louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03026738: Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.
Official title: Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Prolapse
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 30
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: Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.

Detailed description: Rectal prolapse is a disabling condition, which is more common in females and increases in frequency with age.

There are two types of rectal prolapse; external and internal. External rectal prolapse is a circumferential protrusion of all layers of the rectum through the anal sphincter. Internal rectal prolapse, also referred to as rectal intussusception.

The majority of patients with a RP suffer from symptoms of fecal incontinence and constipation, causing a significant negative impact on quality of life.

The aims of the surgical treatment are to correct the anatomical abnormality and to cure the accompanying symptoms of incontinence, constipation and pain, with the lowest rate of complications as possible and an acceptable rate of recurrence.

Since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment for RP have been applied in patients of all ages.

Eligibility criteria: Inclusion Criteria:

* all patients with rectal prolapse either external or internal prolapse

Exclusion Criteria:

* Age below 18 years.
* Pregnancy or breast-feeding.
* Recurrence of rectal prolapse.
* patients with previous complicated abdominal surgery.

Primary outcomes:
measure: improvement of incontinence and / or constipation.
timeFrame: 1 year postoperatively
measure: recurrence rate
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Duration of Surgery
timeFrame: intraoperative
measure: Peri-operative blood loss
timeFrame: during surgery, 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04274608: Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
Official title: Intra-gastric Fundal and Body Injection of Botulinum Toxin A for Weight Loss, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Obesity
Weight Loss
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to compare intra-gastric injection of Botulinum Toxin A (Botox; Allergan Inc. Irvine, Ca, USA) against non-surgical management for obesity (i.e. exercise/diet). Our hypothesis is that intra-gastric injection of Botox into the fundus and body of the stomach will result in greater weight loss than just exercise and diet alone.


Eligibility criteria: Inclusion Criteria:

1. Age 21 to 65yrs old
2. BMI \>32.5 (Class II obesity)

Exclusion Criteria:

1. Pregnancy or lactation
2. Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy)
3. Patients with known liver cirrhosis or known esophageal/gastric varices
4. Known eating disorders
5. Known major cardiovascular or pulmonary conditions
6. Previous gastric/bariatric surgery
7. Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer)
8. Known alcohol or drug abuse
9. Known allergy to any ingredients in Botox or allergic reaction to any other botulinum toxin product

Primary outcomes:
measure: Weight loss
timeFrame: 1 year
measure: Time to weight regain following a single injection of intra-gastric Botox
timeFrame: 1 year
Secondary outcomes:
measure: Gut hormone level
timeFrame: 1 year
measure: Gut hormone level ( Leptin)
timeFrame: 1 year
measure: Satiety index
timeFrame: 1 year
measure: Co-morbidities
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References:
Clinical trial NCT01098708: This is a Study to Get More Information About Non Ambulatory Boys & Men With Duchenne Muscular Dystrophy
Official title: Clinical Outcomes Validation in Non Ambulatory and Young Boys/Men With Duchenne Muscular Dystrophy (DMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Keywords: DMD
non ambulatory
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
name: Boston Children's Hospital
name: University of Minnesota
name: University of California, Davis
First posted: 2010-04-05
Enrollment: 50
Sex: MALE
Minimum age (years): 7
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non ambulatory boys and men with Duchenne muscular dystrophy

Brief summary: Many therapeutic trials in DMD exclude non-ambulatory boys and men. Rate of progression in these non-ambulatory patients has been studied but consensus has not been reached for what measures are most reliable and reproducible. Furthermore, any treatment trial would be expected to demonstrate improved function and improvement in quality of life. Therefore, function, strength, and quality of life must be understood and standardized. While the goal of this proposal is to standardize clinical outcomes for therapeutic trials, careful understanding of the progression of DMD in non ambulatory boys may also lead to better medical treatment.

Detailed description: For Non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year.

Age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years.

Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with biopsy/genetic confirmation in a primary relative.

Eligibility criteria: Inclusion Criteria:

1. For Non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year.
2. Age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years.
3. Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with biopsy/genetic confirmation in a primary relative.

Exclusion Criteria:

1. For Non-ambulatory study, the inability to understand and cooperate with the testing would exclude a subject. -

Primary outcomes:
measure: Dystrophin gene mutations that predispose to early onset cardiomyopathy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Anne Connolly, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04022408: To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation.
Official title: "To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation: A Non-inferiority Trail".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatobiliary-Type Carcinoma
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 60
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: DIAGNOSTIC

Brief summary: Liquid Based Cytology is a method of preparing samples for examination in cytopathology.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Conventional cytology is gold standard for biliopancreatic malignancy examination. This method is operator depended and have high inter observer variation . On site evaluation increases the sensitivity of conventional cytology but requires the presence of pathologist at the time of sampling . Our study will compare LBC with conventional cytology ,If found to be non inferior will be great help in centre were on site evaluation cannot be carried out . It will further reduce the interobserver variation


Eligibility criteria: Inclusion Criteria:

* Consenting patients (or guardian) undergoing EUS guided sampling of suspected pancreato-biliary tumors

Exclusion Criteria:

* Patients on anti-platelet agents(including aspirin).
* Patients with deranged coagulation parameters, defined by platelet counts \<75,000/mm3 and/or INR \>1.8

Primary outcomes:
measure: Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation.
timeFrame: 0 day
Secondary outcomes:
measure: Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with size < 2 cm or > 2 cm
timeFrame: 0 day
measure: Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with respect to site of tumor (pancreas biliary tract or gall bladder).
timeFrame: 0 day
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT03601208: Mitra v Fingerprick Tacrolimus Creatinine
Official title: Comparison of Standard Venous Sampling for Measurement of Tacrolimus and Creatinine Versus Fingerprick Mitra® Volumetric Absorptive Microsampling in Adult Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transplant;Failure,Kidney
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with kidney transplant have blood tests very often. This is normally done in hospital and using a needle inserted into the vein. Two tests are important for kidney transplant patients - creatinine to monitor the health of the kidney; and tacrolimus to measure the level of the medicine which prevents rejection. The investigators would like to compare a fingerprick microsampling method to the standard venous blood. The fingerprick test is the same done by patients with diabetes and we use a microsampling tip which looks like a cotton bud to draw up a small amount of blood. Each tip draws up exactly 10 microlitres which is two drops. The investigators want to compare the results of creatinine and tacrolimus done through the two methods. In the future, this would allow patients to do their creatinine and tacrolimus test at home. The tips dry completely and can be posted to a laboratory. We hope this will make life easier for transplant patients and also help them engage more with the care of their condition.


Eligibility criteria: Inclusion Criteria:

Kidney transplant recipients. Taking tacrolimus

Exclusion Criteria:

Unable to consent

Primary outcomes:
measure: Comparison of creatinine and tacrolimus values for Mitra VAM (test) versus venous sampling (standard).
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02762708: The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
Official title: The Effect of Bariatric Surgery on Metabolism, the Metabolome and the Microbiome in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Obesity
Keywords: Bariatric Surgery
Weight loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?

Detailed description: Roux-en-y gastric bypass (RYGB) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. What are the reasons for this? There is evidence in animals that changes in the composition of gut bacteria after RYGB may be responsible for improvements in how glucose is metabolized in the body. The study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. The investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. A parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after RYGB. Participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. Thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.

Eligibility criteria: Inclusion Criteria:

* Age 20-65 years of age.
* Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
* Type 2 Diabetes Mellitus or impaired fasting glucose with BMI \>35 AND not interested in surgery but are interested in supervised caloric restriction.

Exclusion Criteria:

* Previous treatment with thiazolidinediones.
* Chronic antibiotic therapy.
* Active microvascular or macrovascular complications of diabetes.

Primary outcomes:
measure: Fasting Glucose
timeFrame: At baseline and 12 weeks post intervention
measure: Fasting Glucose
timeFrame: 4 weeks post intervention
measure: Peak Glucose
timeFrame: baseline and 12 weeks post intervention
measure: Peak Glucose
timeFrame: 4 weeks post intervention
measure: Glucose AUC
timeFrame: 0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention
measure: Changes in the Gut Microbiome Following RYGB or Caloric Restriction
timeFrame: baseline and 12 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Meera Shah, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532008: Depression Treatment and Economic Empowerment
Official title: The ASHA Project: Pilot Study of a Depression Treatment/Economic Empowerment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2020-08-31
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 48 women randomized to either intervention or control.
Primary purpose: TREATMENT

Brief summary: This pilot study randomized 48 depressed rural Bangladeshi housewives to either intervention or control groups. The intervention groups received depression treatment and a financial empowerment intervention.

Detailed description: This study was conducted in the rural Sirajganj region of Bangladesh. Working with the International Centre for Diarrhoeal Disease Research, Bangladesh and a local NGO, we recruited 48 depressed rural housewives for the study. Participants were randomized into intervention in control groups. The intervention groups (n=24) received 12 sessions of evidence based depression treatment, financial literacy education, agricultural training and skill building. They opened bank accounts and saved for six months. At the end of the six month period, participants who had met savings and attendance requirements received a cash transfer of approximately $186, which was used to purchase a productive asset. 22 participants purchased an agricultural animal, usually a goat; 1 financed a small retail business, and 1 leased land to grow crops for sale. Depression scores on the PHD-9 were sharply reduced. The study had 100% retention.

Eligibility criteria: Inclusion Criteria:

* Age 18-40
* PHQ greater than 10
* Able to save
* Able to read and write

Exclusion Criteria:

* Not in age range PhQ below 10 Unable to contribute to savings account Illiterate

Primary outcomes:
measure: Depressive Symptoms
timeFrame: 12 months post baseline
Secondary outcomes:
measure: Retention
timeFrame: Assessed at 12 Months post basline
Other outcomes:
Locations:
Study officials:
affiliation: Albert Einstein College of Medicine
name: Alison Karasz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04255108: Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output
Official title: Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Failure
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of California, Los Angeles
First posted: 2020-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and woman over the age of 18 years old.

Brief summary: toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.

Detailed description: This in an introductory clinical study with cardiac ICU patients featuring CoVa Patch. This is a single site, non-blinded, non-randomized study. It will employ a retrospective analysis comparing the accuracy of SV and CO. The 'test sensor', CoVa Patch, which will measure SV and CO quasi-continuously and non-invasively, approximately every 5-30 minutes for a period of time lasting approximately 12-48 hours. These measurements will be compared to those from a 'reference device', which is the pulmonary arterial catheter. It uses an invasive technique called thermodilution that will be made approximately every 4 hours. Measurements between the test and reference devices will be compared in a retrospective analysis once the study has completed.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age at Visit X.
* Subject is a patient in the Cardiac ICU and meets the following criteria: pulmonary artery catheterization scheduled or completed.
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
* Subject is not pregnant at the time of consent

Exclusion Criteria:

* Pregnant in the study.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Subject is unable or unwilling to wear electrode patches as required for a period between 6 to 48 hours.

Primary outcomes:
measure: Accuracy of Stroke Volume
timeFrame: 4 Months
measure: Accuracy of Cardiac Output
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cardiac ICU
state: California
Study officials:
References:
Clinical trial NCT03713008: Assessment Of Carotid Flow During General Anesthesia
Official title: Assessment of Fluid Responsiveness With Carotid Flow Change During General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Fluid Responsiveness
Keywords: Fluid Responsiveness, Anesthesia, Surgery, Stroke Volume Variation, Fluid status,
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients included in the study will receive 4 ml/kg fluid bolus.
Primary purpose: DIAGNOSTIC

Brief summary: Proper identification of patients who would benefit from fluid infusion (fluid responsiveness) is one of the most crucial challenges in anaesthesia and critical care. Reliability of several invasive measurements used for this purpose for many years have been questioned recently. The study will evaluate consistency between carotid artery flow derivatives and standard haemodynamic measurement (LIDCO rapid) in navigation of intraoperative fluid therapy.


Eligibility criteria: Inclusion Criteria:

* Major abdominal surgery
* Artery catheter required

Exclusion Criteria:

* Laparoscopic surgery
* Known history of carotid endarterectomy
* Known history of carotid stenosis
* Non-sinus rhythm
* Systolic or diastolic heart failure
* Chronic kidney disease
* Pulmonary hypertension
* Carotid artery anomaly
* Unable to visualise carotid artery
* Angle of correction \> 60

Primary outcomes:
measure: Change in cardiac output
timeFrame: Before and 2 minutes after intervention
measure: Change in a corrected carotid artery flow
timeFrame: Before and 2 minutes after intervention
Secondary outcomes:
measure: Change in pulse pressure variation
timeFrame: Before and 2 minutes after intervention
measure: Change in stroke volume variation
timeFrame: Before and 2 minutes after intervention
measure: Change in a carotid blood flow
timeFrame: Before and 2 minutes after intervention
measure: Change in a velocity time integral of carotid flow
timeFrame: Before and 2 minutes after intervention
measure: Change in the maximal systolic carotid velocity variation
timeFrame: Before and 2 minutes after intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University Of Warsaw
state: Mazovian
Study officials:
References: