louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01108393: Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
Official title: Efficacy of Agomelatine 25mg/Day (With Possible Increase to 50mg/Day After 8 Weeks of Treatment) Given Orally During 16 Weeks in Patients With Obsessive-Compulsive Disorder. A Randomised, Double-blind, Placebo-controlled, Parallel Groups, International Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
Agomelatine
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 74
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 will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR),
* Y-BOCS total score ≥ 20,
* duration of OCD symptoms of at least one year.

Exclusion Criteria:

* Bipolar disorder, Schizophrenic or Psychotic Disorder
* Severe or uncontrolled organic diseases
* Neurological disorder
* Women of childbearing potential who are not using effective contraception

Primary outcomes:
measure: Y-BOCS total score
timeFrame: 16 weeks
Secondary outcomes:
measure: NIMH-OC score
timeFrame: 16 weeks
measure: MADRS total score
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Department of Psychiatry Chaim Sheba Medical Center
Study officials:
affiliation: Department of Psychiatry Chaim Sheba Medical Center
name: Joseph Zohar, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935493: Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Official title: Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aging
Keywords: guanfacine
aging
cognitive aging
prefrontal cognitive function
executive function
prefrontal cortex
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2009-07-09
Enrollment: 154
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposal aims to determine whether low does of the alpha-2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated cognitive functions in healthy elderly subjects.

Detailed description: Primary:

* To determine whether low does of the α2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated working memory and executive control functions, in healthy elderly subjects. Subjects will be randomly assigned to receive placebo or guanfacine at one of two dose levels: 0.1 mg, or 0.5 mg daily at bedtime in double-blind fashion for twelve weeks.

Secondary:

* To determine whether guanfacine can favorably influence global status and quality of life (QOL) in healthy elderly subjects.
* To determine whether low-dose guanfacine is safe and well-tolerated in healthy elderly subjects.

Eligibility criteria: Inclusion Criteria:

Subjects enrolled will be nondemented, male and female individuals who meet the following inclusion criteria:

* 75 years of age or older
* Fluent in English
* Stable medical condition for at least 4 weeks prior to Screening visit
* Stable dose of non-excluded medications for at least 4 weeks prior to Screening visit

Exclusion Criteria:

* Dementia
* Mild Cognitive Impairment (Amnestic MCI)
* Clinically significant neurologic disease
* Clinically significant or unstable medical conditions that would interfere with participation in the trial
* Known hypersensitivity to guanfacine
* History of alcohol or substance abuse or dependence within the past 5 years
* Active major psychiatric disorders, including major depression
* History of mental retardation
* Significant abnormalities on clinical laboratories, ECG, or physical examination
* Impairment of visual or auditory acuity sufficient to interfere with completion of study procedures
* Education level \< 6 years

Primary outcomes:
measure: Mean in the Prefrontal Executive Function Z-score (PEF6_6)
timeFrame: 12 weeks
Secondary outcomes:
measure: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
timeFrame: 12 weeks
measure: Quality of Life (SF-36 MCS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Alzheimer's Disease Research Unit, Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Christopher H van Dyck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05121493: Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye
Official title: Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single center double-masked study with up to four visits. Subjects who have been diagnosed with dry-eye syndrome at Flaum Eye Institute will be enrolled. The purpose of the study is to determine if using platelet rich plasma drops can improve clinically significant dry eye in patients and determine if there is a difference with using two different uses of the plasma tear drops: platelet rich plasma tears and plasma tears without platelets.


Eligibility criteria: Inclusion Criteria:

* Subjects must be diagnosed with clinically significant dry eye.
* Subjects have no active ocular disease or allergic conjunctivitis.
* Subjects must not be using any topical ocular medications within two weeks prior to enrollment.
* Subjects must be willing and able to follow instructions.
* Subjects must have voluntarily agreed to participate in the study by signing the statement of informed consent.
* Subjects must meet plasma donor criteria as established by University of Rochester Transfusion Medicine \& Blood Bank.

Exclusion Criteria:

* Is pregnant at the time of enrolment in the study determined by urine pregnancy test.
* Is currently on a course of antibiotics
* Is considered by the Investigator to not be a suitable candidate for participation and are not at risk for glaucoma.
* Is considered by the University of Rochester Transfusion Medicine \& Blood Bank not a suitable candidate for blood donation.

Primary outcomes:
measure: Mean change in acuity
timeFrame: baseline to 3 months
measure: Mean change in breakup pattern to appear
timeFrame: baseline to 3 months
measure: Mean change in lipid coverage of the cornea with blinking
timeFrame: baseline to 3 months
measure: Mean change in consistency of lipid compensation
timeFrame: baseline to 3 months
measure: Mean change in temperature over the optical service
timeFrame: baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Flaum Eye Institute at the University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT06650293: Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy
Official title: Effect of Vitamin D Supplementation as Adjuvant Therapy in Neonatal Jaundice in Combination With Phototherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Neonatal jaundice frequently occur during initial week of life. Neonatal jaundice is one of the leading causes of hospital admission and readmission. Some studies have suggested that the healthy newborns with hyperbilirubinemia outside the physiological range have notably reduced serum vitamin D levels. This deficiency is inversely associated with neonatal hyperbilirubinemia, suggesting that low vitamin D levels could be a potential risk factor for jaundice among neonates.


Eligibility criteria: Inclusion Criteria:

* Both genders
* Admitted between 3-28 days of age.
* Indirect hyperbilirubinemia with TSB levels between 14-20 mg/dL
* Born via either cesarean or vaginal delivery
* Birth weight greater than 2500 grams

Exclusion Criteria:

* Prior phototherapy treatment
* Preterm birth (gestational age below 37 weeks).
* SpO2 \< 95% at the time of admission
* Severe respiratory distress or failure
* Neonatal sepsis
* Congenital anomalies
* Parents/guardians unwilling to let their neonates be part of this study.

Primary outcomes:
measure: Total Serum bilirubin levels
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore
Study officials:
affiliation: Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore
name: Zeeshan Afzal, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Medicine Department University of Child Health Sciences, Children's Hospital Lahore
name: Wajiha Rizwan, FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01454193: Are we Loading Our Patients With Sodium During Hemodialysis Treatments?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients at Renal Research Institute and Fresenius clinics

Brief summary: The objectives of the data search is to find out if there is correlation between pre, post serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and associated changes in pre and post systolic and diastolic blood pressure, mean arterial pressure, number of blood pressure medications and adherence to 3 times per week dialysis, mortality.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Renal Research Institute
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02140593: The Laparotomy Study
Official title: Muscle Relaxation During Open Upper Abdominal Surgery - Can the Surgical Conditions be Optimized?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Cancer
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 128
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: The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade.

The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old
* Elective open upper abdominal surgery
* Can read and understand Danish
* Informed consent

Exclusion Criteria:

* Known allergy to rocuronium or sugammadex
* Severe renal disease, defined by S-creatinine\> 0.200 mmol/L, GFR \< 30ml/min or hemodialysis
* Neuromuscular disease that may interfere with neuromuscular data
* Abdominal mesh with size larger than 5\*5 cm
* Lactating or pregnant

Primary outcomes:
measure: Surgical Rating Score
timeFrame: After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes
Secondary outcomes:
measure: The Surgical Rating Score During Fascial Closure
timeFrame: Immediatly after fascial closure
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Nørrebrogade
Study officials:
affiliation: Herlev Hospital
name: Matias V Madsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madsen MV, Scheppan S, Mork E, Kissmeyer P, Rosenberg J, Gatke MR. Influence of deep neuromuscular block on the surgeons assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex. Br J Anaesth. 2017 Sep 1;119(3):435-442. doi: 10.1093/bja/aex241.
citation: Madsen MV, Scheppan S, Kissmeyer P, Mork E, Rosenberg J, Gatke MR. Neuromuscular blockade for improvement of surgical conditions during laparotomy: protocol for a randomised study. Dan Med J. 2015 Oct;62(10):A5139.
Clinical trial NCT06118593: Why in Hospital After Wedge Resection
Official title: Why in Hospital After ERAS VATS Wedge Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery, Video-Assisted
Enhanced Recovery After Surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 150
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: Patients who underwent video-assisted thoracoscopic surgery wedge resection.

Brief summary: In the realm of lung surgery, video-assisted thoracoscopic surgery (VATS) offers distinct advantages, including shorter hospital stays, reduced pain, improved quality of life, and increased postoperative mobility when compared to thoracotomy. Additionally, the enhanced recovery after surgery (ERAS) protocol in lung surgery, characterized by a comprehensive, multidisciplinary approach, have streamlined postoperative recovery, resulting in early discharge and diminished postoperative complications. However, drawing from our extensive experience with fully implemented ERAS VATS for patients undergoing pulmonary lobectomy, we observed that approximately 45% of patients did not experience early discharge.

Based on existing evidence, the length of stay (LOS) following wedge resection typically ranges from 3 to 6 days across various regions, including Europe, the United States, and China. However, there is a notable lack of procedure-specific data for ERAS VATS wedge resection to explore reasons of delaying discharge. This prompts us to undertake an investigation into individuals following pulmonary wedge resection under the same ERAS programs.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent video-assisted thoracoscopic surgery wedge resection

Exclusion Criteria:

* \< 18 year old
* Unable to understand Danish
* No residence in the Eastern Denmark
* Transfer to anatomical resection or cancel surgery
* Reject to join or withdraw from the study

Primary outcomes:
measure: Length of stay
timeFrame: Up to the day of discharge
measure: Reasons for staying in hospital
timeFrame: Up to the day of discharge
Secondary outcomes:
measure: Postoperative pain scale
timeFrame: At the day of surgery
measure: Duration of chest drain
timeFrame: Up to the day of chest drain removed
measure: Postoperative complications
timeFrame: Up to postoperative day 30
measure: 30-day readmissions
timeFrame: Up to postoperative day 30
measure: Postoperative activity
timeFrame: At the day of surgery
measure: Opioid usage
timeFrame: At the day of surgery and at the day of discharge
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet
name: René H Petersen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00727493: Osteoporosis and Dental Implant
Official title: Evaluation of the Influence of Alendronate on Wound Healing After Dental Implants in Patients With Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporosis
Keywords: osteoporosis,
bisphosphonate
therapy
dental implant
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 45
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women \> 2 years after menopause
* Age between 60 and 75 years
* Possibility to insert a dental implant
* Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group)

Exclusion Criteria:

* Pathological findings in the jaw bone
* Chronic inflammatory rheumatoid disease
* Bisphosphonate treatments during the last 12 months
* Inflammatory or metabolic bone disease, excluding osteoporosis
* Systemic corticosteroid treatments of more than one month within previous 12 months
* Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year

Primary outcomes:
measure: Dental CT
timeFrame: baseline, and 3,6,12 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Study officials:
affiliation: Leader of the center for muscle and bone research, Charité
name: Dieter Felsenberg, Prof. D.r
role: STUDY_CHAIR
References:
Clinical trial NCT04429893: Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy
Official title: Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cancer Breast
Chronic Pain Syndrome
Keywords: serratus anterior plane block
magnesium sulphate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.

Detailed description: Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

Eligibility criteria: Inclusion Criteria:

* adult female patients
* American Society Of Anesthesiologists (ASA) class I or II
* scheduled for elective unilateral modified radical mastectomy

Exclusion Criteria

* patient refusal
* bilateral breast surgery
* coagulation disorders
* body mass index\> 35
* allergy to local anaesthetics or magnesium sulphate
* severe respiratory or cardiac disorders
* pre-existing neurological deficits
* liver or renal insufficiency

Primary outcomes:
measure: assessment of the pain intensity
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Rehab Abd Elraof Abd Elaziz
state: Smouha
Study officials:
affiliation: Alexandria University
name: Rehab A. Abd Elaziz, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00403793: Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)
Official title: A Phase II -b, Placebo-Controlled Trial Investigating the Efficacy, Safety and Pharmacokinetics of a Subcutaneous Etonogestrel Implant Combined With i.m. Testosterone Undecanoate for Male Contraception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2006-11-27
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.


Eligibility criteria: Inclusion Criteria:

* Male
* Mentally and physically healthy
* BMI between 18 and 32 kg/m\^2
* Two pre-treatment semen samples \> 20 million/ml with normal morphology and motility

Exclusion Criteria:

* History or presence of psychiatric disease, liver disease, renal disease, diabetes, cardiovascular disease, any malignancy, prostatic disease, or genitourinary infection
* PSA \> 2.5 ng/ml
* Use of drugs known to interfere with pharmacokinetics of steroids
* Use of lipid-lowering drugs

Primary outcomes:
measure: % of men who had a sperm concentration of 1 million/ml or less at week 16.
timeFrame: Week 16
Secondary outcomes:
measure: Semen Parameters
timeFrame: At several timepoints during treatment
measure: Reversibility of Suppression
timeFrame: Post-Treatment
measure: Hormones
timeFrame: At several timepoints
measure: Pharmacokinetics
timeFrame: At several timepoints
measure: Safety
timeFrame: At several timepoints
Other outcomes:
Locations:
Study officials:
References:
citation: Mommers E, Kersemaekers WM, Elliesen J, Kepers M, Apter D, Behre HM, Beynon J, Bouloux PM, Costantino A, Gerbershagen HP, Gronlund L, Heger-Mahn D, Huhtaniemi I, Koldewijn EL, Lange C, Lindenberg S, Meriggiola MC, Meuleman E, Mulders PF, Nieschlag E, Perheentupa A, Solomon A, Vaisala L, Wu FC, Zitzmann M. Male hormonal contraception: a double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2008 Jul;93(7):2572-80. doi: 10.1210/jc.2008-0265. Epub 2008 Apr 15.