louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05405231: Connecting National Guard Service Members Through Education in Crisis Line Facilitation Training
Official title: Connecting National Guard Service Members Through Education in Crisis Line Facilitation Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: Training
Crisis Line
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Michigan Army National Guard
First posted: 2022-06-06
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In Phase 1, we will utilize a cluster randomized control trial (RCT) design to recruit from approximately 12 National Guard (NG) units within the Michigan NG. Soldiers from the selected NG units will be approached for study recruitment during their drill weekends. Only units with \>25 Soldiers (out of \~110 units in Michigan) will be eligible to be selected for study recruitment.
Primary purpose: PREVENTION

Brief summary: National Guard (NG) are affected by suicide at a much higher rate than civilians. The Military and Veterans Crisis Line (MVCL) is not being used as often as we would expect. The purpose of this study is to find out whether a group-based training session will impact awareness and use of the Military and Veterans Crisis Line (MVCL) among members of the National Guard.


Eligibility criteria: Inclusion Criteria:

* Michigan Army National Guard member
* Associated with a unit with more than 25 members

Exclusion Criteria:

- Unable to provide informed consent

Primary outcomes:
measure: Utilization of the Military and Veterans Crisis Line (MVCL)
timeFrame: 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mark Ilgen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03652831: Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
Official title: Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical radiculopathy,
Soft tissue mobilization,
Neural mobilization
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be assigned randomly into two groups: Soft tissue mobilization with neural mobilization and Soft tissue mobilization without Neural mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Soft tissue mobilization with Neural mobilization group. Later on odd and even numbered subjects will be included in specific group.
Primary purpose: TREATMENT

Brief summary: This study will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization.

Detailed description: soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently.

Soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.

Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients with age 18 to 55years
* Patients having pain more than 3months
* Radiating pain in one of the upper limb
* Spurling's test positive

Exclusion Criteria:

* Traumatic injury of upper limb or cervical spine
* Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
* Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
* Circulatory disturbance of upper extremity
* Known history of high level of spinal cord injury and malignancy
* Thoracic Outlet syndrome

Primary outcomes:
measure: Pain intensity
timeFrame: 4weeks
Secondary outcomes:
measure: Recurrence of pain and Neck disability
timeFrame: 4weeks
measure: Neck Range of Motion
timeFrame: 4weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00574431: ICU Nutrition Study Bern
Official title: Implementation of an Evidence-based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Starvation
Enteral Nutrition
Keywords: Critical care
Intensive care unit
Early enteral nutrition
Nutritional management protocol
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2007-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nutritional treatment has become an essential component of the management of critically ill, due to better knowledge about positive impact of nutritional support. Malnutrition among ICU patients is associated with increased morbidity, mortality, length of stay (LOS) and therefore higher costs.Several studies however suggest, that early implementation of nutritional support is associated with improved clinical outcome, shorter LOS, and decreased infection rates. One of the objectives of this study is to determine if an nutrition protocol can improve the delivery of enteral tube feeding in the ICU.


Eligibility criteria: Exclusion Criteria:

* \<18 years of age
* stay less than 72 hours on ICU
* die within 72h after admission
* patients admitted for palliative care

Primary outcomes:
measure: Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
timeFrame: During ICU stay
measure: Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
timeFrame: During ICU stay
measure: Start of enteral feeding after ICU admission
timeFrame: During ICU stay
Secondary outcomes:
measure: ICU mortality
timeFrame: During ICU stay
measure: Hospital mortality
timeFrame: During hospital stay
measure: length of ICU stay
timeFrame: During ICU stay
measure: length of hospital stay
timeFrame: During hospital stay
measure: use of antibiotics (days)
timeFrame: During ICU stay
measure: rate of accurately defined infections
timeFrame: During ICU stay
Other outcomes:
Locations:
Study officials:
affiliation: University hospital of Bern
name: Michele Leuenberger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Bern
name: Stephan M Jakob, MD, PHD
role: STUDY_DIRECTOR
affiliation: University hospital of Bern
name: Zeno Stanga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Bern
name: Margaret Schafer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Bern
name: Jukka Takala, MD, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT00597831: Regulation of Intracerebral Pressure During Electroconvulsive Therapy
Official title: Regulation of Intracerebral Pressure During Electroconvulsive Therapy. Does Systemic Bloodpressure Reflect the Intracranial Pressure?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Intracranial Pressure
Keywords: depression
electroconvulsive therapy
Ultrasonography Doppler Transcranial
intracranial pressure
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 16
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: All patients indicated for unilateral ECT treatment in the Rijnstate Hospital with the diagnosis major depression and psychotic depressionaccording to DSM IV-TR classification. Patients who already started treatment and patients just starting ECT and are of age \> 18 years.

Brief summary: The purpose of this study is to determine whether electroconvulsive therapy (ECT) has an influence on pressure within the human brain before, during and after ECT.

Detailed description: 1. Aim:

   1. Our main objective concerning this study is to determine to what extent ECT does lead to an increase of the Pulsatility Index (as an indicator of intracerebral pressure) measured by a Transcranial Doppler Device (TCD).
   2. As a secondary objective we want to compare the PI measurements with simultaneously measured systemic blood pressure.
2. Study design:

   a.Observational study: cohort study
3. Treatment:

   a. Treatment as usual, PI and blood pressure measurement at baseline, just before ECT, during and 5 minutes after ECT. Data will be collected during unilateral treatment during 3 consecutive ECT treatments.
4. Endpoints:

   1. A minimum of sixteen patients are needed according to the power analysis.

Eligibility criteria: Inclusion Criteria:

* Temporal window to measure PI
* Major depression
* Psychotic depression

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Pulsatility Index before, during and after electroconvulsive therapy
timeFrame: before, during and after three consecutive ECT treatments
Secondary outcomes:
measure: Bloodpressure before, during and after ECT.
timeFrame: before, during and after three consecutive ECT treatments.
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: PAAZ Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: Roy LE Derikx, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171431: The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)
Official title: The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Constipation Predominant
Irritable Bowel Syndrome (IBS-C)
Keywords: IBS-C
female
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.


Eligibility criteria: Inclusion Criteria:

* Female 18 and older
* IBS-C patients diagnosed on the basis of Rome II criteria
* Ability to comply with the requirements of the entire study

Exclusion Criteria:

* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions.
* Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy.
* Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C
measure: by using Multiple Intraluminal Impedance
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03804931: Fecal Microbiota Transplantation for Ulcerative Colitis
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Fecal Microbiota Transplantation
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 120
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: Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).

Detailed description: The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.

Eligibility criteria: Inclusion Criteria:

* Active, moderate to severe severity (Mayo score more than 6)
* Safety using history of 5-ASA
* Able to undergo endoscopy examination

Exclusion Criteria:

* Antibiotic using in 7 days
* High risk of toxic megacolon
* Colon cancer or neoplasia in pathophysiology
* Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Primary outcomes:
measure: Clinical remission in patient as assessed using Mayo score
timeFrame: 12 weeks
measure: Clinical improvement in patient as assessed using Mayo score
timeFrame: 12 weeks
Secondary outcomes:
measure: Intestinal microbiota changing
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital
name: Yuqiang Nie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.
Clinical trial NCT01138631: Selection of Embryos by Time-lapse
Official title: Selection of Embryos for IVF Treatment by Time-lapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IVF, Infertility, embryo selection, embryoscope, time-lapse
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2010-06-07
Enrollment: 59
Sex: FEMALE
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In order to improve success rate by assisted reproductive techniques new techniques are being developed for selection of the embryo with best chance of implantation, establishement of pregnancy and subsequent delivery.The present study is based upon the hypothesis that time-lapse (frequent imaging) may give information about important steps in embryonic development, which could help to optimize selection of embryo(s) for treatment in IVF. The present study evaluates the outcome of conventional embryo culture with culture in a specially developed incubator equipped with a time-lapse system (Embryoscope).

Embryos from 50 IVF cycles (400 embryos) will be randomised to either conventional incubation or to culture in the Embryoscope. Embryos will be cultured for five days to the blastocyst stage. The primary endpoint is fraction of embryos developed to the four cell stage.

Detailed description: In vitro fertilization for infertility has a success rate on average in Europe of 25% in terms of baby take-home rate per cycle. One way to improve this rather low succes rate is to develop new measures for selection of the best embryo among peers as presently evaluated by embryo morphology. One of these promising methods is contineous imaging of embryo development by time-lapse. A new and unique equipment for this purpose - an Embryoscope - har been developed by Unisense Fertilitech. The present study evaluates embryo 4-cell rate during cultivation to blastocyst stage in a conventional incubator with 4-cell rate in the Embryoscope to ensure non-inferiority of the latter.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing 2.nd or 3.rd IVF cycle with expected retrieval of 8 oocytes or more. Age \< 38 years

Exclusion Criteria:

* Endometriosis

Primary outcomes:
measure: 4-cell rate
timeFrame: 2 days after oocyte pick-up
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Fertility Clinic, Aarhus University Hospital, Skejby
Study officials:
affiliation: University of Aarhus
name: Jakob Ingerslev, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02693431: Impact of Art Therapy on Anxiety Identified During Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13
Official title: Impact of Art Therapy on Anxiety Identified During the Quarterly Update of Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13 - Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 23
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 27 children (and their parents) aged 8 to 13 years in 2016 with cystic fibrosis followed at CRCM children Nantes.

Brief summary: Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them and those around them, stressful, rarely expressed, but noticeable by the care team. In line with the recommendations of the High Authority of Health, the multidisciplinary team of Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University Hospital offers a therapeutic education program tailored to the needs of children with cystic fibrosis and their families . The aim is to support children and parents in the acquisition of self-care skills (knowledge and skills) and coping skills, such as managing stress and emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the child, facilitates its expressive capabilities and reduces anxiety.


Eligibility criteria: Inclusion Criteria:

* Children with CF aged 8 to 13 years as part of their monitoring at CRCM children of Nantes University Hospital
* Parents and children willing to participate in research

Non inclusion Criteria:

* Emergency consultation
* Planned move

Primary outcomes:
measure: Changes in the overall score of children's anxiety after 4 visits including art therapy sessions compared to basal mean level of the first two visits without art therapy.
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Valérie DAVID, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383031: Safety and Efficacy Study of Transumbilical Laparoendoscopic Single Site Cholecystectomy
Official title: Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gallstone
Gallbladder Polyps
Keywords: laparoscopic cholecystectomy
single site
randomized controlled trail
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.

Detailed description: As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy .

Eligibility criteria: Inclusion Criteria:

* 18 Years to 5 Years
* Benign gallbladder diseases
* KPS ≥ 70
* informed consent

Exclusion Criteria:

* Obstructive jaundice
* Broadening of the common bile duct
* Gallstone pancreatitis
* Serious heart,brain,lung, metabolic diseases history
* History of upper abdominal surgery
* Pregnancy or breast-feeding women
* Refuse TU-LESSC
* BMI(Body Mass Index)≥ 30

Primary outcomes:
measure: the incidence of surgical complications
timeFrame: up to 12 weeks
Secondary outcomes:
measure: transfer rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: quality of life scores
timeFrame: up to 12 weeks
measure: pain scores
timeFrame: up to 12 weeks
measure: length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: total cost of hospitalization
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 days
measure: Cosmetic results
timeFrame: 1 month
measure: The incidence of adverse events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Bejing
country: China
facility: Bejing Friendship Hospital
state: Bejing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, doctor
role: STUDY_CHAIR
References: