louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05088239: Deep Inferior Epigastric Artery Flap for Breast Reconstruction
Official title: Division of Plastic and Reconstruction Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Perforator Flap
Anti-Infectives Adverse Reaction
Infections
Keywords: Prophylatic antibiotics
DIEP flap
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 108
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study involved 108 patients who underwent immediate DIEP flap breast reconstruction after unilateral or bilateral mastectomy at the Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019.

Brief summary: Background: There is no consensus on the duration of prophylactic antibiotics for autologous breast reconstruction after mastectomy. We try to standardize prophylactic antibiotics use during breast reconstruction with deep inferior epigastric perforator flap following mastectomy.

Methods: This retrospective case series involved 108 patients who underwent immediate breast reconstruction with deep inferior epigastric perforator flap in Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019. Patients were divided into three groups based on prophylactic antibiotic duration: 1 day, 3 days and \>7 days for patients with drains Data were analyzed between January and April, 2021.


Eligibility criteria: Inclusion Criteria:

* This retrospective study involved 108 patients who underwent immediate DIEP flap breast reconstruction after unilateral or bilateral mastectomy at the Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019.

Exclusion Criteria:

* Age \< 20 years old.

Primary outcomes:
measure: surgical site infection (SSI)
timeFrame: Patients were then followed up in the outpatient department for 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chia-Yi City, Taiwan
name: Chien-Liang Fang, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06104839: Safety and Efficacy of Oral NXC-736 in Adult Participants with Moderate and Severe Alopecia Areata
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of NXC736 in Patients with Moderate and Severe Alopecia Areata
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: NEXTGEN Bioscience
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
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 evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).


Eligibility criteria: Inclusion Criteria:

* Men or women between ≥19 and ≤65 years of age at the time of informed consent
* Moderate and severe alopecia areata as assessed by a SALT score of 25% ≤ SALT \< 95% at Screening and Day 1/Baseline
* Current episode of hair loss for ≥6 months but \<8 years
* Stable disease condition (no significant growth of hair) in the last 6 months as assessed by the Investigator
* Willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study

Exclusion Criteria:

* Participants with the following medical history confirmed during screening:

  * ohter Types of alopecia other than alopecia areata (such as cicatricial/scarring alopecia \[including central centrifugal cicatricial alopecia\], traction alopecia, androgenic alopecia, telogen effluvium, etc.)
* Active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the SALT assessment
* Previous use of Janus kinase (JAK) inhibitor (oral or topical), including participation in clinical studies of JAK inhibitors

Primary outcomes:
measure: Change(%) in SALT score from baseline at Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital.
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
References:
Clinical trial NCT00620139: Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma
Official title: Proximal Molecular Effects of Concurrent Chemoradiotherapy on Head and Neck Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: head and neck squamous cell carcinoma
chemoradiotherapy
molecular effects
05-016
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 17
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: MSKCC clinics

Brief summary: This pilot study seeks to evaluate the feasibility of measuring the proximal effects of concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic target molecules in Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, this study proposes to evaluate the extent to which CRT induces the differential expression of components along two critical, and potentially interdependent, molecular pathways: the arachidonic acid and epidermal growth factor receptor (EGFR) signaling pathways.


Eligibility criteria: Inclusion Criteria:

* Untreated HNSCC (\> Stage I) amenable to transoral biopsy.
* Scheduled for concurrent CRT (Cisplatin or Carboplatin/5-FU based) as definitive primary treatment
* Older than 18 years of age.
* Understand and sign informed consent.

Exclusion Criteria:

* Any prior treatment of the index cancer (chemotherapy, immunotherapy, hormonal therapy or radiation therapy) or similar treatment of an unrelated malignancy within 6 weeks of enrollment into this study.
* Breast-feeding, pregnancy or of childbearing potential (including those women who are less than two years post menopausal) and unable to confirm adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) since last menses.
* History of chronic inflammatory disease (e.g. ulcerative colitis, Crohn's disease, rheumatoid arthritis or pancreatitis).
* Corticosteroid use within 6 weeks of enrollment, excluding topical nasal sprays.
* NSAID (including celecoxib) or aspirin (\> 81 mg/day) use within 1 week of enrollment.
* Investigational medication use within 6 weeks of enrollment or is scheduled to receive an investigational drug during the course of the study.

Primary outcomes:
measure: To evaluate the proximal effects of concurrent chemoradiotherapy (CRT) on the expression of potential therapeutic molecular targets along the arachidonic acid and epidermal growth factor receptor (EGFR) signaling pathways in HNSCC.
timeFrame: Conclusion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03174639: High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps
Official title: High Myopia Macular Hole and Retinal Detachment Accepted Internal Limiting Membrane Flip Packing and Free Flap Was the Internal Limiting Membrane (ILM Flap Was Double)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Myopia
Macular Holes
Retinal Detachment
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.

Detailed description: From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.

Eligibility criteria: Inclusion Criteria:

* Macular hole with retinal detachment in high myopia

Exclusion Criteria:

* History of trauma, peripheral retinal breaks

Primary outcomes:
measure: Closure of macular hole
timeFrame: 3 months
Secondary outcomes:
measure: Retinal reattachment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Chen SN, Yang CM. Double Internal Limiting Membrane Insertion for Macular Hole-Associated Retinal Detachment. J Ophthalmol. 2017;2017:3236516. doi: 10.1155/2017/3236516. Epub 2017 Jul 30.
Clinical trial NCT02818439: Anticipating and Tracking: Pack of Gerontological Assessment Embedded
Official title: Anticipating and Tracking: Pack of Gerontological Assessment Embedded
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Keywords: Old person
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 216
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: ARPEGE project fits within the general framework of maintaining functional autonomy in the frail elderly. The early identification of elderly people at risk of frailty is essential to be able to make corrective actions to maintain a quality of life desired by the person. ARPEGE offers tracking and monitoring based on a corpus mobile evaluation of frailty, that could be used in various environments (home, prevention center, office of the general practitioner, geriatric consultation), and manipulated intuitively by professionals not specialists.

This four-year project spearheaded by the University of technology of Troyes in partnership with the University of Reims Champagne-Ardenne also brings a set of partners and experts in the region and outside, so that the proposed solution has the qualities necessary for its deployment in terms of value diagnostic, use, acceptability and perfectly controlled ethics.

The Region has made "longevity aging" theme one of its priorities. This image of driver of innovation in this area can only be enhanced by a program like ARPEGE. Beyond the scientific and technological results expected, one can imagine the potential socio-economic benefits if this tracking solution is deployed on a large scale.


Eligibility criteria: Inclusion Criteria:

* 70 years or older
* GIR 4, 5 or 6
* Consenting to participate in the study

Exclusion Criteria:

* Severe cognitive impairment ( MMSE \< 10)
* Major neurosensory disorders
* Full hospitalization or not (acute care and rehabilitation..)
* Non- affiliation to a social security scheme
* Major protected by law (guardianship, trusteeship)
* Informed consent not provide

Primary outcomes:
measure: Duke Health Profile: Quality of life questionnaire
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT02810639: Pain Prevalence After Cesarean Section in Siriraj Hospital
Official title: Pain Prevalence After Cesarean Section in Siriraj Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: pain
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 297
Sex: FEMALE
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: Patients undergoing Cesarean section

Brief summary: Spinal morphine has been widely provided for acute postoperative analgesia. However, the analgesic effect of spinal morphine usually last 12-24 hours. Therefore the investigators are interested in the pain characteristics during the 2nd postoperative day. The investigators will also explore the regimens for pain therapy in our hospital.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing Cesarean section

Exclusion Criteria:

* History of drug addict

Primary outcomes:
measure: Number of patients who have moderate to severe pain after Cesarean section
timeFrame: 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sirilak Suksompong
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05950139: Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC
Official title: Pilot Study of a Prophylactic Peptide Vaccine in Advanced ALK+ NSCLC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: NSCLC Stage IV
ALK Fusion Protein Expression
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 12
Sex: ALL
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 purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)
2. Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS
3. Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months
4. No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6. Males or females at least 18 years old

Exclusion Criteria:

1. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.
2. Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine
3. Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine
4. Systemic immune suppression:

   1. Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)
   2. Other clinically relevant systemic immune suppression
5. Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted
6. Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed

Primary outcomes:
measure: Incidence of treatment-related adverse events
timeFrame: Up to 2 years
measure: Vaccine-specific immune response
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Vincent Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02533739: Vestibular Disorder and Visuo-spatial Functions
Official title: Impact Des déficits Vestibulaires Sur le développement Des Fonctions Visuo-spatiales.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Vertigo
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 94
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of these studies is to determine whether vestibular disorders could affect visuo-spatial cognition. Visuo-spatial cognition will be evaluated using a new questionnaire and a new computerized test using a digital tablet in different studies.


Eligibility criteria: For participants of the questionnaire study :

Participants with vertigo complaints versus participants without vertigo complaints.

For patients of the behavioural study :

Inclusion Criteria:

* Vestibular disorder (with or without vertigo)
* Deafness / hard of hearing

Exclusion Criteria:

* Neurological or psychiatric conditions
* Cochlear Implant (for functional magnetic resonance imaging study)

Primary outcomes:
measure: Vestibular questionnaire (Newly developed to evaluate cognitive abilities)
timeFrame: Within one week after recruitment
measure: Standard computerized cognitive assessment (For example : Test of attentional performance, digit span, visuo-spatial span, line bisection task,...)
timeFrame: Within one week after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc-UCL
Study officials:
affiliation: Cliniques universitaires Saint-Luc-UCL
name: Naïma Deggouj
role: STUDY_DIRECTOR
References:
Clinical trial NCT00716339: Pseudophakic Accommodation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: pseudophakic accommodation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose:

The aim of this study was to compare the effect of ciliary body training as proposed by manufacturers of accommodating IOLs and patient motivation on the pseudoaccommodative ability with a standard intraocular lens (SA60AT).

Setting:

Department of Ophthalmology, Medical University of Vienna.

Methods:

This randomized, controlled, examiner-masked study comprised 80 eyes of 40 patients that underwent standard cataract surgery. Patients were randomly assigned to a "motivated" or "non-motivated" (control) group. In the motivated group, subjects were told to take part in a special protocol to improve their near-reading ability after cataract surgery and were instructed not to use near adds for at least 3 months. Follow-up examinations included best-corrected distance visual acuity (VA), distance-corrected near VA, best-corrected near VA, defocus curve and reading speed, as well as pilocarpine-, cyclopentolate- and nearpoint-induced IOL shift assessed with partial coherence interferometry.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from age-related cataract who are enrolled for cataract surgery.
* Age 50 to 75 years
* \< 1 D of corneal astigmatism, estimated postoperative VA of 20/30 or better and IOL power between 16 and 27 dpt

Exclusion Criteria:

* Patients with complications during cataract surgery or during the postoperative period, significant other ophthalmic diseases such as glaucoma, diabetic retinopathy, etc., or ophthalmic surgery other than cataract surgery

Primary outcomes:
measure: visual acuity (best-corrected distance VA, distance-corrected near VA, best-corrected near VA)
Secondary outcomes:
measure: IOL shift (pilocarpine-, cyclopentolate- and nearpoint-induced) assessed with partial coherence interferometry
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT06215339: Diet Therapy in Hemodialysis Patients
Official title: The Effect of Hemodialysis Patients' Attitudes Towards Diet Therapy on Dialysis Symptoms: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemolysis
Diet
Symptoms and Signs
Healthy
Keywords: Hemolysis
Diet
Healthy
Symptoms and Signs
Lead sponsor: Gümüşhane Universıty
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: using G\*Power 3.1.9.2. The sample size was deemed sufficient (experiment=30; control=30), and the study was concluded. Participants were selected using a lottery method, and data were collected through a singleblind randomization process.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms.

Detailed description: Diet therapy is a part of the treatment of hemodialysis patients. In order for the treatment to be effective, it is necessary to comply with the diet. Non-compliance with diet treatment affects the symptoms experienced by the patient, resulting in morbidity, low quality of life and mortality. Knowing patients' compliance with diet therapy is important in ensuring symptom control. The aim of this study is to determine the effect of diet therapy on symptom management in hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

Being ≥18 years old,

* Agreeing to participate in the research,
* Being literate,
* Being able to communicate verbally,
* Receiving outpatient HD treatment three sessions a week at the same institution,
* No impairment in mental and cognitive functions,
* Has been receiving HD treatment for at least three months (to be defined as a chronic HD program)

Exclusion Criteria:

* Refusal to participate in the research,
* Being on peritoneal dialysis,
* Being diagnosed with a psychiatric disorder diagnosed by a psychiatrist,
* The general condition (hemodynamically) is unstable (heart rate \< 100 mm/Hg or diastolic BP\< 60 mm/Hg),

Primary outcomes:
measure: Hemodialysis Patients' Attitude Scale Towards Diet Therapy (HDTO)"
timeFrame: 4 week
Secondary outcomes:
measure: "Dialysis Symptom Index (DSI)"
timeFrame: 4 week
Other outcomes:
Locations:
city: Gümüşhane
country: Turkey
facility: Gümüşhane Üniversitesi
state: Kelkit
Study officials:
affiliation: Gümüşhane Universıty
name: Dilan aktepe coşar, lecture
role: PRINCIPAL_INVESTIGATOR
References: