louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01446120: Insulin Loaded Orally Dissolved Films (Insulin-ODF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: this is phase one study. The study population are healthy volunteers.
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick (buccal) , Releasing the insulin to the circulation, while the film is dissolved..

Primary endpoint:

1. The Cmax (Maximum Concentration of insulin in mg).
2. Tmax (the time to Cmax in minutes)
3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.

Secondary endpoints:

1. The glucose and C-peptide levels during six hours of the trial. (mg)
2. The safety of the treatment in a descriptive manner by recording all adverse events in the study population.

Methods

Seven healthy volunteers will be randomly assigned to one of the following groups:

A. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.

The study is designed a crossover, in which each group is treated 3-7 days of washout.

The volunteer subjects will arrive to the clinic after eight hours fasting. Each subject will be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion and exclusion criteria).

An I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels, ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.

Blood Insulin and glucose levels will be evaluated at baseline, and after the following time points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be evaluated at baseline and after the following time points: 60,120,240, 360 minutes.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent.
2. 18.5\<BMI\<30

Exclusion Criteria:

1. Smokers.
2. Known mouth cavity, gums or gastrointestinal disease.

Primary outcomes:
measure: Blood Insulin
Secondary outcomes:
measure: glucose and C-peptide levels
measure: hypoglycemia and irritation.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00117520: The Effect of Caffeine in Elderly Citizens
Official title: The Effect of Caffeine as Endurance Enhancing Drug in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Elderly Citizens
Keywords: caffeine, endurance, postural stability, elderly
Lead sponsor: Herning Hospital
Sponsor class: OTHER
First posted: 2005-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.

Detailed description: Caffeine ingestion increases the endurance of young people exercising at 60%-85% of their maximal oxygen uptake, and it also seems to improve endurance as measured by repeated sub-maximal isometric contraction and decreases the rate of perceived exertion during exercise. Although caffeine increases endurance in young people, an increase in endurance may be of greater interest in the elderly as the population of older adults with a physically active lifestyle is growing rapidly or for increasing endurance fitness through an exercise or rehabilitation program. Therefore the main hypothesis was that caffeine would improve cycling endurance at 65% of expected maximal heart rate, and the secondary hypotheses were that caffeine would improve postural stability, reaction and movement times, isometric arm flexion endurance, and walking speed, and would reduce the rate of perceived exertion after 5 minutes of cycling in healthy elderly citizens.

Eligibility criteria: Inclusion Criteria:

* Healthy elderly individuals aged over 70 years

Exclusion Criteria:

* Dementia or invalidating psychiatric disease
* General debility, angina, or other diseases that would render participation in the test program impossible
* Treatment with beta receptor blocking drugs, calcium-channel blocking drugs, digitalis, or nitroglycerine
* Acute disease and injury
* Diabetes
* Conditions that would contraindicate caffeine ingestion or participation in the test program
* Treatment with medication that interacts with caffeine
* Ingestion of caffeine containing drinks and foods 48 hours before each session

Primary outcomes:
measure: endurance measured on an ergometer bicycle
Secondary outcomes:
measure: postural stability
measure: reactiontime
measure: isometric endurance (armflexion)
measure: walking speed
measure: fatigue
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Surgical Research Department
state: Ringkjoebing
Study officials:
affiliation: Surgical Research Department, Herning Hospital, DK-7400 Herning
name: Charlotte B Norager, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01827020: Effect of Ketamine Addition to Lidocaine in Rhinoplasty
Official title: Effect of Ketamine Addition to Lidocaine for Postoperative Pain Management in Rhinoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nose Deformities, Acquired
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether subanesthetic ketamine addition to lidocaine decreases postoperative pain scores in infiltration anesthesia during rhinoplasty.

Detailed description: In rhinoplasty operations local infiltration anesthesia uses for surgery insight and patient comfort. The investigators designed this study to prolonged the time of infiltration block and preventive analgesia. So, before operation, study drugs will infiltrate to the submucosa of intranasal cavity. Then, surgeon and patient satisfaction, postoperative analgesic demand, postoperative pain scores and side effects will determine.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective rhinoplasty operation under general anesthesia
* Patients with ASA (American Society of Anesthesiology) class I
* Patients between 18-50 years old

Exclusion Criteria:

* Age \<18 and \>50
* ASA \> II
* Preexisting neurological or psychiatric illness
* Systemic diseases (diabetes mellitus, hypertension, coronary heart disease...)
* Having a history of chronic pain and receiving chronic analgesia therapy
* Having a history of drug abuse

Primary outcomes:
measure: Postoperative pain scores on the Visual Analogue Scale
timeFrame: 24 hours
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 24 hour
measure: Analgesic demand
timeFrame: 24 hour
Other outcomes:
measure: Number of participants with adverse effects as a measure of safety and tolerability
timeFrame: 24 hour
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal Medical Center
Study officials:
affiliation: Turgut Ozal Medical Center
name: Mukadder Sanli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Honarmand A, Safavi M, Karaky H. Preincisional administration of intravenous or subcutaneous infiltration of low-dose ketamine suppresses postoperative pain after appendectomy. J Pain Res. 2012;5:1-6. doi: 10.2147/JPR.S26476. Epub 2011 Dec 30.
Clinical trial NCT06612320: Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance
Official title: Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Keywords: Refusal
clinical trial
factors
reasons
pregnancy
pre-eclampsia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 720
Sex: FEMALE
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 will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.

Brief summary: The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving pregnancy and childbirth in France. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

Detailed description: 1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
2. Comparison of demographic characteristics between the two groups

   * Group 1: women accepting to participate in RCT
   * Group 2: women refusing to participate in RCT
3. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
4. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

Eligibility criteria: Inclusion Criteria:

The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.

Exclusion Criteria:

None

Primary outcomes:
measure: Collection of maternal demographic characteristics
timeFrame: Day 1
measure: Collection of obstetric characteristics
timeFrame: Day 1
measure: Collection of characteristics related to information provided
timeFrame: Day 1
Secondary outcomes:
measure: Motivation linked to acceptance
timeFrame: Day 1
measure: Reason for refusing to participate
timeFrame: Day 1
Other outcomes:
Locations:
city: Clamart
country: France
facility: APHP - Antoine Béclère hospital - Maternity
state: IDF
city: Colombes
country: France
facility: APHP - Louis Mourier hospital - Maternity
state: IDF
city: Paris
country: France
facility: APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity
state: IDF
city: Paris
country: France
facility: APHP - Port-Royal Maternity
state: IDF
Study officials:
affiliation: Port-Royal Maternity - APHP
name: Yoann Athiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05955820: Suspension System on Impingement Syndrome
Official title: Effect of a Selected Suspension System Exercise Program on Patients With Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impingement Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of shoulder exercise using a selected suspension system exercise program on pain, disability, functional performance and proprioception in patients with subacromial impingement syndrome.

Detailed description: Two groups were assigned to this study, the first one received four conventional exercises that designed for shoulder impingement syndrome, the second group received the same four conventional exercises plus four selected suspension system exercises.

The sessions were conducted three times per week fir four weeks.

Eligibility criteria: Inclusion Criteria:

1. Fifty-eight subjects with SIS (more than three months).
2. Their age ranges from 20-45 years old
3. Level of pain (at least 2/10 on VAS)
4. Body mass index (BMI) between 18-25
5. Subjects must show positive results in at least two of the following tests: Neer's impingement test, Hawkins-Kennedy test, supraspinatus (empty can) test, apprehension and relocation test.

Exclusion Criteria:

The subjects will be excluded if they had:

1. Received physiotherapy at last 3 months.
2. Received corticosteroids injection in subacromial space at last 3 months.
3. Received anti-inflammatory medications.
4. Have a fracture or dislocation in shoulder, neck and thoracic regions.
5. Have an acute rotator cuff tear.
6. Have tumor or malignancy in shoulder region.
7. Have neurologic problems in shoulder, neck and thoracic regions.
8. Have cooperation difficulties due to cognitive disorders.

Primary outcomes:
measure: Improvement in active shoulder ROM
timeFrame: Baseline
measure: Improvement in functional performance
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university faculty of physical therapy
Study officials:
References:
citation: Chen L, Chen J, Peng Q, Chen J, Zou Y, Liu G. Effect of Sling Exercise Training on Balance in Patients with Stroke: A Meta-Analysis. PLoS One. 2016 Oct 11;11(10):e0163351. doi: 10.1371/journal.pone.0163351. eCollection 2016.
Clinical trial NCT06669520: Correlation of Blood Serum Renalase and Microcirculation Obstruction in Patients with Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention
Official title: Correlation of Blood Serum Renalase and Microcirculation Obstruction in Patients with Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 200
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 population will include 200 patients diagnosed with acute myocardial infarction (AMI) who will undergo primary percutaneous coronary intervention (PCI) at the Third Xiangya Hospital of Central South University, from August 2024 to August 2025.

Brief summary: This research will explore the association between blood serum renalase and microcirculation obstruction in patients with acute myocardial infarction (AMI) after primary percutaneous coronary intervention (PCI). The investigators aim to identify potential risk factors for microcirculation obstruction in AMI patients after PPCI.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. STEMI symptom onset time \< 12 hours;
3. STEMI symptom onset time 12-48 hours with persistent ischemic symptoms, hemodynamic instability, or life-threatening ventricular arrhythmias;
4. High-risk NSTEMI;
5. Emergency PCI;
6. Voluntary informed consent.

Exclusion Criteria:

1. Non-obstructive acute myocardial infarction;
2. Severe chronic kidney disease (defined as estimated glomerular filtration rate \< 20 mL/min per 1.73 m²);
3. Life expectancy \< 1 year;
4. Pregnant or planning to become pregnant;
5. Emergency PCI failure.

Primary outcomes:
measure: Number of Participants with Microvascular Obstruction Assessed by Contrast-Enhanced Magnetic Resonance Imaging 3-7 Days After Percutaneous Coronary Intervention.
timeFrame: 3-7 days after PPCI
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT06611020: Adjuvant VaccInation After Conization for the Treatment for CervicAL Dysplasia
Official title: The Role of Adjuvant VaccInation After Conization for the Treatment for Cervical Dysplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Intraepithelial Neoplasia
Keywords: HPV
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pateints with HPV-related disease

Brief summary: HPV vaccination has emerged as a strategy to reduce the risk of recurrence oafter excisional treatment. However, only few data are aviable. In this trial the investigators aim to assess the role of HPV vaccination in women traeted for HPV-related lesions

Detailed description: Patients treated for HPV-related disease are counseled about the potential protective role of HPV vaccination. The investigators will monitor the risk of HPV recurrence in pateints who choce to have vaccination and who did not.

Eligibility criteria: Inclusion Criteria:

* Treatment of HPV-related disease

Exclusion Criteria:

* Previous HPV vaccination

Primary outcomes:
measure: HPV recurrence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Grazia Casadei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03388320: Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
Official title: Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases, Alcoholic
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2018-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study examining whether an evidence-based recovery support smartphone application, the Addiction Comprehensive Health Enhancement Support System (A-CHESS), can decrease alcohol recidivism in a previously unstudied group of patients with alcoholic liver disease (ALD).

Detailed description: A-CHESS is a smartphone application developed by the University of Wisconsin-Madison based on self-determination theory, with a previous randomized clinical trial showing that use of the app resulted in significantly fewer risky drinking days in patients leaving treatment for alcohol-use disorders. The application is downloaded to the participant's smartphone, and provides ongoing access to peer support and educational materials, monitoring of the risk of relapse, and delivery of reminders and encouragements to the patient. The application also has a survey platform to assess and reassess the participants' most recent alcohol consumption, quality of life, and experience using the application. We anticipate that use of the A-CHESS app will result in decreased drinking and improved abstinence, identifying a potential intervention to offer patients with ALD to improve their mortality, liver disease, and likelihood of liver transplant candidacy status.

Eligibility criteria: Inclusion Criteria:

* Alcoholic liver disease
* Followed or seen at New York Presbyterian Hospital / Weill Cornell Medical Center
* English speaking
* Access to a smartphone

Exclusion Criteria:

* Unable to consent
* Primary language other than English
* No access to a smartphone

Primary outcomes:
measure: Rates of recidivism
timeFrame: 6 months
Secondary outcomes:
measure: Use of A-CHESS
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
state: New York
Study officials:
affiliation: Weill Cornell Medical College/NYPH
name: Robert S Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03320720: Evaluation of Home Treatment for Acute Psychiatric Care
Official title: Evaluation of Home Treatment for Acute Psychiatric Care of the Psychiatric University Hospital Zurich (Switzerland)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorder
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. Following two years, the two treatment modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics.

Detailed description: The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Therefore, psychiatric patients in need of hospitalization who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual) during one year. Home treatment patients are visited by a mobile and multiprofessional care team at their homes. Additionally, patients without a health insurance for home treatment and patients who are directly assigned to home treatment are included in separate study groups. Following two years, it will be checked whether home treatment leads to a reduction of inpatient days as a primary outcome. Further outcomes such as cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics will be also analyzed.

Eligibility criteria: Inclusion Criteria:

* Need for acute psychiatric inpatient care
* Residence in Zurich city
* Health insurance for Home Treatment

Exclusion Criteria:

* none

Primary outcomes:
measure: Inpatient days
timeFrame: 2 years follow-up
Secondary outcomes:
measure: Total days in treatment
timeFrame: 2 years follow-up
measure: Treatment costs
timeFrame: 2 years follow-up
measure: Rehospitalization rate
timeFrame: 2 years follow-up
measure: Adverse events
timeFrame: 2 years follow-up
measure: Global Assessment of Functioning Scale (GAF)
timeFrame: 2 years follow-up
measure: Health of the Nation Outcome Scale (HoNOS)
timeFrame: 2 years follow-up
measure: Clinical Global Impression Scale (CGI)
timeFrame: 2 years follow-up
measure: Patients' satisfaction
timeFrame: 2 years follow-up
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatric University Hospital Zurich
state: Zurich
Study officials:
affiliation: Psychiatric University Hospital, Zurich
name: Matthias Jäger, MD
role: PRINCIPAL_INVESTIGATOR
References: