louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02615652: The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Mental Disorders (CMD)
Psychotic Symptoms
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Jimma University
name: Ludwig-Maximilians - University of Munich
First posted: 2015-11-26
Enrollment: 865
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Young adult male inhabitants of the Gilgel Gibe field research center.

Brief summary: Researchers of the three collaborating universities implement a pilot observational study in "Gilgel Gibe Field Research Center", a health and demographic surveillance system run by the Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in young men for the development of common mental disorders and psychotic symptoms and the stability of distinct symptoms of mental disorders in the community. The investigators will explore in particular the impact of lifestyle on mental health in young men, including the traditional habit of chewing khat leaves, which contain amphetamine-like cathinone. Furthermore, the investigators want to demonstrate the reliability and validity of assessments performed by trained local interviewers.


Eligibility criteria: Inclusion Criteria:

* Male, Age 18 - 30, permanent residents in Gilgel Gibe

Exclusion Criteria:

* Prior existing severe mental health problems

Primary outcomes:
measure: psychotic symptoms
timeFrame: through study completion, within 2 months
measure: symptoms of Common Mental Disorders
timeFrame: through study completion, within 2 months
Secondary outcomes:
measure: amount of khat use
timeFrame: through study completion, within 2 months
measure: amount of alcohol use
timeFrame: through study completion, within 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02340052: Pain Map DK: a Prospective Cohort Study of Pain Treatment in 500 Hip Arthroplasty Patients at Different Danish Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: postoperative pain treatment
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total hip arthroplasty patients

Brief summary: This is a prospective observational cohorte study. The aim is to investigate actual pain treatment and outcomes in a large population of total hip arthroplasty patients at 5 different hospitals in Denmark.


Eligibility criteria: Inclusion Criteria:

* Primary planned total hip arthroplasty, Able to understand and speak english or danish.

Exclusion Criteria:

* patients not able to cooperate, patients with alcohol or drug abuse

Primary outcomes:
measure: NRS pain during mobilization
timeFrame: 6 hours postoperatively
measure: Total morphine-eqv. opioid consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: NRS pain at rest
timeFrame: 6 hours postoperatively
measure: NRS pain at rest
timeFrame: 24 hours postoperatively
measure: NRS pain during mobilization
timeFrame: 24 hours postoperatively
measure: Nausea
timeFrame: 6 hours postoperatively
measure: Nausea
timeFrame: 24 hours postoperatively
measure: Vomiting
timeFrame: Number of episodes during 24 hours postoperatively
measure: Dizziness
timeFrame: 6 hours postoperatively
measure: Dizziness
timeFrame: 24 hours postoperatively
measure: Sedation
timeFrame: 6 hours postoperatively
measure: Sedation
timeFrame: 24 hours postoperatively
measure: Length of hospital stay
timeFrame: Number of days until discharge
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg hospital
state: Sealand
city: Koege
country: Denmark
facility: Koege hospital
state: Sealand
city: Naestved
country: Denmark
facility: Naestved hospital
state: Sealand
Study officials:
affiliation: Head of research, department of anaesthesiology, Koege hospital
name: Ole Mathiesen, MD. PhD
role: STUDY_CHAIR
References:
citation: Geisler A, Dahl JB, Thybo KH, Pedersen TH, Jorgensen ML, Hansen D, Schulze LK, Persson EI, Mathiesen O. Pain management after total hip arthroplasty at five different Danish hospitals: A prospective, observational cohort study of 501 patients. Acta Anaesthesiol Scand. 2019 Aug;63(7):923-930. doi: 10.1111/aas.13349. Epub 2019 Mar 18.
Clinical trial NCT06727032: Automated Detection of Brain Metastases on MRI
Official title: Validation of an AI Software for Detection of Brain Metastases on MRI: AIDED Versus UNAIDED Performance
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Brain Metastases
Lead sponsor: Robovision BV
Sponsor class: INDUSTRY
Collaborators: name: Netherlands Cancer Institute - NKI
First posted: 2024-12-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain Metastasis

Brief summary: This reader study aims at assessing whether the radiologist aided with AI software has at least a non-inferior performance than without AI assistance in detecting brain metastases.

200 retrospective MRI images will be included in the study with 100 positive and 100 negative exams.

Assessment will be completed by 12 readers with varying level of experience. This is a Retrospective Multiple-Reader Multiple-Case (MRMC) randomised study.


Eligibility criteria: Inclusion Criteria:

* subjects older than 18 years with a known or possible primary extracranial cancer who undergo MRI for diagnosis, treatment planning or follow-up of brain metastases.

Exclusion Criteria:

* subjects with primary intracranial tumor(s), with more than 10 brain metastases, with meningeal metastases, with radiation necrosis, or post brain surgery

Primary outcomes:
measure: Detection accuracy
timeFrame: 3 months
Secondary outcomes:
measure: Reading time
timeFrame: 3 months
measure: Inter-reader agreement
timeFrame: 3 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
Study officials:
References:
Clinical trial NCT02100332: A Cross Sectional Disease/Condition Focused Observational Study on Chronic Obstructive Pulmonary Disease (COPD)
Official title: Prevalence of Comorbidities of COPD in the Exacerbator Phenotype - A Cross Sectional Disease/Condition Focused Observational Study on COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Drug Therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 860
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD will be enrolled at hospital and pulmonology departments in Italy.

Brief summary: The purpose of this study is to establish the prevalence of comorbidities in Italian patients with chronic bronchitis with at least 2 exacerbations per year, and to document the appropriateness of instrumental diagnostic tests, such as spirometry of these patients.

Detailed description: This is an observational study so participants will only take medication that is presently prescribed by their regular healthcare provider. No additional study medication will be administered. This study will enroll patients who have been previously diagnosed with COPD. This study will look at the medical history and other diseases that have been diagnosed in people who also have COPD.

The study will enroll approximately 3000 patients.

This multi-centre trial will be conducted in Italy. The overall time to participate in this study is at a single, regularly scheduled visit at the pulmonologists office. There will not be any follow up assessments.

Eligibility criteria: Inclusion Criteria:

1. Age 45-85, of either gender.
2. Signed informed consent.
3. Known COPD documented by spirometric exams showing fixed non reversible respiratory obstruction.
4. Forced Expired Volume measured after 1 second expiration (FEV-1) \< 50% in a previous test (no time limits).
5. Symptoms of chronic bronchitis : chronic productive cough for 3 months at least in each of the 2 years prior to the index visits.
6. On treatment of bronchodilators (no restrictions) for the last 12 months at least.
7. History of at least 2 exacerbations (moderate/severe) in the last 12 months prior to index visit.

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of Comorbidities
timeFrame: Comorbidities captured at the index visit and related to 12 Months Prior to Study Index Visit
measure: Percentage of Participants having Annual Spirometric Tests
timeFrame: 12 months prior and up to the Study Index Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Veruno (Novara)
country: Italy
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT03365232: Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding
Official title: Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.


Eligibility criteria: Inclusion Criteria:

- Patients should have

1. Maxillary sound teeth and undergoing fixed orthodontic treatment.
2. Space problems ranging from spacing to mild crowding.
3. Good oral hygiene.

Exclusion Criteria:

1. Patients with partially erupted teeth in the maxillary arch .
2. Signs of caries, large restorations fluorosis, hypoplasia or abnormalities of crown morphology.
3. The need of banding.
4. Bad oral hygiene measures.

Primary outcomes:
measure: chair side time
timeFrame: an average of 30 minutes
Secondary outcomes:
measure: immediate bond failure
timeFrame: immediately after bonding
Other outcomes:
measure: accuracy of orthodontic attachments transfer
timeFrame: one day after bonding
measure: accuracy of orthodontic attachments transfer
timeFrame: one day after bonding
Locations:
Study officials:
References:
Clinical trial NCT06158932: A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
Official title: A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Hormone Imbalance
Lead sponsor: Optify
Sponsor class: OTHER
Collaborators: name: Citruslabs
First posted: 2023-12-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.


Eligibility criteria: Inclusion Criteria:

* Women aged between 18 - 55
* BMI less than 35
* Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne
* Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
* Self-reported concerns with hormonal skin issues
* Has access to a tape measure for waist measurement
* Generally healthy - don't live with any uncontrolled chronic disease

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* Anyone with known severe allergic reactions
* Anyone who is pregnant or breastfeeding
* Unwilling to follow the study protocol

Primary outcomes:
measure: Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in hormonal skin issues. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in mood. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in stress. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in food cravings. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in sleep quality. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
measure: Changes in energy. [Timeframe: Baseline to Week 12]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT05255952: Epicardial Stimulation of the Cardiac Autonomic Nervous System
Official title: EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Insufficiency
Keywords: cardiac plexus
Electrical stimulation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the EpiCANS study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (SNAC) directly at the epicardial level in humans during heart surgery.

Proof of concept study

Detailed description: Isolated stimulation of the parasympathetic system induces a protective effect on long-term cardiac remodeling, but at the cost of inhibiting the sympathetic system. The role of the sympathetic system is to increase cardiac output in cases of acute heart failure.

Electrical stimulation of the cardiac plexus directly at the level of the heart allows simultaneous stimulation of the sympathetic and parasympathetic systems, whose complementary and not automatically antagonistic role is now recognized. Thus, direct stimulation of the plexus would optimize cardiac function in the short and long term by instantly improving cardiac output and decreasing pulmonary resistance as described in dogs by Kobayashi et al.

The objective of the EpiCANS study is to evaluate this technique in humans during cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Scheduled for elective cardiac surgery for valvular or coronary surgery
* Having received written and oral information about the protocol and having signed a written informed consent
* Affiliated or beneficiary of a social security plan

Exclusion Criteria:

* Patient with an indication for cardiac surgery:
* Urgent or semi-urgent
* Aortic surgery
* Heart transplantation
* Mechanical circulatory assistance
* Patients who have already undergone cardiac surgery
* Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors, persons unable to express their consent, persons hospitalized for a different reason

Primary outcomes:
measure: Variation of cardiac output
timeFrame: 15 min
Secondary outcomes:
measure: Variation of Cardiac rythm
timeFrame: 15 min
measure: Variation of aortic pressure
timeFrame: 15 min
measure: Variation of pulmonary artery pressure
timeFrame: 15 min
measure: Variation of central venous pressure
timeFrame: 15 min
measure: Presence of atrial fibrillation
timeFrame: 15 min
measure: Adverses events
timeFrame: 10 days
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Karl BOU NADER, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00806832: The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia
Official title: The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Heart Rate
Keywords: Medical clowns
Cataract surgery
Blood pressure
Heart rate
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include patients from the town of Afula and its surrounding region who are scheduled for cataract surgery in Ha'Emek Medical Center.

Brief summary: Cataract surgery is the most prevalent surgical procedure. Since most candidates are elderly patients, hypertension is common among these patients. Preoperative anxiety and tension may cause elevation of patient's heart rate and blood pressure and thus expose them to serious potential complications such as stroke and myocardial infarction. Medical clowns are known to reduce preoperative anxiety of both children and their parents. It is possible therefore that medical clown may have such a beneficial effect also on patients scheduled for cataract surgery under local anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing an elective, ambulatory cataract surgery (phacoemulsification technique)
* Surgery planned to be performed under local anesthesia
* Age \> 40 years
* Patients signed an informed consent

Exclusion Criteria:

* Hypertensive patients who did not take their prescribed medications on the day of surgery
* Uncontrolled hypertension during the month preceding the surgery
* Patients with systolic and diastolic BP values of \>190 and 100 mmHg respectively, measured 1hr prior to surgery
* Patients not suitable for surgery under local anesthesia
* Patients in whom the planned phacoemulsification technique was converted to either the ECCE or ICCE technique
* Patients in whom an anterior vitrectomy had to be performed during surgery
* Patients treated regularly by anti-anxiety or analgetic treatment

Primary outcomes:
measure: Blood pressure
timeFrame: day of surgery
Secondary outcomes:
measure: heart rate
timeFrame: day of surgery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Department of Ophthalmology, Ha'Emek MC
Study officials:
affiliation: Dept. of Ophthalmology, Ha'Emek MC, Afula, Israel
name: Yaron Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
Clinical trial NCT00965432: A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
Official title: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy, Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fragile X Syndrome
Lead sponsor: Seaside Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-08-25
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to determine the safety and tolerability of single oral doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral doses of STX107 when administered via an oral suspension


Eligibility criteria: Inclusion Criteria:

* Normal, healthy males 18-50 years old, inclusive.
* Able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).

Primary outcomes:
measure: Adverse events
timeFrame: During the course of the study and for 14 days after completing the study
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
References:
Clinical trial NCT00470132: Ventricular Shunt and Drain Infections - Timing of Reimplantation
Official title: Ventricular Shunt and Drain Infections - Timing of Reimplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Shunt Infection
Keywords: ventricular shunt
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-05-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infected ventricular shunt

Brief summary: The retrospective study will help determine whether or not placement of new devices prior to the recommended time was associated with a high risk of relapse or treatment failure.

Detailed description: The following information will be collected from the medical record retrospectively: demographic data (age, gender, ethnicity, height, weight), past medical history, laboratory results, microbiologic data, data on the patients' devices (type of device, data that it was placed, exchanged or removed), treatment and clinical and microbiological outcomes. This will all be collected retrospectively.

Eligibility criteria: Inclusion Criteria:

* Patients that were cared for by the PI for the purpose of treating an infected ventricular shunt or drainage device for the central nervous system.

Exclusion Criteria:

* Those patients records that do not meet entry criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of PIttsburgh and UPMC
name: Karin Byers, MD
role: PRINCIPAL_INVESTIGATOR
References: