoperative
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-10-31
Enrollment: 907
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this research is to improve perioperative pain treatment, decrease post-operative opioid consumption, diminish opioid related side effects, and reduce postop opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal overdose).

Detailed description: This protocol will test the innovative, paradigm-shifting hypothesis that anesthesia for outpatient surgery with long-duration opioids (methadone), compared with conventional short-duration opioids, achieves better analgesia, with similar or diminished side effects, may reduce development of chronic postsurgical pain, improves recovery, and importantly, decreases postoperative opioid consumption and could hence diminish take-home opioid prescribing and shrink the population reservoir of unused opioids available for diversion and misuse. Two cohorts will be studied, but analyzed separately. 1) Short-stay, anticipated next-day discharge surgery (compare short-duration vs long-duration opioid), 2) Same-day discharge surgery (compare short-duration vs long-duration opioid).

Eligibility criteria: Inclusion Criteria

* Age 18-65 years Undergoing general anesthesia and moderately painful ambulatory surgery with anticipated postop stay of \< 24 hours
* Signed, written, informed consent

Exclusion Criteria

* History of liver or kidney disease.
* Females who are pregnant or nursing.
* Chronic opioid use (e.g. preoperative daily use of methadone, fentanyl transdermal patches, or ≥ 3 oxycodone pills)

Primary outcomes:
measure: Total 30 day post-discharge home opioid use (number of tablets)
timeFrame: Approximately 30 days
Secondary outcomes:
measure: Total intraoperative non-methadone opioid administration
timeFrame: Approximately 12 hours
measure: Total PACU opioid administration
timeFrame: Approximately 2 hours
measure: Total hospital non-methadone opioid administration
timeFrame: Up to 72 hours
measure: Total 7d post-discharge home opioid use
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Evan Kharasch, MD
role: PRINCIPAL_INVESTIGATOR
References: