louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02609555: TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse
Official title: Trans-anal Endoscopic Microsurgery (TEM) Assisted Perineal Rectopexy With Postanal Repair and Anal Cerclage In Treatment of Rectal Prolapse (Novel Technique)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Prolapse
Keywords: TEM
Rectopexy
rectal prolapse
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 7
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.

Detailed description: Perineal Rectopexy is performed by an incision in the intersphincteric space followed by dissection till the sacral promontory then Proctoscope is inserted to complete the dissection .Mesh is inserted and fixed to the sacrum with laparoscopic tacker ( or can be left unfixed) then postanal repair is conducted in two layers ( levatorplasty then sphincteroplasty) and finally Ana cerclage is done with polyglactin 0 sutures

Eligibility criteria: Inclusion Criteria:

* patients with complete or partial rectal prolapse

Exclusion Criteria:

* patients unfit for surgery
* patients with previous surgery for rectal prolapse
* patients with associated anorectal pathology (e.g fistula )
* patients with constipation as a predominant symptom.

Primary outcomes:
measure: Recurrence of prolapse
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of continence state
timeFrame: 12 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh Emile, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01907555: Clinical, Molecular and Physiopathological Study of Cohen Syndrome and Cohen-like Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cohen Syndrome
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohen syndrome

Brief summary: This project will make it possible to better understand the natural history of Cohen Syndrom and the phenotypes associated with mutations in the VPS13B gene, to improve the therapeutic management of patients. It will also provide a better description of Cohen-like syndrome for genetic counselling for the families concerned.


Eligibility criteria: Inclusion Criteria:

* Patients presenting Cohen syndrome and two VPS13B mutations
* who accept a clinical evaluation, and to provide at least one blood sample
* Patients presenting the diagnostic criteria of Cohen syndrome, but without a VPS13B mutation
* Patients presenting neutropenia or pigmentary retinopathy and at least one of the following signs, after exclusion of any other syndrome: mental retardation, microcephaly, truncal obesity

Exclusion Criteria:

* - Patients who do not meet the clinical and/or molecular criteria
* Patients who do not wish to provide a blood sample for question 1,
* Patients who have not provided written informed consent,
* Pregnant or breast-feeding women,
* Persons not covered by National Health Insurance and persons under guardianship or in prison.

Primary outcomes:
measure: spectrum of mutations VPS13B
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT03631355: Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
Official title: Reducing Hemarthrosis in Anterior Cruciate Ligament Reconstruction With BTB Autograft by the Administration of Intravenous Tranexamic Acid: A Double-Blind Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain.

Detailed description: The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.

Eligibility criteria: Inclusion Criteria:

-PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT

Exclusion Criteria:

* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Any patient considered a vulnerable subject
* Have bleeding or clotting disorder
* Preoperative anticoagulation therapy
* Abnormal coagulation profile
* Renal disorder or insufficiency
* Sickle cell disease

Primary outcomes:
measure: POST-OPERATIVE HEMARTHROSIS
timeFrame: Post-operative week 1
measure: POST-OPERATIVE Opioid Consumption
timeFrame: Days 1-7
measure: POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
timeFrame: Post-operative day 7
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Michael Alaia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04143555: Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy
Official title: Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Gastrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopic Submucosal Injection of Indocyanine Green
Keywords: endoscopic submucosal injection
indocyanine green
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy for gastric cancer

Brief summary: Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy

Detailed description: To observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy, and analyze the relevant factors, so as to guide the operation of preoperative indocyanine green submucosal injection better.

This study is prospective and observational. In order to analyze the related factors that affect the imaging effect, we enrolled patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.

Eligibility criteria: Inclusion Criteria:

* patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical gastrectomy.

Exclusion Criteria:

* have simultaneously other cancer

  * have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
  * have upper gastrointestinal surgery
  * Indocyanine green or iodine allergy
  * the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Primary outcomes:
measure: The imaging effect of indocyanine green
timeFrame: During the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Chang chun
country: China
facility: the First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT02189655: Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
Official title: Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Antishivering Effects
Keywords: shivering spinal anesthesia
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.

Detailed description: This prospective randomized double-blinded study was conducted to compare the antishivering effects of two different types of intrathecal administration.Group Control:traditional intrathecal administration; Group Diluting:Diluting with cerebrospinal fluid

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled for elective surgery under spinal anesthesia were enrolled.

Exclusion Criteria:

* Patients with pre-operative fever (\>38℃), diabetes, , Parkinson's disease, hypo or hyperthyroidism, Raynaud's syndrome, obese patients (weight \>100 kg), patients shorter than 152 cm, those with a history of allergy to the study medications, and patients receiving vasodilators were excluded from the study.

Primary outcomes:
measure: antishivering effects of two different types of spinal anesthesia
timeFrame: time point 1: 15 minuntes after spinal anesthesia and time point 2 : when patiets were sent to postoperation care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: The First Hospital of CMU
name: Hong Ma, M.D.,Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02020655: Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin
Official title: Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcers, Bedsores, Decubitus Ulcer
Keywords: IL-1 alpha, Sebutape, shear- force
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 healthy volunteers

Brief summary: Background: A pressure ulcer is localized tissue injury to the superficial layer of the skin and/ or the underlying tissue. Pressure ulcers are most likely to develop in skin areas exposed to pressure, shear and friction. Shear- force is an important contributing factor and wound dressing are possibly capable to reduce shear force at the skin. At this moment there's no good marker to detect the effect of shear- force at the skin. A potential marker could be cytokines (IL-1α) which are released after mechanical loading of the skin. A previous study have shown a significant increased level of IL-1α after the application of pressure. We want to investigate if these cytokines are significant increased after the application of shear- force at the skin.

Objective: The objective of this study is to gather knowledge about cytokine concentrations (IL-1 α) in the skin of healthy volunteers after the application of shear- force. We want to use this knowledge in the future to investigate if different prophylactic wound dressings are capable to reduce shear force at the skin. This could be interesting in the prevention of pressure ulcers.

Study design: With the use of a special developed shear- force model are we going to administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy volunteers for 30 minutes. As a control we ware going to put the shear- force model at the other arm without the application of shear- force. Before the use of the shear- force model we will perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb cytokines from the skin. After the use of the shear force- model we will perform cytokine measurements again. Then we will extract the cytokines from the Sebutape with the use of ELISA.

Study population: 10 Healthy volunteers Age 18- 30 years

Primary outcome: IL-1 α concentration (pg/ml)


Eligibility criteria: Inclusion Criteria:

* Age 18- 30 years
* BMI 20 -30
* Braden score \> 20

Exclusion Criteria:

* Trauma arms
* Skin diseases (eczema, psoriasis)
* Inability to give informed consent
* Muscle disorders
* malignancy

Primary outcomes:
measure: IL-1 α concentration (pg/ml)
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University medical Centre
state: Limburg
Study officials:
affiliation: Department of surgery, Maastricht University Medical Centre
name: Nicole Bouvy, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01938755: Hyperbaric Levobupivacaine for Spinal Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle.

There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.


Eligibility criteria: Inclusion Criteria:

* Approval to participate in the study and spinal anesthesia
* American society of anesthesia (ASA) I,II physical status
* Scheduled for lower extremity surgery

Exclusion Criteria:

* Refuse to participate in the study
* American society of anesthesia (ASA)III, IV physical status
* Hypersensitivity to local anesthetics
* Emergency surgery
* Chronic pain treatment
* Peripheral neuropathy
* Severe systemic disease

Primary outcomes:
measure: degree of motor blockade
timeFrame: until dissolve of motor blockade
Secondary outcomes:
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital
Study officials:
References:
Clinical trial NCT00441155: Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib
Official title: An Extension to a Phase I Multicenter, Dose Escalation Study of Nilotinib in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastrointestinal Stromal Tumors
Keywords: Oncology
Cancer
Imatinib-Resistant Gastrointestinal Stromal Tumors
GIST
Nilotinib
Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST


Eligibility criteria: Inclusion criteria:

* Documented Complete Response, Partial Response, or Stable Disease at the time of entry to extension study and/or possible benefit from continuing treatment in the view of the investigator.
* Normal organ and marrow function as defined in core protocol (CAMN107A2103).
* Extension protocol written informed consent.

Exclusion criteria:

* Inability to swallow the medication.
* Any unresolved adverse events related to participation in the core protocol (CAMN107A2103).
* A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety and tolerability of nilotinib either as single agent or in combination with Imatinib
timeFrame: AE monitored continuously from day 1 cycle 1 to the study completion visit; safety laboratory and cardiac safety monitored every 3 treatment cycles (every 3 months) from day 1 cycle 1 to the study completion visit
Secondary outcomes:
measure: To assess any clinical responses in Imatinib-resistant GIST patients. Assessment of tumor response will be made based on modified RECIST criteria - to be assessed at the end of every cycle of treatment
timeFrame: every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Lyon Cedex
country: France
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: NovartisPharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03799055: Ultrasonography vs Conventional Methods for Prediction of Difficult Airway in Adult Patients
Official title: Ultrasonography(Distance From Skin to Epiglottis) vs Conventional Methods (Mallampati Score & Thyromental Distance) for Prediction of Difficult Airway in Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Intubation
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at Benha University Surgical Hospital scheduled for elective surgical procedures requiring endotracheal tube

Brief summary: The aim of this study to assess and compare between methods of prediction of difficult airway including Mallmpati score , thyromental distance and us measured distance from skin to epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal intubation for an elective surgical procedure.


Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesia class 1,2and 3.
* elective surgical procedure requiring endotracheal intubation.
* Age 18_60 years old.
* BMI less than 40kg/meter square.

Exclusion Criteria:

* patients refusal.
* Unable to give consent.
* Preexisting airway malformations or pathology.
* History of difficult intubation.
* Pregnancy.
* Patients with tracheostomy tube.
* BMI more than 40 kg/meter square.

Primary outcomes:
measure: Prediction of difficult airway
timeFrame: Preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospital
state: Banha
Study officials:
affiliation: faculty of medicine
name: Faculty Of Medicine
role: STUDY_DIRECTOR
References:
Clinical trial NCT00250055: Non-Invasive, Real-Time Technology for Diagnosis of Cervical Tissue
Official title: Non-Invasive, Real-time Technology for Diagnosis of Cervical Tissue
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervix
Cancer
Keywords: NIH
Non-Invasive diagnosis of cervical tissue
Los Alamos/NIH
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance.

Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells.

Develop and implement quantitative and sensitive methods for measuring morphological properties.

Clinical measurements.

Detailed description: Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.

Eligibility criteria: Inclusion Criteria:

* Patients with abnormal Pap smears who are referred for colposcopy.

Exclusion criteria include:

* Anyone of the male sex since this study focuses on cervical cell abnormalities
* Any woman who has had a hysterectomy, LEEP, or chemotherapy.

Primary outcomes:
measure: The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions.
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Harriet Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: