louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06742541: ICL and LASIK for Hyperopic Astigmatism
Official title: Spherical Implantable Collamer Lens With Postoperative Adjunctive LASIK in the Treatment of High Compound Hyperopic Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Astigmatism
Hyperopia
Keywords: ICL
LASIK
Hyperopia
Astigmatism
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 32
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: This study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. The first step involves implanting a specially designed lens inside the eye (a spherical Implantable Collamer Lens, or ICL) to improve vision. Later, a laser procedure (LASIK) is performed to fine-tune the results for even better clarity.

Detailed description: To assess refractive and visual outcomes of a spherical Implantable Collamer Lens (ICL) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (LASIK) in the treatment of high compound hyperopic astigmatism. In this prospective, multi-center, multi-surgeon, single-arm study, eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism underwent surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively. Outcomes measures included postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, spherical (SEQ) and defocus equivalent (DEQ), efficacy index, safety index, and astigmatism vector analyses.

Eligibility criteria: Inclusion Criteria:

* Preoperative hyperopic sphere of ≥+3.50 D
* Astigmatism of ≥+2.00 D
* Stable refraction for the previous 12 months
* Age older or equal to 18 years
* Anterior chamber depth (ACD) from corneal endothelium to anterior lens capsule of 3.0 mm or greater

Exclusion Criteria:

* Age younger than 18 years
* Patients lost to follow-up
* Cataract formation
* History of glaucoma or retinal detachment
* Macular degeneration
* Diabetic retinopathy
* History of ocular inflammation
* Signifcant irregular corneal topography
* Evidence of inconsistent imaging from dry eyes

Primary outcomes:
measure: Post-operative visual acuitiy
timeFrame: 90 days after lasik surgery
Secondary outcomes:
measure: Manifest refraction
timeFrame: 90 days after lasik surgery
measure: Spherical (SEQ) and defocus equivalent (DEQ)
timeFrame: 90 days after LASIK surgery
measure: Efficacy Index and Safety Index
timeFrame: 90 days after LASIK surgery
measure: Astigmatism Vector Analysis
timeFrame: 90 days after LASIK surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Vision Group Canada
Study officials:
affiliation: McGill University
name: Avi Wallerstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06286241: Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room
Official title: Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Myeloma
Keywords: multiple myeloma
autologous stem cell transplantation
HEPA-filtered room
non-HEPA-filtered room
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: multiple myeloma patients who received autologous stem cell transplantation

Brief summary: The goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in HEPA-filtered room and non-HEPA-filtered room. The main questions it aims to answer are:

* The incidence of febrile neutropenia, infection, and duration of hospital stay
* 2-year progression free survival Participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record.


Eligibility criteria: Inclusion Criteria:

* aged 18 - 65 years old
* Patients with multiple myeloma undergoing treatment with autologous stem cell transplantation and having a Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score less than or equal to 2
* Patients must provide signed consent to participate in the research if they undergo ASCT after the study has been approved.
* If patients undergo ASCT before the study approval, retrospective data will be collected.

Exclusion Criteria:

* Patients with concomitant other types of cancer
* Patients who refuse to participate in the study.

Primary outcomes:
measure: febrile neutropenia
timeFrame: during admission
measure: Infection
timeFrame: during admission
measure: duration of admission
timeFrame: during admission
measure: progression free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02648841: A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: gastric cancer
adjuvant chemo-radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2016-01-07
Enrollment: 588
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Gastric cancer;
* D2 and R0 resection;
* Pathologically confirmed stage anyT, N+, M0 (AJCC Cancer Staging);
* Karnofsky performance score (KPS) \>= 70 or Eastern Cooperative Oncology Group(ECOG) score 0-1;
* Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）
* No allergic history of 5-Fu or Platinum drugs;
* No history of chemotherapy or other anti-cancer therapy;
* Informed consent should be signed.

Exclusion Criteria:

* GEJ adenocarcinoma
* Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
* Allergic to Fluorouracil or Platinum drugs;
* Concurrent uncontrolled medical condition;
* Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
* Severe postoperative complications such as anastomotic leakage, etc.;
* Symptoms or history of peripheral neuropathy.

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Local recurrence free survival
timeFrame: 3 years
measure: Distant metastasis free survival
timeFrame: 3 years
measure: Over all survival
timeFrame: 3 years
measure: Adverse Event
timeFrame: 3 years
Other outcomes:
Locations:
city: Bejing
country: China
facility: Cancer Hospital, Chinese academy of medical sciences
state: Beijing
Study officials:
References:
Clinical trial NCT04763941: Clinical Dementia Rating Medical Record
Official title: Reliability of the Clinical Dementia Rating Scale From the Medical Record in Comparison With the Reference Method.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinical Dementia Rating (CDR) From the Analysis of Medical Record
Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient
Keywords: CDR
memory consultation
patient's file
reliability
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 144
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted on the basis of the patient consulting in Memory Consultation, specifically with the information already collected in normal care and the MEMORA cohort.

Brief summary: The assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. However, the systematic assessment of the Clinical Dementia Rating (CDR) scale is limited due to the time required to complete it (approximately 45 min to 1 hour). Insofar as studies have shown correspondences between the CDR and scales measuring cognitive and neuropsychological performance, and as part of memory consultations, several functional and neuropsychological scales are systematically administered, we wish to conduct a study validating the feasibility of the CDR based on information already available in the patient's file compared to the evaluation of the CDR by the usual method (face-to-face interview in consultation).

This study should highlight the feasibility of scoring the CDR-SB from the files of patients in memory consultation, first in terms of reliability of the scores obtained compared to the standard evaluation, and on the other hand in terms of organization and duration of administration.


Eligibility criteria: Inclusion Criteria:

* Patient who has CDR assessment in face-to-face interview during the memory consultation,
* Patient with an isolated cognitive complaint or a neurocognitive disorder
* Patient included in the MEMORA cohort

Exclusion Criteria:

* Patient or caregiver who does not wish their data to be used for research purposes within the framework of the MEMORA cohort.

Primary outcomes:
measure: CDR Sum of boxes (CDR-SB) score out of 18
timeFrame: The CDR-SB score is collected at the baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Hôpital Des Charpennes
Study officials:
affiliation: Hôpital des Charpennes
name: Anthony Bathsavanis, Psy D
role: STUDY_DIRECTOR
affiliation: Hopital Edouard Herriot
name: Pierre Krolak-Salmon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05143541: Use of a New Stapling Device in General Thoracic Surgery
Official title: Use of a New Stapling Device in General Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Cancer
Lead sponsor: Lexington Medical Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 subjects meeting inclusion criteria

Brief summary: The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.

Detailed description: A prospective study was conducted with 80 consecutive thoracic cases. Stapler usage data, intraoperative outcomes, and 30-day post-operative outcomes were evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing planned VATS or open lung resection surgery (lobectomy or wedge resection)

Exclusion Criteria:

* Active bacterial or fungal infection
* Prior history of VATS or open lung surgery
* Use of staple line reinforcement material (buttress)
* Patients under the age of 18 on the date of the surgery
* Any female patient who is pregnant
* Scheduled concurrent surgical procedure other than lobectomy or wedge resection (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)

Primary outcomes:
measure: Number of Participants With Product Malfunction
timeFrame: Within surgery, up to 8 hours
measure: Number of Participants With Intraoperative Staple Line Bleeding
timeFrame: Within surgery, up to 8 hours
measure: Number of Participants With Reported Device-related Adverse Events
timeFrame: Within 30-day post-operative period
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Following hospital admission, up to discharge
measure: Chest Tube Removal
timeFrame: Following surgery, up to chest tube removal
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
References:
Clinical trial NCT02668341: Cross Sectional Analysis of Healthcare for Psoriasis in 4 European Countries
Official title: PsoBarrierEU - Barrier Analysis of Guideline-Compliant Healthcare for Psoriasis in Europe
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Sandoz
First posted: 2016-01-29
Enrollment: 1304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with diagnosed psoriasis vulgaris

Brief summary: Analysis of barriers in psoriasis care from the patient's and the physician's perspective and generation of scientific data on the quality of health care in Denmark, Poland, Spain, and Germany

Detailed description: Cross-sectional, non-interventional study on healthcare for psoriasis in patients and their treating physicians. Clinical data on severity as well as subjective estimates on disease burden, quality of life etc. will be collected. Data collection is planned at multiple, representative sites in fourEuropean countries with different healthcare systems with the aim to identify system-dependent and -independent barriers in guideline-compliant psoriasis care.

Eligibility criteria: Inclusion Criteria:

* clinically diagnosed psoriasis vulgaris
* age ≥ 18
* written informed consent

Exclusion Criteria:

* lack of mental, physical or linguistic ability to participate in a questionnaire survey

Primary outcomes:
measure: Percentage of patients with severe disease receiving systemic treatment
timeFrame: Baseline
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline
measure: Body Surface Area (BSA)
timeFrame: Baseline
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline
measure: EuroQuol (EQ-5D)
timeFrame: Baseline
measure: Percentage of patients with comorbidities receiving treatment.
timeFrame: Baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Hamburg
country: Germany
facility: Nationwide group of dermatological centers, hospitals and medical offices
city: Poznan
country: Poland
facility: Medical University of Poznan
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany
name: Matthias Augustin, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01916941: Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 36
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 study uses neurobiological measures through brain imaging, neuropsychological measures, and selfreport measures to try to understand how an effective treatment for alcoholism works. On the whole, less than 50% of people with alcoholism get better with treatment. This study will help researchers develop better treatments for alcoholism because if the investigators know why the treatments the investigators use are working, and in whom the treatments work best, then the investigators may be able to make treatment more effective by targeting treatments to individuals who would be most likely to benefit and by guiding development of more effective treatments in the future.


Eligibility criteria: Inclusion Criteria:

1. Males and females age 18-65 meeting DSM-IV criteria for alcohol dependence in the past year;
2. seeking but not currently receiving treatment;
3. able to provide voluntary informed consent;
4. have at least 4 drinking days in the past 30 days
5. english-speaking
6. have a primary care physician or psychiatrist willing to continue prazosin if the patient tolerates it well and is finding it beneficial.

Exclusion Criteria:

1. severe neurological (e.g., head injury/stroke) conditions, Meniere's disease, narcolepsy, benign positional vertigo, heart disease or unstable angina, history of dysrhythmia/syncope, SBP\<110, SBP\>160, DBP\>110, HR\<55, HR\>110, irregular heart rhythm, chronic renal or hepatic failure, pancreatitis or insulin-dependent diabetes, or other medical problems requiring immediate attention;
2. schizophrenia, schizoaffective disorder, PTSD, Bipolar I disorder, suicidal thoughts within the last month;
3. current dependence on another drug of abuse (except nicotine);
4. contraindications to MRI (e.g., pacemaker);
5. active legal problems with the potential to result in incarceration;
6. pregnancy or lactation, or child bearing age and not on birth control;
7. currently receiving treatment for alcohol dependence;
8. current use of psychoactive medications including SSRI's and other antidepressants, anti-craving medications, anxiolytics including benzodiazepines, antipsychotics, mood stabilizers or anticonvulsants;
9. history of seizures or DT's during alcohol withdrawal.

Primary outcomes:
measure: Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)
timeFrame: from 2-4 weeks and from 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico, Department of Psychiatry
state: New Mexico
Study officials:
References:
Clinical trial NCT04201041: Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia
Official title: Trans-gluteal Versus Trans-vaginal Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superficial Dyspareunia
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal approaches regarding patient comfort and satisfaction.


Eligibility criteria: Inclusion Criteria:

* women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up

Exclusion Criteria:

* We had excluded women with any abnormality in the transvaginal US guided imagining, or those with any evidence of local gynecological abnormalities on examination. Meanwhile, we had excluded those women with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in the targeted region, those with history of chronic opioid use and women who refused to participate in the study

Primary outcomes:
measure: change in Numerical rating scale
timeFrame: baseline reading -1 day reading-3 days postoperative reading
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Study officials:
affiliation: South Egypt Cancer Institute
name: Alaa Elzohry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02984241: E-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem
Official title: EHealth Coping Skills Training for Women Whose Partner Has a Drinking Problem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: University of Oregon
First posted: 2016-12-06
Enrollment: 456
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner


Eligibility criteria: Inclusion Criteria:

* Resides in New York State
* Fluent in English
* Male partner has an alcohol problem
* Computer access and smart phone
* Married or cohabiting

Exclusion Criteria:

* Substance use disorder
* Serious Mental Disorder
* Participation in prior studies
* Severe relationship violence

Primary outcomes:
measure: Beck Depression Inventory-II (BDI-II) Total Score
timeFrame: Change in BDI score up to 12 months postintervention
measure: State-Trait Anger Expression Inventory - 2 (STAXI-2, State Anger)
timeFrame: Change in STAXI score up to 12 months postintervention
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Clinical and Research Institute on Addiction
state: New York
Study officials:
affiliation: University at Buffalo, Research Institute on Addictions
name: Robert G Rychtarik, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon, Prevention Science Institute
name: Brian G. Danaher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: