louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01551134: Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
Official title: IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux
Fundoplication
Randomized Controlled Trial
General Surgery
Child
Laparoscopy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2012-03-12
Enrollment: 88
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.


Eligibility criteria: Inclusion Criteria:

* Age 0-15 years
* All patients accepted for primary fundoplication at Oslo University Hospital

Exclusion Criteria:

* Age over 16 years
* Parents not speaking Norwegian or English well
* Prior fundoplication
* Patients with comorbidities considered as unsuited for laparoscopic surgery (diaphragma hernia, several previous abdominal operations etc)

Primary outcomes:
measure: Recurrence of reflux
timeFrame: 12, 24 and 48 months
Secondary outcomes:
measure: Postoperative complication rate
timeFrame: 30 days
measure: Inflammatory response
timeFrame: The first 4 p.o days
measure: Parental stress
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
name: Kristin Bjornland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fyhn TJ, Kvello M, Edwin B, Schistad O, Pripp AH, Emblem R, Knatten CK, Bjornland K. Outcome a decade after laparoscopic and open Nissen fundoplication in children: results from a randomized controlled trial. Surg Endosc. 2023 Jan;37(1):189-199. doi: 10.1007/s00464-022-09458-6. Epub 2022 Aug 1.
citation: Kvello M, Avitsland TL, Knatten CK, Fyhn TJ, Malt U, Emblem R, Bjornland K. Psychologic Distress and Anxiety in Mothers of Children With Gastroesophageal Reflux Undergoing Antireflux Surgery. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):818-823. doi: 10.1097/MPG.0000000000002286.
Clinical trial NCT02327234: Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma
Official title: Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.


Eligibility criteria: Inclusion Criteria:

* diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently
* has allergies that trigger asthma
* responds to methacholine challenge at 16mg/ml or less
* has FEV1 \> 69.5% predicted

Exclusion Criteria:

* respiratory illness within 4 weeks
* other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data
* pregnant or lactating females
* hypersensitivity to ibuprofen

Primary outcomes:
measure: Airway response to inhaled allergen
timeFrame: at time of allergen inhalation challenge and for 7 hours after
Secondary outcomes:
measure: Airway response to inhaled methacholine
timeFrame: day before allergen inhalation challenge and 8 hours after allergen inhalation challenge
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Don Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nomani S, Cockcroft DW, Davis BE. Allergen inhalation challenge, refractoriness and the effects of ibuprofen. Allergy Asthma Clin Immunol. 2016 May 24;12:24. doi: 10.1186/s13223-016-0127-z. eCollection 2016.
Clinical trial NCT06704334: The Study of Ginkgo Leaf Dropping Pills and Huperzine a Injection Combined with Median Nerve Electrical Stimulation in the Treatment of Cognitive Impairment After Brain Injury
Official title: The Study of Ginkgo Leaf Dropping Pills and Huperzine a Injection Combined with Median Nerve Electrical Stimulation in the Treatment of Cognitive Impairment After Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cognitive Impairment After Brain Injury
Lead sponsor: Wanbangde Pharmaceutical Group Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Ganzhou City People's Hospital
First posted: 2024-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will conduct a single-center clinical trial to explore the initial therapeutic effect of ginkgo biloba dropping pills, huperzine A injection and median nerve electrical stimulation in patients with cognitive impairment.

Detailed description: Specific experimental research methods were randomized, controlled, single-center, exploratory clinical study, through the treatment of ginkgo biloba dropping pills, huperzine A injection and median nerve electrical stimulation in patients with cognitive impairment, to observe the effects of their neuroprotection and cognitive function improvement.

Eligibility criteria: Inclusion Criteria:

* Be over 18 years old

  * Residual cognitive impairment due to brain injury

    * No previous history of brain-related diseases except this one

Exclusion Criteria:

* The patient had severe underlying disease and unstable vital signs

  * The patient was complicated with consciousness disorder and could not cooperate with cognitive function assessment ③ Allergic to drugs or contraindications in drug use ④ There are contraindications of median nerve electrical stimulation

Primary outcomes:
measure: to assess the MMSE score
timeFrame: baseline，Day10，Day90
Secondary outcomes:
measure: to assess the MoCA score
timeFrame: baseline，Day10，Day90
measure: to assess the ADAS-cog score
timeFrame: baseline，Day10，Day90
measure: to assess the HAMD score
timeFrame: baseline，Day10，Day90
measure: to assess the HAMA score
timeFrame: baseline，Day10，Day90
Other outcomes:
Locations:
city: Ganzhou
country: China
facility: The Ganzhou City People's Hospital
state: Jiang Xi province
Study officials:
References:
Clinical trial NCT02476734: FDG-PET/CT Imaging as Early Predictor of DP
Official title: A Pilot Study Using FDG-PET/CT Imaging as an Early Predictor of Disease Response in Lymphoma Subjects Receiving Redirected Autologous CART- 19 T-cell Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: REDIRECTED AUTOLOGOUS CART- 19 T-CELL IMMUNOTHERAPY
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with DLBCL and FL treated on a phase I study with Autologous T cells

Brief summary: In this study the investigators would like to describe FDG-PET/CT responses in patients who are receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects will undergo two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan at about 1 month after infusion.

Detailed description: In this study the investigators described FDG-PET/CT responses in patients who were receiving CART-19 immunotherapy for Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL) as part of UPCC #13413. Subjects underwent two FDG-PET/CTs. One performed within 6 weeks of CART-19 infusion and a repeat scan at about 1 month after infusion.

Eligibility criteria: Inclusion Criteria:

* Subjects enrolled on the study UPCC 13413 Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-Cd19 Attached To Tcr And 4-1bb Signaling Domains In Patients With Chemotherapy Resistant Or Refractory Cd19+ Lymphoma CART-19 autologous T-cell trial with relapsed or refractory DLBCL and FL. As this is a pilot study, we plan to enroll 4 subjects from the two disease types of interest.
* Subjects ≥ 18 years of age
* Subjects able to provide informed consent and agree to comply with study procedures

Exclusion Criteria:

* Subjects who are pregnant or lactating.
* Subjects will be co-enrolled in this study and UPCC 13413 and therefore must comply with the UPCC 13413 Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-Cd19 Attached To Tcr And 4-1bb Signaling Domains In Patients With Chemotherapy Resistant Or Refractory Cd19+ Lymphoma requirements pertaining to pregnancy, lactation, conception and contraception use throughout their participation in both studies.

Primary outcomes:
measure: Global objective tumor response measured from serial PET/CT scans
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Jakub Svoboda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700934: Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema
Official title: Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema. A National Registry.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alpha 1-Antitrypsin Deficiency
Emphysema
Keywords: FEV1
mortality
Quality of life
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-06-19
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: Emphysema associated alpha-1 antitrypsin deficiency

Brief summary: The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin associated emphysema and to figure out associated prognostic factors.

Detailed description: All patients who suffer from this disease are followed every 6 months during a 5 years period. FEV1 decline is the primary endpoint. Quality of life assessed using the Saint George's Respiratory Questionary is recorded too.

Eligibility criteria: Inclusion Criteria:

* Serum alpha one antitrypsin \< 0.8 g/l
* Emphysema diagnosed by CT scan
* Adult
* Obstructive disorder

Exclusion Criteria:

* Liver or lung transplantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'épidémiologie, Hôpital Bichat
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gabriel Thabut, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gauvain C, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Thabut G. Health-related quality of life in patients with alpha-1 antitrypsin deficiency: the French experience. COPD. 2015 May;12 Suppl 1:46-51. doi: 10.3109/15412555.2015.1022645.
citation: Thabut G, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Porcher R. Performance of the BODE index in patients with alpha1-antitrypsin deficiency-related COPD. Eur Respir J. 2014 Jul;44(1):78-86. doi: 10.1183/09031936.00168113. Epub 2014 Feb 13.
Clinical trial NCT03020134: Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China
Official title: Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Danoprevir/r
Ravidasvir
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent
* Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
* If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
* If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
* If female, negative pregnancy test during the screening period.
* Others as specified in the detailed protocol

Exclusion Criteria:

* History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor.
* Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
* History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
* Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
* Others as specified in the detailed protocol

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 40 days
Secondary outcomes:
measure: Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
timeFrame: Up to 24 weeks
measure: Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
timeFrame: Up to 24 days
Other outcomes:
Locations:
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Huoling Tang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00851734: A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)
Official title: A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keratoconjunctivitis Sicca
Lead sponsor: Lux Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
* Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
* Corrected Snellen acuity of 20/40 or better in both eyes

Exclusion Criteria:

* Subjects diagnosed with any ocular disease other than refraction error
* Subjects with intraocular pressure \>21 mmHg
* Use of a contact lens within 7 days prior to administration of the first dose
* Subjects with history of ocular surgery
* Subjects with a history of laser refractive surgery

Primary outcomes:
measure: ocular irritation
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Conshohocken
country: United States
facility: Product Investigations
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00689234: Diaphragm Plication in Adults With Phrenic Nerve Paralysis
Official title: Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phrenic Nerve Paralysis
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm plication in a prospective randomised controlled way on symptoms, pulmonary function including gas exchange, respiratory muscle strength, exercise capacity and breathing during sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least 1 year without any evidence of spontaneous recovery.


Eligibility criteria: Inclusion Criteria:

* Uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year
* With reduced VC, at least in supine position and no significant change in VC for at least 6 months
* At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea

Exclusion Criteria:

* No informed consent obtained
* Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,....
* Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease
* Known diseases resulting in abnormal blood coagulation
* Proven oncological origine of the phrenic nerve paralysis
* Age below 18 yrs old

Primary outcomes:
measure: Dyspnea
timeFrame: 6 months after inclusion
measure: Dyspnea
timeFrame: 12 months after inclusion
measure: Exercise capacity
timeFrame: 6 months after inclusion
measure: Exercise capacity
timeFrame: 12 months after inclusion
Secondary outcomes:
measure: Pulmonary function
timeFrame: 6 months after inclusion
measure: Pulmonary function
timeFrame: 12 months after inclusion
measure: Sleep
timeFrame: 6 months after inclusion
measure: Sleep
timeFrame: 12 months after inclusion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg Divisionof Pulmonology
Study officials:
References:
Clinical trial NCT01835834: Clinical Study on Zirconia Bridges
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Missing Teeth
Keywords: zirconia crown
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.


Eligibility criteria: Inclusion Criteria:

The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.

* The subject is healthy and compliant with good oral hygiene
* The subject is in need of a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible.
* The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
* Obtained informed consent from the subject the subject should be available for the 5-year term of the investigation.
* No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
* Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
* The subject should be available for the 5-year term of the investigation.

Exclusion Criteria:

* The subject is not able to give her/his informed consent to participate.
* Alcohol or drug abuse as noted in patient records or in patient history.
* Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
* An existing condition where acceptable retention of the restoration is impossible to attain
* Mobility of the tooth to be restored.
* Pathologic pocket formation of 4 mm or greater around the tooth to be restored
* Severe bruxism or other destructive habits
* Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
* Health conditions, which do not permit the restorative procedure

Primary outcomes:
measure: survival rate of NobelProcera™ Bridge Shaded Zirconia
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: