louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01114464: Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer
Official title: Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ovarian Reserve
Keywords: Breast cancer
Ovarian reserve
Anti-Mullerian Hormone (AMH)
Chemotherapy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women with breast cancer

Brief summary: The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up ...) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.


Eligibility criteria: Inclusion Criteria:

* female 18-39 years
* suffering from breast cancer
* treated with adjuvant or neoadjuvant chemotherapy

Primary outcomes:
measure: To evaluate the effects of adjuvant or neoadjuvant chemotherapy treatment on ovarian reserve for in situ breast cancer patients
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Caen
country: France
facility: Centre François BACLESSE
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: CRLC de Bourgogne Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre de Lutte Contre le Cancer Léon Bérard
city: Montpellier
country: France
facility: Centre Val d'Aurelle - Paul Lamarque
city: Paris
country: France
facility: Institut Curie
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint Herblain
country: France
facility: Centre de Lutte Contre le Cancer Nantes Atlantique René Gauducheau
Study officials:
affiliation: Nantes University Hospital
name: Paul Barrière, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06201364: External Oblique Intercostal Block Versus Paravertebral Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Patients
Official title: External Oblique Intercostal Block Versus Paravertebral Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare external oblique intercostal block versus paravertebral block for post operative analgesia in patients undergoing laparoscopic cholecystectomy to decease post operative opioid consumption and use the least dose of local anesthesia.

Detailed description: Paravertebral Block (PVB) involve injection of local anesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.

The external oblique intercostal block is a novel motor- and opioid-sparing technique which blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves which innervate the upper abdominal quadrant.

Eligibility criteria: Inclusion Criteria:

* Patients between 20-60 years old
* Patients with ASA clinical status I\\II
* Patients schedule for laparoscopic cholecystectomy

Exclusion Criteria:

* Patients refusal
* Coagulopathy
* Infection at site of injection
* Allergy of local anesthesia
* Sever cardiac disease
* Patients with chest wall deformities

Primary outcomes:
measure: total morphine consumption
timeFrame: first 24 hours postoperatively
Secondary outcomes:
measure: Time of first rescue analgesia
timeFrame: hours
measure: Visual analogue scale (VAS)
timeFrame: at 0.5 ,1,2,4,8,12,24 hours postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04395664: Arrhythmias in Patients With COVID-19
Official title: The ACOVID-19 Study - A Prospective Cohort Study Investigating the Acute Effect of COVID-19 on the Heart by Continuous ECG Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 1000
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: In.patients from hospitals of the greater Copenhagen area

Brief summary: The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

* All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 \> 18 years of age.

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable to understand and sign "informed consent"

Primary outcomes:
measure: In-hospital mortality during hospitalization and a confirmed COVID-19 diagnosis
timeFrame: 4 months
measure: Incident intensive care unit admission during hospitalization and a confirmed COVID-19 diagnosis
timeFrame: 4 months
Secondary outcomes:
measure: Incident pulmonary embolism during hospitalization and a confirmed COVID-19 diagnosis
timeFrame: 4 months
measure: Incident cardiac arrest during hospitalization and a confirmed COVID-19 diagnosis
timeFrame: 4 months
measure: Incident hypoxic respiratory failure during hospitalization and a confirmed COVID-19 diagnosis
timeFrame: 4 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Herlev & Gentofte Hospital
state: Hellerup
Study officials:
References:
Clinical trial NCT01991964: The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
Official title: The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stridor
Laryngomalacia
Keywords: stridor
laryngomalacia
ultrasound
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-11-25
Enrollment: 40
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The hypothesis of the study is that laryngeal US can accurately and reliably diagnose laryngomalacia in infants with congenital stridor.

Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold standard. However, FLB under sedation has some drawbacks as it requires venous access, use of sedative agents, may cause discomfort for the patient and is costly.

Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. It allows for dynamic assessment of moving structures in an awake patient and the results can be easily displayed and recorded.


Eligibility criteria: Inclusion Criteria:

Infants referred for FLB and bronchoscopy due to congenital stridor at the Department of Pediatric Pulmonology, Critical Care and Sleep Medicine at the Tel Aviv Sourasky Medical Centre

Exclusion Criteria:

* Prior knowledge of the cause for stridor
* History of foreign body aspiration

Primary outcomes:
measure: The yield of US in diagnosing laryngomalacia in comparison to FLB.
timeFrame: December 2013- January 2015 (13 months)
Secondary outcomes:
measure: The yield of US in diagnosing other causes of congenital stridor compared to FLB.
timeFrame: December 2013- January 2015 (13 months)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00236964: Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
Official title: Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Anemia
Chronic Kidney Disease
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 96
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 purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

Detailed description: Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis. The duration of the study was five months. After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days. Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests. Efficacy parameters included hematologic parameters.

Eligibility criteria: Inclusion Criteria:

* Creatine Clearance \<40 mL/min
* Average Baseline Hemoglobin \< 10.5g/dL
* Serum Transferrin Saturation (TSAT) \< 25% and Ferritin \<300ng/mL

Exclusion Criteria:

* Blood Transfusion within 30days
* Uncontrolled Hypertension
* Suffering form concommitant disease of the liver
* Serious bacterial infection
* Pregnancy / lactation
* Symptomatic HIV
* Expected to under dialysis or renal transplant during study

Primary outcomes:
measure: Mean Change in Hemoglobin
timeFrame: Baseline and Day 43
measure: Mean Change in Serum Ferritin
timeFrame: Baseline and Day 43
Secondary outcomes:
measure: Clinical Success (Change in Hemoglobin)
timeFrame: Baseline and Day 43
measure: Clinical success (change in Ferritin)
timeFrame: Baseline and Day 43
Other outcomes:
Locations:
Study officials:
affiliation: Medical Director
name: Mark Falone, MD
role: STUDY_DIRECTOR
References:
citation: Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. doi: 10.1159/000085049. Epub 2005 Apr 11.
Clinical trial NCT00877864: Diabetes Exercise and Lifestyle Trial
Official title: Diabetes Exercise and Lifestyle Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus
Keywords: diabetes
exercise
printed materials
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 26
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).

Detailed description: Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* A1c 0.700-0.099
* ability to read and write English
* signed ICF

Exclusion Criteria:

* participation in previous 6 months in exercise \> 2 times per week for at least 20 min per session
* insulin therapy changes in medication for diabetes, BP or Lipids

Primary outcomes:
measure: The primary outcome will be A1c at the end of 6 months supervised exercise period.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ron Sigal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410964: Non-Linear Imaging of Skin In Vivo
Official title: Non-Linear Imaging of Skin In Vivo: VIO In Vivo Skin Imaging evaluatiON (VISION)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Skin Condition
Skin Diseases
Skin Lesion
Skin Abnormalities
Lead sponsor: Enspectra Health
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2022-06-08
Enrollment: 122
Sex: ALL
Minimum age (years): 2
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics

Brief summary: The overall objective of this study is to investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health.


Eligibility criteria: Inclusion Criteria:

1. Subjects, ages 2 - 90 years old.
2. Subject, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements.
3. Subject or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device.
4. Subject and guardian, if applicable, must comply with the protocol requirements.
5. Subject or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies.

Exclusion Criteria:

1. Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use
2. Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne)
3. Any known allergies to any materials used in the preparation of skin and/or device use
4. Has a temporary or permanent electrical implanted medical device

   -

Primary outcomes:
measure: VIO System Imaging Performance
timeFrame: 3 hours
measure: VIO System Image Quality
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Enspectra Health
state: California
Study officials:
References:
citation: Ward WH, Farma JM, editors. Cutaneous Melanoma: Etiology and Therapy [Internet]. Brisbane (AU): Codon Publications; 2017 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK481860/
Clinical trial NCT01526564: Clinical Study on Acetyl-L-Carnitine
Official title: Phase III Study of Acetyl-L-Carnitine (ALC) Hydrochloride Enteric-coated Tablets in Treatment of Peripheral Sensory Neuropathy in Anti-cancer Chemotherapeutics Induce
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Sensory Neuropathy
Keywords: Chemotherapy-induced peripheral neuropathy (CIPN)
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Jiao Tong University School of Medicine
name: Shanghai Changzheng Hospital
First posted: 2012-02-06
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.

Detailed description: This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics induce.

Eligibility criteria: Inclusion Criteria:

* Patients had signed the Informed Consent Form
* Male or Female
* Age 18-75 years old
* Patients who have treated with Taxoids, Satraplatin and Vincristine; The peripheral sensory neuropathy grading after chemotherapy was \>/=grade 3 or grade 2 lasting for one month
* The course of neuropathy was \</=6 months
* No need to continue chemotherapy according to the condition nor refusing chemotherapy
* At least one of the neuroelectrophysiological examine results were abnormal
* Physical Condition Score (KPS) \>/=60
* Anticipated lifetime\>/=60.

Exclusion Criteria:

* Patients whose peripheral sensory neuropathy was induced by medicines except of the Taxoids, Satraplatin and vincristine anti-cancer chemotherapeutics
* Diabetics
* Peripheral sensory neuropathy was induced by Vitamin deficiency, infections, trauma, toxicosis, compression, and ischemia
* Peripheral sensory neurologic dysfunction that induced by lesions of central nervous system; hereditary neuropathy
* Patients who have treated by other medicines for peripheral sensory neuropathy in 30 days
* Patients had treated by other clinical trial medicines or participated into other trials in 30 days
* Patients had active infections
* Any clinical problems out of control
* Women in pregnancy and lactation, Subjects with no compliance.

Primary outcomes:
measure: Changes in peripheral sensory neuropathy grades
timeFrame: Base and eighth week
Secondary outcomes:
measure: Changes in Neuroelectrophysiological test
timeFrame: Base and eighth week
measure: Changes in Cancer-related fatigue level
timeFrame: Base and eighth week
measure: Changes in Physical Condition Score
timeFrame: Base and eighth week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06045364: Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
Official title: Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nausea and Vomiting
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.

Detailed description: This study is a prospective, double-blind, randomized controlled trial. Patients who meet the criteria of our center and need to undergo ERCP lesion resection will be included and randomly divided into groups. After receiving Glycopyrrolate (experimental group) and Anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ERCP. The inhibitory effect of Glycopyrrolate on postoperative nausea and vomiting of ERCP will be analyzed statistically.

Main outcome measure: incidence of nausea and vomiting after ERCP Secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ERCP operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events

Eligibility criteria: Inclusion Criteria:

* 1.Adults 18-80 years old 2.ASA :I-III 3.Patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ERCP

Exclusion Criteria:1: Use of anticholinergic drugs

2: pregnancy

3: glaucoma

4: Myasthenia gravis

5: Obstructive gastrointestinal diseases

6: Obstructive urinary tract disease (prostatic hyperplasia)

7: Heart disease (coronary heart disease, congestive heart failure)

8: hyperthyroidism

9: Previous history of abdominal or intestinal surgery

10: Chronic renal failure

-

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: Timepoint：24 hours after the ERCP
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital Of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Guangyou Duan, doctor
role: STUDY_DIRECTOR
References: