louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00845260: Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder
Official title: Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Panic Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2009-02-18
Enrollment: 113
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: Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.


Eligibility criteria: Inclusion Criteria:

* Primary Panic Disorder with or without Agoraphobia (PD/A)

Exclusion Criteria:

* active substance abuse
* physiological etiology of panic symptoms
* under 18 years of age
* severe depression or suicidal ideation.
* if on drugs for PD, not having had a constant dosage for 2 months
* undergoing other cognitive behavioral treatment

Primary outcomes:
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: Pre, post at 6-month follow-up
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)
timeFrame: Pre, post and 6-month follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Study officials:
affiliation: Karolinska Institutet
name: Nils Lindefors, MD, PhD, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lonsdorf TB, Ruck C, Bergstrom J, Andersson G, Ohman A, Lindefors N, Schalling M. The COMTval158met polymorphism is associated with symptom relief during exposure-based cognitive-behavioral treatment in panic disorder. BMC Psychiatry. 2010 Nov 26;10:99. doi: 10.1186/1471-244X-10-99.
citation: Bergstrom J, Andersson G, Ljotsson B, Ruck C, Andreewitch S, Karlsson A, Carlbring P, Andersson E, Lindefors N. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial. BMC Psychiatry. 2010 Jul 2;10:54. doi: 10.1186/1471-244X-10-54.
Clinical trial NCT05682560: Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome
Official title: A Randomized Controlled Phase IIa, Two-arm Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Long COVID
Post-COVID Syndrome
Post COVID-19 Condition
Keywords: Long COVID
Post-COVID Syndrome
Post-COVID condition
Umbilical cord blood
RegeneCyte
Lead sponsor: StemCyte International, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: StemCyte Taiwan Co., Ltd.
First posted: 2023-01-12
Enrollment: 30
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: TREATMENT

Brief summary: REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.

Detailed description: This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.

Eligibility criteria: Inclusion Criteria:

* 1. Male or female aged ≥ 18
* 2. With post-COVID syndrome
* 3. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
* 4. Able to provide signed informed consent (by the subject or his/her legally authorized representative)
* 5. Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent

Exclusion Criteria:

* 1. Neurological disorders prior to COVID-19 diagnosis
* 2. With pre-existing terminal illness
* 3. With known immune disease
* 4. Is pregnant or breastfeeding
* 5. Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
* 6. Has received any vaccination within 3 weeks prior to the first IP infusion
* 7. Judged by the investigator to be not suitable for study participation
* 8. Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters

Primary outcomes:
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change of fatigue score as measured by CFQ-11
timeFrame: Baseline, Week 6, 12, 18 and 26
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Myrak Research Center
state: Florida
Study officials:
References:
Clinical trial NCT00944060: A Pilot Study of Diabetes Risk Reduction Program With WIC Mothers(The Special Supplemental Nutrition Program for Women, Infants, and Children) Overweight WIC Mothers
Official title: A Pilot Study of Diabetes Risk Reduction Program With Overweight WIC Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Weight Gain
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2009-07-22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: 1) to evaluate treatment fidelity of DRRP: study design, training of interventionists, delivery and receipt of the intervention, and application of the intervention in real-life settings; 2) to identify successful strategies for participant recruitment and maintaining active participation; 3) to collect and analyze preliminary indicators of DRRP's effect on dietary intake, physical activity, stress responses, and body weight; and 4) To evaluate sample representativeness of the target audience, implementation and acceptability of DRRP, and attrition rate.


Eligibility criteria: Inclusion Criteria:Non-pregnant women between 18 and 34 years old who understood and spoke English and had a measured BMI between 25.0 and 39.9 kg/m2 were eligible for this study. Additional inclusion criteria included having a youngest child between 6 weeks and 3.5 years of age enrolled in one of our three collaborating WIC locations, not planning to become pregnant or change WIC clinics during the study, providing accurate contact information, agreeing to notify researchers with changes in contact information or pregnancy status, willingness to accept randomized participation assignments, being willing to participate in the project for 1.5 years, and consenting to have blood glucose tested via finger stick.

Exclusion Criteria: women with fasting blood glucose greater than 126 mg/dl or random blood glucose greater than 200 mg/dl, self-reported type 1 or 2 diabetes or an eating disorder, or inability to walk more than one block without resting or shortness of breath were excluded. Eligible participants provided their individual telephone and address and a telephone number of one back-up contact (relative, friend, or neighbor).

Primary outcomes:
measure: body weight
Secondary outcomes:
measure: dietary fat intake, fruit and vegetable intake, physical activity, stress, affects
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan Stat University College of Nursing
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University College of Nursing
state: Michigan
Study officials:
References:
citation: Chang MW, Brown R, Nitzke S. Participant recruitment and retention in a pilot program to prevent weight gain in low-income overweight and obese mothers. BMC Public Health. 2009 Nov 21;9:424. doi: 10.1186/1471-2458-9-424.
Clinical trial NCT06990360: Accuracy of Computer Guided Implant Placement in Edentulous Mandible A Three-Dimensional In Vitro Study
Official title: Accuracy of Computer Guided Implant Placement in Edentulous Mandible A Three-Dimensional In Vitro Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Alveolar Ridge
Edentulous Alveolar Ridge In Mandible
Keywords: Computer-guided implant placement
Edentulous mandible
3D printed surgical guide
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Five styrofoam mandibles

Brief summary: Five stryofoam mandibles were included in this study to assess the accuracy of using computer guided surgical stent in placement of dental implants. The mandibles were CBCT scanned and imported to 3diagnosys software to implant planning. 8 implants were placed in each mandible virtually, 4 anterior implants and 4 posterior implants were placed. The plan was exported as STL file to be imported to the CAD software for designing of the stent. The surgical stent is printed using Micro DGP printer and invision tec e-shell 600 clear resin was used. Stainless steel sleeves were placed in the surgical guide then placed in ethanol 99% to remove the excess monomer.

The stent in placed over the mandible and sequential drilling was done until the desired osteotomies width was approached followed by the placement of the implants. Post-operative CBCT was done for the mandible including the implants to assess the accuracy, angulation and position of the placed implants


Eligibility criteria: Inclusion Criteria:

* Five styrofoam mandibles

Exclusion Criteria:

* no fractures or pathology

Primary outcomes:
measure: Mesiodistal (MD) Angle
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: future university in Egypt
state: Giza
Study officials:
References:
Clinical trial NCT02189460: Effect of Normal Aging on Language Processing
Official title: Cognitive Mechanisms and Cerebral Substrate of Naming Impairment During Aging. Behavior and Neuroimaging Approaches.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognition
Keywords: Cognition
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 33
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 healthy adults will participate to the study. There will be 3 age groups: 30-50, 50-70, \> 70 years. Ech group will contain 20 volunteers.

The volunteers are recruited by means of ads on Laboratory websites and Universities.

Brief summary: The purpose of this study is to understand the effect of age on language abilities. The investigators aim at investigating the cerebral modifications that take place in normal aging, at the functional an anatomical level.


Eligibility criteria: Inclusion Criteria:

* Age of 30 years and above
* Right handed
* French native speakers
* Affiliation to French social security (Sécurité Sociale)
* Medical interview
* Consent form signed

Exclusion Criteria:

* Cerebral or respiratory pathologies
* Any MRI contrindication

Primary outcomes:
measure: Blood Oxygen Level Dependent functional MRI
timeFrame: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.
measure: Anatomical MRI
timeFrame: There will be a unique MRI measurement for each participant. Group analyses presentation after 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: IRMaGe facility
Study officials:
affiliation: Neuroradiology department, Grenoble Hospital, INSERM, Grenoble University.
name: Alexandre Krainik, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory of Psychology and NeuroCognition, CNRS, Grenoble University.
name: Monica Baciu, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06621160: Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation
Official title: Investigation of Spinal Posture and Anthropometric Characteristics of Women with Chronic Constipation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Constipation
Keywords: Chronic Constipation
Posture
Anthropometric Measurement
Physical Activity
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with and without chronic constipation

Brief summary: The aim of this study was to compare the spinal posture and anthropometric characteristics of women with Chronic Constipation (CC) and healthy women.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for women with chronic constipation:

  * Constipation according to Rome IV criteria between the ages of 18-65
  * Volunteer
  * Literacy
* Inclusion criteria for healthy women:

  * No constipation according to Rome IV criteria between the ages of 18-65
  * Volunteer
  * Literacy

Exclusion Criteria:

* Cancer, neurological disease, serious or uncontrolled systemic or metabolic disease

  * Being pregnant
  * Having a mental problem that will prevent cooperation
  * Having alarm symptoms over the age of 50
  * Having a diagnosis of secondary constipation
  * Being BMI\&gt;35
  * Having megacolon/megarectum and inactive (lazy) bowel syndrome
  * Having had colostomy surgery
  * Having a history of recent abdominal surgery
  * Having an open wound or local tumor in the abdominal region
  * Having an abdominal hernia

Primary outcomes:
measure: Anthropometric Characteristics
timeFrame: 1 year
measure: Spinal Posture
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Abant İzzet Baysal University
Study officials:
References:
Clinical trial NCT00429260: A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
Official title: A 1-week, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Outpatients With Depression Who Completed 8 Weeks of Treatment With Saredutant 100 mg Once Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Keywords: depression
antidepressive agents
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-01-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with saredutant 100 mg once daily.

The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label treatment with saredutant 100 mg once daily in outpatients with depression.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria

Exclusion Criteria:

* Total score of \<22 on the Montgomery-Asberg Depression Rating Scale (MADRS).
* Duration of the current depressive episode is less than 1 month or greater than 2 years.
* Total score of \<25 on the Mini Mental State Examination (elderly patients ≥65 years only).
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 6 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: The primary endpoint is the change from baseline (Day 56) to Day 63 in the post-baseline average daily number of discontinuation-emergent signs or symptoms from the 17-item Discontinuation-Emergent Signs and Symptoms checklist.
Secondary outcomes:
measure: The main secondary endpoints are the change from baseline in the maximum number of post-baseline discontinuation-emergent signs or symptoms and the proportions of patients with any newly-occurring post-baseline discontinuation-emergent signs and symptoms
Other outcomes:
Locations:
city: Malvern
country: United States
facility: Administrative Office
state: Pennsylvania
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT01326260: Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)
Official title: Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Resuscitation, Trauma Patients
Keywords: resuscitation
trauma
THAM
colloids
crystalloids
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to San Francisco General Hospital from 2005 through 2009 with severe traumatic injury requiring emergent surgery who develop severe acidosis

Brief summary: This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.

Detailed description: The study objective is to assess the efficacy of fluid resuscitation and treatment of acidosis in patients who were managed with use of amine buffer THAM (tris-hydroxymethlaminomethane) versus those who were resuscitated with crystalloids or colloids and may have have received sodium bicarbonate for the treatment of acidosis.

Eligibility criteria: Inclusion Criteria:

* Presence of severe traumatic injury requiring emergent surgery
* Peri-operative development of severe acidosis (defined arterial ph less than or equal to 7.20 or base deficit greater than or equal to 10 mEq/dL)
* Acidosis was treated with either THAM or "usual care" (defined as crystalloid either or without sodium bicarbonate)

Exclusion Criteria:

* None

Primary outcomes:
measure: Total amount of fluids and blood products used during the operative and 72 hr post-operative period.
timeFrame: Operative period and ICU (72 hr) post-op period
Secondary outcomes:
measure: Intra-operative, intensive care unit and hospital mortality
timeFrame: From the operative procedure onset to discharge out of the ICU or expiration
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco at San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julin Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06248060: Comparison and Opinion on the Safety of Teleconsultation Versus Traditional Anaesthetic Consultation in a Day Hospital
Official title: Comparison and Opinion on the Safety of Teleconsultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-anaesthetic Consultation
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Before - After study
Primary purpose: SCREENING

Brief summary: A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of the procedure and the type of anaesthetic proposed. In a world moving towards virtualisation, a number of medical specialities have opted for remote consultations, either by telephone or video-conferencing. Teleconsultation seems to offer greater satisfaction, not only for patients, but also for surgeons and anaesthetists. It is also associated with a reduction in the distance travelled by patients, costs and financial expenditure, with no increase in the rate of cancellation of surgery. For the first time at the Brussels University Hospital (Erasme), the anaesthesia and intensive care team will gradually introduce the system of pre-anaesthetic teleconsultation by telephone from October 2023.

The aim of our study is to evaluate the effectiveness of preanaesthetic teleconsultation at the Erasme HUB. In fact, it would be better to have results based on local expertise in order to give an answer on the effectiveness, safety and security of this innovative method, which will be officially implemented in October 2023.


Eligibility criteria: Inclusion Criteria for prospective group (AFTER):

* Patients scheduled for any surgery at one day hospital and who have signed the consent form.
* Pre-anaesthetic consultation by telephone.

Inclusion Criteria for retrospective group (BEFORE):

* patients having undergone any surgery at one day hospital during the period between 01/01/2023 and 31/06/2023.
* Pre-anaesthetic consultation carried out face-to-face.
* Patients eligible for teleconsultation

Exclusion Criteria:

* Participation in another clinical study within the previous month.
* Patient unable to complete the questionnaire.

Primary outcomes:
measure: Score of Patient endangerment (0-4)
timeFrame: at the 1 day of surgery
Secondary outcomes:
measure: Satisfaction scores reported on LIKERT scale (1-5)
timeFrame: Baseline (before the procedure)
measure: Pre-operative anxiety scorereported on LIKERT scale (1-5)
timeFrame: Baseline (before the procedure)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Boudart Céline
Study officials:
affiliation: HUB
name: boudart céline
role: PRINCIPAL_INVESTIGATOR
References: