louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01740999: Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint
Official title: Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Finger Joint
Arthroplasty
Replacement
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.

The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.


Eligibility criteria: Inclusion Criteria:

* primary osteoarthritis in the distal interphalangeal joint
* require surgical treatment
* patient aged 18 years and over
* signed written informed consent

Exclusion Criteria:

* posttraumatic osteoarthritis
* rheumatoid disease
* pregnant woman
* any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* legal incompetence
* no knowledge of German

Primary outcomes:
measure: Michigan Hand Questionnaire (MHQ)
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Change of Michigan Hand Questionnaire Score
timeFrame: preoperative, 3mo/6mo/36mo postoperative
Other outcomes:
measure: Change of objective clinical parameters
timeFrame: preoperative, 3mo/6mo/12mo/36mo postoperative
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References:
Clinical trial NCT02747199: ENdothelial Healing Assessment With Novel Coronary tEchnology
Official title: Comparison Between SYNERGY™ vs. Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - ENdothelial Healing Assessment With Novel Coronary tEchnology)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: SYNERGY
Neointimal formation
OCT
coronary angioscopy
coronary artery disease
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Kurume University
First posted: 2016-04-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS

Detailed description: All of the subject will received SYNERGY™ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.

Eligibility criteria: Inclusion Criteria:

1. Subject is 20 years old or older
2. Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI
4. Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries.
5. Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation.
6. Subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure

Exclusion Criteria:

1. Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure
2. Subject has known left ventricular ejection fraction (LVEF) \< 30%
3. Subject is receiving hemodialysis
4. Target vessel were treated by PCI within 12 months
5. Target lesion is located within a saphenous vein graft or an arterial graft
6. Target lesion is located in ostium
7. Target lesion is located highly tortuous equal to or greater than 60 degrees
8. Target lesion with TIMI flow 0 (total occlusion)

Primary outcomes:
measure: Apposition and neointimal coverage on the stent and scaffold strut
timeFrame: 4 months
Secondary outcomes:
measure: Apposition and neointimal coverage on the stent and scaffold strut
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University Malaya Medical Center
name: Wan Azman Wan Ahmad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03941899: The Analgesic Effect of QLB II After Robotic Prostatectomy. (QLB II: Quadratus Lomborum Block II Type)
Official title: The Analgesic Effect of Qudratus Lomborum Block II Type After Robotic-Assisted Laparoscopic Radical Prostatectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Pain, radical prostatectomy, QLB II type
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Simon's Two-Stage single arm study
Primary purpose: TREATMENT

Brief summary: The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic radical prostatectomy, will be assessed.

Detailed description: Quadratus Lomborum Block II type will be performed before performing robotic-assisted laparoscopic radical prostatectomy.

The post-operative analgesic effect will be assessed, by using Numeric Rate Scale for pain.

The pain assessment will be evaluated during the first 24 hours from surgery. The opioids requirement and side effects will be also assessed.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist status I-III
* Written informed consent

Exclusion Criteria:

* Body mass Index \> 35 kg/m2
* Allergies to local anesthetics
* primaries or secondaries coagulopathies
* addiction to drugs
* severe kidney and liver diseases
* cognitive impairment

Primary outcomes:
measure: Analgesia
timeFrame: The first 24 hours from surgery
Secondary outcomes:
measure: Opioids
timeFrame: The first 24 hours from surgery
measure: Postoperative Nausea and Vomiting
timeFrame: The first 24 hours from surgery
measure: Bowel function
timeFrame: The first 24 hours from surgery
measure: Length of stay
timeFrame: Day after surgery
Other outcomes:
Locations:
city: Coppito
country: Italy
facility: San Salvatore Academic Hospital
state: L'Aquila
Study officials:
affiliation: San Salvatore Academic Hospital
name: Franco Marinangeli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04246099: Opioid-free Anesthesia in Thoracic Surgery
Official title: Effect of Opioid-free Anesthesia on Perioperative Period After Video-assisted Thoracoscopic Lobectomy: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic
Surgery
Keywords: Post-operative pain
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy in Department of Anesthesiology and Intensive Care at Louis Pradel University Hospital.

If patient benefit of the OFA protocol, he was part of the group OFA (opioid free anesthesia) If patient don't benefit of the OFA protocol, he was part of the group OBA (opioid based anesthesia)

Brief summary: No study has been conducted to demonstrate the feasibility and safety of an Opioid-Free Anesthesia (OFA) protocol compared to Opioid-Based Anesthesia (OBA) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. The aim of the present study was to evaluate the effect of OFA on post-operative opioids consumption, pain and the post-operative period after lobectomy by Video-Assisted Thoracoscopy Surgery (VATS). systems.

Investigators perform a retrospective, single-center study in 2019. Patients were divided into two groups: OFA (with dexmedetomidine) or OBA (sufentanyl).

Investigators analyse the total postoperative opioid consumption in the 48 h after surgery. Investigators asses pain intensity in the 48 h after surgery, operative hemodynamic stability, Post-Operative Pain (POP) in Post-Anesthesia Care Unit (PACU) and POP on day 30.

All data are available in the medical record

Hypothesis: OFA can reduce post-operative opioids consumption, pain in lobectomy by video-assisted thoracoscopy surgery (VATS).


Eligibility criteria: Inclusion Criteria:

* All consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy
* Opioid Free Anesthesia (OFA) administration was left to the discretion of the attending anesthetist according to his or her practices and habits.
* age 18 or over
* lobectomy or wedge resection by Video-Assisted Thoracoscopy Surgery (VATS)

Exclusion Criteria:

* toxicomania,
* epidural analgesia use,
* thoracotomy conversion
* Patient-Controlled Analgesia with morphine (PCA)
* Patient who object to take part of the study.

Primary outcomes:
measure: Cumulative dose of postoperative opioid
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Department of Anesthesiology and Intensive Care - Louis Pradel University Hospital - Hospices Civils, Lyon, France
Study officials:
References:
Clinical trial NCT03832699: Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer
Official title: Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer: a Non-inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ART
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current trial is intended to assess the efficacy of oral versus vaginal progesterone for luteal support in frozen IVF cycles.

Detailed description: Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF. Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone in frozen IVF cycles.

Eligibility criteria: Inclusion Criteria:

* Ages 18-39
* Modified natural cycle (induction of ovulation with HCG)
* Consent to participation

Exclusion Criteria:

* None

Primary outcomes:
measure: Live birth rate
timeFrame: Up to 9 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: Outcome assesed 6-7 weeks following treatment
measure: Implantation rate
timeFrame: Outcome assessed 6-7 weeks following treatment
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Edith Wolfson Medical Center
name: Hadas Ganer Herman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209299: Biomarkers in Predicting Response to Chemotherapy in Patients With Advanced or Metastatic Melanoma Previously Treated With Carboplatin and Paclitaxel With or Without Sorafenib Tosylate
Official title: Integrated Molecular Signature for the Prediction of Response to Carboplatin/Paclitaxel-Based Chemotherapy in Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage IIIC melanoma
stage IV melanoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E2603 from whom samples were submitted for research

Brief summary: RATIONALE: Studying samples of tissue in the laboratory from patients receiving carboplatin and paclitaxel with or without sorafenib tosylate may help doctors learn more about the effects of this treatment on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy in patients with advanced or metastatic melanoma previously treated with carboplatin and paclitaxel with or without sorafenib tosylate.

Detailed description: OBJECTIVES:

* To independently correlate the gene expression and promoter methylation profiles to chemotherapy response in patients with advanced or metastatic melanoma treated with carboplatin and paclitaxel with versus without sorafenib on clinical trial ECOG-E2603.
* To develop a predictive model of chemotherapy response utilizing integrated analysis of gene expression and promoter methylation data.
* To evaluate whether the NER pathway haplotypes are associated with platinum drug resistance and survival.

OUTLINE: This is a multicenter study.

Archived paraffin-embedded tissue samples are analyzed for gene expression and promoter methylation profiles, and genes involved in the NER pathway.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of melanoma

  * Unresectable locally advanced or stage IV disease
* Received carboplatin and paclitaxel with versus without sorafenib on clinical trial ECOG-E2603
* Archived paraffin-embedded tissue samples

  * Responder (complete or partial response, or stable disease) and non-responder (disease progression or unavailable)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation between gene expression and promoter methylation profiles to chemotherapy response
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Hussein A. Tawbi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02146599: Patient Perception of Visual Quality and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 301
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bilaterally-implanted pseudophakic subjects over 22 years of age who meet the inclusion criteria.

Brief summary: The purpose of this study is to evaluate the visual quality and function of pseudophakic patients.


Eligibility criteria: Inclusion Criteria:

* Minimum 22 years of age
* Pseudophakic patients who have been bilaterally implanted with the same type of intraocular lenses in both eyes
* Ability to understand, read and write English to give consent and complete the study questionnaires
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
* Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Other protocol-defined inclusion criteria might apply

Exclusion Criteria:

* Any ocular pathology of clinical significance, as determined by the investigator, that may affect visual outcomes or influence subjective ocular/visual symptoms
* Patient is pregnant or is lactating
* Concurrent participation or participation within 30 days prior in any other clinical trial
* Other protocol-defined exclusion criteria might apply

Primary outcomes:
measure: Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery
timeFrame: Baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Daniel Chang, M.D.
state: California
Study officials:
References:
Clinical trial NCT03506399: A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive
Official title: Effect of Lanabecestat on the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2018-04-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 days prior to first dose.


Eligibility criteria: Inclusion Criteria:

* Are healthy female participants
* Women not of childbearing potential; women of childbearing potential using a non-hormonal intrauterine device (IUD)
* Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square (kg/m²)

Exclusion Criteria:

* Have a history of or current significant ophthalmic disease, which includes participants with clinically significant eye abnormalities, particularly any eye problem involving the retina, as determined by the investigator
* Have vitiligo or any other clinically significant disorder of skin or hair pigmentation, as determined by the investigator
* Have a history of or current neuropsychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state, or personality disorder

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under The Concentration Curve (AUC) of Ethinyl Estradiol
timeFrame: Baseline though 120 hours after administration of the study drug (lanabecestat)
measure: PK: AUC of Levonorgestrel
timeFrame: Baseline though 120 hours after administration of the study drug (lanabecestat)
measure: PK: Maximum Observed Concentration (Cmax) of Ethinyl Estradiol
timeFrame: Baseline though 120 hours after administration of the study drug (lanabecestat)
measure: PK: Cmax of Levonorgestrel
timeFrame: Baseline though 120 hours after administration of the study drug (lanabecestat)
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01614899: A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Official title: Randomized, Double-blind, Parallel- Group, Placebo-controlled, Confirmatory Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patient meets DSM-IV-TR criteria for schizophrenia.
* Patient is aged 18 through 74 years at informed consent.
* Patient understands the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion Criteria:

* Patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus.
* Patient has Parkinson's disease.
* Patient has a history or complication of malignancy.

Primary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
timeFrame: Baseline and 6 week
Secondary outcomes:
measure: Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in PANSS Positive Subscale Scores at Week 6
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in PANSS Negative Subscale Scores at Week 6
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6
timeFrame: Baseline and 6 weeks
measure: Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline to 6 weeks
measure: Proportion of Participants With TEAEs Leading to Discontinuation
timeFrame: From Baseline to 6 weeks
measure: Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: From Baseline to 6 weeks
Other outcomes:
Locations:
city: Tokyo, Etc
country: Japan
facility: 69 Sites
city: Seoul, Etc
country: Korea, Republic of
facility: 22 Sites
city: Kuala Lumpur, Etc
country: Malaysia
facility: 10 Sites
city: Taipei, Etc
country: Taiwan
facility: 14 Sites
Study officials:
affiliation: Sumitomo Pharma Co., Ltd.
name: Clinical Development Drug development Division
role: STUDY_DIRECTOR
References: