louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02127437: Lanreotide In Polycystic Kidney Disease Study
Official title: Lanreotide In Polycystic Kidney Disease Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD
Keywords: Autosomal dominant polycystic kidney disease,
Glomerular filtration rate,
Somatostatin,
lanreotide
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: IPSEN pharmaceutical company, Boulogne-Billancourt, France
First posted: 2014-04-30
Enrollment: 159
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: LIPS study (Lanreotide In Polycystic kidney disease Study) is a prospective randomized double blind placebo controlled study. The main objective is to prove that lanreotide, a somatostatin analog, is able to reduce the glomerular filtration rate decline over 3 years by at least 30%. Cardiovascular outcomes, blood pressure, quality of life and safety are among the secondary outcomes. The study, which will include 180 ADPKD patients, is scheduled to start in early 2014.

An equal number of patients with chronic kidney disease stage 2 (90 patients with GFR 89 to 60 ml/mn/1.73 m2) and chronic kidney disease stage 3 (90 patients with GFR 59 to 30 ml/mn/1.73 m2) will be included. The primary endpoint (GFR decline) will be assessed by repeated measures, in the overall population as well as in the two GFR stratus.


Eligibility criteria: Inclusion Criteria:

* autosomal dominant polycystic kidney disease (clinical, familial, imaging grounds)
* measured GFR : 30 to 89 ml/mn/1.73m2
* age \> 18
* affiliated with health insurance
* written informed consent

Exclusion Criteria:

* iohexol /iodine allergy
* diabetes mellitus
* other associated nephropathy suspected
* evolutive or recent malignant disease ( in the previous 5 years)
* cholelithiasis
* uncontrolled hypertension (BP\>160/100 mmHg)
* cardiac failure of grade III or IV according to the NYHA (New York Heart Association) classification
* liver failure
* psychiatric illness
* pregnancy, lactation, lack of contraception
* use of somatostatin analogs during the last 6 months

Primary outcomes:
measure: Glomerular filtration rate (GFR)
timeFrame: month 36
Secondary outcomes:
measure: Glomerular filtration rate (GFR)
timeFrame: month 18
measure: Glomerular filtration rate (GFR) decline
timeFrame: month 36
measure: Safety, tolerance
timeFrame: month 36
measure: Onset or worsening of hypertension
timeFrame: month 18
measure: Onset or worsening of hypertension
timeFrame: month 36
measure: Quality of life
timeFrame: month 0
measure: Quality of life
timeFrame: month 18
measure: Quality of life
timeFrame: month 36
measure: Cystic pain
timeFrame: month 36
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker hospital
Study officials:
affiliation: Necker hospital
name: Dominique JOLY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03443037: Benefits of Amantadine in Patients With Coma State
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coma; Prolonged
Amantadine
Keywords: Coma
Disability
amantadine
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with the coma state duo to ischemic stroke, brain hemorhage, anoxic brain damage included in this study.

Brief summary: The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.


Eligibility criteria: Inclusion Criteria:

* ≥18 years, ≤ 65 years
* GCS score ≤ 8
* Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage

Exclusion Criteria:

* \<18 years, \> 65 years
* Patients admitted to the critical care without diagnosis of coma state
* Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
* Metastatic malignant neoplazm
* Congenital or acquired brain function problem (cerebral palsy, autism etc)
* Patients with amantadine allergy
* Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)

Primary outcomes:
measure: Change in Glascow Coma Score
timeFrame: 1. At the time of enrollment 2. 12 weeks after the enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Necati Gokmen, MD
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Kutlay Aydin
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Kutlay Aydin
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Begum Ergan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03297437: Predictors for Successful Neurofeedback Training
Official title: Predictors for Successful Neurofeedback Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to identify predictors of neurofeedback training success.

Detailed description: In the last decades, neurofeedback has been established as a promising scientific tool. Learning voluntary control over their own brain activity allows for establishing causal links between brain activity and mental functions. However, patients participants differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand why some participants are more successful in regulating their own brain activity than others. The objective of the present study is thus to identify predictors for successful learning self-regulation with real-time fMRI neurofeedback. To achieve this goal, we will evaluate the introspection ability of healthy participants using standardized psychological questionnaires and tasks. These scores will then be correlated with how well they learned self-regulation skills using established real-time fMRI neurofeedback protocols.

Eligibility criteria: Inclusion Criteria:

Age 18 - 65 years. Magnetic resonance imaging compatibility.

Exclusion Criteria:

Physical or psychiatric disorders (DSM-V diagnosis). Current substance abuse. Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).

Primary outcomes:
measure: correlation between introspection scores and learning success
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Hospital of Psychiatry, University of Zurich
state: Zürich-
Study officials:
References:
Clinical trial NCT01792037: Single Dose of Etomidate and Adrenal Cortex
Official title: the Effect of Single Dose of Etomidate Used During Emergency Intubation on Hemodynamics and Adrenal Cortex: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adrenocortical Deficiency
Hemodynamic Instability
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: we aim to evaluate the effects of single dose of etomidate or use of steroid prior to etomidate during emergency intubation on hemodynamics and adrenal cortex.


Eligibility criteria: Inclusion Criteria:

* Patients between 25-65 years old with American Society of Anesthesiology scores III or IV that have applied to emergency department and receives an indication for intubation by the intensive care unit physicians will be included to the study

Exclusion Criteria:

* Patients using steroid prior to the intubation and/or patients with chronical inflammatory diseases will be excluded from the study.

Primary outcomes:
measure: effect of use of steroid on adrenal cortex prior to single dose etomidate by comparing cortisol levels
timeFrame: 24 hours
Secondary outcomes:
measure: compare effects of midazolam and etomidate on systemic blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
state: Fatih
Study officials:
affiliation: Chairman of the Department of Anesthesiology
name: Fatis Altindas, Prof.
role: STUDY_DIRECTOR
References:
citation: Tekwani KL, Watts HF, Sweis RT, Rzechula KH, Kulstad EB. A comparison of the effects of etomidate and midazolam on hospital length of stay in patients with suspected sepsis: a prospective, randomized study. Ann Emerg Med. 2010 Nov;56(5):481-9. doi: 10.1016/j.annemergmed.2010.05.034. Epub 2010 Sep 15.
Clinical trial NCT00198237: Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer
Official title: Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for Stage II-III Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-09-20
Enrollment: 40
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 primary objective of this study is to determine the efficacy \& toxicity of combined docetaxel \& capecitabine as primary chemo for subjects w/ stage II-III breast cancer.

Detailed description: The primary objective of this study is to determine the efficacy \& toxicity of combined docetaxel \& capecitabine as primary chemotherapy for subjects with stage II-III breast cancer.Subjects will be randomized into one of two groups: Docetaxel followed by four cycles of docetaxel \& capecitabine vs. capecitabine followed by four cycles of docetaxel and capecitabine.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the breast w/ Stage II-III disease w/ a primary tumor \>/=2cm or clinically palpable axillary lymph nodes.
* Pre-treatment core or incisional bx w/ adequate tissue for histology \& genomic/proteomic analysis.
* Primary tumor must be bi-dimensionally measurable by physical exam or dx breast imaging. Measurements must be obtained w/in 3 wks prior to study entry.
* Adequate organ fxn:AGC\>1500; Hb\>/=9.0;plts\>/=100K; Crt\</=2.0;Cacl Crt Clr\>/=50; total bili\</=ULN; LFTs\<2.0 ULN
* ECOG performance status 0-1
* Neg. pregnancy test

Exclusion Criteria:

* Pts may not have had definitive primary surgery.
* Metastatic breast cancer
* Any prior chemo or hormonal therapy for breast cancer
* Prior history of malignancy w/in the previous 5 yrs.
* No active unresolved infection
* No major surgery w/in 2wks of start of study

Primary outcomes:
measure: The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemotherapy for subjects with stage II-III breast cancer.
Secondary outcomes:
measure: To evaluate genomic and proteonomic changes after initial therapy with docetaxel & capecitabine as monotherapy after combined docetaxel & capecitabine therapy.
measure: To compare pre-treatment genomic and proteomic profiles in responders and non-responders.
measure: To compare the results of serum-based and tissue-based proteomic analyses.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Kathy Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05151237: Incidence of Perioperative Hypothermia in Adults
Official title: Incidence of Perioperative Hypothermia and Associated Risk Factors in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia; Anesthesia
Hypothermia Following Anesthesia
Keywords: hypothermia
perioperative
intraoperative
postoperative
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients scheduled for any elective operation (except for open heart surgery) will be recruited.

Brief summary: Perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. Perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. In this study the investigators aimed to detect the incidence of perioperative hypothermia in adult patients in the operating room, and to detect the possible associated risk factors.


Eligibility criteria: Inclusion Criteria:

* Any elective operation
* ASA I-III physical status

Exclusion Criteria:

* Emergency operations
* ASA IV-V physical status
* Open heart surgeries

Primary outcomes:
measure: Body temperature
timeFrame: Perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
state: Pendik
Study officials:
affiliation: Marmara University Department of Anesthesiology and Reanimation
name: Ruslan Abdullayev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774237: Safety and Efficacy Study of BRIMOCHOL™, BRIMOCHOL™ F, and Carbachol in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Official title: A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy With Carbachol Topical Ophthalmic Solution in Subjects With Emmetropic Phakic and Pseudophakic Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Presbyopia
Lead sponsor: Visus Therapeutics
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy Study of BRIMOCHOL™ vs. BRIMOCHOL™ F vs. Carbachol Monotherapy Topical Ophthalmic Solutions in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Detailed description: A 3-Dose, Multicenter, Randomized, Double-Masked, Crossover Phase 2 Safety and Efficacy Study of BRIMOCHOL™ Topical Ophthalmic Solution vs. BRIMOCHOL™ F Topical Ophthalmic Solution vs. Monotherapy with Carbachol Topical Ophthalmic Solution in Subjects with Emmetropic Phakic and Pseudophakic Presbyopia

Eligibility criteria: Inclusion Criteria:

* Male or female in good general health
* Must have presbyopia

Exclusion Criteria:

* History of allergic reaction to the study drug or any of its components
* Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results

Primary outcomes:
measure: Proportion of Subjects With a >=15 Letter Gain Without a < 5 Letter Loss in Near Visual Acuity
timeFrame: Day 1, Hour 1 post-dose
Secondary outcomes:
measure: Change From Baseline ETDRS Letters Score in Distance Visual Acuity
timeFrame: Day 1, Hour 1 post-dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
Study officials:
References:
Clinical trial NCT06176937: Hyaluronic Acid Gel in Ridge Preservation
Official title: Efficacy of Hyaluronic Acid Gel in Ridge Preservation After Tooth Extraction: A Randomized Controlled Clinical Trial With Radiographic and Histomorphometric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyaluronic Acid Gel for Preservation the Extraction Socket
Keywords: hopeless anterior tooth
atraumatic extraction
hyaluronic acid gel
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: hyaluronic acid gel applied at the extraction socket after extraction immediately to preserve the socket from post extraction resorption. hyaluronic acid has ability for osteogenesis and new bone formation.

Detailed description: twenty-four patients with one hopeless tooth at least, first CBCt before extraction to evaluate the dimension of the socket, then atraumatic extraction of the tooth to preserve the bony wall of the socket, after extraction and curettage the socket applied hyaluronic acid gel inside the socket and applied collagen membrane to secure the socket. After 4 months of extraction, CBCt was done to evaluate the dimension of the socket and the effect of hyaluronic acid. Furthermore, The core biopsy was taken by trephine bur at the time of implant placement for evaluate the histological appearance of the bone to evaluate the secondary outcome. then after three months the crown was delivered as a prosthetic part.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire
2. Both genders.
3. Age from 20 -50 years old.
4. Having at least one hopeless teeth indicated for extraction.
5. Esthetic zone teeth (anterior or premolar).
6. Sockets type 1 or 2 .
7. Patient should agree to sign a written consent after the nature of the study will be explained.

   -

   Exclusion Criteria:

1- Smokers. 2- Pregnant and breast-feeding females. 3- Mentally retarded Patients. 4- Prisoners and handicapped patients. 5- Patients with malocclusion.

-

Primary outcomes:
measure: clinical outcome
timeFrame: baseline(before extraction)/ four months later after extraction
measure: Radiographic measurement
timeFrame: baseline(before extraction)/ four months later after extraction
measure: Radiographic measurement
timeFrame: baseline (before extraction)/ four months later after extraction
Secondary outcomes:
measure: histological analysis
timeFrame: after 4 months of extraction at the time of implant placement.
measure: histomorphometric analysis
timeFrame: after 4 months of extraction at the time of implant placement.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams University
Study officials:
affiliation: Faculty of dentistry-Ain shams university
name: Suzan M Ibrahim, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03688737: Low Level Laser in Isolated Cleft Palate Repair Versus Surgical Correction Without LLL in Healing Process
Official title: The Effect of Adjunctive Use of Low Level Laser (LLL) After Surgical Correction of Isolated Cleft Palate Versus Surgical Correction Without LLL in Healing Process
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Palate Children
Laser
Keywords: low level laser , cleft palate , healing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either control or study group in the ratio of 1:1 using random number table.
Primary purpose: TREATMENT

Brief summary: Does the use of low level laser (LLL) after surgical correction of cleft palate improve healing and decrease incidence of oronasal fistula?

Detailed description: Primary objective:

To evaluate the effect of adjunctive use of LLL after surgical correction of cleft palate in improving healing among children with cleft palate Secondary objectives To evaluate the effect of adjunctive use of LLL after surgical correction of cleft palate in decreasing incidence of oronasal fistula after surgical repair among children with cleft palate Study group: Will use LLL after surgical correction of cleft palate at day of surgery, 1st day and 3rd day Control group: Surgical correction of cleft palate without Adjunctive use of LLL

Inclusion criteria:

1. Age: between 6 to 18 months of age
2. Patient has isolated cleft palate

Exclusion criteria:

1. Systemic disease
2. Hematological disorder Outcome: Outcome measure (s) (1ry, 2ry) 1ry: healing assessment 2ry: occurrence of oronasal fistula

Eligibility criteria: Inclusion Criteria:

1. Age: between 6 to 18 months of age
2. Patient has isolated cleft palate

Exclusion Criteria:

1. Systemic disease
2. Hematological disorder

Primary outcomes:
measure: wound healing
timeFrame: 2 years
Secondary outcomes:
measure: occurrence of oronasal fistula
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: