louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01607437: Clinical Follow-up After ACL Reconstruction
Official title: 10-year Follow-up After ACL Reconstruction With Howells Guide, Transtibial Drilling and Hamstrings Graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deficiency of Anterior Cruciate Ligament
Injury of Anterior Cruciate Ligament
Lead sponsor: Bergen Knee Group
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 96
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients reconstructed with Howells guide, hamstrings graft and transtibial drilling at Haraldsplass Deaconess Hospital from 1999 to 2001.

Brief summary: No former studies have done long-term evaluation on patients reconstructed with hamstrings graft, the use of Howells tibial guide and transtibial drilling of the femoral graft tunnel. The investigators aim to evaluate clinical, radiographic and subjective outcome at a minimum of 10 years after surgery. According to former published studies on alike methods, the use of transtibial drilling of the femoral graft tunnel causes an increased rotational instability of the knee. The investigators aim to map the clinical stability of this group as well as evaluating the general outcome at the long-time horizon.

Detailed description: Patients will be invited to a clinical follow-up with x-ray of the knee, scoring of Lysholm and IKDC subjective scores, clinical examination including instrumented testing with a KT-1000. After informed consent data will be collected from patient records and stored in a secured internal database. Analysis will be done with the SPSS package.

Eligibility criteria: Inclusion Criteria:

- Patients reconstructed with the given technique

Exclusion Criteria:

* Patients reconstructed with other techniques
* Concomitant ligamental surgery
* Bilateral ACL injury
* Revision surgery

Primary outcomes:
measure: Revision surgery
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconess Hospital
Study officials:
affiliation: Bergen Knee Group
name: Eivind Inderhaug, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00511537: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
Official title: Standard of Care Trial: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CML
ALL
AML
Myelodysplasia
Lymphoma
Myeloproliferative Disorders
Keywords: AML
ALL
CML
Lymphoma
Myelodysplasia
Unrelated stem cell transplantation
Hematopoietic disorders
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hematopoeietic Disorders

Brief summary: This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.

Detailed description: This protocol identifies a standard-of-care method for unrelated stem cell transplantation in adults. Performing this service in a consistent and documented fashion allows investigators to obtain informed consent from recipients. Data is tabulated locally for quality-control comparisons with nationally-reported standards. As a condition of maintaining transplant center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome data to the NMDP. As a result, UCSF is contributing to the resolution of remaining uncertainties regarding particular transplantation practices.

Eligibility criteria: Inclusion Criteria:

* Age \>15 and \<55
* Adequate renal function with serum creatinine \<2.0 mg/dl
* Pulmonary diffusing capacity\>50% of predicted
* Cardiac ejection fraction \>40% as measured by radionuclide wall motion study or echocardiography
* Total bilirubin must be \<2.5 mg/dl.
* Alkaline phosphatase and AST must be less than three times the upper limit of normal
* Negative serology for the human immunodeficiency virus
* Available HLA-matched donor
* Signed informed consent

Exclusion Criteria:

* No fully or single-antigen-mismatched sibling donor is available to donate stem cells
* No active liver disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas G. Martin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05879237: Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
Official title: Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2023-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.
Primary purpose: TREATMENT

Brief summary: To study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.

Detailed description: o study the efficacy of vitamin D in conjunction with Helicobacter pylori treatment in children in eradication of helicobacter pylori.

our study include 2 patient groups:

1. st group included 100 child diagnosed Helicobacter pylori infection by upper gastrointestinal endoscopy and biopsies with pathology, will receive H.pylori eradication treatment and vitamin D as an adjuvant therapy .
2. nd group will also diagnosed Helicobacter pylori infection by upper gastrointestinal endoscopy and biopsies with pathology, will receive H.pylori eradication treatment only.

Helicobacter pylori treatment :

1. amoxcillin on 50 mg/kg/day for 2 weeks
2. clarithromycin 20mg/kg/day for 2 weeks
3. proton pump inhibitor 1mg/kg/day for 1month Vitamin d dose..1000unit /day for 1 month

Eligibility criteria: Inclusion Criteria:

- Age:4-18 years children with symptomatic H pylori infection presenting with (epigastric pain, persistent vomiting and hematemesis)diagnosed by upper gastrodeudonoscopy , rapid urease test and histopathologic examination of gastric biopsies from antrum and body of the stomach.

Exclusion Criteria:

* Patient on vitamine D supplémentation
* Patient who has defect in vitamin D metabolism (chronic renal and hepatic patients, malabsorption syndromes)
* Patients who had received treatment of H.pylori previously .

Primary outcomes:
measure: Role of Vitamin D Supplementation as an Adjuvant Therapy inTreatment of Helicobacter Pylori in Children
timeFrame: Six month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Minia University, faculty of medicine
name: samir M mounir, ass prof
role: STUDY_DIRECTOR
affiliation: ain shams university .faculty of medicine
name: Yosra M awad, lecturer
role: STUDY_DIRECTOR
affiliation: Minia University, faculty of medicine
name: shimaa M yassin, ass lect
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232137: Traditional Ethiopian Coffee Ceremony in a Rural Ethiopian Hospital to Increase Hospital-based Delivery Rates
Official title: Traditional Ethiopian Coffee Ceremony in a Rural Ethiopian Hospital to Increase Hospital-based Delivery Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Setting
Maternal Health
Keywords: Coffee ceremony
Hospital-based deliveries
Maternal health
Ethiopia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Gambo General Rural Hospital
name: University of Missouri, Kansas City
First posted: 2020-01-18
Enrollment: 439
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates if organizing a postpartum traditional Ethiopian coffee ceremony will provide an incentive for our antenatal care patients to eventually deliver in our hospital. Patients are randomized to either receiving, or not receiving, a postpartum coffee ceremony for them and their relatives.

Detailed description: Ethiopia has one of the highest maternal mortality rates in the world, with an estimated maternal mortality ratio of 497 per 100,000 live births. Cultural factors contribute to the underutilization of maternal health services. In 2014, only 20% of our antenatal care patients delivered in our hospital. In order to increase health facility-based delivery rates, government-funded hospitals and health centers facilitate traditional Ethiopian coffee ceremonies after delivery. We hypothesized that organizing postpartum coffee ceremonies would motivate our antenatal care patients to deliver in our hospital and would thus increase the hospital-based delivery rate.

Eligibility criteria: Inclusion Criteria:

* Pregnant patient
* First visit to antenatal care clinic

Exclusion Criteria:

* Non-viable pregnancy

Primary outcomes:
measure: Hospital-based Delivery Rate
timeFrame: Up to 9 months
Secondary outcomes:
measure: Health Center or Health Post-delivery Rate
timeFrame: Up to 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Tobias Limperg, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284037: Improvement in Baroreflex Sensitivity in OSAS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: obstructive sleep apnea,
baroreceptors
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2006-01-31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death, was investigated in OSAS patients.


Eligibility criteria: Inclusion Criteria:

* obstructive sleep apnea syndrome

Exclusion Criteria:

* diabetes mellitus, chronic obstructive lung disease, coronary or valvular heart disease, congestive heart failure, renal failure, or endocrine dysfunction. Moreover, none of them were taking b-blockers, vasodilators, or inotropic agents at the time of enrollment in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University of Health Sciences
Study officials:
affiliation: Department of Cardiovascular Genome Science, Nagoya University School of Medicine, Nagoya, Aichi, Japan
name: Mitsuhiro Yokota, MD.PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05669937: Validity and Reliability of the Baby Preparation and Worry Scale
Official title: Turkish Validity and Reliability of the Baby Preparation and Worry Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mothers
Keywords: Infant Preparation
Worry
Mother health
Assessment Tool
Validity and Reliability,
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2023-01-03
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population for this methodological study comprised pregnant women in the third trimester reached online through pregnancy platforms (Instagram, Facebook, pregnancy class WhatsApp groups, etc.).

Brief summary: Background: Reliable and valid measurement tools are needed to capture key components of prenatal distress, including anxiety and anxiety states that may put women and children at increased risk in the postpartum period.

Aim: The aim of this study is to determine the validity and reliability of the Baby Preparation and Worry Scale (Baby-PAWS), by adapting it to Turkish culture.

.


Eligibility criteria: Inclusion Criteria:

- Women who were married, older than 18 years, at least primary school graduates, in the third trimester of pregnancy and who accepted participation in the study were included.

Exclusion Criteria:

- Pregnant women with chronic disease and psychiatric disease history were not included in the research.

Primary outcomes:
measure: "Baby Preparation and Worry Scale (Baby-PAWS)" developed by Erickson et al. to Turkish culture and perform validity and reliability studies to contribute a new scale tool specific to this field to the literature
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ordu University
Study officials:
References:
Clinical trial NCT00516737: Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.


Eligibility criteria: Inclusion Criteria:

* Greater than one year history of migraine
* Attacks typically mild when they begin and progress to moderate or severe
* Experience 1-4 migraine attacks per month

Exclusion Criteria:

* More than 15 headache days per month
* Heart disease
* Uncontrolled high blood pressure

Primary outcomes:
measure: Number of Participants Who Are Pain Free at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Number of Participants With 24-Hour Sustained Pain Freedom
timeFrame: 24 hours post-dose
measure: Number of Participants With no Rescue Use up to 24 Hours Post-Dose
timeFrame: 24 hours post-dose
measure: Number of Participants With Absence of Photophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Absence of Nausea at 2 Hours Post-dose
timeFrame: 2 hours post-dose
measure: Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
timeFrame: 2 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.
Clinical trial NCT01746537: Analysis of Anterior Chamber Inflammation by Optical Coherence Tomography
Official title: Automated Analysis of Anterior Chamber Inflammation by Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveitis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inactive and active uveitis.

Brief summary: A prospective, observational, case series investigating the feasibility of utilizing OCT scans of the anterior chamber of eyes with uveitis.


Eligibility criteria: Inclusion Criteria:

* All patients presenting to Cole Eye Institute with uveitis.

Exclusion Criteria:

* Inability to provide informed consent, including non-English speaking and cognitively/mentally impaired.
* Severe corneal opacities preventing imaging of anterior chamber

Primary outcomes:
measure: Use the OCT to objectively image and grade the degree of anterior chamber inflammation in eyes with inactive and active uveitis.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cole Eye Institute
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sunil K Srivastva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01863537: Using Multimedia Technologies to Disseminate an HIV Prevention
Official title: Using Multimedia Technologies to Disseminate an HIV Prevention Program for Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-05-29
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This RCT will randomly assign 40 of the CBOs to receive the Multimedia intervention and training package (Multimedia)and the other 40 to receive the original, manualized Connect intervention and training package (Traditional). The technology transfer process involves all agencies receiving four days of training and two planned technical assistance conference calls, by study investigative staff, in the first four months following training. Telephone assessments completed by up to 6 staff at each agency will measure primary outcomes, mediating, moderating and process measure variables at baseline, 6, 12 and 18 months post-technology transfer. The primary outcome of the study is adoptions of the Connect intervention. The unit of analysis is the CBO.


Eligibility criteria: Inclusion Criteria:

To be eligible for the study, CBOs must have reported that they

* had 501c3 status;
* provided at least a minimum level of direct contact HIV prevention services to clientele; and
* that their target population for services included heterosexual men and women.

Exclusion Criteria:

-

Primary outcomes:
measure: The mean number of Connect sessions per client/couple implemented by participating staff (at each agency) in the prior 6 months
timeFrame: 18 months
Secondary outcomes:
measure: To test whether key variables mediate adoption outcomes (e.g. staff attitudes and opinions towards programming and technology).
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Social Intervention Group
state: New York
Study officials:
affiliation: Columbia University
name: Susan S. Witte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witte SS, Wu E, El-Bassel N, Hunt T, Gilbert L, Medina KP, Chang M, Kelsey R, Rowe J, Remien R. Implementation of a couple-based HIV prevention program: a cluster randomized trial comparing manual versus Web-based approaches. Implement Sci. 2014 Sep 11;9:116. doi: 10.1186/s13012-014-0116-x.
Clinical trial NCT00226837: Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling
Official title: Quantifying Nitrous Oxide Effect on Depth of Anaesthesia Using Theoretically Based Time Series Modelling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depth of Anaesthesia
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: Australian and New Zealand College of Anaesthetists
First posted: 2005-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically based time series modelling will result in improved ability to determine nitrous oxide anaesthetic effect

Detailed description: We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Presenting for surgery under general anaesthesia

Exclusion Criteria:

* Poor English language comprehension
* Risk of reflux
* Epilepsy or other EEG abnormality

Primary outcomes:
measure: EEG index value during three concentrations of nitrous oxide
timeFrame: During induction of anaesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorn
country: Australia
facility: Swinburne University
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Kate Leslie, MD
role: PRINCIPAL_INVESTIGATOR
References: