louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00325429: Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes
Official title: A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Vildagliptin
HbA1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Patients who have been placed on diet and exercise therapy without achieving target blood glucose levels
* Outpatients

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant cardiovascular complications as defined by the protocol
* Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Adverse events profile after 52 weeks of treatment
Secondary outcomes:
measure: Change from baseline to endpoint on HbA1c at 52 weeks
measure: Change from baseline to endpoint on fasting plasma glucose at 52 weeks
measure: Change from baseline to endpoint in HOMA B at 52 weeks
measure: Change from baseline to endpoint in HOMA IR at 52 weeks
measure: Change from baseline to endpoint in body weight at 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00654329: Dexmedetomidine vs Fentanyl for BMT
Official title: Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Otitis
Keywords: Dexmedetomidine, transmucosal, myringotomy,
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2008-04-08
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.


Eligibility criteria: Inclusion Criteria:

* Subjects must meet all of the following inclusion criteria to be eligible for participation:

  1. The subject is 6 months to 6 years of age
  2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
  3. The subject is scheduled for elective bilateral myringotomy with tube placement
  4. The subject's parent/legally authorized guardian has given written informed consent to participate

     Exclusion Criteria:
* Subjects will be excluded from study participation if any of the following exclusion criteria exists:

  1. The subject has a history or a family (parent or sibling) history of malignant hyperthermia
  2. The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
  3. The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
  4. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
  5. The subject has know central nervous system disease or neurological impairment
  6. The subject is an ASA classification of 3 or greater (See Appendix 1)
  7. The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
  8. The subject refuses inhalation induction
  9. The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)

Primary outcomes:
measure: Incidence of Pain
timeFrame: up to 24 hours
Secondary outcomes:
measure: Length of Stay in PACU
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Julia C Finkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03501329: Investigation of Change in The WHO-5 Well-Being Index During a Year in a Community Psychiatry in Denmark
Official title: Investigation of Change in The WHO-5 Well-Being Index During a Year in a Community Psychiatry in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Rehabilitation
Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 204
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: The 752 patients registered as receiving service in district psychiatry during 2017

Brief summary: Patient reported quality of life was measured using the WHO-5 Well-Being Index in a group of outpatients in the Community Psychiatry in Holbaek, Denmark.

Methods

The first and last answer were compared and significance of change in various subgroups of patients was estimated using the PSPP statistical program.

Detailed description: Investigation of the change of The WHO-5 Wellbeing Index during a year in a Community Psychiatry in Denmark.

Introduction

In the Community Psychiatry of the town Holbaek part of Region West of The Region Sjaelland in eastern Denmark the WHO-5 Well-Being Index has for 5 years been used in order to obtain the patients personal evaluation of their actual quality of life. That has given the possibility of following changes during the treatment. The questionnaire is easy to understand and to use as part of a consultation. The patients will answer the 5 questions in a few minutes. The WHO-5 questionnaire is thoroughly evaluated internationally and described and used in many clinical situations also outside of psychiatry and fulfill measures of psychometric quality. With this work the intention was to try to answer often critical questions from our administration and from the press and in the society. There was no funding for the work.

Eligibility criteria: Inclusion Criteria:

* all patients able and willing to participate

Exclusion Criteria:

* patients with mental conditions making them unable to answer simple questions about their daily life (in general severe psychosis and severe organic mental disorders)

Primary outcomes:
measure: Change in The WHO-5 Well-Being Index
timeFrame: The Time Frame was from the beginning of the participation in the study (baseline) and at the completion of the study participation (approximately 1 year).
Secondary outcomes:
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Psykiatrisk Forskningsenhed
state: Region Zealand
Study officials:
affiliation: Psykiatrisk Forskningsenhed
name: Erik Simonsen, Professor
role: STUDY_DIRECTOR
References:
citation: Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
Clinical trial NCT06544629: Imjudo & Imfinzi PMS
Official title: Imjudo & Imfinzi Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 246
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: Patients who initiate treatment with study drugs after the contract date for the first time.

Brief summary: Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated according to the approved indications in Korea.

Detailed description: Primary Objective:

To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea

Secondary Objective:

To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea

Exploratory Objective:

To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea

Eligibility criteria: Inclusion criteria:

1. Patients eligible for the study drugs according to the approved label in Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion criteria:

1. Other off-label indications according to the approved label in South Korea
2. Current participation in any interventional trial

Primary outcomes:
measure: Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
timeFrame: For Imjudo will be conducted for 90 days from the first dose of the treatment. For Imfinzi will be separately conducted for 1 year from the first dose.
Secondary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: For 1 year from the first dose of the treatment
Other outcomes:
measure: Disease Control Rate (DCR)
timeFrame: For 1 year from the first dose of the treatment
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Goyang
country: Korea, Republic of
facility: Research Site
city: Seongnam
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
Study officials:
References:
Clinical trial NCT04761029: Rhomboid Intercostal and Subserratus Plane Block
Official title: Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy
Postoperative Pain
Nerve Block
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: retrospective
Primary purpose: TREATMENT

Brief summary: Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. For this type of surgery, many different field blocks have been used for postoperative analgesia.

Detailed description: In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study

Exclusion Criteria:

* bleeding disorders,
* mental incapacity,
* known allergy to the local anesthetics,
* body mass index ≥35 kg/m2

Primary outcomes:
measure: tramadol consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Numeric Rating Scale rest
timeFrame: postoperative 24 hours
measure: Numeric Rating Scale during movement
timeFrame: Postoperative 24 hours
measure: additional analgesic use
timeFrame: Postoperative 24 hours
measure: side effect profile
timeFrame: Postoperative 24 hours
measure: sensorial dermatomal block-level
timeFrame: 30 minutes after the block administration and at the postoperative 2nd hour
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
name: Korgün Ökmen, Assoc. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580329: The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow
Official title: The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow for Patients With Pregnancy Related- Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Injury
Keywords: neuromuscular electrical stimulation
renal function
renal blood flow
Acute kidney injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized prospective controlled study aims to evaluate the effect of neuromuscular electrical stimulation on the renal function and renal blood flow of post partum women with acute kidney injury.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or old and hemodynamically stable.
* Post-partum women who developed AKI.

Exclusion Criteria:

* Pregnant women .
* Patients who required any emergency or elective surgery during the study; those who presented acute heart or lung disease, skin rashes, tumors, infections, diabetes mellitus or hypoesthesia in the region that the neuromuscular electrical stimulation would be applied.
* Patients with a Pacemaker.
* Epileptic Patients.
* Patients with recent effects of stroke (less than 3 months).
* Uncontrolled hypertension (systolic blood pressure \> 230 mm Hg and diastolic blood pressure \> 120 mm Hg).

Primary outcomes:
measure: renal function change
timeFrame: for 7 days
measure: renal blood flow change
timeFrame: for 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Talaat Ahmed
city: Assiut
country: Egypt
facility: Ahmed Talaat Ahmed
Study officials:
affiliation: Assiut University
name: Ahmed T Ahmed, A professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05953129: Novel Predictors of Post Spinal Hypotension in Cesarean Sections: Evaluating Jugular Vein Collapsibility Index and Shock Indices
Official title: Novel Predictors of Post Spinal Hypotension in Cesarean Sections: Evaluating Jugular Vein Collapsibility Index and Shock Indices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cesarean Section Complications
Regional Anesthesia Morbidity
Hemodynamic Instability
Shock
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between the ages of 18-45 who were scheduled for cesarean section and who gave consent to participate in the study and to apply spinal anesthesia will be included in this study.

Brief summary: Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18-45 who had a planned cesarean section and approved to participate in the study and to apply spinal anesthesia

Exclusion Criteria:

* Patients with Preeclampsia, Eclampsia, HELLP syndrome

Primary outcomes:
measure: Prediction of hypotension
timeFrame: 15 min
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training Research Hospital
Study officials:
References:
Clinical trial NCT01446380: Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort
Official title: Phenotypic Expressions in a French Pseudoxanthoma-Elasticum Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudoxanthoma Elasticum
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-10-05
Enrollment: 350
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: Patients diagnosed for a PXE disease from any part of France and requesting a follow-up and clinical management of there disease (opthalmic and vascular complications mainly).

Brief summary: The cohort is intended to study the phenotypic expressions of the pseudoxanthoma elasticum (PXE) disease in various tissues (eye, skin, arteries, etc).

Detailed description: This national french cohort is intended to improve our knowledge on the PXE disease. The study of phenotypic expression of the diseases is focused on cutaneous, opthalmologic and vascular tissues. All investigations are included in a yearly follow-up for these patients and collected in a database.

Plasma are also collected for all patients and stored in our clinical research biological center in Angers, including genetic (DNA) material extracted from diagnostic skin biopsy. French Ministry of Teaching and Research Authorisation number for the PXE collection is AC 2008 871. Declarative number is DC 2008 870.

Eligibility criteria: Inclusion Criteria:

* Patients with PXE disease
* Informed consent obtained
* Patient affiliated to Health care system (french social security)

Exclusion Criteria:

* No informed consent
* No affiliation to a Health care system

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
state: Pays de Loire
Study officials:
affiliation: UH Angers
name: Ludovic MARTIN, MD PhD
role: STUDY_DIRECTOR
References:
citation: Naouri M, Boisseau C, Bonicel P, Daudon P, Bonneau D, Chassaing N, Martin L. Manifestations of pseudoxanthoma elasticum in childhood. Br J Dermatol. 2009 Sep;161(3):635-9. doi: 10.1111/j.1365-2133.2009.09298.x. Epub 2009 Jun 9.
citation: Martin L, Maitre F, Bonicel P, Daudon P, Verny C, Bonneau D, Le Saux O, Chassaing N. Heterozygosity for a single mutation in the ABCC6 gene may closely mimic PXE: consequences of this phenotype overlap for the definition of PXE. Arch Dermatol. 2008 Mar;144(3):301-6. doi: 10.1001/archderm.144.3.301.
citation: Biere L, Donal E, Terrien G, Furber A, Martin L, Prunier F. Left ventricular function in a large cohort of pseudoxanthoma elasticum patients. PLoS One. 2014 Mar 20;9(3):e90364. doi: 10.1371/journal.pone.0090364. eCollection 2014.
Clinical trial NCT01594580: Contamination of Hospital Scrubs
Official title: A Novel Agent to Decrease Contamination of Hospital Scrubs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Contamination
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will:

- Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering

This study will gather information by obtaining swabs from scrubs treated with an antimicrobial and from non-treated scrubs.

Detailed description: The outcome of interest is the contamination of scrubs with Staphylococcus aureus, Enterococcus species or Gram-negative bacteria as determined by surface swabs of healthcare worker scrubs after a full 8-hour shift. The outcomes will be analyzed both individually and collectively.

Contamination will be defined as:

- A swab that is determined to be positive for any Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.

Eligibility criteria: Inclusion Criteria:

* Nursing staff engaging in direct patient care
* Working in select/participating intensive care and intermediate care units
* Working at least 8 day shifts in one month (study period)

Exclusion Criteria:

* Pregnant
* Unable to provide consent
* Unable to follow study schedule

Primary outcomes:
measure: Bacterial contamination of scrubs
timeFrame: Outcome will be assessed at the end of the hospital shift ( approx 8 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland, Baltimore
name: J Kristie Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542280: Does Endometrial Injury Improve Intrauterine Insemination Outcome?
Official title: Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.

Detailed description: In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.

Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.

Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.

Eligibility criteria: Inclusion Criteria:

* 18 - 38 years.
* patent fallopian tunes.
* mild male factor.
* anovulation.
* unexplained infertility.

Exclusion Criteria:

* indications for ICSI.
* evidence of pelvic inflammatory disease.

Primary outcomes:
measure: Chemical Pregnancy Rate
timeFrame: two weeks after intrauterine insemination
measure: Clinical Pregnancy Rate
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.
name: Ahmed Bahaa
role: PRINCIPAL_INVESTIGATOR
References: