louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01778725: Early Identification of Brain Insult in Chorioamnionitis
Official title: S100B as a Marker for Fetal Brain Injury in Premature Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chorioamnionitis
Cerebral Palsy
Keywords: Chorioamnionitis, S100B, Brain, Neuro-development
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with premature rupture of the amniotic sac.

Brief summary: Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus. Fetus' brain is highly vulnerable and could be harmed even by mild inflammation before fulminant infection is developed. The aim of this study is to identify, as early as, possible signs of brain injury. S100B protein will be used as a marker for brain insult. S100b level were associated with the occurrence and size of stroke and brain trauma in adults and children. Moreover, S100B crosses the membrane and its level in women with preterm labor was associated with brain injury of preterm infant.

The study question is whether the levels of S100B in women with early amniotic fluids breakdown are associated with future brain injury of the infant, as assessed by head ultrasound and neurological examination.


Eligibility criteria: Inclusion Criteria:

* Rupture of the amniotic sac before 32 weeks
* Gestational age less than 32 weeks
* Singleton

Exclusion Criteria:

* Intrauterine growth restriction
* Positive TORCH
* Fetus' brain malformation
* Fetus' brain hemorrhage
* Maternal medication with teratogenic effect

Primary outcomes:
measure: Developmental assessment
timeFrame: 18 month
measure: Developmental assessment
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Seba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Boaz Weisz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02888925: Anterior Temporal Epilepsy Neuropsychological Assessment of Faces
Official title: Evaluation of Neuropsychological Effects of Drug-resistant Anterior Temporal Epilepsy and Anterior Temporal Lobectomy in Face Perception
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Temporal Epilepsy
Anterior Temporal Lobectomy
Face Perception
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched.

Secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).


Eligibility criteria: Inclusion Criteria:

ALL:

* Informed consent
* Affiliation to social security
* Preliminary medical examination

PATIENTS WITH EPILEPSY:

* Symptomatic drug-resistant anterior temporal epilepsy (confirmed with video-electroencephalography and magnetic resonance imaging and if necessary intracerebral SEEG exploration)
* Patient needing anterior temporal lobectomy and undergoing pre-surgery conventional intercritical assessment for surgery decision
* Nonverbal IQ ≥ 70 (WAIS-IV)
* At least 6 successful VOSP tests (perception test)

Exclusion Criteria:

ALL:

* persons under legal protection or incapable to consent
* Persons deprived of liberty by juridical or administrative decision

PATIENTS WITH EPILEPSY:

- Sever visual disorders of neurological or ophthalmological origin

CONTROL INDIVIDUALS:

* Psychiatric or neurological disorders
* Important ophthalmological disorders

Primary outcomes:
measure: Scores obtained with Benton test by patients with anterior temporal epilepsy and matched control individuals
timeFrame: day 0
Secondary outcomes:
measure: Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)
timeFrame: day 0 and after 12 to 18 months
measure: Change of scores obtained with Benton test by epilepsy patients before and after lobectomy and control individuals (only patients having undergone anterior temporal lobectomy and matched control individuals)
timeFrame: day 0 and after 24 to 30 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service de Neurologie, Hôpital Central, CHU de Nancy
Study officials:
affiliation: Service de Neurologie, Hôpital Central, CHU de Nancy, France
name: Louis Maillard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01929525: Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula
Official title: Effectiveness of Silver Nitrate Solution in the Treatment of Anal Fistula: A Novel Strategy for Managing Anal Fistula
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal Fistula
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 70
Sex: MALE
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: Patients with the diagnosis of anal fistula

Brief summary: Effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated.

Detailed description: The anal fistula is a granulation tissue-lined tract, we thought of a way to ablate this granulation tissue using a chemical agent, which would eventually induce healing with fibrosis and closure of the tract without any surgical intervention. Aiming to reduce the surgery related complications; we investigated the effectiveness of silver nitrate solution as a chemical agent in the treatment of anal fistula.

Eligibility criteria: Inclusion Criteria:

All patients with the diagnosis of anal fistula Patients with recurrence

Exclusion Criteria:

Patients who do not sign the informed consent

Primary outcomes:
measure: Number of anal fistula patients treated with silver nitrate solution.
timeFrame: 1 year
Secondary outcomes:
measure: Therapeutic factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: MarmaraUSM
Study officials:
affiliation: Marmara University
name: S.CUMHUR YEGEN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00231725: Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin
Official title: Complaints Associated With Use of Pre-Filled Pen B When Used by Patients With Type 2 Diabetes on Twice-Daily Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 370
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection \[rDNA origin\] Low Mix twice daily during the trial.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* Already on Lilly insulin or beginning insulin therapy
* 25 to 75 years old inclusive

Exclusion Criteria:

* Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country
* More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial

Primary outcomes:
measure: To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.
Secondary outcomes:
measure: To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia
measure: To assess overall patient perception of the device's performance through a patient questionnaire.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Tennessee
city: Pamplona
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Requena
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Middlesbrough
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05403125: SDF Application in Oral Cancer Patients to Prevent Dental Caries
Official title: Silver Diamine Fluoride: Novel Addition to the Prophylactic Bundle for Dental Management of Radiation-Induced Dental Caries in Oral and Pharyngeal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Oral and Pharyngeal Cancer
Xerostomia
Silver diamine fluoride
Sodium fluoride gel 5000 PPM
Lead sponsor: Texas A & M University Baylor College Of Dentistry
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2022-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial, Intention to Treat
Primary purpose: TREATMENT

Brief summary: The Texas A \& M College of Dentistry, with partner Texas Oncology-Baylor Charles A. Sammons Cancer-Center Radiation-Oncology, proposes to conduct a preliminary clinical study (NIH Stage 0) to pilot test a randomized clinical trial of the efficacy of professionally applied 38% silver diamine fluoride to prevent tooth decay in 60 patients who are being treated with radiation for life threatening head and neck cancer.

Detailed description: Head and neck cancer has increased in Texas over the last two decades. Radiation-induced tooth decay is a devastating yet potentially preventable side effect of the cancer treatment. Silver diamine fluoride, already the standard of care in children, is inexpensive, easy to apply, and safe. The objective of the research is to conduct a single site pilot RCT (NIH Stage 0) to determine feasibility and preliminarily assess the efficacy of 38% silver diamine fluoride and 5000 PPM fluoride gel for prevention of radiation-induced dental caries over 6 months. Eligible participants will be up to 60 head and neck cancer patients who are scheduled for radiotherapy. The proposed intervention will be applied within 1 m before and at 1- and 3-m post radiation. The primary outcome is dental caries surfaces at 6 months post-radiotherapy (DMFS).Secondary outcomes are The Gingival Index, Gingival Bleeding Index, MDASI-HN, and Oral Health Quality of Life score will be secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Head and Neck cancer

Exclusion Criteria:

* Prognosis less than 1 year
* Radiation field of treatment does not involve jaws

Primary outcomes:
measure: Dental Caries (DMFS)
timeFrame: 6 months
Secondary outcomes:
measure: Gingival Index
timeFrame: 6 months
measure: Bleeding Index
timeFrame: 6 months
measure: Oral Health Quality of Life
timeFrame: 6 months
measure: MD Anderson Symptom Inventory-Head and Neck
timeFrame: 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor College of Dentistry
state: Texas
Study officials:
affiliation: TAMU Baylor College of Dentistry
name: Amal Noureldin, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00344825: Vitalis Study - Observational Study on the Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia (B-CLL)
Official title: Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, B-Cell, Chronic
Keywords: B- Chronic Lymphocytic Leukemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-06-27
Enrollment: 300
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, aged \>/= 18 years, either sex with B-CLL, who are starting a new pharmacological treatment for B-CLL (1st, 2nd, 3rd, 4th), duration of CLL therapy \</= 6 months, WHO Performance Status \&#8804; 2, life expectancy \>/= 6 months

Brief summary: 300 patients, starting a new pharmacological treatment for B-CLL, were enrolled by 36 Italian Centres for assessing the Quality of Life (QoL). A descriptive analysis of QoL and the correlation of the age, sex, stage of disease, Time from first B-CLL diagnosis, Number of previous B-CLL treatments, reason of starting of the new B-CLL treatment: therapeutic Regimen, type of Centre, B-CLL treatment lasting, response to B-CLL treatment.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Aged \>/=18 years
* Patients of either sex with B-CLL, who are starting a new pharmacological treatment for B-Chronic Lymphocytic Leukemia (1st, 2nd, 3rd, 4th)
* Foreseen duration of CLL therapy \</= 6 months
* B-Chronic Lymphocytic Leukemia progressive stage A, stage B or C (according to Binet system), or II-IV (according to Rai system)
* WHO Performance Status \</= 2
* Life expectancy \</= 6 months
* Signed Informed consent for personal data's treatment and availability to fill in the QoL questionnaire

Exclusion Criteria:

* Patients with any other tumour disease
* Chronic Lymphocytic Leukemia therapy in the last 30 days before V0
* More than 3 previous CLL treatments (the therapy is defined by the drug and/or the treatment period)
* Previous stem cells transplantation
* Concurrent or in the last 30 days participation to any other clinical trial
* Any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the QoL questionnaire

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Many locations
country: Italy
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01470625: Improving Quality of Care for the Dying Patient in Hospice: A Quasi Experimental Trial in Liguria Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-of-Life
Keywords: Dying
Patients
Hospice
Liverpool Care Pathways
Lead sponsor: Regional Palliative Care Network
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 282
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a before-after phase II study, according to the Medical Research Council framework, investigating the feasibility of introducing the Liverpool Care Pathway for the dying patient (LCP) in 5 Ligurian hospices.


Eligibility criteria: Inclusion Criteria:

* All patients deceased in the hospice during the evaluation period
* Approval of ethics committee

Exclusion Criteria:

* Prior use of LCP in the hospice
* Deceased was a relative of a hospice member of staff

Primary outcomes:
measure: feasibility of LCP implementation
timeFrame: 6 months after the end of LCP implementation
Secondary outcomes:
measure: quality of information provided to patients and to family
timeFrame: 2-4 months after the patient's death
measure: Level of advanced care planning among patients
timeFrame: 2 - 4 months after the patient's death
measure: Provision of care focusing on patient's individual needs.
timeFrame: 2 - 4 months after the patient's death
measure: Quality of emotional support to family members before an after the patient's death
timeFrame: 2 - 4 months after the patient's death
measure: Level of care coordination
timeFrame: 2 - 4 months after the patient's death
measure: Family support levels
timeFrame: 2 - 4 months after the death of the patient
measure: Appropriateness of therapeutic and diagnostic procedures
timeFrame: the last 3 days of life
measure: Overall quality of care experience for patients and family
timeFrame: 2 - 4 months after the death of the patient
measure: Quality of communication between General Practitioner and hospice
timeFrame: an expected average of 2 months after the patient's death
Other outcomes:
Locations:
city: Chiavari
country: Italy
facility: Hospice ASL 4
state: Genova
city: Genova
country: Italy
facility: Hospice Gigi Ghirotti "Albaro"
city: Genova
country: Italy
facility: Hospice Gigi Ghirotti "Bolzaneto"
city: Imperia
country: Italy
facility: Hospice ASL1 Liguria
city: Savona
country: Italy
facility: CENTRO MISERICORDIA" SANTA M.G.ROSSELLO. Ist.Figlie Ns Signora Misericordia
Study officials:
affiliation: IRCCS AOU San Martino- IST
name: Massimo Costantini
role: STUDY_CHAIR
References:
Clinical trial NCT04923425: Gustatory Modulators Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy
Official title: Gustatory Modulators Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy. A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Taste Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Depressed Egyptian adults under anti-depressants therapy The patients will be recalled using their phone numbers recorded in their follow up records in order to come to the Diagnosis center at the faculty of Dentistry, Cairo University to be assessed for possible gustatory dysfunction modulators and will be given identification numbers and divided into three groups, to which the operator shall be blinded.

Brief summary: Identify possible modulators for developing gustatory dysfunction among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Detailed description: PECO

* P Population: depressed Egyptian adults under anti-depressants therapy
* E1 Exposure 1: commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL)
* E2 Exposure 2: commonly prescribed Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine)
* C control (non exposure) : non-pharmacological treatment ( psychotherapy)
* O Outcome: Identify possible gustatory dysfunction modulators among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Eligibility criteria: Inclusion Criteria:

* • Depressed Egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy)

  * Age from 20 to 50 years old

Exclusion Criteria:

* Antipsychotics

  * Hypnotics
  * Anticonvulsants
  * Ages other than the mentioned • Olfactory dysfunction
  * Chemosensory dysfunction

Primary outcomes:
measure: Gustatory dysfunction modulators
timeFrame: during a period of 7months from February 2020 till August 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT04372225: Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy
Official title: Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy: is Safe Discharge Without Supplementation Possible?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism
Keywords: thyroidectomy
hypocalcemia
hypoparathyroidism
discharge
PTH
Lead sponsor: Aix Marseille Université
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 477
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Analysis of calcium and PTH levels in postoperative day 1

Brief summary: With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia.

The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.

Detailed description: Our study consists of analyzing the calcium (mmol/l) and PTH (pmol/l) levels on the first postoperative day. Postoperative treatment with calcium and vitamin D and the length of hospital stay is also taken into consideration.

We also analyze post-operative complications.

Eligibility criteria: Inclusion Criteria:

• Total thyroidectomy

Exclusion Criteria:

* concomitant parathyroidectomy for primary hyperparathyroidism
* lobectomy only
* completion thyroidectomy
* central and lateral neck dissection
* patients with calcium and/or vitamin D supplementation prior surgery
* patients with known and significant osteoporosis and renal failure

Primary outcomes:
measure: calcium and PTH thresholds
timeFrame: one years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Conception Hospital
Study officials:
References:
citation: Paladino NC, Guerin C, Graziani J, Morange I, Loundou A, Taieb D, Sebag F. Predicting risk factors of postoperative hypocalcemia after total thyroidectomy: is safe discharge without supplementation possible? A large cohort study. Langenbecks Arch Surg. 2021 Nov;406(7):2425-2431. doi: 10.1007/s00423-021-02237-2. Epub 2021 Aug 10.