louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01338662: Comparison of the Incidence of Dyskinesia in Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist
Official title: A 10-year Observational Study of the Incidence of Dyskinesia in Patients With Early Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatient clinic in SNUH

Brief summary: The purpose of this study is to compare the onset time and severity of dyskinesia in amantadine or Dopamine agonist initial treated groups in Parkinson's disease.

Detailed description: 1. Dopamine agonist can delay the risk of dyskinesia by initiating treatment rather than levodopa. Amantadine is typical antidyskinetic drug. There is no data about comparison of risk of dyskinesia in amantadine and dopamine agonist by initiating treatment.
2. Prospective , randomized, open label study compare the onset time and severity of dyskinesia between groups randomized assigned order of amantadine and dopamine agonist

Eligibility criteria: Inclusion Criteria:

* 30\<age\<60
* IPD
* H \& Y\<3

Exclusion Criteria:

* previous dopaminergic medication history
* dyskinesia
* Parkinson plus
* clinically significant or unstable medical or surgical condition

Primary outcomes:
measure: dyskinesia onset
timeFrame: up to 10 years from the start of durg (Amantadine or dopaimine agonsit)
Secondary outcomes:
measure: UPDRS, severity of dyskinesia between groups
timeFrame: observe duration of onset of dyskinesia from initial treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Beom S Jeon
Study officials:
affiliation: Seoul National University Hospital
name: Beom S Jeon, MD, PhD
role: STUDY_CHAIR
References:
citation: Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.
citation: Montastruc JL, Rascol O, Senard JM, Rascol A. A randomised controlled study comparing bromocriptine to which levodopa was later added, with levodopa alone in previously untreated patients with Parkinson's disease: a five year follow up. J Neurol Neurosurg Psychiatry. 1994 Sep;57(9):1034-8. doi: 10.1136/jnnp.57.9.1034.
Clinical trial NCT01207362: Assessing and Improving Balance Using Platform Perturbations
Official title: Assessing and Improving Balance Using Platform Perturbations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Balance
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The purpose of this study is to compare current standing balance assessment methods to a new method that measures weight shift during small movements of a sliding platform. It will also be used to determine if balance improves with repeated exposure as part of a 4-week training program.


Eligibility criteria: Inclusion Criteria:

* Healthy no balance deficits age 20-35 or 50-65

Exclusion Criteria:

* moderate to severe arthritis

Primary outcomes:
measure: Improvement in static sway
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: W. Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
Study officials:
References:
Clinical trial NCT06745362: Weight Reduction with the Low-Insulin-Method - Self Monitoring of Breath Acetone
Official title: Weight Reduction with the Low-Insulin-Method - Self Monitoring of Breath Acetone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obese Volunteers
Keywords: lifestyle intervention
weight reduction
ketosis
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 42
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: The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.

Researchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.

Participants will:

Get a lifestyle intervention via the LIM-App for 12 months. Report body weight.

Detailed description: Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.

Method: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.

Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index \> 25kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: body weight
timeFrame: 3 months
Secondary outcomes:
measure: body weight
timeFrame: 12 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West German Center of Diabetes and Health
Study officials:
References:
Clinical trial NCT04353362: Alternative Antibiotic Regimen in Periodontitis Treatment
Official title: Comparison of Ofloxacin and Metronidazole/Amoxicillin on the Treatment of Periodontitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Amoxicillin
Metronidazole
Ofloxacin
Periodontitis
Root Planing
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Context and Aims: Several studies have demonstrated an association between obesity, periodontitis, and exercise. This study aimed to investigate the effects of regular exercise on obese women with periodontal disease, using serum, saliva, and gingival crevicular fluid (GCF) samples.

Settings and Design: A before-after study design was adopted to evaluate the effects of 12 weeks of regular exercise on obese women grouped according to periodontal status, without a control group (no exercise).

Methods and Material: The study sample comprised fifteen patients without periodontitis (NP group) and 10 patients with chronic periodontitis (CP group), from whom periodontal parameters were measured and serum, saliva, and GCF samples were collected. Body mass index (BMI), anthropometric measurements, somatotype-motoric tests, and maximal oxygen consumption (VO2max) were recorded at baseline and after exercise.

Statistical analysis used: MedCalc was used for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* The periodontal diagnosis of participants with generalized periodontitis stage III-IV/grade C. Systemically healthy participants with generalized periodontitis were enrolled if they were between 18 and 40 years of age, and had no allergies to penicillin, metronidazole or quinolones, a history of antibiotic therapy or periodontal therapy within the preceding six months

Exclusion Criteria:

* Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status, allergies to quinolones, penicillin or metronidazole, a history of antibiotic therapy, or periodontal treatment within the preceding six months

Primary outcomes:
measure: Probing depth
timeFrame: 6-months
Secondary outcomes:
measure: Clinical attachment loss
timeFrame: 6-months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Begum Alkan
Study officials:
References:
Clinical trial NCT03834480: Intraartecular Platelet Rich Plasma for Sacroiliitis
Official title: Ultra Sound Guided Injection of Platelet Rich Plasma Versus Steroid for Sacroiliac Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliitis
Keywords: Platelet reach plasma
sacroiliac
Ultrasound
Steroid
Chronic low back Pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison between the effect of steroids and platelet-rich plasma on low back pain after ultrasound-guided sacroiliac injection to determine any is more effective and of long duration

Detailed description: A prospective randomized controlled study was conducted at the department of anesthesiology Mansoura University Hospital during the period from December 2017 to January 2019 on fifty ASA I-III adult patients, of both sex after approval of IRB (Institutional Review Board) ID number MS17.10.03 \& IRB date 12-11-2017. The patients were randomly allocated into two groups each of 25 patients according to computer-generated random number codes that were placed in sealed envelopes, double blinded, with parallel-group comparison.

Steroid Group (S) (n. 25):- Patients were injected by 4 ml of sterile water containing the methylprednisolone Acetate (Depo-Medrol) per-kg calculated dose (0.5mg/kg up to a lean muscle body weight of 80kg in the painful sacroiliac joint).

Platelet rich plasma Group (P) (n. 25):-Patients received fixed volume of 4 ml platelet-rich plasma in the inflamed painful sacroiliac joint.

Eligibility criteria: Inclusion Criteria:

* 1. Patients of either sex. 2. ASA I\&III. 3. Age between 18 - 70 years. 4. Chronic lower back pain of sacroiliac origin. 5. Anatomy of the joint can identified by the ultrasonography. Exclusion criteria

  1. Patients with contraindications to sacroiliac injection.
  2. Patients known to be allergic to platelet rich plasma or local anesthetics.
  3. History of immune suppression or immune compromised diseases
  4. Patient below age of 18 as the joint will undergo normal physiological changes.
  5. Patient over 70 years.
  6. Sacroiliac pain of multiple sources.
  7. Preoperative shivering or fever (\>38oc).
  8. Hepatic, renal and heart failure patients.
  9. Patients on; anticoagulants, antiplatelet, and with INR≥1.5.
  10. Exclude corticosteroid injection in the sacroiliac joint at the last three months.
  11. Patient refusal.

Primary outcomes:
measure: visual analog score
timeFrame: Basal and after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura faculty of Medicine
state: Dakahlia
Study officials:
References:
Clinical trial NCT02512380: Neoadjuvant SLOT Versus SOX in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer
Official title: Neoadjuvant S1, Oxaliplatin, and Docetaxel (SLOT) Versus S1, Oxaliplatin(SOX) in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2015-07-30
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer.

Detailed description: Two arms, phase 3 study of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer. 380 Patients will be enrolled in this trial. The primary objective of this study is to determine the 5-year survival of the two arms.

Eligibility criteria: Inclusion Criteria:

* Histologically proven gastric or GE junction adenocarcinoma;
* Age: 18 to 70;
* ECOG 0-2;
* Adenocarcinoma of the stomach or GE junction according to staging classification TNM Scannographic: T3-4 N0/N + M0 ;
* Completion of baseline quality of life questionnaire
* Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy;
* Active infection requiring antibiotics
* Pregnant, lactating women
* Psychiatric illness, epileptic disorders
* Concurrent systemic illness not appropriate for chemotherapy
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma

Primary outcomes:
measure: 5 year overall survival
timeFrame: 6 years
Secondary outcomes:
measure: 3 year relapse free survival
timeFrame: 5 years
measure: Surgical complete resection rate (R0)
timeFrame: 2.5 year
measure: Pathological response rate
timeFrame: 2.5 year
Other outcomes:
measure: quality of life questionnaire
timeFrame: 6 year
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Hospital, CAMS
name: Jing Huang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04966780: Refeeding Like Syndrome in Acute Disease
Official title: Dose-response Relation Between the Development of a Refeeding-like Syndrome and Sodium Balance in Patients Undergoing Acute Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refeeding Syndrome
Acute Abdomen
Keywords: refeeding syndrome
acute abdominal disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2021-07-19
Enrollment: 48
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: Consecutive, adult patients for acute, abdominal surgery were asked top be included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.

Brief summary: The refeeding syndrome has been reported without any evidence of prolopnged semistarvation, thus being different from the traditional disease.

The investigators wanted to investigate, if sodium infusions could be part of the explanation.

Detailed description: Background: Refeeding syndrome is conventionally connected to start of feeding after prolonged periods of semi-starvation and adaption. However, it is also described in acutely ill patients and in ICU patients without a history of adaption, but sometimes only defined as a drop in p-phosphate without clinical manifestations. The investigators hypothesize, that a positive sodium balance could induce the refeeding-like syndrome (RLS).

Method: Consecutive patients for acute, abdominal surgery were included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.

Eligibility criteria: Inclusion Criteria:

* age \> 18 yr
* ready for acute surgery
* able to understand and cooperate.

Exclusion Criteria:

* pregnancy or breastfeeding
* renal insufficiency (p-creatinine\>400 micr mol/l)
* re-operations
* expected hospital stay \< 24 hours.

Primary outcomes:
measure: sodium balance
timeFrame: 7 days
Secondary outcomes:
measure: plasma phosphate
timeFrame: 7 days
measure: urinary excretion of phosphate
timeFrame: 7 days
measure: phosphate balance
timeFrame: 7 days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital
Study officials:
affiliation: University of Copenhagen
name: jens R Andersen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01078480: Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone
Official title: Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Displaced Midshaft Fracture of the Collar Bone
Keywords: Fracture
Collar bone
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Central Jutland Regional Hospital
name: Vejle Hospital
name: Randers Regional Hospital
name: Swemac Orthopaedics ApS
First posted: 2010-03-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.

The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).


Eligibility criteria: Inclusion Criteria:

* fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.

Exclusion Criteria:

* bilateral fracture
* imminent skin perforation
* open fracture
* associated neurovascular effect
* unstable fracture of neck of scapula "floating shoulder"
* fracture of coincidental upper extremity distal for the shoulder
* pathologic fracture
* the patient states that there was a unilateral or bilateral shoulder problem before the fracture
* fracture realized more than 14 days after it arose
* circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
* circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
* medical contraindication against surgery or general anaesthesia
* former participation in the trial
* former fracture contra/ipsilateral at the age of 15 or older

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 6 weeks, 3 months, 6 months, 1 year
Secondary outcomes:
measure: Constant-Murley Score
timeFrame: 6 weeks, 3 months, 6 months, 1 year
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Orthopaedic Division, Randers Hospital
state: Central Jutland
Study officials:
affiliation: Orthopaedic Division, Central Jutland, Randers Hospital, Denmark
name: Carsten M Jensen, M.D.Sci.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qvist AH, Vaesel MT, Jensen CM, Jakobsen T, Jensen SL. Minimal Pain Decrease Between 2 and 4 Weeks After Nonoperative Management of a Displaced Midshaft Clavicle Fracture Is Associated with a High Risk of Symptomatic Nonunion. Clin Orthop Relat Res. 2021 Jan 1;479(1):129-138. doi: 10.1097/CORR.0000000000001411.
Clinical trial NCT02711280: The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children
Official title: The Effect of Sevoflurane and Propofol on Oxidative Stress and Apoptosis Status in Children Undergoing Hypospadias Repair Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 47
Sex: MALE
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether Propofol and Sevoflurane affect the oxidative stress and apoptosis status in children undergoing hypospadias repair surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (ASA) I-II, undergoing selective surgery for hypospadias repair.

Exclusion Criteria:

* a history of developmental delay or mental retardation, which could make observational pain intensity assessment outside the norm;
* a history of central nervous system diseases;
* a known or suspected coagulopathy;
* a known allergy to any of the study drugs;
* abnormalities of the sacrum and any signs of infection at the site of the proposed caudal block.

Primary outcomes:
measure: the change of blood glutathione peroxidase(GPx) level in perioperative period
timeFrame: immediately after anesthetic induction, 2h and 3 days after operation
measure: the change of blood-separated erythrocytes superoxide dismutase (SOD) activities in perioperative period
timeFrame: immediately after anesthetic induction, 2h and 3 days after operation
measure: the change of blood-separated erythrocytes catalase (CAT) activities in perioperative period
timeFrame: immediately after anesthetic induction, 2h and 3 days after operation
measure: the change of blood-separated lymphocytes caspase-3 mRNA level in perioperative period
timeFrame: immediately after anesthetic induction, 2h and 3 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Department of Anesthesiology, the First-Affiliated Hospital of Sun Yat-Sen University
name: Xue Zhou, Master
role: PRINCIPAL_INVESTIGATOR
References: