louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01442818: Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
Official title: Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: vaginal reconstructive surgery
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.

Detailed description: The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery.

In order to determine if there is a significant correlation, secondary outcomes will include the daily and total narcotic volume used, common side effects from the opioid including nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel movement, all complications, and procedure performed.

Eligibility criteria: Inclusion Criteria:

* The patients will be limited to those from the Division of Urogynecology to ensure similar surgical techniques. They will be between the ages of 18 and 70 and undergoing major vaginal reconstruction.
* All patients must undergo vaginal reconstructive surgery including: anterior repair, posterior repair, and intraperitoneal vaginal vault suspension. The addition of vaginal hysterectomy, enterocele repair, or suburethral sling is not cause for exclusion.

Exclusion Criteria:

* Any patient who has an allergy to hydromorphone/Dilaudid.
* Any patient already taking chronic opioids, defined as daily use.
* All patients with renal insufficiency or failure.
* All patients with liver failure.
* Any patient who is not having general anesthesia.
* Any patient undergoing abdominal or laparoscopic procedures: sacral colpopexy, laparoscopic hysterectomy or oophorectomy, Burch procedure, or any procedure that enters the abdominal fascia.

Primary outcomes:
measure: Patient Pain Control
timeFrame: post operative day 1
Secondary outcomes:
measure: Patient Satisfaction with Pain Control
timeFrame: post operative day 1
measure: patient perceived pain at 2 weeks
timeFrame: 2 weeks post op
measure: patient dissatisfaction with pain control at 2 weeks
timeFrame: 2 weeks post op
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Division of Urogynecology
name: Catrina C Crisp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04382118: Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome
Official title: Var_DFO:Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valgus Malalignment of the Knee
Keywords: Closed Wedge Distal Femoral Varus Osteotomy (CWDFO)
Open Wedge Distal Femoral Varus Osteotomy (OWDFO)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who received a DFO for valgus knee arthritis at the Clinic of Orthopaedics and Traumatology at the University Hospital Basel between 1.1.2013 and 31.12.2017 will be included in this study.

Brief summary: This study is to analyze the indications of the two most popular techniques of distal femoral osteotomy (DFO) performed in patients with valgus malalignment and symptomatic degenerative changes in the lateral compartment of the knee and to evaluate the clinical and radiological outcome of a case series of patients who have received this operation at the Department of Orthopaedics and Traumatology and the Department of Surgery of the University Hospital Basel.


Eligibility criteria: Inclusion Criteria:

* patients who received a distal femoral osteotomy (DFO) for valgus knee osteoarthritis between 1.1.2013 and 31.12.2017

Exclusion Criteria:

* Absence of informed consent
* Absence of X-Rays documenting the preoperative deformity or postoperative result

Primary outcomes:
measure: Accuracy of the correction of the deformity
timeFrame: at Baseline
Secondary outcomes:
measure: incidence of disruptive hardware
timeFrame: at Baseline
measure: pain level
timeFrame: at Baseline
measure: pain medication intake preoperatively and at the final follow up
timeFrame: at Baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic for Orthopaedics and Traumatology, University Hospital basel
state: Basel Stadt
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Annegret Muendermann, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00748618: Vitamin D Replacement After Kidney Transplant
Official title: Vitamin D Replacement After Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Vitamin D Deficiency
Keywords: Kidney transplantation (KTX)
Vitamin D deficiency
Cardiovascular Disease (CVD)
Vascular risk
Parathyroid hormone (PTH)
Carotid intima media thickness (CIMT)
Insulin resistance (IR)
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

Detailed description: This trial will assess the following aims:

1. Time to plateau vitamin D concentrations after initiating vitamin D supplements
2. Safety of vitamin D replacement based on serum and urine calcium
3. Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone
4. Effect of vitamin D on markers of insulin resistance and inflammation

Eligibility criteria: Inclusion Criteria:

* Kidney transplant more than 6 months ago
* 19 years or older
* 25-hydroxy vitamin D ≤35 ng/ml

Exclusion Criteria:

* Estimated Glomerular filtration rate (GFR) \<30 ml/min/1.73m²
* Previous small bowel or lung transplant
* Pancreas transplant less than 6 months ago
* Cancer or any condition that would change their weight dramatically in the near future such as malabsorption
* Willing to return for testing every two months
* Women who are pregnant or \< 6 weeks postpartum
* Calcium \> 10.5 mg/dl
* Phosphate \> 4.8 mg/dl
* Drinking more than 2 alcohol drinks a day or 14 drinks per week
* History of parathyroid surgery
* Known granulomatous disease
* Taking any seizure medication that affects vitamin D
* Taking Zemplar ® and/or Rocaltrol ®
* History of kidney stones in the past 20 years
* Not on a stable dose of bisphosphonate for the past three months
* Planning on a pancreas transplant within the next year
* In any other research study

Primary outcomes:
measure: Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.
timeFrame: baseline and 6 months
measure: The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.
timeFrame: 6 months
measure: The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.
timeFrame: Baseline and 6 months
measure: The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jennifer L Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00028418: Clofarabine in Chronic Lymphocytic Leukemia
Official title: Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Neoplasms
Lymphoproliferative Disorders
Leukemia
Leukemia, Lymphocytic, Chronic
Keywords: Acute Leukemia
Chronic Lymphocytic Leukemia
Antineoplastic Agents
Nucleosides
Dose-Response Relationship, Drug
Cladribine
Fludarabine
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.

Detailed description: The first group of patients will be treated at the starting dose level of 2 mg/m2 over 1 hour daily for 5 days. Dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course. Subsequent dose escalations will be by 50% until Grade 2 toxicity, then by 35% until the maximum tolerated dose.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Diagnosis of chronic lymphocytic leukemia
* Diagnosis of other acute leukemia
* At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy
* Recovered from toxic effects of prior therapy
* Bilirubin no greater than 2 mg/dL
* Creatinine no greater than 1.5 mg/dL

Exclusion criteria:

* Candidate for treatment of higher efficacy or priority
* Pregnant or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Hagop M. Kantarjian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04009018: Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
Official title: Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scales, Repression-Sensitization
Anesthesia Awareness
Keywords: scale
validity
reliability
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia. In the Turkish version of the scale, a blind reverse translation method will use. And validity and reliability analyses will conduct.

Detailed description: The aim of the present research is to contribute to the international literature determining and describing the factor structure and psychometric qualities of the Perioperative Satisfaction Scale in Regional Anesthesia. An additional aim is to contribute to the national literature regarding the performance of the instrument in cross-cultural adaptation. The following steps will be taken: (a) translation of the scale from English into Turkish, (b) data collection, and (c) checking validity and reliability evidence for the adapted Perioperative Satisfaction Scale in Regional Anesthesia.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the research
* Participants are over 18 years of age
* Provided regional anesthesia
* Postoperative second day
* No cognitive problems in self-expression

Exclusion Criteria:

* Lack of Turkish literacy
* Use of anesthesia technique other than regional anesthesia

Primary outcomes:
measure: Patient satisfaction
timeFrame: postoperative 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Fatih Mehmet Yazar, MD
role: STUDY_CHAIR
References:
citation: Mui WC, Chang CM, Cheng KF, Lee TY, Ng KO, Tsao KR, Hwang FM. Development and validation of the questionnaire of satisfaction with perioperative anesthetic care for general and regional anesthesia in Taiwanese patients. Anesthesiology. 2011 May;114(5):1064-75. doi: 10.1097/ALN.0b013e318216e835.
citation: Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
Clinical trial NCT05559918: Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
Official title: Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Pretreatment
Diagnostic angiography
ad-hoc PCI
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 1462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients aged 18 years and older who have been referred for diagnostic CAG due to symptoms suggestive of obstructive coronary artery disease with optional ad-hoc PCI.

Brief summary: To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.


Eligibility criteria: Inclusion Criteria:

* Adult men and women aged at least 18 years
* Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease

Exclusion Criteria:

* Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers)
* Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke)
* Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor)
* Patients using VKA (e.g. acenocoumarol, fenprocoumon)
* Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)
* Inability to give informed consent (e.g., language barrier)
* Patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier

Primary outcomes:
measure: Net adverse clinical events (NACE)
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding (classified as BARC type 2, -3 and -5 bleeding)
timeFrame: In-hospital, at 30 days
measure: Patient oriented clinical events (POCE)
timeFrame: In-hospital, at 30 days
measure: All-cause mortality
timeFrame: In-hospital, at 30 days
measure: Myocardial infarction
timeFrame: In-hospital, at 30 days
measure: Stent thrombosis (definite/probable)
timeFrame: In-hospital, at 30 days
measure: Stroke
timeFrame: In-hospital, at 30 days
measure: Repeat revascularisation
timeFrame: In-hospital, at 30 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam Universitair Medisch Centrum (AUMC) - Locatie VUMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam University Medical Center, location AMC
name: Ronak Delewi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00458718: Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch
Official title: Single Country, Double-Blind, Randomized, 2-Arm, Parallel-Group Study, Evaluating Efficacy and Safety of Rimonabant 20 mg OD, With/Without Association of Nicotine Patch, as Aid to Smoking Cessation During 9-Week Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: abstinence
nicotine patch
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-11
Enrollment: 755
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 primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit.

Secondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.


Eligibility criteria: Inclusion Criteria:

* Smokers smoking at least 15 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* non tobacco cigarettes consumption
* chronic use of marijuana
* pregnancy
* breastfeeding
* any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

Primary outcomes:
measure: Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements
Secondary outcomes:
measure: Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
measure: Safety data
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Rigotti NA, Gonzales D, Dale LC, Lawrence D, Chang Y; CIRRUS Study Group. A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain. Addiction. 2009 Feb;104(2):266-76. doi: 10.1111/j.1360-0443.2008.02454.x.
Clinical trial NCT05177718: Natalizumab and Chronic Inflammation
Official title: Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis, MRI, blood brain barrier, myelin
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2022-01-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, prospective longitudinal study.
Primary purpose: TREATMENT

Brief summary: In this study the investigators will assess the ability of Natalizumab, a medication given to treat multiple sclerosis (MS), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (BBB).

Detailed description: The investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwRRMS) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and selective inversion recovery quantitative magnetization transfer imaging (SIR-qMT). pwRRMS will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. Changes in ktrans, a measure of BBB permeability derived from DCE-MRI, and in pool saturation ratio (PSR) a measure of myelin integrity derived from SIR-qMT will be computed to assess the ability of natalizumab to fully restore BBB integrity.

As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.

Eligibility criteria: Inclusion Criteria:

1. multiple sclerosis
2. clinical eligibility to treatment with Natalizumab
3. no previous exposure to Natalizumab treatment

Exclusion Criteria:

1. inability to perform an MRI with contrast
2. inability to undergo a paper-pencil questionnaires and blood work

Primary outcomes:
measure: Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans
timeFrame: 12 months
Secondary outcomes:
measure: Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR)
timeFrame: 12 months
Other outcomes:
measure: Effect of Natalizumab on Questionnaire Derived Measures of Quality of Life
timeFrame: 12 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Francesca Bagnato, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: