louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02112266: Depression Online Assessment and Therapy
Official title: Online Assessment for Therapy Expectation and Quality of Life and Online Therapy of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: depression
online therapy
cognitive behavioural therapy
quality of life
alexithymia
therapy expectation and satisfaction
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Makora
First posted: 2014-04-11
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: One Aim of the current study is to better understand why some patients suffering from depression do not seek professional help by doctors but in the internet.

Furthermore patients with depression will receive Online Therapy for depression. Aim of this part of the study is to investigate whether quality of life changes accordingly to improvement of symptoms after online therapy.

Detailed description: * German speaking patients can register online. There will be no side visits.
* After screening: patients which meet inclusion criteria and no exclusion criteria can take part in online therapy for depression.
* After 12 weeks 2nd online survey. After this survey patients can use the program the following 6 months (follow-up)
* After 6 months 3rd and last online-survey.
* According to the aims of the study cross-sectional as well as longitudinal data will be obtained and analysed

Eligibility criteria: Inclusion Criteria:

* German language
* depression at least slight according BDI (Beck depression inventory) and at least 2 weeks

Exclusion Criteria:

* severe depression according BDI
* suicidal ideation
* alcohol or drug dependency
* history of psychotic symptoms
* history of bipolar disorder or previous mania
* current in-patient care or semi-residential treatment

Primary outcomes:
measure: Change of Quality of life
timeFrame: at screening, post treatment (3 months) and follow-up (6 months after post)
Secondary outcomes:
measure: change of Sleep quality
timeFrame: screening, post treatment (3 months), follow-up(6 months after post)
measure: change of severity of depression
timeFrame: 3 time points screening, + 3 months + 6 months
Other outcomes:
measure: change of therapy expectation during online-therapy
timeFrame: 3 time points screening + 3 months + 6 months
measure: alexithymia
timeFrame: screening
measure: satisfaction with current and former therapies and influence on decision for online therapy
timeFrame: screening
measure: sense of coherence
timeFrame: screening
measure: changes in sense of coherence
timeFrame: + 3 months after screening (post) and + 6 months after post
measure: changes alexithymia
timeFrame: + 3 months after screening (post) , + 6 months after post
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich - only online recruitment
Study officials:
affiliation: USZ, UZH
name: S Weidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554366: Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars
Official title: Bacterial Load Reduction by GentleWave and EdgePro Irrigation Systems in Mandibular Necrotic Molars: An In-vivo Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulp Necroses
Keywords: Root canal
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 30
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 purpose of this study is to compare the efficacy of GentleWave versus EdgePro irrigation in the disinfection of infected root canals of human permanent teeth with necrotic pulp.


Eligibility criteria: Inclusion Criteria:

* Permanent teeth that are diagnosed with pulp necrosis.
* elected to have a permanent tooth nonsurgical root canal treatment
* Signed informed consent.

Exclusion Criteria:

* Teeth with root fractures or previously root canal treated teeth.
* Teeth with severe loss of structure
* Teeth with vital pulps.

Primary outcomes:
measure: Bacterial count reduction checked by 16 S rDNA next-generation sequencing analysis (NGS)
timeFrame: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Secondary outcomes:
measure: Presence of proteolytic versus non-proteolytic bacteria in the root canals
timeFrame: Baseline, after cleaning and shaping of the root canal (about 30 minutes after baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: David Jaramillo, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00415766: Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders
Official title: Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: recombinant hCG
urinary hCG
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 150
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 purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.

Detailed description: Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.

Eligibility criteria: Inclusion Criteria:

* At least 14 follicles \>11mm on the day of triggering final oocyte maturation
* Pretreated with GnRH antagonist protocol

Exclusion Criteria:

* Poor responders
* Women with 25 or more follicles on the day of trigger

Primary outcomes:
measure: Percentage of mature oocytes
timeFrame: Day of oocyte retrieval (Day 0)
Secondary outcomes:
measure: Positive test per embryo transfer
timeFrame: 15 days post oocyte retrieval
measure: Clinical pregnancy per embryo transfer
timeFrame: 7 weeks of gestation
measure: Ongoing pregnancy per embryo transfer
timeFrame: 12 weeks of gestation
measure: Level of serum hCG on day of oocyte retrieval
timeFrame: Day of oocyte retrieval
measure: Number of oocytes (COC) retrieved
timeFrame: Day of oocyte retrieval
measure: Number of mature oocytes (MII)
timeFrame: Day of oocyte retrieval
measure: Oocyte retrieval rate
timeFrame: Day of oocyte retrieval (Day 0)
measure: Incidence of severe early OHSS
timeFrame: up to Day 5 post oocyte retrieval
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia
Study officials:
affiliation: Eugonia
name: Tryfon Lainas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38. doi: 10.1186/1477-7827-4-38.
citation: Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. doi: 10.1002/14651858.CD003719.pub2.
Clinical trial NCT00196066: Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Arterial Disease (PAD)
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.


Eligibility criteria: Inclusion Criteria:

* Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery.
* Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion.
* Patient has given informed consent.

Exclusion Criteria:

* Patient is less than 50 years of age
* Patient is participating in another investigational drug or device study.
* Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure.
* Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated.
* Patient is pregnant or breast-feeding.

Primary outcomes:
measure: The primary endpoint of the study is major adverse event (MAE) rate at the 9-month follow-up.
Secondary outcomes:
measure: Additional endpoints include acute procedure and hemodynamic success, secondary patency, 9-month restenosis rate based on ultrasound examination, and 9-month functional status improvement.
Other outcomes:
Locations:
Study officials:
affiliation: Baptist Cardiac and Vascular Institute
name: Gerald Zemel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krol KL, Saxon RR, Farhat N, Botti CF, Brown OW, Zemel G, Raabe RD, Voorhees WD 3rd, Katzen BT. Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2008 Jan;19(1):15-22. doi: 10.1016/j.jvir.2007.08.031.
citation: Jaff MR, Katzen BT. Two-year clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv Radiol. 2010 Oct;21(10):1489-94. doi: 10.1016/j.jvir.2010.06.013.
Clinical trial NCT01592266: F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With Acute Myeloid Leucemia(AML)
Official title: F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With AML
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leucemia
Keywords: FLT
PET
bone marrow
AML
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 10
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 with new diagnosis of AML

Brief summary: PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution. Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic disease either in bone marrow or extramedullary.

F18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive study can replace bone marrow biopsy and predict response vs. non response to therapy.


Eligibility criteria: Inclusion Criteria:

* new diagnosis of AML

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Measure of extent and intensity ( by standardized uptake value - SUV) of disease in bone marrow demonstrated on PET/CT images before and after treatment.
Secondary outcomes:
measure: prediction of treatment response by dynamics of FLT uptake(by SUV)in comparison to bone marrow biopsy
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
References:
Clinical trial NCT06281366: Diamine Oxidase and Adverse Pregnancy Outcomes
Official title: Diamine Oxidase and Adverse Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Complications
Keywords: Preeclampsia
PPROM
preterm birth
Fetal death
Low birthweight
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: DR Healthcare
First posted: 2024-02-28
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single pregnancies between 11+0 and 16+6 weeks of gestation and high risk for preeclampsia in the first trimester screening (risk ≥1/50)

Brief summary: In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.

First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity.


Eligibility criteria: Inclusion Criteria:

* Single pregnancy
* Maternal age ≥18
* High risk (≥1/50) in the first-trimester screening for preeclampsia
* Gestational age between 11+0 and 16+6 weeks of gestation

Exclusion Criteria:

* Fetal malformation
* Fetal death
* Maternal digestive inflammatory disease or intolerance
* Refusal to give informed consent

Primary outcomes:
measure: Diamine oxidase activity first trimester
timeFrame: 11-16+6 weeks of gestation
measure: Diamine oxidase gene polymorphisms
timeFrame: 11-16+6 weeks of gestation
Secondary outcomes:
measure: Blood Diamine oxidase activity at delivery
timeFrame: At the time of delivery
measure: Placental Diamine oxidase activity at delivery
timeFrame: At the time of delivery
measure: Blood histamine levels at delivery
timeFrame: At the time of delivery
measure: Placental histamine levels at delivery
timeFrame: At the time of delivery
measure: Urine histamine levels at delivery
timeFrame: At the time of delivery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Manel Mendoza
Study officials:
References:
Clinical trial NCT03624166: Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery
Official title: Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery :Prospective , Randomized Double- Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of sub anesthetic dose of ketamine on vasopressor (Ephedrine) requirement to prevent maternal hypotension after spinal anesthesia in caesarean section.


Eligibility criteria: Inclusion Criteria:

* Physical status American Society of Anesthesiologist(ASA) I or II. Full term pregnancy

Exclusion Criteria:

* ,Pre-eclampsia.
* Chronic hypertension.
* Cardiovascular troubles.
* any contraindications to spinal anesthesia as back infection , coaguolopathy , patient refusal

Primary outcomes:
measure: incidence of hypotension
timeFrame: 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT01271166: Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Colorectal Cancer
Keywords: Colorectal,
Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
* ECOG 0 or 1
* Measurable disease

Exclusion Criteria:

* Prior first line therapy for advanced disease
* Significant bulk of metastatic disease or rapid progression
* If prior adjuvant therapy, relapse within 6 months of a 5-FU based regimen or 12 months of an oxaliplatin based regimen

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Tumour response as assessed by CT scan and RESIST
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Novarts Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04753866: Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations
Official title: Facial Scanning for Lip Support Assessment in Full Arch Implant Rehabilitations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip
Prosthesis User
Soft Tissue
Keywords: Dental Esthetics
Dental Implants
Three-Dimensional Imaging
Oral Surgery
Lead sponsor: Implantology Institute
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be quantifiably evaluated regarding facial esthetics and compared before and after the full arch implant supported rehabilitation.
Primary purpose: DIAGNOSTIC

Brief summary: Lip support plays an important role in facial esthetics, being a relevant factor when realizing full arch implant supported rehabilitations. However, there is a lack of research on the three dimensional impact of such restorations.

Detailed description: As lip support is becoming more determinant in the facial esthetics outcome after full arch implant rehabilitation, there is a need to know the influence of said rehabilitation in the lower third profile of the patients. Then, through facial scanning, this study's purpose is to evaluate three dimensional changes that arise since the initial state that the patient presents to the office until is rehabilitated through 3D discrepancies and 2D linear measurements.

Eligibility criteria: Inclusion Criteria:

* Indication for full arch implant rehabilitation

Exclusion Criteria:

* Presence of facial hair, braces, make up, earrings or any facial deformity

Primary outcomes:
measure: Lip Support Changes in 3D (μm)
timeFrame: 1 month
Secondary outcomes:
measure: Facial Alterations in 2D (mm)
timeFrame: 1 month
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Instituto de Implantologia
Study officials:
affiliation: Implantology Institute
name: João Caramês, DDS PhD
role: STUDY_DIRECTOR
affiliation: Implantology Institute
name: Duarte Marques, DDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001366: Mapping the Areas of the Brain Associated With Language in Children With Epilepsy
Official title: MRI-Based Functional Language Mapping in Children With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Seizures
Keywords: Neuroimaging
Seizures
Cerebral Localization
Partial Epilepsy
Epilepsy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Researchers are interested in studying if magnetic resonance imaging (MRI) is practical for locating the areas of the brain associated with language in children with epilepsy.

When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also.

Patients participating in the study will be asked to perform tasks designed to test language skills while undergoing an MRI to detect areas of the brain using oxygen and receiving blood flow.

Detailed description: We propose to study the feasibility of utilizing MRI to perform functional mapping of language cortex in children with epilepsy. We will use 1.5 Tesla MRI to study cerebral blood flow and tissue oxygenation during cognitive activation tasks derived from previous adult studies.

Eligibility criteria: Children aged 5-17 years.

Partial epilepsy (localized).

Ability to cooperate with task paradigms (IQ greater than 65).

No cardiac pacemakers, cochlear implants, shrapnel, vascular clips, braces, or claustrophobia.

No one with inability to cooperate with task paradigms.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Hertz-Pannier L, Gaillard WD, Mott SH, Cuenod CA, Bookheimer SY, Weinstein S, Conry J, Papero PH, Schiff SJ, Le Bihan D, Theodore WH. Noninvasive assessment of language dominance in children and adolescents with functional MRI: a preliminary study. Neurology. 1997 Apr;48(4):1003-12. doi: 10.1212/wnl.48.4.1003.
citation: Bookheimer SY, Zeffiro TA, Blaxton T, Malow BA, Gaillard WD, Sato S, Kufta C, Fedio P, Theodore WH. A direct comparison of PET activation and electrocortical stimulation mapping for language localization. Neurology. 1997 Apr;48(4):1056-65. doi: 10.1212/wnl.48.4.1056.
citation: Malow BA, Blaxton TA, Sato S, Bookheimer SY, Kufta CV, Figlozzi CM, Theodore WH. Cortical stimulation elicits regional distinctions in auditory and visual naming. Epilepsia. 1996 Mar;37(3):245-52. doi: 10.1111/j.1528-1157.1996.tb00020.x.