louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00116909: A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy
Official title: A Phase II Study of Single-Agent OSI-7904L in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed First-Line Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Recurrent or Metastatic Cancer of the Head and Neck
Must Have Failed First-Line Therapy
Lead sponsor: OSI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy


Eligibility criteria: Inclusion Criteria:

Histologically or cytologically confirmed metastatic or locally recurrent SCCHN that is incurable with surgery or radiation therapy ECOG performance status 0-2 No more tha 1 prior chemotharapy regimen for metastatic or locally recurrent disease Adequate bone marrow, Hepatic and renal function. At least one target lesion greater than or equal to 20 mm.

Exclusion Criteria:

Symptomatic brain metasteses which are not stable, are not adequately controlled, are potenially life threatening or required radiation in the last 28 days Pregnant or lactating women. Concurrent anticancer therapy or other investigational drugs Patients with active or uncontrolled infections or other serious illnesses or medical conditions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: The Vanderbilt Cancer Center
state: Tennessee
Study officials:
References:
Clinical trial NCT00184509: Continued Early Intervention for Recent-onset Schizophrenia
Official title: Continued Early Intervention for Recent-onset Schizophrenia. A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
psychosocial treatment
outcome
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether outreach integrated treatment of first episode schizophrenia was more effecive than standard outpatient treatment.

Detailed description: Early intervention for schizophrenia has spawned considerable enthusiasm among clinicians without solid research evidence to suport its benefits and costs. The present study is a random-controlled study of integrated biomedical and psychosocial treatment on a population of recent-onset cases.

Comparison(s): 50 consecutive referrals with schizophrenic disorders of less than two years duration were allocated randomly to a comprehensive model of integrated treatment or standard care for two years. Main outcome measures was psychopathology, psychosocial functioning and hospital admissions.

Eligibility criteria: Inclusion Criteria:

* first-episode schizophrenia

Exclusion Criteria:

* acute psychosis

Primary outcomes:
measure: Rehospitalizations and psychotic relapse at two years
Secondary outcomes:
measure: Psychopathology, psychosocial changes, functioning, antipsychotic medication
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: K. Gunnar Gøtestam, MD
role: STUDY_DIRECTOR
References:
citation: Sigrunarson V, Grawe RW, Lydersen S, Morken G. Predictors of long term use of psychiatric services of patients with recent-onset schizophrenia: 12 years follow-up. BMC Psychiatry. 2017 Jan 14;17(1):18. doi: 10.1186/s12888-016-1186-x.
citation: Sigrunarson V, Grawe RW, Morken G. Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial. BMC Psychiatry. 2013 Jul 30;13:200. doi: 10.1186/1471-244X-13-200.
citation: Morken G, Widen JH, Grawe RW. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia. BMC Psychiatry. 2008 Apr 30;8:32. doi: 10.1186/1471-244X-8-32.
citation: Morken G, Grawe RW, Widen JH. Effects of integrated treatment on antipsychotic medication adherence in a randomized trial in recent-onset schizophrenia. J Clin Psychiatry. 2007 Apr;68(4):566-71. doi: 10.4088/jcp.v68n0409.
Clinical trial NCT04709809: Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating
Official title: Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vessels; Anomaly
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Data driven analysis
Primary purpose: DIAGNOSTIC

Brief summary: Analysis of Retinal Vessel Analyzer (RVA) recordings of retinal vessel pulsations, and putting them in context of intraocular pressure (IOP) pulsations by means of electrocardiographic (ECG) gating, in order to determine the lead source for pulsations of retinal veins.

Detailed description: Rationale / Objective is to construct the retinal vessels wall pulsation cycle using an electrocardiographic gating, and to analyse it in comparison with an analogue intraocular pressure (IOP) cycle.

Based on the amplitude and on the phase shift of pulsations of retinal vessel wall, the goal is to identify a lead source of the retinal venous pulsations (IOP pulsations, or alternative sources, e.g. cerebrospinal fluid pulsations).

Subjects will be recruited from the environment of the master thesis medical students, colleagues and friends and the informed consent will be handed to them personally. Exclusion criteria will be addressed. One random eye per subject will be selected. On the study day, first the mydriasis drops - phenylephrine + tropicamide - will be applied, then ECG electrodes attached; 20 minutes after the mydriasis drops, the first set of measurements will be performed: RVA recording with ECG gating, and Pascal Dynamic Contour Tonometry (DCT) recording with ECG gating. Ten minutes after this measurements, 100% oxygen 5 liters/min through nasal cannula will be applied for 2 minutes and then the same measurements repeated. Approximate time needed for the whole run - around 60 minutes per subject, including (dis)mounting the ECG electrodes and the mydriasis time.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

Known ophthalmological disease, in particular vascular disease.

Primary outcomes:
measure: Phase shift between pulsations
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Eye Hospital
state: Baseö
Study officials:
References:
Clinical trial NCT04076709: Cardiovascular Effects of Muscle Relaxation During Laparoscopic Surgery
Official title: The Impact of Neuromuscular Relaxation and Nociception Guided Anaesthesia on Hemodynamic Variables During Lower Abdominal Laparoscopic Surgery: a Strategy Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 34
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: Many surgical procedures are performed using the laparoscopic approach. However, insufflation of the abdomen (pneumoperitoneum) has detrimental hemodynamic effects. The investigators intend to investigate the effect of deep neuromuscular block and nociception guided anaesthesia on hemodynamic variables during pneumoperitoneum for lower abdominal laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

ASA 1-3;

* Scheduled for lower laparoscopic abdominal surgery;
* Ability to give oral and written consent;

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia;
* Women who are or may be pregnant;
* Preexisting cardiac disease (any);
* Untreated or uncontrolled hypertension;
* COPD gold 3 or higher
* Preexistent esophageal pathology (stricture, tumor, diverticulum)
* Any increased risk factor for upper gastro intestinal tract bleed:
* History of GI surgery;
* History of GI bleed;
* Esophageal varices;
* Gastric or esophageal inflammation;
* Severe thrombocytopenia (less than 50k) or severely elevated INR (\>4).

Primary outcomes:
measure: Blood pressure
timeFrame: 30 minutes after installation of pneumoperitoneum
Secondary outcomes:
measure: Blood pressure
timeFrame: 5 minutes after installation of pneumoperitoneum
measure: Blood pressure
timeFrame: 60 minutes after installation of pneumoperitoneum
measure: Cardiac output
timeFrame: 5 minutes after installation of pneumoperitoneum
measure: Cardiac output
timeFrame: 30 minutes after installation of pneumoperitoneum
measure: Cardiac output
timeFrame: 60 minutes after installation of pneumoperitoneum
Other outcomes:
measure: Ejection fraction
timeFrame: 5 minutes after installation of pneumoperitoneum
measure: Ejection fraction
timeFrame: 30 minutes after installation of pneumoperitoneum
measure: Ejection fraction
timeFrame: 60 minutes after installation of pneumoperitoneum
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
References:
Clinical trial NCT01734109: Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
Official title: A 12-week, Single Site, Randomized Controlled Trial to Compare the Efficacy of Quantum NPWT With and Without Simultaneous Irrigation Versus Standard of Care on Reduction of the Volume of Stage III/IV Pressure Ulcers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pressure Ulcers
Keywords: Negative Pressure Wound Therapy
Irrigation Therapy
Pressure Ulcers
Sacral Ulcers
Lead sponsor: Innovative Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 90
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: Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III \& IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.


Eligibility criteria: Inclusion Criteria:

* Male or Female between the ages of 18 and 70
* Any patient with a stage III/IV pressure ulcer of the size large enough to indicate use of Negative Pressure Treatment.

Exclusion Criteria:

* Clinical evidence of active, gross infection.
* Patient or patient's guardian refuses consent.

Primary outcomes:
measure: Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care
timeFrame: 12-weeks
Secondary outcomes:
measure: Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation
timeFrame: 12 weeks
Other outcomes:
measure: Pain
timeFrame: 12 weeks
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital System
state: Michigan
Study officials:
affiliation: Innovative Therapies, Inc.
name: Sandra J Berriman, Ph.D.
role: STUDY_DIRECTOR
affiliation: Henry Ford Hospital System
name: Kenneth Moquin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03957109: Influence of Anesthesia Methods on Surgical Outcomes and Renal Function
Official title: Influence of Anesthesia Methods on Surgical Outcomes and Renal Function in Retrograde Intrarenal Stone Surgery: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who underwent retrograde intrarenal surgery (RIRS) were randomly allocated to general anesthesia (GA) or spinal anesthesia (SA) groups. Renal function was assessed using estimated glomerular filtration rate, and relative renal function was evaluated using nuclear medicine tests. Maneuverability and accessibility were evaluated after every surgery. We analyzed the influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal surgery in a prospective, randomized controlled study.


Eligibility criteria: Inclusion Criteria:

* older than 20 years with renal stones greater than 10 mm

Exclusion Criteria:

* patients who have urologic anatomical abnormalities
* patients with ASA status ≥ grade III, a contraindication for spinal anesthesia or RIRS, or unexpected intraoperative renal injury

Primary outcomes:
measure: Renal function change according to anesthesia method
timeFrame: prior to procedure, and at 3 months after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kwon O, Lee JM, Park J, Cho MC, Son H, Jeong H, Ryang SH, Cho SY. Influence of anesthesia methods on surgical outcomes and renal function in retrograde intrarenal stone surgery: a prospective, randomized controlled study. BMC Anesthesiol. 2019 Dec 23;19(1):239. doi: 10.1186/s12871-019-0901-9.
Clinical trial NCT02989909: Clinical Evaluation of CATS Tonometer Prism
Official title: Clinical Evaluation of CATS Tonometer Prism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Hypertension
Lead sponsor: Intuor Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).

Of the 200 eyes, at least 10 highly astigmatic eyes (\>3 D of corneal astigmatism) each in the low, medium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group.


Eligibility criteria: Inclusion Criteria:

* Written informed consent (and assent when applicable)obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
* Male and female patients, at least 18 years of age

Exclusion Criteria:

* Subject has undergone ocular surgery within the last 3 months
* Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
* Pregnant or nursing women
* Subjects with only one functional eye
* Those with one eye having poor or eccentric fixation
* Eyes displaying an oval contact image
* Those with corneal scarring or who have had corneal surgery including corneal laser surgery
* Microphthalmos
* Buphthalmos
* Contact lens wearers
* Severe Dry eyes
* Lid squeezers - blepharospasm
* Nystagmus
* Keratoconus
* Any other corneal or conjunctival pathology or infection.
* Central corneal thickness greater than 0.600 mm or less than 0.500 mm (2 standard deviations about the human mean)

Primary outcomes:
measure: All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.
timeFrame: From date of randomization until 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Eye Consultants
state: Arizona
Study officials:
References:
citation: McCafferty SJ, Tetrault K, McColgin A, Chue W, Levine J, Muller M. Modified Goldmann prism intraocular pressure measurement accuracy and correlation to corneal biomechanical metrics: multicentre randomised clinical trial. Br J Ophthalmol. 2019 Dec;103(12):1840-1844. doi: 10.1136/bjophthalmol-2018-313470. Epub 2019 Feb 22.
Clinical trial NCT00805909: NI-0401 in Patients With Acute Renal Allograft Rejection
Official title: A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Renal Transplant Rejection
Lead sponsor: Light Chain Bioscience - Novimmune SA
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.


Eligibility criteria: Main inclusion Criteria:

* evidence of cellular rejection in a renal biopsy according to Bannff 97 criteria
* rise in Serum Creatinine concentration by \>20% compared to baseline value

Main Exclusion Criteria:

* previous therapy with anti-CD3 mAB(OKT3) or anti-lymphocytes polyclonal antibodies (ATG, Atgam)
* patients with cardiac insufficiency or fluid overload
* severe HLA sensitization (\>50% panel reactive antibodies prior transplantation)
* defined concomitant disease

Primary outcomes:
measure: Nature,frequency,intensity,causality and seriousness of adverse events
timeFrame: Studay day 1 to week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker
Study officials:
References:
Clinical trial NCT06185309: Evaluation of Different Psychiatric Symptoms in Patients With Thyroid Dysfunction
Official title: Assessment of Different Psychiatric Symptoms in Patients With Thyroid Dysfunction: Pre and Post Thyroid Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anxiety
Depression
Thyroid Dysfunction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients newly diagnosed as having thyroid dysfunction.

Brief summary: 1. Evaluate psychiatric symptoms in patients with thyroid dysfunction.
2. Investigate effect of treatment on psychiatric symptoms after 2 months.

Detailed description: Thyroid dysfunction is associated with psychiatric symptoms in addition to endocrinal manifestations.

The study aims to evaluate the prevalence of psychiatric symptoms in patients with thyroid dysfunction and investigate the response after thyroid treatment.

Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed as having thyroid dysfunction.

Exclusion Criteria:

* Patients with other endocrinological disorders or significant medical or neurological diseases.
* Alcohol or substance abuse

Primary outcomes:
measure: The effect of thyroid treatment on psychiatric symptoms
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Romany Hosny Gabra Henein, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Khaled Ahmed Mohamed, Professor
role: STUDY_DIRECTOR
References:
citation: Aslan S, Ersoy R, Kuruoglu AC, Karakoc A, Cakir N. Psychiatric symptoms and diagnoses in thyroid disorders: a cross-sectional study. Int J Psychiatry Clin Pract. 2005;9(3):187-92. doi: 10.1080/13651500510029129.
citation: Gulseren S, Gulseren L, Hekimsoy Z, Cetinay P, Ozen C, Tokatlioglu B. Depression, anxiety, health-related quality of life, and disability in patients with overt and subclinical thyroid dysfunction. Arch Med Res. 2006 Jan;37(1):133-9. doi: 10.1016/j.arcmed.2005.05.008.
Clinical trial NCT00553709: Study of Nicotine for the Prevention of PONV
Official title: The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Keywords: nausea
vomiting
retching
emesis
surgery
anesthesia
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2007-11-04
Enrollment: 200
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: PREVENTION

Brief summary: The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery


Eligibility criteria: Inclusion Criteria:

* Adults (18-80 years)
* ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
* Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
* Consenting to take part in the study will be included.

Exclusion Criteria:

* Smokers (cigarette, pipe, cigar)
* Patients undergoing nicotine replacement therapy
* Prolonged postoperative intubation
* Postoperative nasogastric tube

Primary outcomes:
measure: Prevention of PONV
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Division of Anesthesiology, Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Martin R Tramèr, MD, DPhil
role: STUDY_CHAIR
affiliation: Medical Faculty, Geneva University
name: Daniel Bertrand, PhD
role: STUDY_CHAIR
References: