louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04293302: Early Postnatal Management of Gestational Brain Sonographic Malformations.
Official title: Early Postnatal Management of Gestational Brain Sonographic Malformations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Abnormalities
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-03-03
Enrollment: 350
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants who were born in Hillel Yaffe medical center during 2010-2019

Brief summary: Gestational sonographic follow up may find some brain malformations. The trial is about to characterize these findings and correlate with the immediate postnatal findings.

Detailed description: Gestational sonographic follow up may find some brain malformations (such as ventricular enlargement, agenesis of corpus callosum, etc.).The trial is about to characterize these findings and correlate with the immediate postnatal findings.

Eligibility criteria: Inclusion Criteria:

* All term newborn infants who underwent a neurologic consultation or brain ultrasound.

Exclusion Criteria:

* Prematurity

Primary outcomes:
measure: Any postnatal clinical neurologic or sonographic brain abnormality
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Neonatal intensive care unit, Hillel Yaffe medical center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Erez Nadir, MD
role: STUDY_CHAIR
References:
citation: Ghi T, Carletti A, Contro E, Cera E, Falco P, Tagliavini G, Michelacci L, Tani G, Youssef A, Bonasoni P, Rizzo N, Pelusi G, Pilu G. Prenatal diagnosis and outcome of partial agenesis and hypoplasia of the corpus callosum. Ultrasound Obstet Gynecol. 2010 Jan;35(1):35-41. doi: 10.1002/uog.7489.
Clinical trial NCT02238002: Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification
Official title: To Investigate Changes in Anterior Chamber Angle Configuration After Phacoemulsification
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Shallow Anterior Chamber
Narrow Angle
Keywords: shallow anterior chamber
narrow angle
SS-OCT
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical University

Brief summary: To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).

Detailed description: To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation in eyes with a shallow anterior chamber and narrow angle, compared with the eyes with normal anterior chamber and open angle using Swept-Source Optical Coherence Tomography (SS-OCT).

Eligibility criteria: Inclusion Criteria:

ACD was less than 2.68mm. the anterior chamber angle width on gonioscopy≤Shaffer 2 .

Exclusion Criteria:

primary or secondary glaucoma, peripheral anterior synechiae, history of ocular surgeries

Primary outcomes:
measure: anterior chamber angle parameters increased
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: WenZhou
country: China
facility: Eye Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Yun e Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964002: Efavirenz in Treating Patients With Metastatic Prostate Cancer
Official title: A Phase II Trial to Assess the Efficacy of Efavirenz in Metastatic Patients With Androgen-independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage IV prostate cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Efavirenz may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well efavirenz works in treating patients with metastatic prostate cancer.

Detailed description: OBJECTIVES:

Primary

* To assess the effect of efavirenz on the PSA non-progression rate at 3 months in patients with castration-refractory metastatic prostate cancer.

Secondary

* To assess the effect of efavirenz on the PSA non-progression rate at 6 months.
* To assess the effect of efavirenz on overall survival.
* To assess the effect of efavirenz on PSA progression-free survival..
* To assess the tolerability and safety profile of efavirenz.

OUTLINE: This is a multicenter study.

Patients receive oral efavirenz once daily in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed prostate cancer

  * Metastatic disease
  * Castration-refractory disease
* No clinical symptoms related to disease progression

PATIENT CHARACTERISTICS:

* WHO performance status 0-2

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Percentage of Participants Without Prostate-specific Antigen Progression at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Participants Without Prostate-specific Antigen Progression at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
Study officials:
affiliation: Institut Bergonié
name: Nadine Houede
role: PRINCIPAL_INVESTIGATOR
References:
citation: Houede N, Pulido M, Mourey L, Joly F, Ferrero JM, Bellera C, Priou F, Lalet C, Laroche-Clary A, Raffin MC, Ichas F, Puech A, Piazza PV. A phase II trial evaluating the efficacy and safety of efavirenz in metastatic castration-resistant prostate cancer. Oncologist. 2014 Dec;19(12):1227-8. doi: 10.1634/theoncologist.2014-0345. Epub 2014 Oct 29.
Clinical trial NCT01192802: Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
Official title: Effect of Intestinal Helminths on Gut Microflora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intestinal Diseases
Helminthiasis
Keywords: albendazole
ascaris
trichiurus
hookworms
Lead sponsor: Albert Schweitzer Hospital
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy in the school children population. The aim of this study is to evaluate the efficacy of the albendazole one versus two and three doses, in school children infected with intestinal helminth.


Eligibility criteria: Inclusion Criteria:

* presence of intestinal helminths eggs in the stool

Exclusion Criteria:

* allergy to imidazole derivate
* No intestinal helminths

Primary outcomes:
measure: parasite cleared and reduced up to 80% at day 42
timeFrame: 42 days
Secondary outcomes:
measure: Prevalence of major gut bacteria
timeFrame: 42 days
Other outcomes:
Locations:
city: Lambarene
country: Gabon
facility: Medical research Unit of Lambaréné
state: Moyen ogooue
Study officials:
References:
citation: Adegnika AA, Zinsou JF, Issifou S, Ateba-Ngoa U, Kassa RF, Feugap EN, Honkpehedji YJ, Dejon Agobe JC, Kenguele HM, Massinga-Loembe M, Agnandji ST, Mordmuller B, Ramharter M, Yazdanbakhsh M, Kremsner PG, Lell B. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection. Antimicrob Agents Chemother. 2014 May;58(5):2535-40. doi: 10.1128/AAC.01317-13. Epub 2014 Feb 18.
Clinical trial NCT03375502: A Study of MG1111 in Healthy Children
Official title: A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy Children
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2017-12-18
Enrollment: 814
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator


Eligibility criteria: Inclusion Criteria:

* Healthy children aged 12 months to 12 years.
* Subjects or parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures
* Negative history of Varicella and varicella vaccine
* Subject in good health, based on medical history and physical examination

Exclusion Criteria:

* Subjects who have a history of Varicella or administration of varicella vaccine
* Subjects who have ahd an acute febrile episode at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash.

Primary outcomes:
measure: Proportion of subjects who achieved seroconversion
timeFrame: 42 days after vaccination
Secondary outcomes:
measure: Geometric mean titer(GMT) measured by the FAMA assay
timeFrame: At day 0 and Day 42 post-vaccination
measure: Geometric mean titer(GMT) measured by gpELISA
timeFrame: At day 0 and Day 42 post-vaccination
Other outcomes:
measure: Incidence of Local/systemic solicited AEs [Safety]
timeFrame: during the first 7 days after administration of IP
measure: Incidence of Unsolicited AEs [Safety]
timeFrame: Until Day 42 after administration of IP
measure: Incidence of Serious adverse events [Safety]
timeFrame: Until 6 months after administration of IP
Locations:
city: Banpo-dong
country: Korea, Republic of
facility: The catholic university of Korea, Seoul st. mary's hospital
state: Seoul
Study officials:
References:
Clinical trial NCT05436002: Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial
Official title: Treatment of Buccal Ginvigal Recessions With the Tunnel Technique in Conjunction With Cross-linked Hyaluronic Acid and Subepithelial Connective Tissue Graft. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cross-linked Hyaluronic Acid
Keywords: cross-linked hyaluronic acid
tunnel technique
gingival recession
Lead sponsor: University of Lisbon
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

Detailed description: To evaluate the outcomes of buccal gengival recession type 1 (RT1) treated with the tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

To evaluate the esthetic outcome as perceived by periodontists, using the root coverage esthetic score (RES).

Test Group - Tunnel technique in conjunction with a cross-linked hyaluronic acid and subepithelial palatal connective tissue grafts.

Control Group - Tunnel technique and subepithelial palatal connective tissue grafts.

Eligibility criteria: Inclusion Criteria:

* None of the patients were smokers and all were systemically healthy without any signs of periodontal disease.
* Each patient had to display at least one ginvigal recession (RT1) of a depth of ≥ 2 mm.
* Patients exhibited an adequate level of oral hygiene evidenced by a full- mouth plaque score (FMPS) \< 25%39 and full-mouth bleeding score (FMBS) \< 25%.

Exclusion Criteria:

* Smokers
* Gingival recesstion RT 2 or RT 3 (Cairo 2011).

Primary outcomes:
measure: Gingival margin
timeFrame: 6 month after surgery
measure: Marginal tissue contour
timeFrame: 6 month after surgery
measure: Soft tissue texture
timeFrame: 6 month after surgery
measure: Mucogingival junction
timeFrame: 6 month after surgery
measure: Gingival color
timeFrame: 6 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Lisbon
name: Vanessa Rodrigues, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204802: Patient-Centered Advance Care Planning
Official title: A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Renal Failure
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.


Eligibility criteria: Inclusion Criteria:

* At high risk for impending death in the next 12 months

Exclusion Criteria:

* Patient not having decision-making capacity

Primary outcomes:
measure: efficacy of PC-ACP
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Karin T Kirchhoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirchhoff KT, Hammes BJ, Kehl KA, Briggs LA, Brown RL. Effect of a disease-specific planning intervention on surrogate understanding of patient goals for future medical treatment. J Am Geriatr Soc. 2010 Jul;58(7):1233-40. doi: 10.1111/j.1532-5415.2010.02760.x.
Clinical trial NCT00722202: Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males
Official title: Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of ERB-257 Administered Intravenously as a 30-Minute Infusion to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV administered ERB-257 as single ascending doses to healthy Japanese male subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy Japanese men between the ages of 20 and 50.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg2.
3. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.

Primary outcomes:
measure: To evaluate the safety and tolerability of ERB-257 as a single IV dose
timeFrame: 4 days
Secondary outcomes:
measure: To evaluate the pharmacokinetics of ERB-257 as a single IV dose
timeFrame: 4 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sekino Clinical Pharmacology Clinic
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05025202: Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training
Official title: Blood Pressure and Cardiac Autonomic Adaptations to Isometric Exercise Training: a Randomised Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, sham-controlled intervention measuring the effects of isometric exercise training (IET) on blood pressure and cardiac autonomics.

IET has been proven effective in a plethora of randomized trials, but very little research has employed a sham-controlled design. This researched involved the recruitment of 30 participants who completed a 4 week IET intervention, sham control of the IET intervention, or a non-intervention control period. Pre and post blood pressure and cardiac autonomic measures were acquired and analysed.

The hypothesis of this trial was a significant effect of IET on blood pressure, with no such effects following the sham control or normal control interventions.


Eligibility criteria: Inclusion Criteria:

* Healthy with no significant health conditions contraindicating exercise
* Over 18 years of age
* Physically inactive

Exclusion Criteria:

* Achieving current physical activity guidelines
* Abnormal resting ECG
* under 18

Primary outcomes:
measure: Blood pressure (systolic, diastolic and mean BP)
timeFrame: At the start of the intervention (pre 4 week intervention)
measure: Blood pressure (systolic, diastolic and mean BP)
timeFrame: At the end of the intervention (post 4 weeks)
measure: Cardiac autonomics measured at HRV
timeFrame: At the start of the intervention (pre 4 week intervention)
measure: Cardiac autonomics measured at HRV
timeFrame: At the end of the intervention (post 4 weeks)
Secondary outcomes:
measure: continuous 5-minute blood pressure (systolic, diastolic and mean BP)
timeFrame: At the start of the intervention (pre 4 week intervention)
measure: continuous 5-minute blood pressure (systolic, diastolic and mean BP)
timeFrame: At the end of the intervention (post 4 weeks)
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: Canterbury Christ Church University
state: Kent
Study officials:
References:
citation: Decaux A, Edwards JJ, Swift HT, Hurst P, Hopkins J, Wiles JD, O'Driscoll JM. Blood pressure and cardiac autonomic adaptations to isometric exercise training: A randomized sham-controlled study. Physiol Rep. 2022 Jan;10(2):e15112. doi: 10.14814/phy2.15112.
Clinical trial NCT01981902: Non-Invasive Optical Spectroscopic Methods for Dehydration Identification in Marathon Trainees
Official title: Non-Invasive Optical Spectroscopic Methods for Dehydration Identification in Marathon Trainees
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dehydration
Keywords: Dehydration
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2013-11-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population are the volunteers who are training for a marathon individually or under the guidance of the Leukemia Society Team in Training, the American Heart Association, or similar groups. These organizations run programs that include providing group-training situations for individuals interested in preparing for a marathon while participating in fund raising efforts.

Brief summary: Dehydration can result from exposure to harsh environments including hot and dry desert climates. Soldiers and non-military workers are frequently required to work in hot, dry conditions, and dehydration can be productivity limiting and life threatening if unrecognized.

Detailed description: The research can use low power laser technology to take measurements of muscle tissue water content in volunteers before and after marathon training runs to detect dehydration. Two slightly different devices can be used to detect dehydration. 1). diffuse optical spectroscopy and 2). spatial frequency domain imaging-modulated imaging The researchers can determined by use other methods to assess the level of dehydration status in runners. These methods will include taking weight and temperature before and after run, skin-fold measurements pre and post run, and obtaining saliva samples from before and after run. The researchers can determine the study use non-invasive, laser light technology measure tissue water concentrations, as an indicator of dehydration.

Eligibility criteria: Inclusion Criteria:

* male female ages of 18 and 60
* training for a marathon

Exclusion Criteria:

1. Poorly controlled diabetes mellitus
2. Diabetes insipidus (excessive urination of water) as diagnosed by your physician
3. disorder of the intestine
4. Irritable bowel syndrome with excessive diarrhea, as diagnosed by a physician
5. Congestive heart failure and subsequent use of a diuretic "water pill" to remove excess water from the body
6. Have poor kidney function
7. Have been diagnosed with hyperthyroidism/hypothyroidism by your physician

Primary outcomes:
measure: Hydration
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute University of California Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Matthew Brenner, MD
role: PRINCIPAL_INVESTIGATOR
References: