louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02043561: The Effect of Inhibitory Control Processes Induced by Rectal Distension on Impulse Control Measured by Stroop Task Performance and Intertemporal Discounting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2014-01-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study will be to investigate the effect of rectal distension, controlled by electronic barostat, on cognitive control ability in healthy subjects. We will use the Stroop task and an intertemporal choice task as standard instruments. Like bladder control and rectal control, both Stroop task performance and intertemporal choices - though very different tasks at the surface - are dependent on the conflict monitoring function of the anterior cingulate cortex. The Stroop task requires the naming of the print color of a series of visually presented color words, and reaction time and error rates are typically used as performance indicators. When word color and word meaning do not match, performance of the task (color naming) requires the inhibition of a (near) automatic response (word reading). The intertemporal choice task consists of a series of choices between a sooner smaller monetary reward and a larger but later reward. The choices are constructed such that they allow the estimation of a discount parameter, which is an index for the level of impulsiveness manifested by the participant at the time the choices are made.

The hypothesis is that the inhibition induced by the urge generated during rectal distension will improve cognitive inhibitory performance, as has previously been shown for bladder filling.


Eligibility criteria: Inclusion Criteria:

* healthy male and non-pregnant, non-breastfeeding female participants, aged 18-60 years old at the time of consent.

Exclusion Criteria:

* use of medications within 48 h of dose initiation; structural or metabolic diseases that affect the gastrointestinal system and functional gastrointestinal disorders; previous abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as diabetes, cardiovascular or lung disease; current psychiatric disorders (anxiety, depression, substance use); use of agents that influence bowel habit, i.e. anticholinergics (not including antihistamines with anticholinergic properties), spasmolytics and prokinetics in the 7 days before the study.

Primary outcomes:
measure: cognitive inhibitory performance on Stroop task (reaction time, in milliseconds) and intertemporal choice task (discount parameter, no unit)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, campus Gasthuisberg
Study officials:
References:
Clinical trial NCT01372761: Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
Official title: Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obese
Obesity
Overweight
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

Detailed description: This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility criteria: Inclusion Criteria:

* Obese but otherwise healthy females
* Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
* BMI ≥ 30 and ≤ 50 kg/m2
* Stable body weight during the past month

Exclusion Criteria:

* Use of weight loss agents in the past month
* History of eating disorder
* History of gastric bypass surgery
* Current smokers

Primary outcomes:
measure: Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
timeFrame: Approximately 4 weeks
Secondary outcomes:
measure: Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability.
timeFrame: Approximately 4 weeks
measure: Peak plasma concentration of ZGN-433 to assess relationship to weight loss.
timeFrame: Approximately 4 weeks
measure: Elimination half-life of ZGN-433 to assess relationship to weight loss.
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
state: Queensland
Study officials:
affiliation: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
name: J K Marjason, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148261: Epinephrine and Cortisol in Depression
Official title: The Effects of Epinephrine and Cortisol on Emotion in Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effects of two hormones called epinephrine and cortisol on how the brain processes emotional material using functional MRI to measure brain activity. The study hopes to learn how epinephrine and cortisol affect the brain differently in depressed and non-depressed individuals.


Eligibility criteria: Inclusion Criteria:

* Weight of less than 280 pounds
* HAM-D Score of greater than 7 for depression participants

Exclusion Criteria:

* Psychotropic medications
* Recent surgery
* Endocrine disorders
* Liver disease
* Kidney disease
* Thyroid disorder
* History of malaria
* Tuberculosis
* Osteoporosis
* Glaucoma or cataracts
* Chronic expressed infections (herpes, HIV, etc)
* History of congestive heart failure
* History of recurring seizures
* Stomach ulcers
* Comorbid psychosis
* Current use of illicit drugs
* Diabetes
* Any cardiovascular disease (angina, hypovolemia, coronary artery disease, low/high blood pressure, etc)
* Any pulmonary disease
* Any cerebrovascular disease
* Sulfate hypersensitivity
* Glaucoma
* Infection
* Pregnancy
* Parkinson's Disease
* Panic Disorder
* Over 280 pounds in weight
* In-dwelling ferrous metals
* Left handed
* Abnormal hearing
* Claustrophobic
* Head injury with loss of consciousness
* Active suicidal ideation

Primary outcomes:
measure: Sadness-induced subgenual cingulate activity as measured by functional magnetic resonance imaging
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Keith Sudheimer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01415661: Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study
Official title: Efficacy of Cricoid Pressure in Occluding the Esophageal Entrance: A Glidescope ® Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspiration
Lead sponsor: Procare Riaya Hospital
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 89
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: PREVENTION

Brief summary: This investigation was designed to assess the patency of the esophageal entrance during cricoid pressure (CP) in anesthetized, paralyzed obese and non obese patients using the Glidescope ® video laryngoscope (GVL).

Detailed description: Eighty-nine patients undergoing surgeries necessitating general anesthesia and tracheal intubation were enrolled in this study. Group 1 (OB) including obese patients (n= 59) was undergoing bariatric surgery. Following rapid sequence induction/intubation (RSII) anesthesia with cricoid pressure, clear view of the vocals cord and the entrance to the esophagus were assessed using Glidescope® video laryngoscope before intubation and following intubation. Following securing the airway, efficacy of cricoid pressure was tested by the capability to insert gastric tubes (20 and 38 Fr) under direct vision using GVL. Group 2 (NOB) including non-obese patients (n=30) was undergoing moderate surgery requiring tracheal intubation under general anesthesia. Efficacy of cricoid pressure was also tested similarly using GT's (20 and 38 Fr) following induction of anesthesia and before intubation. Inability of GT insertion was recorded as non-patent esophagus (effective CP) and successful insertion of GT was recorded as patent esophagus (ineffective CP). Then CP was released and insertion of GT achieved for correct verification of the esophageal opening position in both groups.

Eligibility criteria: Inclusion Criteria:

* Obese patients ( BMI 40-70 kg/m2)
* No Contre indication to cricoid pressure
* No-obese patients (BMI \< 40)

Exclusion Criteria:

* ASA 3 and 4
* Contre indication to cricoid pressure

Primary outcomes:
measure: Efficacy of Cricoid Pressure for Prevention of Aspiration
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Al Khobar
country: Saudi Arabia
facility: procare Riaya Hospital
state: Estern
Study officials:
affiliation: Procare Riaya Hospital
name: AHED ZEIDAN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06676761: Outcomes of a Novel Technique Minimal Scar Mastectomy
Official title: Outcomes of a Novel Technique Minimal Scar Mastectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: breast cancer
nipple sparing mastectomy
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-06
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer patients with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy.

Brief summary: Nipple sparing mastectomy is oncologically safe and has a good cosmetic outcome. However, nipple sparing mastectomy was conventionally performed with reconstruction. Minimal scar mastectomy (MSM) is a novel technique which could allow women, with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy. This is the first study on the oncologic and surgical outcomes of MSM.


Eligibility criteria: Inclusion Criteria: breast cancer patients who opted for minimal scar mastectomy -

Exclusion Criteria: breast cancer patients who underwent conventional mastectomy

-

Primary outcomes:
measure: oncological outcome
timeFrame: 5 years from operation
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
References:
citation: Lim GH, Allen JC, Ng RP. Oncoplastic round block technique has comparable operative parameters as standard wide local excision: a matched case-control study. Gland Surg. 2017 Aug;6(4):343-349. doi: 10.21037/gs.2017.03.06.
citation: Lim GH. How to do minimal scar mastectomy: first-reported novel concept of nipple sparing mastectomy without reconstruction. ANZ J Surg. 2018 Dec;88(12):1345-1346. doi: 10.1111/ans.14941. Epub 2018 Nov 1. No abstract available.
Clinical trial NCT05324761: Management of Pain Associated With Failed Back Surgery Syndrome
Official title: Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Failed Back Surgery Syndrome
Keywords: Pregabalin
Gabapentin
neuropathic pain
spine surgery
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 60
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: Neuropathic pain is a common complication following different types of spine surgery making negative impact on health, along with life style changes and management, many neurologist prescribed either Pregabalin or Gabapentin to manage this condition with overall good results.

our study aims to evaluate the efficacy of Pregabalin and Gabapentin in the management of this condition and to compare between them


Eligibility criteria: Inclusion Criteria:

* Patients with Previous spine surgery and subsequent chronic back pain

Exclusion Criteria:

* Patients with connective tissue diseases
* Patients with psychiatric illnesses

Primary outcomes:
measure: Efficacy in Neuropathic pain management
timeFrame: outcome will be assessed one month after the initiation of medication
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Laith Thamer Al-Ameri
Study officials:
affiliation: University of Baghdad - Al-Kindy College of Medicine
name: Laith Al-Ameri
role: STUDY_DIRECTOR
References:
Clinical trial NCT06319261: Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets.
Official title: Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.

the objectives are

1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.

the hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.

The participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.

For each patient, each site will be randomly assigned to either treatment protocol:

1. Sites treated with GBT.
2. Sites treated with conventional manual instrumentation only.


Eligibility criteria: Inclusion Criteria:

1. Adult patients, aged more than 18 years.
2. No history of any systemic diseases.
3. Diagnosed with Stages 3 and 4 periodontitis according to the 2017 World Workshop on the Classification of Periodontal disease.
4. The presence of deep periodontal pocket ≥ 6 mm in two non-adjacent teeth.

Exclusion Criteria:

1. Smokers.
2. Pregnant and lactating mothers.
3. History of any previous subgingival instrumentation in the last 3 months.
4. The use of antibiotics/non-steroidal anti-inflammatory drugs in the last 3 months.
5. Regular use of medication to control systemic illness.
6. The presence of perio-endo lesion.

Primary outcomes:
measure: Periodontal pocket depth (PPD)
timeFrame: 3 months
Secondary outcomes:
measure: Plaque index
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 3 months
measure: Relative attachment level
timeFrame: 3 months
measure: Changes in the bacterial load
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00347061: Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
Official title: A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasiam
Adrenergic alpha-antagonist
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 148
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary:

To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.

Secondary:

* To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
* To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.


Eligibility criteria: Inclusion Criteria:

* Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography
* Suffering for at least 6 months from lower urinary tract symptoms related to BPH
* An I-PSS total score ≥ 13
* Out patient

Exclusion Criteria:

* Patients previously treated with SL77.0499-10.
* Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.
* Isolated bladder neck disease.
* Diagnosed carcinoma of the prostate.
* Previous prostatic surgery or other invasive procedures (thermotherapy...) for the treatment of BPH.
* Patients having an indwelling catheter.
* A residual urine \> 200mL.
* Patients with Moderate or sever hepatic insufficiency.
* Known hypersensitivity to alpha1-blockers.
* Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
* Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.

Primary outcomes:
measure: One year safety data of SL77.0499-10
Secondary outcomes:
measure: One year efficacy data and plasma concentration of SL77.0499-10
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00716261: Bio-Feedback to Improving Stability in Elderly Population
Official title: Using Bio-Feedback for Improving Stability in Walking and Everyday Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease Patients
Keywords: Parkinson's disease
Audio feedback
postural control
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-07-16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.

Detailed description: The aim of the study is to treat Parkinson's patients and elderly fallers. The intervention is intensive training with Biofeedback to try to correct stooped posture, and to improve stability in standing and in walking.

Eligibility criteria: Inclusion Criteria:

* Idiopathic PD for \>2 yrs
* Between 50-90 Yrs
* On anti-Parkinsonian medication
* Hoehn \& Yahr 2-3 in "ON"
* Free of serious co-morbidities
* Able to walk but reports difficulties in gait
* Can use assistive device

Exclusion Criteria:

* Significant orthopedic disturbances or pain
* Major depression (DSM IV)
* Dementia (MMSE\<24)
* Clinically significant hearing problems
* Unstable medical condition (2 wks from meds change)
* Deep Brain Stimulation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
name: Jeffrey M Hausdorff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05439811: Retrospective Data Analysis on the Application of Swan-Ganz Catheter in Cardiac Surgery
Official title: Retrospective Data Analysis on the Application of Swan-Ganz Catheter in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Complications
Keywords: Swan-Ganz Catheter
Cardiac Surgery
Postoperative complications
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan Asia Heart Hospital
First posted: 2022-06-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults undergoing cardiac surgery

Brief summary: The investigators aimed to investigate postoperative complications associated with Swan-Ganz Catheter based on the clinical data of Wuhan Union Hospital and Wuhan Asian heart hospital for 10 years, including major cardiovascular, respiratory adverse events, ICU time, mechanical ventilation time, length of hospital stay, in-hospital mortality, and 30-day postoperative mortality events.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old;
* Patients undergoing major cardiac surgery under general anesthesia;
* Patients with complete sex, age, use of floating catheter and prognosis data

Exclusion Criteria:

* ASA grade V and above;
* End stage renal disease requiring (or undergoing) renal replacement therapy;
* Pregnant or lactating women

Primary outcomes:
measure: Number of participants with cardiovascular events
timeFrame: one week after operation
measure: Number of participants respiratory adverse events
timeFrame: one week after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: