louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02509715: Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
Official title: Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid
Keywords: thyroidectomy
nerve monitoring
Lead sponsor: Lütfiye Nuri Burat Government Hospital
Sponsor class: OTHER_GOV
First posted: 2015-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: "Effect of intraoperative nerve monitoring on voice quality during thyroid surgery"

Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable decrease in the complication rates. In case of these advances, patients still have fear related with their voice. In this study, investigators aimed to investigate voice changes during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.

Detailed description: In order to minimize the complication rates and voice disturbances during thyroidectomy, intraoperative nerve monitoring(IONM) is a widely used intervention. In this study investigators will compare conventional surgery with IONM used surgery. Randomly chosen half of the patients will be operated with IONM. Vagus, recurrent and superior laryngeal nerves will be monitored during surgery and measured for nerve integrity . Rest of the patients will be operated with standard conventional method. All participants will be analyzed with a computer program for their voice quality preoperatively and postoperatively at 14th day of surgery.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of nodular or multinodular goiter
* Clinical, radiological and pathologically diagnosed thyroid cancer
* Must be able to speak (for voice recording)

Exclusion Criteria:

* Pregnancy
* Previous thyroid surgery
* Previous laryngeal operations
* Professional voice users (e.g. singers)

Primary outcomes:
measure: Voice analysis
timeFrame: up to 2nd week voice recording
Secondary outcomes:
measure: Operation time
timeFrame: duration of surgery, up to 3 hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Lutfiye NBGH
Study officials:
affiliation: Lutfiye Nuri Burat Goverment Hospital
name: Turgut Donmez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080715: Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance
Official title: A Randomized, Double-blind, Placebo-controlled Examination of the Effects of Tolcapone (TASMAR) on Vigilance in Healthy Volunteers After Sleep Deprivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Sleep-wake
regulation
volunteers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are identified by measurement of vigilance and cognitive performance as well as EEG measurements during wake and sleep.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* Healthy male subjects
* Age: 20-30 years
* written informed consent
* right handed
* non smoker

Exclusion criteria:

* sleep disturbances
* irregular sleep-wake rhythm
* travelling with time-shift
* liver diseases (ALT: \> 82 U/l; AST: \> 76 U/l)
* diseases of the nervous system
* acute internal medicine diseases
* medication or drug abuse
* intake of more than 3 caffeine-containing drinks
* intake of more than 5 alcoholic drinks per week
* heart pacemaker or implanted medical devices
* Body-Mass-Index (BMI): 20\< BMI \>26

Primary outcomes:
measure: Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo
timeFrame: Participants will be studied during two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Institute of Pharmacology and Toxicology
Study officials:
affiliation: University of Zurich, Institute of Pharmacology and Toxicology
name: Hans-Peter Landolt, Professor
role: STUDY_CHAIR
affiliation: University Hospital Zurich, Department of Neurology
name: Christian Baumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04214015: A Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Metastatic Mesothelioma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mesothelioma
Mesothelioma Malignant
Mesothelioma; Lung
Mesotheliomas Pleural
Mesothelioma Peritoneum
Mesothelioma; Liver
Mesothelioma; Omentum
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic mesothelioma

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Metastatic Mesothelioma

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of metastatic mesothelioma through biopsy and/or advanced imaging

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127815: Identify the Clinical Significance and Potential Implications of Peritoneal Washing Cytology (PWC) in Patients With Pancreatic Cancer
Official title: Identify the Clinical Significance and Potential Implications of PWC in Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: Peritoneal washing cytology
pancreatic cancer
peritoneal metastasis
anoikis
to determine the relationship between PWC results and clinicopathologic parameters of pancreatic cancers
to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes
to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: operated in Surgical Department of National Taiwan University Hospital

Brief summary: Pancreatic cancer is a disease with an extremely poor prognosis. Such poor results are largely due to a high incidence of local or peritoneal recurrence even after curative R0 resection. If occult microscopic metastasis or residual cancer could be predicted correctly and identify the high risk of peritoneal recurrence, we may have chance to treat these patients by different multimodal locoregional or adjuvant therapy to improve the treatment outcome.

Detailed description: The purpose of this study has three specific aims: (1) to determine the relationship between peritoneal washing cytology (PWC) results and clinicopathologic parameters of pancreatic cancers, (2) to identify the predictive value of PWC and postoperative drainage cytology on the peritoneal recurrence or outcomes, (3) to dissect the molecular mechanism of peritoneal recurrence, especially on the PWC-inducing peritoneal seeding process.

Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic cancers, other non-ductal pancreatic cancers , and benign pancreatic tumors (as negative control population) operated in Surgical Department after IRB proof and receiving patients' informed consent.

Exclusion Criteria:

* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Ching-Yao Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636415: Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis
Official title: Intra-Articular Morphine Versus Bupivacaine on Knee Motion in Patients With Osteoarthritis: Randomized and Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Analgesia
Morphine
Bupivacaine
Osteoarthritis
Knee
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to compare the analgesic effect of intra-articular bupivacaine and morphine in patients with knee osteoarthritis.

DESIGN AND SETTING: A randomized and double-blind study was performed at a Pain Clinic of São Paulo Federal University.

METHODS: Thirty-nine patients with pain for more than 3 months and an intensity higher than 3 on a numerical scale (zero to 10) were included. G1 patients received 1 mg (1 ml) morphine diluted in 9 ml saline by the intra-articular route, and G2 patients received 25 mg (10 ml) 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic complementation with 500 mg paracetamol was also determined.

Detailed description: Among the 39 patients selected, two patients from group 1 and five from group 2 were excluded from some of the analyses because they did not return on the day of assessment or because they used a complementary analgesic different from that standardized in the study

Eligibility criteria: Inclusion Criteria:

* Older than 50 years with a radiological confirmation of chronic knee osteoarthritis
* Pain lasting for more than 3 months either at rest or under strain, morning stiffness
* Absence of heat at the site
* Crepitation during movement and a pain score ranging from three to ten.

Exclusion Criteria:

* Patients with coagulopathy
* Infection or malignant disease
* Patients who underwent knee or hip surgery; AND
* Patients using opioids 24 hours prior to the study

Primary outcomes:
measure: Pain relief
timeFrame: 1 year
Secondary outcomes:
measure: bupivacaine and morphine
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Pain Setor of Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Adriana M Issy, PhD
role: STUDY_CHAIR
References:
citation: Gazi MB, Sakata RK, Issy AM. Intra-articular morphine versus bupivacaine for knee motion among patients with osteoarthritis: randomized double-blind clinical trial. Sao Paulo Med J. 2008 Nov;126(6):309-13. doi: 10.1590/s1516-31802008000600003.
Clinical trial NCT03630315: CLN-0046: Treatment of AMD Subjects With OTX-TKI
Official title: A Phase 1 Open-Label, Dose Escalation Study of OTX-TKI for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).

Detailed description: A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.

Eligibility criteria: Inclusion Criteria:

* Are at least 50 years of age
* Are eligible for standard therapy
* Have active primary CNVM secondary to AMD, either newly diagnosed or previously treated with documented response to anti-VEGF therapy in the study eye \[primary subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea\] documented by FA and SD-OCT
* Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception
* Are able and willing to comply with all study requirements and visits

Exclusion Criteria:

* Have previous laser photocoagulation to the center of the fovea in the study eye
* Have participated in any study involving an investigational drug either in the U.S. or outside the U.S. within the past 30 days
* Are an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
* Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments

Primary outcomes:
measure: Incidence of treatment emergent adverse events for each subject
timeFrame: 9 months
Secondary outcomes:
measure: Determine the Maximum Tolerated Dose of the OTX-TKI injection
timeFrame: 9 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Ocular Therapeutix, Inc.
state: Site 1
city: Sydney
country: Australia
facility: Ocular Therapeutiux, Inc.
state: Site 2
city: Sydney
country: Australia
facility: Ocular Therapeutiux, Inc.
state: Site 3
city: Adelaide
country: Australia
facility: Ocular Therapeutix, Inc.
city: Albury
country: Australia
facility: Ocular Therapeutix, Inc.
city: Melbourne
country: Australia
facility: Ocular Therapeutix, Inc.
Study officials:
References:
Clinical trial NCT03861715: Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.
Official title: Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Premature Ovarian Failure
Keywords: antagonist protocol
degarelix antagonist protocol
degarelix
IVF
Lead sponsor: Assisting Nature
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 20-34 years old who follow COS with a single GnRH antagonist Degarelix or multidose GnRH antagonist Ganirelix.

Brief summary: A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.

Detailed description: A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.

Eligibility criteria: Inclusion Criteria:

* age 20-34 years;
* body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35 days,
* AMH levels age appropriate (≥2.3 ng/ml)
* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).

Exclusion Criteria:

* women with diabetes and other metabolic disease
* women with hereditary genetic diseases;
* women with heart disease, QT prolongation,heart failure
* elevated liver enzymes, liver failure, hepatitis
* women with inflammatory or autoimmune disease
* abnormal karyotype;
* endometriosis stage III/IV;
* history of recurrent miscarriage;
* severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.

Primary outcomes:
measure: Live birth rate according to stimulation protocol
timeFrame: Up to 38 weeks after embryo transfer
Secondary outcomes:
measure: Blastulation rate according to stimulation protocol
timeFrame: Up to 6 days post oocyte retrieval
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Assisting Nature
Study officials:
affiliation: Assisting Nature
name: Evaggelos Papanikolaou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assisting Nature
name: Robert Najdecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00202215: Chrysalis Day Program Body Mass Index Study
Official title: A Study on the Effects of a Personality Disorder Day Hospital Program on Clients Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Eating Disorders
Keywords: Day hospital treatment
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to determine if the approach taken to treat patients in the Chrysalis Day Hospital Program will favourably effect their health status as assessed by Body Mass Index (BMI)

Detailed description: As part of the Providence Continuing Care Center's continuing quality improvement initiatives this study is to more systematically evaluate the success of the Chrysalis Day Hospital Program in dealing with some features of eating disorders commonly experienced by its patients.

At intake all clients will be approached to give informed consent to participate. If they do consent they will have their height and weight recorded( if they request they will not be told their weight)as part of the usual intake process conducted by a dietician.

When clients exit the program they again will be approached to be weighed. The body mass index will be calculated and compared to admission values.

The Chrysalis Program is a unique day hospital approach to treating individuals with severe personality disorders (primarily Borderline)that views the eating disordered behaviour common to these clients as a symptom of many and by addressing core issues of affect dysregulation as well as psychoeducation about eating the eating problems will improve .

Eligibility criteria: Inclusion Criteria:

* clients of the Chrysalis Program

Exclusion Criteria:

* clients of the Chrysalis Program who do not consent to the study

Primary outcomes:
measure: Body Mass Index at time of enrolling in programme and at leaving
timeFrame: at entry and upon leaving the program
Secondary outcomes:
measure: patient demographics relationship to outcome
timeFrame: upon entry and exit from the program
measure: programme changes and relation to outcome
timeFrame: from start to the end of the study
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Care Centre Mental Health Services
state: Ontario
Study officials:
affiliation: Queens University
name: Stephen H McNevin, MD
role: PRINCIPAL_INVESTIGATOR
References: