louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01381302: Trodat 1 SPECT and Dopamine Polymorphism
Official title: Association of Polymorphism in Genes Associated With Control of Dopamine Levels in Parkinson's Disease and Tc-99m-Trodat-1 SPECT Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Severity of disease
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-06-27
Enrollment: 90
Sex: ALL
Minimum age (years): 35
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: 100 early Israeli PD patients Of jewish origin, males or females Undergoing DAT-scan examination in Wolfson medical center at early stage of disease, accompanied by a UPDRS evaluation at that stage,performed by a trained neurologist

Brief summary: The study population will include 100 parkinsonian patients in early stage of disease, with total duration not exeeding 5 years.

The patients will undergo neurologic examination and evaluation of disease severity using the unified PD rating scale. Subsequently a brain SPECT will be performed using Tc-99m-Trodat1.

Detailed description: The study sample will include 100 Israeli Jewish patients with early idiopathic PD who were not treated with anti-parkinson drugs. The clinical diagnosis will be based on the criteria of the United Kingdom Parkinson Disease Society Brain Bank.5 All patients will undergo Tc-99m-Trodat1 SPECT. The severity of the motor symptoms will be assessed with the Unified PD Rating Scale (UPDRS). Genomic DNA is extracted from peripheral blood leukocytes for genetic analysis.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria were

1. early Israeli PD patients
2. Of jewish origin, males or females
3. Undergoing DAT-scan examination in Wolfson medical center at early stage of disease, accompanied by a UPDRS evaluation at that stage,performed by a trained neurologist
4. Patients did not use any type of anti-parkinsonian drug type, at time of DAT-scan performance and UPDRS evaluation
5. DNA sample was obtained
6. Patients were able to sign an informed consent form to participate in this study.

Exclusion Criteria:

* Patients were excluded if they features secondary parkinsonism or if they were treated with medications that block dopamine receptors.

Primary outcomes:
measure: Disease severity versus genetic polymorphism
timeFrame: 1 year
Secondary outcomes:
measure: Severity of PD compared to specific striatal DAT activity as measures by Tc-99m Trodat SPECT.
timeFrame: 1 year
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson medical Center
Study officials:
affiliation: Edith Wolfson Medical Center
name: Mordechai Lorberboym, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00481702: A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Official title: A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intra-abdominal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 300
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: A multicenter study to evaluate the effectiveness of ertapenem compared to ceftriaxone/metronidazole in treating certain abdominal infections that require surgery in adult patients.


Eligibility criteria: Inclusion Criteria:

* Male or female patients age 18 or older
* Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Exclusion Criteria:

* Patient has another infection, other than abdominal
* Female patient is pregnant or planning to become pregnant

Primary outcomes:
measure: That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of abdominal infection
timeFrame: 4 weeks after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Navarro NS Jr, Campos MI, Alvarado R, Quintero N, Branicki FJ, Wei J, Shivaprakash M, Vrijens F, Giezek H, Chan CY, DiNubile MJ; Oasis II Study Team. Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections. Int J Surg. 2005;3(1):25-34. doi: 10.1016/j.ijsu.2005.03.010.
Clinical trial NCT02095002: The Effect of Modified Valsalva Maneuver on Filling Degree of Internal Jugular Vein
Official title: The Effect of Modified Valsalva Maneuver on Filling Degree of Internal Jugular Vein
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Filling of Jugular Vein Before Anesthesia With and Without Valsalva Maneuver
Keywords: modified valsalva maneuver, internal jugular vein
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female genecology patients, age 18-60 years old; weight 45-70 kg; body mass index (BMI)\>20 kg/m2 and \<30 kg/m2; American Society of Anesthesiologists (ASA) grade I-II.

The exclusion criteria were as follows: a history of chronic throat disease; upper respiratory tract infection within two weeks before surgery; and history of mental illness or communication barriers.

Brief summary: To explore the effect of modified valsalva maneuver on the filling degree of right internal jugular vein.

Method: The anteroposterior diameter and left-right diameter of right internal jugular vein in thirty adult gynecology patients were recorded during normal respiration and modified valsalva maneuver respectively.

Investigators hypothesis that modified valsalva maneuver would enchance the filling degree of right internal jugular vein.


Eligibility criteria: Inclusion Criteria:

- female patients age 18-60 years

Exclusion Criteria:

* heart or lung disease mental illness communication barriers.

Primary outcomes:
measure: the change of the diameter of right internal jugular vein after modified valsalva maneuver
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT00004802: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paralysis, Hyperkalemic Periodic
Hypokalemic Periodic Paralysis
Paramyotonia Congenita
Keywords: neurologic and psychiatric disorders
periodic paralysis
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Ohio State University
First posted: 2000-02-25
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic paralysis, and hypokalemic periodic paralysis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and diagnosis.

The weekly attack rate is determined during an 8-week assessment prior to therapy initiation and at crossover.

Patients are randomly assigned to oral dichlorphenamide (DCP) or placebo for 9 weeks and then cross to the alternate treatment. Patients on DCP at baseline continue on the same dose; those on acetazolamide (ACZ) at baseline receive a DCP dose equivalent to one fifth of the ACZ dose.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Hypokalemic periodic paralysis Typical clinical profile Normal serum thyroxine Hypokalemia during spontaneous or glucose-induced paralytic attack in subject or affected family member

Periodic paralysis associated with sodium channel 17q alpha-subunit, e.g.:

* Hyperkalemic periodic paralysis with or without myotonia
* Paramyotonia congenita with periodic paralysis

Distinct, regular episodes of weakness at least once a week and no more than 3 times a day

No history of worsening symptoms with carbonic anhydrase inhibitor

No history of life-threatening weakness episodes prior to treatment

No atypical periodic paralysis without demonstrable 17q alpha-subunit defect

--Prior/Concurrent Therapy--

No requirement for the following agents, unless for periodic paralysis:

* Diuretics
* Antiepileptics
* Antiarrhythmics
* Magnesium supplements
* Steroids
* Calcium supplements
* Beta-blockers
* Potassium supplements
* Calcium channel blockers

--Patient Characteristics--

Hepatic: No hepatic disease

Renal:

* No renal failure
* No nephrolithiasis

Cardiovascular:

* No heart disease
* No cardiac arrhythmia

Pulmonary: No restrictive or obstructive lung disease

Other:

* No active thyroid disease
* No pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Jerry R. Mendell
role: STUDY_CHAIR
References:
Clinical trial NCT01181102: A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Official title: A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: anticoagulant
venus thromboembolism
thrombosis
thromboembolism
embolism and thrombosis
deep vein thrombosis
DU-176b
Edoxaban
factor Xa
total knee arthroplasty
Enoxaparin sodium
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 716
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

* Subjects with risks of hemorrhage
* Subjects with thromboembolic risks
* Subjects who weigh less than 40 kg
* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.

Primary outcomes:
measure: Incidence of Subjects With Venous Thromboembolism Events.
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
city: Kaohsiung
country: Taiwan
Study officials:
affiliation: Osaka Koseinenkin Hospital
name: Takeshi Fuji
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.
citation: Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S, Nakamura M. Clinical benefit of graduated compression stockings for prevention of venous thromboembolism after total knee arthroplasty: post hoc analysis of a phase 3 clinical study of edoxaban. Thromb J. 2016 Jun 8;14:13. doi: 10.1186/s12959-016-0087-z. eCollection 2016.
citation: Fuji T, Wang CJ, Fujita S, Kawai Y, Nakamura M, Kimura T, Ibusuki K, Ushida H, Abe K, Tachibana S. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thromb Res. 2014 Dec;134(6):1198-204. doi: 10.1016/j.thromres.2014.09.011. Epub 2014 Sep 21.
Clinical trial NCT01439802: Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery
Official title: Transcesarean IUD Insertion: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrauterine Device Expulsion
Keywords: Postpartum IUD
Cesarean Delivery
6 months postpartum
satisfaction
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

Detailed description: This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.

Eligibility criteria: Inclusion Criteria:

* singleton gestation
* greater than 35 weeks gestation
* speaks English or Spanish
* desires IUD for contraception
* undergoing a cesarean delivery

Exclusion Criteria:

* evidence of chorioamnionitis
* history of chlamydia within this pregnancy

Primary outcomes:
measure: Number of Participants With Expulsion of IUD
timeFrame: 6 week postpartum
Secondary outcomes:
measure: Satisfaction of IUD Placement
timeFrame: 6 months postpartum
measure: Number of Participants With Expulsion of IUD
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center, Weiler Division
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Amitasrigowri Murthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04319302: Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.
Official title: Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Obstruction
Choledochal Cyst
Keywords: Choledochal cyst
Paediatric
Roux-en-Y
Bile drainage
Gastric conduit
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 8
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective review of all paediatric patients at Greys Hospital who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years

Brief summary: This was a retrospective case series experience of paediatric patients who had an Isolated vascularized gastric tube biliary enteric drainage procedure for biliary obstruction over the past five years. We reviewed our experience and outcomes.

Detailed description: Background

Despite the enormous surgical advancements in the last century, access to the biliary system is lost when a Roux-en-Y (RY) biliary drainage procedure is performed. Attempts have been made to overcome this inconvenient sequel of RY biliary drainage by the use of variations in the RY anastomosis, small bowel grafts and vascular grafts. These have been predominantly unsuccessful. The use of an Isolated Vascularized Gastric Tube (IVGT) graft has been reported in the literature, and this was successfully used for adult patients with common bile duct injuries. The investigators have adopted the technique of using an IVGT graft for bile duct reconstruction in the paediatric patients at their institution.

Method

The investigators reviewed theirr experience at Greys Hospital, Pietermaritzburg. This was a retrospective review of all paediatric patients who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years. The investgators looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.

Eligibility criteria: Inclusion Criteria:

* All patients from birth to 12 years with biliary tract obstruction requiring surgery.

Exclusion Criteria:

* biliary atresia

Primary outcomes:
measure: Bile drainage
timeFrame: 30 days
Secondary outcomes:
measure: Complications of procedure
timeFrame: 30 days
Other outcomes:
measure: Complications
timeFrame: 1 year
Locations:
city: Pietermaritzburg
country: South Africa
facility: Greys Hospital
state: Kwazulu Natal
Study officials:
References:
Clinical trial NCT04154202: The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.
Official title: The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Infection
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-06
Enrollment: 70
Sex: ALL
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: DIAGNOSTIC

Brief summary: This is a prospective study. Patients' cohort is composed of 70 consecutive post joint replacement and post tibial ORIF patients, referred by their orthopedic surgeon to the Nuclear Medicine institute of Tel Aviv Sourasky Medical Center in the diagnostic work up of post operative bone infection and or mechanical loosening.

The proposed study will be presented to the ethical committee of the medical center and will be started once approved.


Eligibility criteria: Inclusion Criteria:

1. Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening.

Exclusion Criteria:

1. Patients younger than 18 years;
2. Shorter than 3 month surgical intervention at the suspected area; Newly diagnosed (\<3 months) fractures around the prosthesis;
3. Pathological fractures (e.g. Metastatic).

Primary outcomes:
measure: To assess the role of NM imaging in the diagnosis work up of joint prosthesis and tibial ORIF complications by using GE NM/CT 870 DR camera and its accompanied tools..
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03302702: Duration of Exercise Program in Interstitial Lung Diseases.
Official title: A Comparison Trial of Eight Weeks Versus Twelve Weeks of Exercise Program in Interstitial Lung Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: exercise
duration
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We aimed to compare the functional results of the 8th week with the results of the 12th week of the exercise programs applied to the patients with ILD.

Detailed description: Exercise programs (EP) have been shown to be the effective approach for functional outcomes in interstitial lung diseases (ILD). In many studies, the duration of exercise programs varies between 8-12 weeks. However, the optimal duration of exercise program is still unknown.

We aimed to compare the results of the 8th week with the results of the 12th week of the PR programs applied to the patients with ILD.

A total of 14 patients with ILD referred to our PR unit \[11 idiopathic pulmonary fibrosis, 2 sarcoidosis (stage 3 and 4) and 1 nonspecific interstitial pneumonia\] were included in the study. Pulmonary function test, arterial blood gas analysis, 6- minute walk test, mMRC dyspnea scale, quality of life questionnaires and hospital anxiety depression scale were performed before, at the 8th and 12th weeks after the exercise program applied to the patients twice a week.

Eligibility criteria: Inclusion Criteria:

* Completed the 12 week exercise program
* Diagnosed with ILD

Exclusion Criteria:

* Not completed 12 week exercise program

Primary outcomes:
measure: Six minute walk test
timeFrame: 6 minute
Secondary outcomes:
measure: mMRC
timeFrame: 5 minutes
measure: Pulmonary Function Test
timeFrame: 20 minutes
measure: SGRQ
timeFrame: 30 minutes
measure: SF-36 Health Survey
timeFrame: 30 minutes
measure: Hospital Anxiety and Depression Inventory
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02000102: Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab

Brief summary: Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes.


Eligibility criteria: Inclusion Criteria: Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab -

Exclusion Criteria: None

-

Primary outcomes:
measure: Visual Acuity
timeFrame: 1 year
Secondary outcomes:
measure: Central Subfield Thickness on Optical Coherence Tomography
timeFrame: 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
Study officials:
References: