louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00414375: Early Versus Delayed Operation for Perforated Appendicitis
Official title: Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendiceal Abscess
Keywords: Perforated Appendicitis
Abscess
Appendectomy
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-12-21
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess.

The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.

Detailed description: This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. This will be a pilot study.

Power calculations are not used for a pilot study. One group will undergo a primary laparoscopic appendectomy. The other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. All 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. The surgeon will not induce a significant confounding variable into this study. The laparoscopic appendectomy is approached in the same manner by all members of our group. Those named on the form are qualified by the IRB to obtain consent and/or will be accountable for overseeing the study.

Both groups will have the same antibiotic regiment. All data will be analyzed on intention-to-treat basis.

Eligibility criteria: Inclusion Criteria:

* Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
* Children of any age will be included.

Exclusion Criteria:

* Patients with immune deficiency
* Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
* Acute sepsis or severe pain from perforation not allowing for delayed management.

Primary outcomes:
measure: Pilot
timeFrame: 3 months
Secondary outcomes:
measure: PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time
timeFrame: 3 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518375: Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus
Official title: A Comparative, Open-label Study to Evaluate Graft Function in de Novo Renal Allograft Recipients Treated With Either a 'Reduced Dose' or a 'Standard Dose' of Cyclosporine in Combination With Sirolimus and Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

Detailed description: This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.

Eligibility criteria: Inclusion Criteria:

* Adults more than 18 years of age
* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
* Patients with a secondary transplant must have maintained their primary graft for at least 6 months

Exclusion Criteria:

* Planned antibody induction therapy
* Multiple organ transplants
* Patients at a high risk of acute rejection

Primary outcomes:
measure: Calculated creatinine clearance to evaluate renal function at 12 months post transplantation
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00396175: Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)
Official title: A Double-Blind, Placebo-Controlled, Multicenter Study To Examine the Effects of Finasteride 1 MG on Serum Prostate-Specific Antigen in Men With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Androgenetic Alopecia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 355
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to collect additional data in order to characterize the reduction in PSA with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the ages of 40 to 60 years.


Eligibility criteria: Inclusion Criteria :

* Men 40 to 60 years of age, and in good general physical and mental health, with androgenetic alopecia

Exclusion Criteria :

* History of previous bladder surgery, acute urinary retention, urethral strictures, repeated urethral catheterizations, repeated urinary tract infections, or active urinary tract infections
* History of treatment with finasteride (PROSCAR or PROPECIA) or hypersensitivity to any component of finasteride.

Primary outcomes:
measure: Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment
Secondary outcomes:
measure: Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: D'Amico AV, Roehrborn CG. Effect of 1 mg/day finasteride on concentrations of serum prostate-specific antigen in men with androgenic alopecia: a randomised controlled trial. Lancet Oncol. 2007 Jan;8(1):21-5. doi: 10.1016/S1470-2045(06)70981-0.
Clinical trial NCT04424875: The Effect of Melatonin Application Following Removal of Impacted Third Molar
Official title: Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impacted Third Molar Tooth
Keywords: impacted third molar
melatonine
bone healing
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket.


Eligibility criteria: Inclusion Criteria:

* Age ≥18ys
* no systemic disease
* impacted mandibular third molar class II position B on Pell- Gregory classification

Exclusion Criteria:

* history of metabolic or systemic diseases affecting bone or healing process,
* local infection,
* tobacco use,
* oral contraceptive,
* pregnancy and lactation
* patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study

Primary outcomes:
measure: Bone density
timeFrame: 6months
Secondary outcomes:
measure: Osteoprotegerin (OPG)
timeFrame: 4weeks postoperatively
measure: pain sensation
timeFrame: 7 days postoperative
measure: swelling
timeFrame: 7 days postoperative
measure: trismus
timeFrame: 7days postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
citation: Cobo-Vazquez C, Fernandez-Tresguerres I, Ortega-Aranegui R, Lopez-Quiles J. Effects of local melatonin application on post-extraction sockets after third molar surgery. A pilot study. Med Oral Patol Oral Cir Bucal. 2014 Nov 1;19(6):e628-33. doi: 10.4317/medoral.19851.
Clinical trial NCT04175275: Middle Ear Implant: Assessment of Satisfaction in the Medium Term
Official title: Middle Ear Implant: Assessment of Satisfaction in the Medium Term
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all living patients who have benefited from the placement of a middle ear implant since 1998 at Hospices Civils of Lyon.

Brief summary: Currently, the data from the literature do not evaluate the use of the middle ear implant in implanted patients in the medium term (10 years and over) but only in the short term (1-5 years).

Based on the observation of the absence of these data, we considered it necessary to evaluate in the medium term the satisfaction of the patients carrying a middle ear implant and their rate of abandonment with a horizon of 10 to 20 years of apparatus.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient accepting to participate to this study
* Patient having a middle ear implant since 10 - 20 years at time of inclusion

Exclusion Criteria:

* patient not dead

Primary outcomes:
measure: the abandonment rate
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot
Study officials:
affiliation: Service de chirurgie ORL et cervico faciale
name: Eric TRUY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03704675: Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects
Official title: Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: MedPacto, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 16
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 2weeks not including screening.

Detailed description: Through screening (D-30 \~ D-1) prior to the first dose of the investigational product, a total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. This clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned schedule

Eligibility criteria: Inclusion Criteria:

1. Healthy sterile males
2. BMI 18.0kg/m2 - 27.0 kg/m2
3. No congenital or chronic disease and no pathological symptoms or pathological findings
4. Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science)

Exclusion Criteria:

1. Has pathological symptoms or pathological findings
2. Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug
3. SBP\>140 or \<90 mmhg , DBP\>90 or \<60mmHg ,Pulse\>100
4. No abnormal Clinical Lab findings

Primary outcomes:
measure: Pharmacokinetics:Maximum Concentration (Cmax)
timeFrame: Pre-dose through 24 hours post-dose in each period of the. study
measure: Pharmacokinetics:Area Under the Concentration Curve (AUC)
timeFrame: Pre-dose through 24 hours post-dose in each period of the. study
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
affiliation: MedPacto, Inc.
name: Sunjin Hwang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05953675: Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
Official title: Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hemodialysis Catheter-Associated Bacteremia
Hemodialysis Complication
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 280
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: The aim of this study is to examine the effect of ethanol (70%) as lock-solution after hemodialysis on:

* The frequency of dialysis catheter-related bacteremia among patients under observation of potential complications
* Other complications of the use of hemodialysis-catheters eg. dysfunction of the catheter due to thrombosis.


Eligibility criteria: Inclusion Criteria:

* Age at or above 18 years.
* Currently recieving hemodialysis treatment with tunneled intravenous hemodialysis-catheter
* Written informed consent after verbal and written information is given.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Intolerance to ethanol or contraindications for the use of ethanol. Eg. possible interactions, former alcohol dependency.
* Earlier infections to current catheter (exit-site, tunnel-infection and catheter-related bloodstream infection

Primary outcomes:
measure: Time to hemodialysis catheter-related bacteremia
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of hemodialysis catheter-related bacteremia
timeFrame: 2 years
measure: Time to exit-site infection
timeFrame: 2 years
measure: Time to removal of catheter due to infection
timeFrame: 2 years
measure: Complications eg. catheter-thrombosis and pulmonary embolus
timeFrame: 2 years
measure: Life quality
timeFrame: 2 years
measure: Economical costs
timeFrame: 2 years
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Lothar Wiese, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04284475: Relationship Between Muscle Strength and Physical Function in ICU
Official title: Analysis of the Relationship Between Muscle Strength and Physical Function in ICU Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Muscle Weakness
Physical Disability
Physical Dependence
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study includes all critical ill patients staying in ICU for at least 48 hours. They are screened as soon as they are collaborative.

Brief summary: This observational study aims to assess the relationship between muscle strength and physical function in critical ill patients. Grip and quadriceps strengths are measured using a standardized protocol of dynamometry. Physical function is assessed using the validated ICU mobility scale.


Eligibility criteria: Inclusion Criteria:

* ICU stay of at least 48h
* Collaborative (RASS score -1 to +1)

Exclusion Criteria:

* Refusal
* Coma
* Non collaborative
* Hemi / tetra paresis or plegia

Primary outcomes:
measure: Quadriceps strength
timeFrame: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
measure: Handgrip strength
timeFrame: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
measure: ICU mobility scale
timeFrame: as soon as collaborative during ICU stay and up to 1 month following ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
affiliation: University hospital of Liège
name: Anne-Françoise Rousseau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Liège
name: Isabelle Kellens, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914875: Kidney Function After Pneumoperitoneum and Analgesia
Official title: Kidney Function After Laparoscopic Cholecystectomy and Tramadol Anesthesia Plus Dipyrone or Ketorolac
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Cholecystectomy
Keywords: kidney function tests
anti-inflammatory agents, non-steroidal
laparoscopic cholecystectomy
adult
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2009-06-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol plus ketorolac or dypirone

Brief summary: double blind study of kidney function of two groups of adult patients submitted to laparoscopic cholecystectomy and analgesia from tramadol associated to dipyrone or ketorolac

Detailed description: Background: The laparoscopic cholecystectomy (LC) reduces surgical trauma and hospital stay but requires effective and safe postoperative analgesia. This prospective and double blind study aimed to study the effects of tramadol analgesia associated to dipyrone or ketorolac in the kidney function of patients submitted to LC, using creatinine (Cr), cystatin C, and enzymuria evaluations.

Methods: In the pre- and postoperative (PO) periods, estimated glomerular filtration rates (GFR), obtained from two formulas dependants of blood Cr and one from blood cystatin C values, and tubular enzymuria - alkaline phosphatase (AP), γ-glutamyltransferase (γ-GT) - were determined in patients who underwent LC and analgesia with tramadol and dipyrone (G1, n=63) or tramadol and ketorolac (G2, n=63). In the recovery room (RR), pain and need of rescue analgesia with morphine were evaluated.

Eligibility criteria: Inclusion Criteria:

* From 18 to 60 years
* Normal kidney function
* Free consented participation

Exclusion Criteria:

* Renal and hepatic dysfunction
* Prior (one month) use of anti-inflammatory agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: UPECLIN
state: São Paulo
Study officials:
affiliation: Botucatu Medical School
name: Yara M Castiglia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06537375: Use of Ketamine in Severe Pain Syndromes
Official title: Use of Intravenous Ketamine in Patients with Severe Chronic Pain Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Intractable
Pain, Chronic
Pain Syndrome
Pain Measurement
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 89
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: All patients who received ketamine as treatment for a pain syndrome during january 2010 until june 2024 at Erasme University Hospital

Brief summary: Ketamine has been shown to have a certain efficiency in chronic pain syndromes. However, it is still not clearly known what is its efficiency and how ketamine is used in real world patients. In this retrospective study, all patients treated with ketamine for chronic pain in our hospital will be reviewed. Patients demographics, pain syndromes as well as outcome criteria will be collected to describe the use of ketamine in pain syndromes.

Detailed description: The American Society of Regional Anesthesia and Pain Medicine, together with the American Academy of Pain and the American Society of Anesthesiologists published a consensus guideline in 2018 on the use of ketamine in chronic pain. A review of medical charts of all patients who received ketamine for chronic pain between january 2010 and june 2024 will be done. Demographic data, detailed pain scores, as well as description of the type of pain will be collected. Ketamine usage will be recorded for the dosage, as well as duration of the treatment. Outcome will be measured by before/after pain scores for neuropathic pain, as well as on a visual analog scale. A more global score (good-medium-no effect) will also be collected to get the patient's impression on their treatment. Concomitant pain medication will be collected.

Eligibility criteria: Inclusion Criteria:

- All patients who received ketamine as treatment for a pain syndrome during january 2010 until june 2024 at Erasme University Hospital

Exclusion Criteria:

* Age \< 18 years
* Patients who expressed their opposition to the use of their medical data
* incomplete medical chart

Primary outcomes:
measure: Patient satisfaction
timeFrame: 6 month
measure: DN4
timeFrame: 6 month
measure: VAS
timeFrame: 6 month
Secondary outcomes:
measure: Concomitant pain medications
timeFrame: 6 month
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire de Bruxelles - Hôpital erasme
Study officials:
References: