louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00461357: Sirolimus Based Immunosuppression for Patients Undergoing Kidney Transplantation in the Eurotransplant Senior Program
Official title: Outcome After Renal Transplantation of a Randomized Prospective Trial in the Eurotransplant Senior Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Function After Transplantation
Outcome After Kidney Transplantation
Keywords: Old for Old
Eurotransplant Senior Program
Glomerular Filtration Rate
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The Eurotransplant Senior Program (ESP) started in 1999 with local allocation of kidneys from deceased donors elder than 65 years to recipients elder than 65 years. The requirements for immunosuppression in this group of patients are high due to the large amount of comorbidities.

This prospective randomized trial compared the standard immunosuppressive protocol based on cyclosporine A (CyA) used at our center within the ESP, to a calcineurin inhibitor-free protocol based on sirolimus (SRL).

The aim of this study is to investigate the effect of a CNI-free therapy on the function of elderly kidneys 6 months post transplantation, measured by GFR.


Eligibility criteria: Inclusion Criteria:

* Recipients of the Eurotransplant Senior Program
* negative cytotoxic crossmatch
* signed informed consent

Exclusion Criteria:

* High sensitized recipients (PRA \> 40%)
* Non heart Beating Donor
* Hyperlipidemia
* Leucocytopenia (\< 3000/mm3)
* Thrombocytopenia (\< 75000/mm3)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna; Department of Transplantation
name: Ferdinand Muehlbacher, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05214157: Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT
Official title: A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Post-operative Pain
Cholecystectomy, Laparoscopic
Pain Assessment Pain Intensity
Pain Intensity
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-01-28
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.

Detailed description: Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.

Eligibility criteria: Inclusion Criteria:

* Patients who were having symptoms consistent with biliary colic,
* had ultrasound evidence of gall stones,
* classified as American Society of Anesthesiology (ASA) I and II
* ages ranging from 18 to 65 years

Exclusion Criteria:

* Patients who refused to give consent,
* pregnant,
* had a history of drug abuse,
* had CBD stones,
* acute cholecystitis,
* acute pancreatitis,
* previous abdominal surgery,
* history of peritonitis,
* had carcinoma of the gall bladder Patients who were converted to open surgery,
* patients who required placement of drains
* patients with intraoperative complications (CBD injury or liver bed bleeding).

Primary outcomes:
measure: postoperative pain intensity
timeFrame: 6 - 24 hours
Secondary outcomes:
measure: hospital stay
timeFrame: 1-5 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: Zagazig University
name: mohamed l ali, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT05700357: Different Local Anesthetic Volumes for TPVB in Post-thoracotomy Analgesia
Official title: Comparison of Different Local Anesthetic Volumes of Thoracic Paravertebral Block Application in Post-thoracotomy Analgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Paravertebral Block
Thoracotomy
Postoperative Analgesia
Acute Pain
Local Anesthetic
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracotomy is one of the most painful operations known. Therefore, it causes severe acute pain. If pain is not controlled, it increases the frequency of postoperative pulmonary complications and postoperative morbidity. It can even cause chronic pain in the future. Thoracic epidural analgesia (TEA) is the gold standard method in the treatment of pain after thoracotomy. Thoracic paravertebral block (TPVB) is known as the most effective method after TEA. The fact that TPVB has fewer side effects than TEA increases the use of TPVB. There is no consensus on the dose of analgesia in studies. In the literature, volumes between 20 ml and 30 ml are frequently used for TPVB in recent years. This study, it was aimed to compare the efficacy of 20 ml, 25 ml, and 30 ml volumes of TPVB with local anesthetic at the same concentration (0.25% bupivacaine) on postoperative analgesia in patients undergoing thoracotomy.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old
* American Society of Anesthesiologists (ASA) physical status I-II-III
* BMI 18 to 40 kg/m2
* Elective thoracotomy surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* History of chronic opioid or analgesic used

Primary outcomes:
measure: Pain Scores
timeFrame: 1st hour after surgery
measure: Pain Scores
timeFrame: 2nd-hour after surgery
measure: Pain Scores
timeFrame: 4th-hour after surgery
measure: Pain Scores
timeFrame: 12th-hour after surgery.
measure: Pain Scores
timeFrame: 24th-hour after surgery.
measure: Pain Scores
timeFrame: 48th-hour after surgery.
Secondary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Ankara City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT01100957: Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation
Official title: Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Difficult Airway
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is in two parts

Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.

Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.

The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.


Eligibility criteria: Inclusion Criteria:

1. Study part 1:

   * Patients scheduled for tracheal intubation and predicted to have a normal airway
   * ASA class I, II or III
   * \>18 years
2. Study part 2:

   * Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
   * ASA class I, II or III
   * \>18 years

Exclusion Criteria:

1. Study part 1:

   * Massive bleeding from the mouth
   * Previously abandoned flexible optical intubation
2. Study part 2:

   * Massive bleeding from the mouth
   * Previously abandoned flexible optical intubation
   * Patients with audible stridor
   * Patients with dyspnea

Primary outcomes:
measure: time for completion of intubation
timeFrame: September 2010
Secondary outcomes:
measure: time for preparing and cleaning the endoscopes
timeFrame: september 2010
measure: number of intubation attempts
timeFrame: september 2010
measure: success rate of endotracheal intubation
timeFrame: september 2010
measure: total time for the intubation-procedure inclusive the time for distributing local analgesics
timeFrame: september 2010
measure: Quality of the image from the videoscope
timeFrame: september 2010
measure: Evaluation of the insertion cord of the flexible scope
timeFrame: september 2010
measure: Evaluation of the working-/-injection-channel
timeFrame: september 2010
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael S Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04500457: Exposure-Based Treatment for Perfectionism
Official title: A Preliminary Evaluation of an Exposure-Based Treatment for Perfectionism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perfectionism
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is examining the efficacy of a computerized, exposure-based, intervention for perfectionism.

Detailed description: The primary aim of this study is to evaluate the effects of a two-week computerized exposure-based treatment for perfectionism (ETP). Individuals with elevated perfectionism will be randomly assigned to ETP or a waitlist (WL) control condition. ETP will consist of three tasks in which they will repeatedly make mistakes, repeated for five sessions over a two-week period (one session every 3 days).

Eligibility criteria: Inclusion Criteria:

* Score of at least 29 on the Frost Multidimensional Perfectionism Scale- Concern over Mistakes subscale

Exclusion Criteria:

* Current moderate or severe substance use disorder, psychotic disorder, or bipolar disorder
* Current suicidal ideation (imminent risk)
* Currently participating in psychotherapy
* Any changes to psychotropic medications in the past four weeks

Primary outcomes:
measure: Frost Multidimensional Perfectionism Scale (FMPS)- Concern Over Mistakes Subscale
timeFrame: Levels of perfectionism from baseline to post treatment (2 weeks)
Secondary outcomes:
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Depression symptoms from baseline to post treatment (2 weeks)
measure: State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
timeFrame: Anxiety symptoms from baseline to post treatment (2 weeks)
measure: Social Phobia Inventory (SPIN)
timeFrame: Social anxiety symptoms from baseline to post treatment (2 weeks)
measure: Eating Attitudes Test (EAT-26)
timeFrame: Eating disorder symptoms from baseline to post treatment (2 weeks)
measure: Obsessive-Compulsive Inventory- Revised (OCI-R)
timeFrame: Obsessive-compulsiveness from baseline to post treatment (2 weeks)
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University, Department of Psychology
state: Florida
Study officials:
References:
Clinical trial NCT05559957: Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes
Official title: Isolated Oligohydramnios is Associated With Less Favorable Delivery and Composite Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oligohydramnios, Delivered
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-09-29
Enrollment: 636
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 32 and 41 weeks with otherwise normal pregnancy. Isolated oligohydramnios group are diagnosed with amniotic fluid index less than 5.

Brief summary: Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.

Detailed description: Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases with oligohydramnios (amniotic fluid level index \<5) to normal amniotic fluid cases (amniotic fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal outcomes (including mortality, NICU admission, low Apgar score and sepsis)

Eligibility criteria: Inclusion Criteria:

1. Third trimester pregnancy
2. Isolated oligohydramnios

Exclusion Criteria:

1. Multiple pregnancy
2. less than 32 weeks
3. medical disorders like DM HPN
4. Fetal jeopardy

Primary outcomes:
measure: Delivery mode
timeFrame: through study completion, an average of 1 year
measure: Composite neonatal outcomes
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Induction of labor rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: Armed Forces Hospitals Southern Region
Study officials:
affiliation: Armed Forces Hospitals Southern Region KSA
name: Hytham Atia Atia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Troendle J, Meikle S, Klebanoff MA, Rayburn WF. Isolated oligohydramnios is not associated with adverse perinatal outcomes. BJOG. 2004 Mar;111(3):220-5. doi: 10.1111/j.1471-0528.2004.00060.x.
Clinical trial NCT02003157: Efficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: hypnosis embryo transfer IVF ICSI
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-12-06
Enrollment: 460
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical benefits that can be expected by the Embryo transfert procedure with hypnosis to the usual embryo transfer procedure


Eligibility criteria: Inclusion Criteria:

Consent to participate in study Age ≥ 18 years and \< 41 years IVF or IVF/ICSI attempt GnRH antagonist or agonist stimulation protocol Scheduled transfer of 1 or 2 embryos

Exclusion Criteria:

Refusal to provide consent refusal hypnosis FSH \> 13 mUImL CFA \< 8 follicles AMH \< 0.5 ngml Patient not covered by the social security system (NHS)

Primary outcomes:
measure: pregnancy rate
timeFrame: between weeks 5 and 7 after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU angers
Study officials:
References:
Clinical trial NCT00536926: Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation
Official title: Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation - an Open, Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Transplantation
Keywords: telemedicine
lung transplantation
home spirometry
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Corscience, Inc.
First posted: 2007-09-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In an investigation should be evaluated in contrast to a control group with standard post-treatment therapy (using home spirometry) after lung transplantation if transfer of home spirometry recordings to the transplant center via cell phones will lead to less complications, cost savings and bigger constancy of therapy.

Detailed description: Home spirometry is used as a standard of care in lung transplant recipients in many centers worldwide. In case of deteriorating lung function response until therapy depends on patients efforts to reach the transplant center and the contactability of the transplant center.

Therefore transfer of home spirometry recordings to the transplant center via cell phones will lead to less complications, cost savings and bigger constancy of therapy compared to the home spirometry alone.

Eligibility criteria: Inclusion Criteria:

* Patients after lung transplantation (single and double lung transplantation incl. combined organ transplantation) before hospital discharge

Exclusion Criteria:

* Dependency on long term care
* Restricted ability to communicate

Primary outcomes:
measure: Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Latency: symptom onset to transplant team contact patient contacts emergency visits hospitalisations
timeFrame: 6 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Dpt. resiratory Medicine OE6870
Study officials:
affiliation: Dpt. Respiratory Medicine
name: Jens Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sengpiel J, Fuehner T, Kugler C, Avsar M, Bodmann I, Boemke A, Simon A, Welte T, Gottlieb J. Use of telehealth technology for home spirometry after lung transplantation: a randomized controlled trial. Prog Transplant. 2010 Dec;20(4):310-7. doi: 10.1177/152692481002000402.
Clinical trial NCT02826226: Effect of Bronchodilatator Testing on Multiple-breath-washout (MBW) Derived Lung Function Parameters
Official title: Effect of Bronchodilatator Testing on Multiple-breath-washout (MBW) Derived Lung Function Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Ventilation Disorders
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with known or suspected obstructive ventilation disorder and clinical indication for bronchodilator testing

Brief summary: The investigators aim to evaluate the effect of bronchodilatator testing on multiple-breath-washout derived lung function parameters.


Eligibility criteria: Inclusion Criteria:

* known or suspected obstructive ventilation disorder
* clinical indication for bronchodilator testing

Exclusion Criteria:

* pregnancy
* inability to participate

Primary outcomes:
measure: change of lung clearance index (LCI) as determined by multiple breath washout
timeFrame: 60 minutes
Secondary outcomes:
measure: repeatability of lung clearance index (LCI)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
Study officials:
References:
Clinical trial NCT05950126: Maternal Pain Catastrophizing Score is Related With Children's Postoperative Circumcision Pain
Official title: Is Pain Perception Communicated Through Mothers? Maternal Pain Catastrophizing Score is Related With Children's Postoperative Circumcision Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Catastrophizing
Keywords: postoperative pain
circumcision
pain catastrophizing
mother
children
VAS
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 197
Sex: MALE
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among the children who come to the preoperative anesthesia outpatient clinic with their mothers to undergo elective circumcision will be accepted if their mothers agreed to participate in the study.

Brief summary: The aim of this study was to evaluate the relation of maternal pain catastrophizing score with child's who underwent circumcision postoperative pain. A cross-sectional study and this study was performed at the Samsun University, Samsun Training and Research Hospital, Samsun, Türkiye. The mothers were divided into low pain catastrophizing (Group 1) and high pain catastrophizing (Group 2) group. Children's postoperative pain intensity was measured using the visual analog scale (VAS) and a faces pain scale (FPS).

Detailed description: Now, the study is continuing.

Eligibility criteria: Inclusion Criteria:

* Age 5-12 years,
* Being operated under general anesthesia.

Exclusion Criteria:

* Children without biological mothers, or with a parent other than the mother,
* Children aged under five or over 12,
* History of previous surgery,
* Being operated under regional anesthesia,
* Use of analgesic, antiepileptic, or sedative medications, and
* Other procedures being performed in addition to circumcision (such as herniorrhaphy, tonsillectomy, orchiopexy, and appendectomy).

Primary outcomes:
measure: PCS, mother, and child
timeFrame: 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
References:
citation: Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.