louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02852538: Outcomes of a Skill-Based Program for Eating Disorders
Official title: An Innovative Family Based Treatment for Adults With Anorexia Nervosa Using Insights From Neurobiology
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Eating Disorders Association
First posted: 2016-08-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to measure the effect of a neurobiologically-guided intensive family based treatment for adults with anorexia nervosa.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of anorexia nervosa
* Illness onset at least 2 years prior to study
* Medically stable
* Identified carer to participate in treatment with participant

Exclusion Criteria:

* Developmental or intellectual disorder
* Diagnosis of substance abuse or dependence in 3 months prior to study
* Current suicidal thoughts
* Severe comorbid psychiatric disorder (e.g., psychotic disorder, bipolar disorder)

Primary outcomes:
measure: Body Mass Index
timeFrame: 3 months post-treatment
Secondary outcomes:
measure: Eating Disorder Examination Total Score
timeFrame: 3 months post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Columbus
country: United States
facility: The Center for Balanced Living
state: Ohio
Study officials:
affiliation: University of California, San Diego
name: Christina Wierenga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Center for Balanced Living
name: Laura Hill, PhD
role: STUDY_CHAIR
References:
citation: Knatz S, Wierenga CE, Murray SB, Hill L, Kaye WH. Neurobiologically informed treatment for adults with anorexia nervosa: a novel approach to a chronic disorder. Dialogues Clin Neurosci. 2015 Jun;17(2):229-36. doi: 10.31887/DCNS.2015.17.2/sknatz.
citation: Kaye WH, Wierenga CE, Knatz S, Liang J, Boutelle K, Hill L, Eisler I. Temperament-based treatment for anorexia nervosa. Eur Eat Disord Rev. 2015 Jan;23(1):12-8. doi: 10.1002/erv.2330. Epub 2014 Nov 6.
citation: Hill L, Peck SK, Wierenga CE, Kaye WH. Applying neurobiology to the treatment of adults with anorexia nervosa. J Eat Disord. 2016 Dec 5;4:31. doi: 10.1186/s40337-016-0119-x. eCollection 2016.
Clinical trial NCT02359838: Patient-Centered Care for the Older Adult With Hematologic Malignancy
Official title: Patient-Centered Care for the Older Adult With Hematologic Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancy
Keywords: Hematologic Malignancy
Geriatric Assessment
Geriatric Oncology
Frailty
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 160
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research study is evaluating if co-management by a geriatrician embedded in the oncology clinic can improve outcomes for frail older adults with blood cancers. A rigorous pre-entry frailty assessment by a trained research assistant will be followed by randomization to geriatrician co-management versus usual care for patients found to be frail or pre-frail.

Detailed description: Older adults have unique health concerns, and in particular, older adults with blood cancers may have different disease and other health related issues than younger adults with similar diagnoses. One aspect of aging which can make older adults more vulnerable is frailty. Frailty is a general term that describes a decline in multiple areas of health, including the loss of energy, physical ability, and mental ability. Frailty can make it difficult for patients with cancer to respond to treatment and more likely to have side effects. On the other hand, many older patients are not frail despite advanced age. This study is being done to determine if co-management by a geriatrician of older adults who are found to be frail through a detailed baseline assessment can improve outcomes.

Eligibility criteria: Inclusion Criteria:

* All patients aged 75 and older who present for an initial consultation at the Dana-Farber/Brigham and Women's Cancer Center for hematologic malignancy (transplantation consultation excluded).
* Assessed to be pre-frail or frail on formal baseline geriatric assessment.

Exclusion Criteria:

* Not willing to participate

Primary outcomes:
measure: Overall Survival
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana Faber Cancer Institute
name: Gregory A. Abel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Jane A Driver, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03263338: Mobile Sleep and Growth Study
Official title: Mobile Health Sleep and Growth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Sleep Promotion
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 31
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to see if we can help parents to get their children to go to bed earlier. This may help children to improve their sleep. The study will use a web-based study platform and an activity monitor.


Eligibility criteria: Inclusion Criteria:

1. Males or females age 10 to 12 years.
2. Speak, read and write in English.
3. Parental/guardian permission (informed consent) and child assent.
4. Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
5. Typically spend 8-9 hours in bed at night (e.g. 8 hour time in bed: go to bed at 10pm \& get out of bed at 6am).

Exclusion Criteria:

1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).
2. Syndromic obesity.
3. Diagnosed with a psychiatric disorder \[e.g. Attention-deficit/hyperactivity disorder (ADHD), depression, anxiety\].
4. Diagnosed with an eating disorder.
5. Musculoskeletal or neurological disorder that limits physical movement and activity.
6. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.

Primary outcomes:
measure: Time in bed
timeFrame: 50-days
Secondary outcomes:
measure: Total sleep time
timeFrame: 50-days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Research Assistant Professor
name: Jonathan Mitchell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021.
Clinical trial NCT04637438: Fecal Microbiota Transplantation in Postoperative Crohn's Disease
Official title: Fecal Microbiota Transplantation in Postoperative Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: Fecal Microbiota Transplantation
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Joint Authority for Päijät-Häme Social and Health Care
name: Kuopio University Hospital
name: Helsinki University Central Hospital
name: Tampere University
First posted: 2020-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pilot study aims to detect possible trends or signals suggesting efficacy of FMT on prevention of delay of POR, to determine the safety of FMT in post operative CD, and asses if a full randomised controlled trial is feasible in this setting. With microbiota analysis we aim to assess if changes in gut microbiota are related to disease course of CD after operation.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Able to provide written consent
* Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection

Exclusion Criteria:

* Pregnancy
* Active infection, abscess or fistula at the time of the first colonoscopy
* Life expectancy \<1 year
* Unable to provide written consent
* Use on antibiotics or probiotics at the time of first colonoscopy

Primary outcomes:
measure: Change in endoscopic Rutgeerts score between first and second colonoscopy
timeFrame: 1 year
Secondary outcomes:
measure: Safety of FMT using FinFMT-Questionnaire
timeFrame: 3 months, 12 months, 5 years
measure: Clinical activity of Crohn's disease using Harwey-Bradshaw Index
timeFrame: 6 months, 12 months, 5 years
measure: Histologic activity of Crohn's Disease using modified Global Histological Activity Score
timeFrame: 1 years, 5 years
measure: Change of microbiota in stool samples and in intestinal biopsies
timeFrame: 6 weeks,12 weeks, 48 weeks, 5 years
measure: Patient reported outcome
timeFrame: 12 weeks, 48 weeks,years 5
measure: Change in inflammatory marker CRP mg/l
timeFrame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
measure: Need for hospitalization
timeFrame: Through study completion, an avarage of 1 year and 5 years
measure: Need for treatment escalation
timeFrame: Through study completion, an avarage of 1 year and 5 years
measure: F-calpro microg/g
timeFrame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
measure: Hb mg/l
timeFrame: 6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
Clinical trial NCT04845438: Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
Official title: Evaluation of Biliary Reflux After Mini-gastric Bypass With Using the Biliary Reflux Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcer, Gastric
Bile Reflux
Lead sponsor: Private Healthcare Institution Clinical Hospital RGD-Medicine
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: MGB is considered to be the best alternative to Roux-en-Y gastric bypass (RYGB) due to the shorter operation time and fewer possible complications.

The purpose of this study was to determine biliary reflux in patients undergoing MGB/OAGB with a hand-sewn gastroenteroanastomosis, and MGB/OAGB with a stapler gastroenteroanastomosis.


Eligibility criteria: Inclusion Criteria:

* morbid obesity
* BMI above 35 kg/m2 with obesity related comorbidity
* BMI above 40 kg/m2
* undergoing MGB/OAGB
* no bile reflux during preoperative period

Exclusion Criteria:

* revisional operations
* therapy-resistant bile reflux during preoperative period
* history of bariatric surgery

Primary outcomes:
measure: Success
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Rostov-on-Don
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
Study officials:
References:
Clinical trial NCT01578538: Safety of Mesh Used Repairs in Emergency Abdominal Wall Hernias. Prospective Randomized Multicenter Trial
Official title: Mesh Used Repairs in Emergency Abdominal Wall Hernias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia
Keywords: hernia, abdominal, strangulation, emergency, wall
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.

Detailed description: Repairing of emergency (strangulated) abdominal wall hernias with mesh is controversary. Strangulated abdominal hernias are not clean surgical wounds so applying prostetic materials such as meshes are problematic. Using of prostetic materials in un-clean wounds (clean contaminated, contaminated and dirty) is not proposed. But in surgical practice meshed surgical repair techniques are using largeley. In this multicenter study we try to find the answer for emergency hernia repairs meshed or not.

Eligibility criteria: Inclusion Criteria:

1. Older than 16 years old,
2. Strangulated abdominal wall hernia
3. No any contrindications to operation

Exclusion Criteria:

1. Younger than 16 years old,
2. Non-strangulated abdominal wall hernis
3. Any causes of contrindications to operation

Primary outcomes:
measure: wound infection
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Marmara
Study officials:
References:
Clinical trial NCT03302338: Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries
Official title: Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Necrotizing Enterocolitis
Keywords: Feeding intolerance
Simulated amniotic fluid like solution
Necrotizing enterocolitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 40
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Amniotic fluid plays a significant role in fetal gut maturation and development. The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among neonates recovering from surgery for congenital bowel abnormalities, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering from GIT surgeries.

Detailed description: Neonates with congenital GIT anomalies will participate after being operated.

Participants will be followed for the duration of hospital stay until discharge or death.

Eligibility criteria: Inclusion Criteria:

* Neonates with operable congenital bowel abnormalities

Exclusion Criteria:

* Critically ill babies.
* Presence of any contraindications to enteral feeding

Primary outcomes:
measure: Signs of feeding intolerance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Necrotizing enterocolitis
timeFrame: The outcome measure will be assessed within 2 months
measure: hospital stay
timeFrame: through study completion, an average of 1 year
measure: mortality
timeFrame: he outcome measure will be assessed within 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: ASU
name: Rania A El-Farrash, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04604938: The Effects of Losartan on Reward Reinforcement Learning
Official title: The Role of the Renin-angiotensin System in Reward Reinforcement Learning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Losartan
Reward reinforcement learning
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate whether a single dose of losartan (50 mg) can affect learning from positive and negative outcomes and its related neural mechanisms.

Detailed description: Emerging evidence suggests that the renin-angiotensin system can impact dopamine (DA) transmission and its modulatory role in reward processing. For instance, recent animal models have found that the angiotensin antagonist losartan reduces rewarding effects of methamphetamine and nicotine by modulating DA release in the striatum.The present study thus will investigate losartan effects on reward reinforcement learning and the underlying neural mechanisms. In a double-blind, between-subject, placebo-controlled design, 60 healthy male subjects will be randomly assigned to receive single-dose losartan (50 mg) or placebo, 90 minutes before performing a probabilistic reinforcement learning task during fMRI.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Right-handedness
* Normal or corrected-normal version

Exclusion Criteria:

* History of head injury
* Medical or psychiatric illness
* Hypertension
* General cardio-vascular alteration or diseases
* Allergy against medications
* Visual or motor impairments
* Claustrophobia
* Drug addiction
* Nicotine dependence
* FMRI contradictions

Primary outcomes:
measure: BOLD-level activity as assessed by fMRI during the learning phase
timeFrame: 90 minutes to 110 minutes after treatment
measure: BOLD-level activity as assessed by fMRI during the learning transfer phase
timeFrame: 111 minutes to 120 minutes after treatment
Secondary outcomes:
measure: Choice accuracy for the stimulus with the high reward probability during the learning phase
timeFrame: 90 minutes to 110 minutes after treatment
measure: Learning rate for positive and negative outcomes
timeFrame: 90 minutes to 110 minutes after treatment
measure: Choice accuracy during the learning transfer phase
timeFrame: 111 minutes to 120 minutes after treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Benjamin Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03215238: Intraoperative Pleth Variability Index (PVI) Variability
Official title: Intraoperative Pleth Variability Index (PVI) Variability
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intraoperative Monitoring
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 10
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: Neurosurgical and neurointerventional patients will be enrolled as these patients do rarely have sudden intravascular volume changes. Neurointerventional patients typically have no significant intravascular fluid changes, but do not routinely have intra-arterial catheters. Neurosurgical patients have slow, steady fluid shifts due to mannitol administration. Since most all of these patients have intra-arterial cannulas, it allows arterial waveform data collection which can be compared to the PPG signal.

Brief summary: Pleth Variability Index (PVI) is a variable that is derived from photoplethysmography (PPG) signal. It is used as a surrogate for intravascular volume status intraoperatively. PVI can have significant amount of baseline variability which appears to oscillate at a very low frequency (5-10 minute cycles). This study aims to investigate the origin of these baseline oscillations.

Detailed description: PVI is derived from the infrared photoplethysmography signal. Intraoperatively during mechanical ventilation it reflect fluid responsiveness which is a surrogate endpoint of intravascular volume.

PVI signal appears to have significant baseline variability which can not be explained by rapid changes in intravascular fluid volume. The baseline PVI changes also appear to oscillate at a very low frequency, much below any previously identified spontaneous vascular oscillations.

The aim of this study is to investigate weather the PVI variability originates from changes in the infrared photoplethysmography signal or if they are possibly due to the algorithm calculating PVI.

Eligibility criteria: Inclusion Criteria:

* Neurosurgical patients for tumor resection
* neurointerventional patients
* general anesthesia with mechanical ventilation
* communicates in english (consent)
* over 18 years of age

Exclusion Criteria:

* unable to sign consent
* less than 18 years of age

Primary outcomes:
measure: PVI variability
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Pekka Talke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04173338: Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
Official title: Phase I Study of Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Non-squamous Non-small-cell Lung Cancer
Urothelial Carcinoma
Malignant Mesothelioma
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 9
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: This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.


Eligibility criteria: Inclusion Criteria:

* Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
* 18 years or older.
* At least one prior chemotherapy before entering in this trial.
* Not pregnant or breastfeeding.

Exclusion Criteria:

* Prior treatment with cabozantinib.
* Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study).
* History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.

Primary outcomes:
measure: Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
timeFrame: 4 weeks or 28 days assessment.
Secondary outcomes:
measure: Assess objective response rate (RR)
timeFrame: To be measured through study completion; an average of 1 year.
measure: Progression-free survival (PFS)
timeFrame: To be measured through study completion; an average of 1 year.
measure: Overall survival (OS).
timeFrame: OS measured through study completion, and an average of 1 year
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Georgia Cancer Center
state: Georgia
Study officials:
affiliation: Augusta University Georgia Cancer Center
name: Nagla A Karim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: