louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02847481: A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS
Official title: A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Keywords: Fecal Microbiota Transplantation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: OpenBiome
First posted: 2016-07-28
Enrollment: 80
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: This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.


Eligibility criteria: Inclusion Criteria:

* IBS with diarrhea

Primary outcomes:
measure: stable engraftment of donor microbiota
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Anthony Lembo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.
Clinical trial NCT00550381: Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects
Official title: Ascending Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-357 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-29
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single doses of HKI-357 administered to healthy subjects.


Eligibility criteria: Eligibility Criteria:

* Healthy adult men or women of nonchildbearing potential, aged 18-50.

Primary outcomes:
measure: Safety, tolerability, PK
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00104481: Group Counseling for Smoking Cessation
Official title: Cognitive Behavior Therapy for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking
Keywords: cognitive behavior therapy
coping
smoking cessation
acceptance
expectancies
quit smoking
quitting smoking
Lead sponsor: American University
Sponsor class: OTHER
First posted: 2005-03-02
Enrollment: 240
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 purpose of this study is to evaluate the effectiveness of group therapy for cigarette smoking cessation. The group meets for 8 sessions and includes education and group discussion about the effects of smoking and ways to cope with withdrawal symptoms and other challenges to maintaining abstinence. In one condition, the groups also learn techniques based on cognitive therapy, to help cope with negative feelings.

Detailed description: The comparison condition is the same length as the cognitive behavior therapy condition but omits the cognitive restructuring component. In both conditions, smokers prepare for a quit date by using scheduled reduced smoking, which involves smoking on a set schedule that gradually reduces the number of cigarettes smoked. Post-treatment assessments occur one week after the end of treatment, and at 3-month followup.

Pre- and post-treatment assessments include measures of coping skills and emotional acceptance, as well as smoking rate.

Eligibility criteria: Inclusion Criteria:

* Regular daily smokers interested in quitting

Exclusion Criteria:

* Significant suicidal ideation

Primary outcomes:
measure: cigarette smoking abstinence
Secondary outcomes:
measure: cognitive coping skills
measure: depressive symptoms
measure: acceptance
measure: distress tolerance
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
affiliation: American University
name: David A Haaga, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haaga DA, Thorndike FP, Friedman-Wheeler DG, Pearlman MY, Wernicke RA. Cognitive coping skills and depression vulnerability among cigarette smokers. Addict Behav. 2004 Aug;29(6):1109-22. doi: 10.1016/j.addbeh.2004.03.026.
Clinical trial NCT03259581: Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin
Official title: Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Bilirubinemia
Keywords: transarterial chemoembolization
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.


Eligibility criteria: Inclusion Criteria:

* hepatocellular carcinoma (HCC)
* Direct or conjugated bilirubin \< 3 mg/dl
* Total bilirubin \> 3 mg/dl
* Willing and able to provide informed consent
* \>18 years of age

Exclusion Criteria:

* Currently pregnant
* Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
* Arterial anatomy which would preclude selective transarterial chemoembolization
* Patients who have a INR or platelet count which are not correctable to \<1.8 and \>35,000 respectively
* Patients with extrahepatic metastases
* Patients with portal vein invasion

Primary outcomes:
measure: Procedure related adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Radiologic Response
timeFrame: 1 month
measure: Progression free survival
timeFrame: 1, 3, 6, 12, 18, and 24 months
measure: Overall survival
timeFrame: 24 months
measure: Change in Model for end stage liver disease (MELD)
timeFrame: 7 and 30 days
measure: Change in Child Pugh score
timeFrame: 7 and 30 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT03065881: RETeval All Comers Trial (REACT)
Official title: RETeval All Comers Trial (REACT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Disease, Electroretinogram
Lead sponsor: LKC Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The primary objective of this study is to collect electroretinogram ERG measurements from visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data from the visually normal subjects will be used to create reference intervals for the device. Secondary objectives of the study are to provide ERG waveforms representative of disease states encountered and to analyze how well an ERG detects the various disease states encountered.


Eligibility criteria: Inclusion Criteria:

* All volunteers (age 0.5 to 95) willing to participate in the study as a part of their routine eye exam.
* While not specifically targeting vulnerable groups such as for example children and pregnant women, we invite them to participate in the study. Collecting normative data from these less represented populations is particularly difficult and we welcome the opportunity to gather these rare data.
* Subjects under the age of 18 will be included with the assent of the subject (for those at least 10 years of age) and consent from one parent/guardian (for those under age of 10).
* In any case patient is not able to provide the consent by him/her self and is willing to participate in the study the same person that is consenting for the routine eye exam can consent for the REACT study.

Exclusion Criteria:

* Subjects with photosensitive epilepsy , allergies to pupil dilating agents, or history of cardiac dysrhythmia will not be invited to participate in this study. - Subjects with history of glaucoma can either be included in the group of non dilated subjects or can have dilated ERGs if the dilation was recommended by the health professional as the part of the routine eye exam.
* Exclusion criteria will be based on volunteer's providing this information at the time of signing the consent form.
* If patient is not aware of his photosensitive epilepsy and it occurs during the recording, the test will be interrupted immediately.
* Statistically, 1 person out of 3600 people can suffer from photosensitive epilepsy in US.
* There is a rather small possibility we will encounter such a person during the collection of ERGs from the group of 1000 volunteers

Primary outcomes:
measure: Retinal function assessed with an electroretinogram (ERG)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Eye Clinic
state: Arkansas
Study officials:
References:
Clinical trial NCT05481281: Comparison Of Dexmedetomidine & Ketamine For Control Of Shivering In Vaginal Hysterectomy Under Spinal Anesthesia
Official title: Comparison Of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chills
Keywords: spinal anesthesia
vaginal hysterectomy
shivering
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 104
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either group Dexmedetomidine (receiving I/V bolus of dexmedetomidine 0.1 mg/kg as a 20 ml solution, followed by 0.04mg/kg/hr infusion till surgery completion) OR group Ketamine (receiving 0.2 mg/kg iv of ketamine diluted to 20 ml followed by 0.1 mg/kg/hr infusion till surgery completion) through sequentially numbered opaque sealed envelope. Anesthesiologist and patients both will be blinded to the administered drug in two groups. Either of the drugs will be injected after giving spinal anesthesia and confirmation of achievement of desired level of block.

In the recovery room Shivering grade, and vitals of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively. 1st reading taken 15minutes after giving the drug will be labelled as Zero time.
Primary purpose: TREATMENT

Brief summary: comparison of Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia.

Detailed description: In this study the participants aim to Compare Dexmedetomidine And Ketamine For Control Of Shivering In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.

Eligibility criteria: Inclusion Criteria:

1. Patients of age 45-55 years requiring vaginal hysterectomy
2. American Society of Anesthesiology (ASA) of Grade I-II

Exclusion Criteria:

1. Patients unwilling or non-cooperative for spinal anesthesia
2. Patients with uncontrolled hypertension, vascular or coronary disease,
3. patients with increased intraocular or intracranial pressure
4. Patients with known bleeding and psychiatric disorders
5. Patients taking anti platelets drugs.

Primary outcomes:
measure: Change in Shivering grade
timeFrame: Shivering grade of patients will be evaluated every 15 minutes interval after giving the drug till 1hour postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hamdard University
name: Nida Shahid, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03388710: Position of the Endotracheal Tube Cuff in Relation to Cricoid in Children.
Official title: Consultant Anesthesiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: D009863
Keywords: airway, children, endotracheal tube, cuff
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2018-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children for any surgical procedure requiring endotracheal intubation

Brief summary: To verify the exact location of cuff of the endotracheal tube in children.

Detailed description: The exact location of the cuff of the endotracheal tube in children has not been studied. This study is the first attempt to verify the position of the cuff in the airway with relation to cricoid.

Eligibility criteria: Inclusion Criteria:

* Children aged 1 month to 8 years

Exclusion Criteria:

* Any airway pathology

Primary outcomes:
measure: Cuff position
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: Consultant
name: Tariq Wani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03744481: Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia
Official title: Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anoxic-Ischemic Encephalopathy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full term children with perinatal asphyxia and with clinical signs of mild EAI without indication of therapeutic hypothermia

Brief summary: There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs.

There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia.

The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.


Eligibility criteria: Inclusion Criteria:

* Full-term children, gestational age\> 36 weeks of amenorrhea
* Between the 1st of January 2012 and the 31st of December 2016
* Hospitalized in the neonatal resuscitation department of Croix Rousse in Lyon
* Perinatal asphyxia with clinical signs of encephalopathy
* Indication of therapeutic hypothermia not retained because EAI mild
* Where parents were informed and did not object to participation in the study

Exclusion Criteria:

* Dysmorphic syndrome
* Stroke
* Children transferred for other criteria (respiratory distress, heart failure ...)

Primary outcomes:
measure: Existence of abnormalities
timeFrame: maximum 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Réanimation néonatale - Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT00000310: Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2
Official title: Serotonin/Dopamine Antagonism of Cocaine Effect
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: VA Boston Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Detailed description: Risperidone in low doses is compared with placebo in a 6-week randomized trial. Subjects also receive supportive counseling. Outcome measure include rating of behavior, mood, drug abuse, global function, and urine toxicology.

Eligibility criteria: Inclusion Criteria:

Cocaine abuse or dependence

Exclusion Criteria:

Dependence on other drugs. Major psychiatric illness

Primary outcomes:
measure: Urine toxicology for cocaine
measure: Analog mood scales
measure: POMS
measure: EPS sx
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Medicine
state: Rhode Island
Study officials:
affiliation: Brown University
name: Lawrence Price, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00938210: Rehabilitation Following Laparoscopic Colonic Surgery
Official title: Changes in Fatigue and Physical Function Following Laparoscopic Colonic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Cancer
Postoperative Care
Fatigue
Keywords: Colonic surgery
Postoperative care
Fatigue
Physical function
Quality of life
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The standard procedure for treating colonic cancer is changing from open surgery to laparoscopic surgery. Following open colonic surgery patients are fatigued and loss body mass and have a reduction in physical function, but the investigators do not know if this is also the case following laparoscopic surgery.

This study examines how fatigue, quality of life, physical function, and body composition changes following laparoscopic colonic surgery.

Patients are examined preoperatively and postoperative day 10 and 30.


Eligibility criteria: Inclusion Criteria:

* elective colonic cancer surgery
* hemicolectomy or sigmoid resection
* informed consent

Exclusion Criteria:

* disseminated cancer
* contraindications for laparoscopic surgery
* dementia or serious psychiatric disease
* diseases or other aspects that prohibit participation

Primary outcomes:
measure: Fatigue
timeFrame: Preoperative to postoperative day 10
Secondary outcomes:
measure: Muscular strength
timeFrame: From preoperatively to postoperative day 10 and 30
measure: Change in work capacity (pulse rate)
timeFrame: From pre- to postoperative day 10 and 30
measure: Balance (sway)
timeFrame: From preoperatively to postoperative day 10 and 30
measure: Pain at rest and when moving
timeFrame: From preoperatively to postoperative day 10 and 30
measure: Quality of life (Short Form 36 - SF-36)
timeFrame: From preoperatively to postoperative day 10 and 30
measure: Body weight
timeFrame: From preoperatively to postoperative day 30
measure: Body composition (fat mass and fat free mass estimated by bio-impedance)
timeFrame: From preoperatively to postoperative day 10 and 30
measure: Social support
timeFrame: From preoperatively to postoperative day 10 and 30
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Department of Surgery, Herning Hospital
city: Randers
country: Denmark
facility: Department of Surgery
Study officials:
affiliation: Research Unit for General Practice in the North Denmark Region, Institute of Public Health, Aarhus University
name: Martin B Jensen, MD, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery P, Aarhus University Hosptial
name: Søren Laurberg, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04219410: Assessment of a Modified Minimally Invasive Esophagectomy
Official title: Assessment of a Modified Minimally Invasive Esophagectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive sample of all patients undergoing the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center during the study period

Brief summary: This is a retrospective case series of a novel fully minimally invasive esophagectomy procedure for patients with primary esophageal cancer.


Eligibility criteria: Inclusion Criteria:

* patient with primary esophageal cancer of any cell type
* underwent the novel minimally invasive esophagectomy procedure at the Kaiser Permanente Northern California Oakland Medical Center by one of the study author-surgeons

Exclusion Criteria:

* non-elective procedure
* less than 90 days of post-discharge follow-up

Primary outcomes:
measure: Hospital length of stay
timeFrame: Through study completion, an average of 2.9 years
Secondary outcomes:
measure: Intensive care unit length of stay
timeFrame: Through study completion, an average of 2.9 years
measure: Feeding tube placement
timeFrame: Intra-operatively
measure: Number of patients with inpatient mortality
timeFrame: Through study completion, an average of 2.9 years
measure: 90-day total mortality
timeFrame: 90 days post discharge
measure: Number of patients with hospital readmission within 30 days
timeFrame: 30 days post discharge
measure: Number of patients with complications
timeFrame: Hospital stay and 30 days post discharge
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Andrew Avins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: