louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00684424: Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Official title: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients

Brief summary: The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase


Eligibility criteria: Inclusion Criteria:

* age over 18 years old, patients with epilepsia with partial seizures
* Enrollment to study is fully on physician decision in compliance with current SPC.

Exclusion Criteria:

* Patient who did not meet indication according to SPC Lyrica

Primary outcomes:
measure: Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
timeFrame: Baseline through Week 16
Secondary outcomes:
measure: Antiepileptic Drugs Used in the Past
timeFrame: Baseline
measure: Change in 28 Day Partial Seizure Frequency
timeFrame: Baseline through Week 16 (Final Visit )
measure: Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study
timeFrame: Week 8 up to Week 16 (Last 4 weeks of the treatment period)
measure: Concomitant Drug Treatments
timeFrame: Baseline through Week 16 (Final Visit)
measure: Average Dosage of Pregabalin Taken at Baseline and Final Visit
timeFrame: Baseline, Week 16 (Final Visit )
measure: Visual Analog Scale of Anxiety (VAS-A)
timeFrame: Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward
measure: Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)
timeFrame: Baseline, Week 16 (Final Visit), Last Observation Carried Forward
measure: Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline
measure: Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
timeFrame: Week 16 (Final Visit)
measure: Medical Outcomes Sleep Scale (MOS-S)
timeFrame: Baseline, Week 16 (Final Visit )
measure: Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
timeFrame: Baseline, Week 16 (Final Visit)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01576224: Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures
Official title: Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Volar locking plate osteosynthesis
Early mobilization
DASH
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Region Sjællands sundhedsvidenskabelige Forskningsfond
First posted: 2012-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the post operational mobilization after volar locking plate osteosynthesis of distal radius fractures. One group is admitted training exercises just after the fracture treatment, one group after 14 days immobilization in a cast.

The primary hypothesis is, that immediate training leads to earlier and faster recovery.

Our second hypothesis is, that immediate training does not lead to increased risk of fracture displacement.

Detailed description: Patients were followed for one year with controls after one, three, six and twelve months. Occupational therapists blinded for the intervention examined the patients at all times. ROM, strength and DASH score was performed.

Eligibility criteria: Inclusion Criteria:

* Over 50 years of age
* Distal radius fracture suitable for volar locking plate osteosynthesis
* Inhabitants in Region Sjaelland

Exclusion Criteria:

* Dementia
* Abuse of drugs, medication or alcohol
* Open fractures
* Multitrauma or other injures on same extremity
* Earlier wrist fracture
* Delay of osteosynthesis of more than 14 days

Primary outcomes:
measure: Disability of arm, shoulder and hand score (DASH)
timeFrame: After 4 weeks
measure: Disability of arm, shoulder and hand score (DASH)
timeFrame: After 3 months
measure: Disability of arm, shoulder and hand score (DASH)
timeFrame: After 6 months
measure: Disability of arm, shoulder and hand score (DASH)
timeFrame: After 12 months
Secondary outcomes:
measure: Range of motion
timeFrame: After 4 weeks
measure: Range of motion
timeFrame: After 3 months
measure: Range of motion
timeFrame: After 6 months
measure: Range of motion
timeFrame: After 12 months
measure: Grip strength
timeFrame: After 4 weeks
measure: Grip strength
timeFrame: After 3 months
measure: Grip strength
timeFrame: After 6 months
measure: Grip strength
timeFrame: After 12 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Køge Sygehus
Study officials:
affiliation: Køge Sygehus, Denmark
name: Thomas J Sørensen, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02873624: Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy
Official title: Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury ,Laparoscopic Cholecystectomy
Keywords: Acute Kidney Injury , Laparoscopic Cholecystectomy
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2016-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A single center prospective observational cohort study will be conducted. 100 patients undergoing elective laparoscopic cholecystectomy in the Galilee Medical Center will be included.

Brief summary: The aim of this study is to establish AKI incidence in patients who are undergoing laparoscopic cholecystectomy and to identify the potential risk factors associated with the development of AKI.

Detailed description: Introduction: Laparoscopic procedure produces adverse effects on splanchnic organs. Pneumoperitoneum is a non-physiologic condition that causes a higher intra-abdominal pressure (IAP) and is associated with significant direct and indirect effects on renal physiology.

Aim of the study:

To establish AKI incidence in patients who are undergoing laparoscopic cholecystectomy.

To identify the potential risk factors associated with the development of AKI. To establish the relationship between the IAP during the procedure and the AKI incidence.

Study Design:

Study population: A single center prospective cohort study will be conducted. 100 patients undergoing elective laparoscopic cholecystectomy in the Galilee Medical Center will be included.

Inclusion criteria: age \> 18 years, able to sign the consent form, stable kidney function.

Exclusion criteria: end stage renal disease, acute kidney injury or need of dialysis three months prior the procedure, acute infection, acute inflammation, BMI \> 40, malignancy and pregnancy.

The diagnosis of AKI will be made based on Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline 2012, by comparing the baseline and post-operative serum creatinine and cystatin C and monitoring urine output during the procedure and after the procedure for 24 hours.

Data Analysis: Results will be presented as mean ± standard deviation for quantitative data. A p value of \<0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years, able to sign the consent form, stable kidney function.

Exclusion Criteria:

* end stage renal disease
* acute kidney injury or need of dialysis three months prior the procedure
* acute infection
* acute inflammation
* malignancy
* pregnancy

Primary outcomes:
measure: The incidence of AKI following a laparoscopic cholecystectomy
timeFrame: Up to one week after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
References:
Clinical trial NCT04145024: Giessen Pulmonary Hypertension Registry and Biobank
Official title: Giessen Pulmonary Hypertension Registry and Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes patients referred to our tertial PH expert center in Giessen with suspected PH.

Brief summary: Giessen Pulmonary Hypertension Registry and Biobank

Detailed description: Long-term transplant-free survival and its determinants will be investigated in patients with Pulmonary Hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in Giessen, Germany.

Eligibility criteria: Inclusion Criteria:

* Right heart catheterization for PH diagnosis in Giessen

Exclusion Criteria:

* informed consent missing

Primary outcomes:
measure: Survival
timeFrame: Up to 20 years after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Department of Intermal Medicine - Universities of Giessen and Marburg Lung Center
Study officials:
affiliation: University Clinics of Giessen and Marburg
name: Khodr Tello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gall H, Felix JF, Schneck FK, Milger K, Sommer N, Voswinckel R, Franco OH, Hofman A, Schermuly RT, Weissmann N, Grimminger F, Seeger W, Ghofrani HA. The Giessen Pulmonary Hypertension Registry: Survival in pulmonary hypertension subgroups. J Heart Lung Transplant. 2017 Sep;36(9):957-967. doi: 10.1016/j.healun.2017.02.016. Epub 2017 Feb 17.
Clinical trial NCT02399124: Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma
Official title: ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: RCC
Renal Cell Carcinoma
Kidney tumors
Lead sponsor: IceCure Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Bnai Zion Medical Center
name: Assaf-Harofeh Medical Center
First posted: 2015-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This experiment is designed for post marketing data collection of a cryosurgical system \[PROSENSE™ of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).

Detailed description: A post marketing data collection of a cryosurgical system \[PROSENSE™\] of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).

Eligibility criteria: Inclusion Criteria:

1. Patient is above 18 years old.
2. The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging.
3. Patient's mass size is up to 5 cm at its largest dimension.
4. Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
5. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.

Exclusion Criteria:

1. Patients with permanent coagulation disorders or severe medical instability or active infection.
2. Patients with any terminal illness.
3. Patient participating in other trials using drugs or devices.

Primary outcomes:
measure: Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure.
timeFrame: During intervention
measure: Recurrence free survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones.
timeFrame: a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnei Zion Medical Center
city: Zerifin
country: Israel
facility: Shamir Medical Center
Study officials:
affiliation: Bnei Zion Medical Center, Israel
name: Halachmi Sarel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02847624: Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
Official title: Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Kidney, Autosomal Dominant
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 1672
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical institutes all over Japan

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.


Eligibility criteria: Inclusion Criteria:

* diagnosed ADPKD
* total kidney volume of 750 or more

Exclusion Criteria:

-

Primary outcomes:
measure: total kidney volume
timeFrame: 8 years
Secondary outcomes:
measure: liver function
timeFrame: 8 years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Otsuka Pharmaceutical Co., Ltd.
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Yasuhiko Fukuta, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02116634: Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis
Official title: Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Alzahra Hospital, Iran
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Whether the mesenchymal injection on ALS patients is effective or not?

Detailed description: After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.

Eligibility criteria: Inclusion Criteria:

1. sporadic ALS according to escorial criteria
2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months
3. mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount
4. normal polysomnography
5. Signed consent form

Exclusion Criteria:

1. pregnancy or lactation,
2. vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease
3. Hospitalization due to serious illness in the last two months
4. survival time less than two years
5. Hypersensitivity to any component used in the cell culture

Primary outcomes:
measure: Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS
timeFrame: every 6 months up 2 years after transplantation
Secondary outcomes:
measure: ALS-FRS(functional rating scale) score and EMG scale
timeFrame: before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation
measure: FVC (forced vital capacity)and DWSE±QoL score
timeFrame: before transplantation and every 6 months up 2 years after transplantation
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Neurosciences Research Center
Study officials:
affiliation: Isfahan neurosciences research center
name: keivan basiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00069134: Study of Antioxidants and Oxidants in Malnourished Children
Official title: Glutathione Homeostasis and Oxidant Damage in Kwashiorkor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein-energy Malnutrition
Kwashiorkor
Marasmus
Keywords: glutathione kinetics
oxidant damage
anti-oxidant capacity
oxidative stress
cysteine kinetics
severe childhood malnutrition
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2003-09-17
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is believed that the organs of severely malnourished children malfunction because harmful compounds called oxidants injure the tissues in these organs. In a healthy person oxidants are made harmless because another compound called glutathione neutralizes them. Glutathione is made from three amino acids that we get from the protein we eat in our food. We found that malnourished children were not making enough glutathione because they lacked one of these amino acids called cysteine. In this study we determine why malnourished children do not have sufficient cysteine, and we will feed malnourished children a whey-based diet which is rich in cysteine during their treatment to determine whether they will make more glutathione. This in turn may make their organs recover faster. These findings will let us know whether malnourished children can recover faster if they are given more cysteine during the early phase of treatment.


Eligibility criteria: * Infants and toddlers, 6-18 months of age
* Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor

Primary outcomes:
measure: small intestine, skin function and red blood cell gluathione synthesis
timeFrame: after intervention
measure: immune capacity
timeFrame: after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: Tropical Metabolism Research Unit, University of the West Indies
state: Saint Andrew
Study officials:
affiliation: Baylor College of Medicine
name: Farook Jahoor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badaloo A, Hsu JW, Taylor-Bryan C, Green C, Reid M, Forrester T, Jahoor F. Dietary cysteine is used more efficiently by children with severe acute malnutrition with edema compared with those without edema. Am J Clin Nutr. 2012 Jan;95(1):84-90. doi: 10.3945/ajcn.111.024323. Epub 2011 Dec 14.
Clinical trial NCT03212534: Inpatient Mortality Prediction Algorithm Clinical Trial (IMPACT)
Official title: A Randomized Clinical Trial of a Mortality Prediction Algorithm
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Decompensation, Heart
Decompensation; Heart, Congestive
Death
Keywords: Dascena
patient mortality
machine learning
algorithm
diagnostic
Lead sponsor: Dascena
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2017-07-11
Enrollment: 0
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: Through the mapping of retrospective patient data into a discrete multidimensional space, a novel algorithm for homeostatic analysis, was built to make outcome predictions. In this prospective study, the ability of the algorithm to predict patient mortality and influence clinical outcomes, will be investigated.


Eligibility criteria: Inclusion Criteria:

* All adult patients admitted to the participating units will be eligible.

Exclusion Criteria:

* All patients younger than 18 years of age will be excluded.

Primary outcomes:
measure: In-hospital mortality
timeFrame: Through study completion, an average of 30 days
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Through study completion, an average of 30 days
Other outcomes:
measure: Hospital readmission
timeFrame: Through study completion, an average of 30 days
measure: ICU length of stay
timeFrame: Through study completion, an average of 30 days
Locations:
city: San Francisco
country: United States
facility: UCSF Moffit-Long Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: David Shimabukuro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desautels T, Calvert J, Hoffman J, Mao Q, Jay M, Fletcher G, Barton C, Chettipally U, Kerem Y, Das R. Using Transfer Learning for Improved Mortality Prediction in a Data-Scarce Hospital Setting. Biomed Inform Insights. 2017 Jun 12;9:1178222617712994. doi: 10.1177/1178222617712994. eCollection 2017.
citation: Calvert J, Mao Q, Rogers AJ, Barton C, Jay M, Desautels T, Mohamadlou H, Jan J, Das R. A computational approach to mortality prediction of alcohol use disorder inpatients. Comput Biol Med. 2016 Aug 1;75:74-9. doi: 10.1016/j.compbiomed.2016.05.015. Epub 2016 May 24.
citation: Calvert JS, Price DA, Barton CW, Chettipally UK, Das R. Discharge recommendation based on a novel technique of homeostatic analysis. J Am Med Inform Assoc. 2017 Jan;24(1):24-29. doi: 10.1093/jamia/ocw014. Epub 2016 Mar 28.
citation: Calvert J, Mao Q, Hoffman JL, Jay M, Desautels T, Mohamadlou H, Chettipally U, Das R. Using electronic health record collected clinical variables to predict medical intensive care unit mortality. Ann Med Surg (Lond). 2016 Sep 6;11:52-57. doi: 10.1016/j.amsu.2016.09.002. eCollection 2016 Nov.