louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01406457: Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage
Official title: Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Keywords: Subarachnoid Hemorrhage
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subarachnoid hemmorhage clinical symptoms

Brief summary: The goal in this research is to develop better ways to detect and treat the damage caused by bleeding in the brain.

Detailed description: Patients who suffer from a bleeding in the brain (stroke or hemorrhage) often experience secondary complications that can occur up to 2 weeks after the initial bleeding. Complications can include decrease of consciousness, weakness or paralysis, difficulty with speech and language, and worsening of brain damage. These decrease a patient's chances for a good recovery. A brain scan will be used to determine the damage caused by the bleeding, and the brain's electrical activity will be monitored to detect abnormal activity. These measures will be analyzed together with routine medical information to better understand and diagnose complications.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 70 years
2. World Federation of Neurosurgery (WFNS) grade III-IV, and grade V patients who improve within 24h after ventriculostomy
3. Diffuse thick or localized thick subarachnoid clot \>1 mm on baseline CT (Fisher grade 3-4)
4. Ruptured saccular aneurysm demonstrated by CT-angiography or DSA
5. Onset of aSAH clinical symptoms within the preceding 72h
6. Treatment of aneurysm within 24 h after admission
7. Treatment of aneurysm by clip ligation

Exclusion Criteria:

1. SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm)
2. Only a thin diffuse layer or no visible subarachnoid blood in the initial CT
3. Admission in a clinical state with unfavourable prognosis (e.g., bilateral dilated, non-reactive pupils for more than 1h)
4. Coagulopathy (thrombocytes \<60,000/ml or INR\>1.5)
5. Pregnancy
6. Presence of incompatibilities for MRI, such as non-removable metals, artificial joints, electronic devices (pace maker, pumps), etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jed Hartings, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01081457: Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
Official title: Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
deep brain stimulation
GI motility
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.


Eligibility criteria: Inclusion Criteria:

* patient over 18 yo
* patient with Parkinson's disease implanted for deep brain stimulation
* patient responders to deep brain stimulation (UPDRS improved by at least 40%)
* patient covered by the french health care system
* patient not taking anti-parkinsonian medication the day before evaluation
* French speaking

Exclusion Criteria:

* patient below 18 yo
* pregnancy
* Severe psychiatric or cognitive disorders
* diabetes mellitus
* morbid obesity
* compulsive eating disorders
* diffuse GI motility impairment (except Parkinson's disease)
* other evolutive neurologic disorders
* previous history of significant GI resection
* inability to swallow or defecate when asked

Primary outcomes:
measure: Anal pressure
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
citation: Derrey S, Chastan N, Maltete D, Verin E, Dechelotte P, Lefaucheur R, Proust F, Freger P, Leroi AM, Weber J, Gourcerol G. Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study. Neurogastroenterol Motil. 2015 Sep;27(9):1214-22. doi: 10.1111/nmo.12607. Epub 2015 Jun 5.
Clinical trial NCT02997657: Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
Official title: Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Truth Initiative
First posted: 2016-12-20
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions), while also providing skills that may buffer against stress and negative affect. The overall objective of this project is to conduct a randomized controlled trial to test the efficacy of PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation treatment. Participants in both treatment conditions will receive nicotine replacement therapy and a validated text-messaging intervention for smoking cessation that monitors progress in quitting smoking and extends smoking counseling outside of the individual face-to-face context.


Eligibility criteria: Inclusion Criteria:

1. be 18 years of age or older
2. smoke at least 5 cigarettes per day for longer than one year with no current regular use of other nicotine/tobacco products including e-cigarettes
3. have a baseline carbon monoxide level of at least 4 ppm
4. be willing to use the nicotine patch
5. report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking (where 10 = extremely important);
6. have an active cell phone and be willing to send and receive text messages for the duration of the intervention.

Exclusion Criteria:

1. Contact study site for details

Primary outcomes:
measure: 7-day Point Prevalence Smoking Abstinence at 12 Weeks
timeFrame: 12 weeks
measure: 7-day Point Prevalence Smoking Abstinence at 26 Weeks
timeFrame: 26 weeks
measure: 7-day Point Prevalence Smoking Abstinence at 52 Weeks
timeFrame: 52 weeks
measure: Continuous Smoking Abstinence
timeFrame: 52 weeks
Secondary outcomes:
measure: Engagement in PPT-consistent Quitting Strategies
timeFrame: During treatment - weeks 1-4 after quit date
measure: Residual Attraction to Smoking
timeFrame: At end of treatment (4 weeks after quit date)
measure: Self-efficacy for Resisting Smoking
timeFrame: At end of treatment (4 weeks after quit date)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Partners Healthcare and Massachusetts General Hospital
state: Massachusetts
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies, Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Christopher Kahler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01392157: Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
Official title: Acceptability and Continuation Rate of Implanon in a Brazilian Public Sector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraceptive Usage
Bleeding Due to Intrauterine Contraceptive Device
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main side-effect of Implanon is the changes induces in bleeding patterns including amenorrhea, infrequent to irregular bleeding and frequent and prolonged bleeding; without any previous symptom and it was characterized as "breakthrough bleeding" (BTB). BTB is the main causes of early discontinuations. Unfortunately, there is no indication to predict prior to insertion what sort of bleeding pattern any individual woman may have after insertion and the proposed treatments were disappointed. Nevertheless, previous studies with other progestin-only contraceptives (including Implanon) provide evidence that the provision of adequate and intensive counseling to potential users and new acceptors about bleeding changes can help to improve method continuation.

The availability of Implanon in the public sector could help in the development of strategies to introduce the method in the public sector network and the training of medical residents.

Detailed description: 100 women were either allocated to received Implanon contraceptive implant, the LNG-IUS or TCu380A copper-IUD. The women were allocated according to their preference on each of the contraceptive methods.

half of the women will receive the common counseling at the clinic and the other 50% will receive intense counselling about menstrual changes induced by these three contraceptive methods. The continuation rate up to one year will be evaluated through life-table analysis

Eligibility criteria: Inclusion Criteria:

* Women 18 to 40 years
* New users of Implanon, IUDs and the LNG-IUS TCu380A

Exclusion Criteria:

* Contraindications to contraceptive methods

Primary outcomes:
measure: Assessment of acceptability of Implanon in comparison to the TCu380A IUD and the LNG-IUS
timeFrame: Participants will receive counseling before admission and at 12 months after
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: SP
Study officials:
affiliation: University of Campinas, Brazil
name: Luis Bahamondes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modesto W, Bahamondes MV, Bahamondes L. A randomized clinical trial of the effect of intensive versus non-intensive counselling on discontinuation rates due to bleeding disturbances of three long-acting reversible contraceptives. Hum Reprod. 2014 Jul;29(7):1393-9. doi: 10.1093/humrep/deu089. Epub 2014 May 8.
Clinical trial NCT01228357: Predict Antidepressant Responsiveness Using Pharmacogenomics
Official title: Predict Antidepressant Responsiveness Using Pharmacogenomics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Depressive Symptoms
Keywords: Pharmacogenomics
Depressed Patients
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether genetic information associated with individual depressive symptoms.

Detailed description: The primary hypothesis is that the variations of the candidate genes are associated with individual symptoms in patients with depression.

The Second hypothesis is that patients with the associated genetic variation suffer longer from the associated symptom than the patients without the associated genetic variation.

Eligibility criteria: Inclusion Criteria:

* Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
* interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

* received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
* potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Primary outcomes:
measure: Presences of each individual symptom of depression at 1,2,4,6,12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02956057: Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
Official title: A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: Faculty Hospital Kralovske Vinohrady
First posted: 2016-11-04
Enrollment: 1044
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: Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy

Detailed description: To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.

Eligibility criteria: Inclusion Criteria:

* Subjects referred to diagnostic or therapeutic colonoscopy

Exclusion Criteria:

* ileus
* known or suspected bowel obstruction
* active bowel inflammation
* pregnancy
* any presence of serious medical conditions
* history of prior colonic or rectal surgery
* inability to obtain valid data from subject

Primary outcomes:
measure: Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)
timeFrame: One day
Secondary outcomes:
measure: Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)
timeFrame: One day
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
affiliation: Nemocnice T.Bati
name: Vladimir Kojecky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kojecky V, Matous J, Keil R, Dastych M, Kroupa R, Zadorova Z, Varga M, Dolina J, Kment M, Hep A. A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy: which is the best? A multicentre, randomized trial. Int J Colorectal Dis. 2017 Dec;32(12):1763-1766. doi: 10.1007/s00384-017-2901-x. Epub 2017 Sep 24.
Clinical trial NCT06809257: Effect of Exercise on MiR-126 in Individuals With Prediabetes
Official title: Effect of Exercise on MiR-126 in Individuals With Prediabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
microRNA
Exercise
Keywords: MiR-126
Exercise
Prediabetes
MicroRNA
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes.

Detailed description: This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes. The hypothesis of our study is that regular aerobic exercise will increase miR-126 expression. Determining the effect of exercise on miR-126 in individuals with prediabetes will contribute to the elucidation of the pathways through which exercise is effective in prediabetes via epigenetic mechanisms.

Eligibility criteria: Inclusion Criteria:

* Individuals who were newly diagnosed with prediabetes according to the Oral Glucose Tolerance Test (OGTT) and/or HbA1C criteria
* between the ages of 18-60
* were physically inactive (Level 1 according to the International Physical Activity Questionnaire)
* were motivated to exercise
* Individuals who had no obstacle to exercise as a result of the evaluation made by a cardiologist (ECG, exercise ECG test, etc.)
* and who did not show a change in body weight of more than ±2.5 kg in the last six months were included in the study.

Exclusion Criteria:

* presence of serious medical conditions (e.g. advanced cancer, major neurological or endocrine disorders, respiratory failure)
* current cardiovascular disease, BMI \<19 kg/m²
* history of metformin use within the last 6 months
* receiving hormone replacement therapy
* life expectancy less than one year
* HIV positivity
* substance use
* or orthopedic and cognitive disorders that may prevent exercise

Primary outcomes:
measure: Delta CT mir-126
timeFrame: 1 week
Secondary outcomes:
measure: BMI
timeFrame: 1 day
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Sultan 2. Abdülhamid Han Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Sultan 2. Abdülhamid Han Training and Research Hospital
name: Elif Yıldırım Ayaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03702257: DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection
Official title: Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant Recipient
Donor Specific Antibodies
Antibody Mediated Rejection
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.

Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.


Eligibility criteria: Inclusion criteria:

* Patient older than 18 years
* Transplanted pulmonary or cardiopulmonary patient
* And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold \> 1000 of MFI in the 30 days preceding the inclusion visit
* Affiliation to the French social security
* Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent

Exclusion criteria:

* Patient whose anti-HLA antibodies are not directed against the graft (no DSA)
* Contraindication to performing a bronchial fibroscopy with transbronchial biopsies
* Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion)
* Plasma exchanges (less than 3 months before inclusion)
* Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments)
* Impossibility of giving the subject informed information
* Subject under the protection of justice Subject under guardianship or curatorship
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: Diagnosis of AMR
timeFrame: 2 years
Secondary outcomes:
measure: Comparaison in gDSA+ vs gDSAs- patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Hôpital Marie Lannelongue
city: Marseille
country: France
facility: CHU Nord
city: Paris
country: France
facility: Hôpital Bichat
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
References:
Clinical trial NCT02012257: Success Rate of Anterior Middle Superior Alveolar (AMSA) Nerve Block in Three Different Sites of Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Functional
Keywords: anterior middle superior alveolar nerve
electric pulp tester
local anesthesia
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to second premolar teeth of one quadrant can be anesthetized. The aim of the present study was to evaluate the efficacy of AMSA nerve block injection at an anterior and a posterior positions compared to commonly administrated site.

Detailed description: AMSA: Anterior middle superior alveolar

Eligibility criteria: Inclusion Criteria:

* Healthy subject
* Subjects had all their maxillary teeth from second premolar of one side to the second premolar of another Neither of these teeth was non vital, nor had large restorations, prosthetic crowns, caries, periodontal disease, history of trauma, and hypersensitivity.

Exclusion Criteria:

* Use medications alleviating or altering the pain sensation
* Allergy to anesthetics Pregnancy

Primary outcomes:
measure: Pulpal anesthesia of central incisor to second premolar by electric pulp tester (EPT)
timeFrame: After each injection (base line) to 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Masoud Yaghmaei, DMD, MS
role: STUDY_CHAIR
References: