linjc16/ctgov huggingface dataset:
Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects such as itch (pruritis) and nausea & vomiting are common and have been shown to be the most common cause for dissatisfaction. The incidence of pruritis is 74% even with current available medications. Acupuncture has been shown to be effective for morphine related side effects but has not been evaluated for prophylaxis of itch in pregnant population. PRIMARY OBJECTIVE: Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under spinal with intrathecal morphine

Official Title
-----------------
Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery

Conditions
-----------------
Acupuncture, Morphine Induced Pruritis

Intervention / Treatment
-----------------
* Device: ACUPUNCTURE AT LI11
* Device: SHAM ACUPUNCTURE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: ASA I & II patients undergoing elective caesarean delivery under spinal with intrathecal morphine Exclusion criteria: Patient refusal ASA III & IV patients Pre-existing pruritis Eczema Bleeding tendencies Known allergy to any of medications used Any contra indication to spinal anaesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACUPUNCTURE<br> | Device: ACUPUNCTURE AT LI11<br>* ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES<br>|
| Sham Comparator: SHAM ACUPUNCTURE<br> | Device: SHAM ACUPUNCTURE<br>* SHAM ACUPUNCTURE AT A POINT 2 CM LATERAL TO LI11 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pruritis | To determine acupuncture at li 11 reduces the incidence of pruritis after elective caesarean delivery under spinal anaesthesia with intrathecal morphine | First 24 hr post intrathecal morphine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pruritis | To determine acupuncture reduces: Severity of pruritis Requirement of relief medications | 1, 4, 8, 24 hr post intrathecal morphine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caesarean Delivery, Pruritis, Intrathecal Morphine, Acupuncture At LI11
Asymptomatic Bacteriuria, Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors and UTI Risk

Study Overview
=================
Brief Summary
-----------------
The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors are risk factors for UTI in women. There is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of SGLT2 inhibitors. The aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors on UTI risk in a prospective cohort of women with type 2 diabetes mellitus.

Official Title
-----------------
Urinary Tract Infection Risk in Women With Asymptomatic Bacteriuria or Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors

Conditions
-----------------
Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection

Intervention / Treatment
-----------------
* Diagnostic Test: urine culture and urinalysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female >18 years old Type 2 Diabetes Mellitus Initiated SGLT2 inhibitors Available informed consent Exclusion Criteria: Having urinary tract or genital tract symptoms at the enrollment Treated for urinary tract or genital tract infection in the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| positive for bacteriuria/ urinalysis abnormality<br>The patients who have any growth in urine culture or urinalysis abnormality at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin) | Diagnostic Test: urine culture and urinalysis<br>* urine culture and urinalysis<br>|
| negative for bacteriuria/ urinalysis abnormality<br>The patients who do not have growth in urine culture or do not have abnormality in urinalysis at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin) | Diagnostic Test: urine culture and urinalysis<br>* urine culture and urinalysis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection | Number of participants with urinary tract infection - Any urinary tract infection treated or diagnosed by the physician clinically or by testing | 3 months |
Volume Deficit Prior to Surgery

Study Overview
=================
Brief Summary
-----------------
It is the purpose of the researchers to identify the variation in intravascular deficits which can have relevance in high risk patients for minor and medium sized surgery. The investigators will also estimate fluid deficit in healthy, non-fasting subjects for comparison.

Detailed Description
-----------------
Intravascular volume optimization has shown to improve outcome after surgery. In minor and medium surgery , however, the preoperative volume deficit has not been estimated with functional parameters. Patient scheduled for minor surgery are included. After the patient is anesthetized the intravascular volume is optimized by stroke volume maximization by colloid boluses. Stroke volume is obtained by esophageal Doppler technique which is a minimally invasive method. The volume estimated for optimization is considered as the functional volume deficit. In the healthy subjects the probe will be placed in the awake subject. A standardized meal and fluid intake secures that the subjects are in a non-fasting state.

Official Title
-----------------
Estimation of Volume Deficit in Patients Prior to Surgery

Conditions
-----------------
Hypovolemia, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned minor or medium sized surgery Exclusion Criteria: Oesophageal pathology Age >90 yr or < 18 yr Alcohol abuse, Insulin dependent DM

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minor surgery, Volume optimization, Volume deficit, Epidural anesthesia
Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in At-risk Patients

Study Overview
=================
Brief Summary
-----------------
One-step exchange arthroplasty is more and more used in the treatment of chronic infections, especially in patients at risk anesthetic. This strategy is not recommended in patients infected with multidrug-resistant organisms or difficult to treat because of a risk of bacterial persistence on the new implant. Antibiotic pretreatment by a narrow-spectrum molecule and for which resistance acquisition is difficult might be of interest to try to reduce the inoculum and avoid contamination of the new implant.

Official Title
-----------------
Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in

Conditions
-----------------
Prosthetic Joint Infection, Antibiotic Resistant Infection

Intervention / Treatment
-----------------
* Other: Antibiotic pretreatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had a antibiotic pretreatment targeted before a one step exchange arthroplasty Exclusion Criteria: none

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antibiotic pretreatment<br>patients having had an antibiotic pretreatment before a one-step exchange arthroplasty | Other: Antibiotic pretreatment<br>* a strategy with antibiotic pretreatment before one-step exchange arthroplasty in patients who bacteria responsible for the infection has been indentified (puncture, blood cultures,...)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Treatment Failure | Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of use of this strategy | descriptions of patients managed with this strategy | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 
| rate of bacteria responsible for infection | bacterial epidemiology | Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone and joint infection, Antibiotic pretreatment
Survival Outcomes of Ovarian Malignancies in Chinese Population

Study Overview
=================
Brief Summary
-----------------
This study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in China and relevant risk factors in a prospective cohort study.

Official Title
-----------------
Survival Outcomes of Ovarian Malignancies in Chinese Population

Conditions
-----------------
Survival, Ovarian Neoplasms

Intervention / Treatment
-----------------
* Other: Follow up for death and recurrence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary ovarian malignancies. Exclusion Criteria: Metastatic malignancies to ovaries.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Follow up for death and recurrence|Patients are followed up to determine the specific date of diagnosis, recurrence and death.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Periods from diagnosis of ovarian cancer to death | 5 years | 
| Progression-free survival | Periods from diagnosis of ovarian cancer or remission of disease to next recurrence | 5 years |
SMAS: a Prospective Study in a Single Institution

Study Overview
=================
Brief Summary
-----------------
Superior Mesenteric Artery Syndrome (SMAS) is a rare cause of duodenal obstruction, that should be suspected in cases of chronic, refractory upper digestive symptoms. Between 2008 and 2016, 39 consecutive patients with chronic gastrointestinal symptoms and a diagnosis of SMAS were prospectively included in the study, in order to describe their demographic, clinical and outcome features. All patients underwent duodenojejunostomy.

Official Title
-----------------
Superior Mesenteric Artery Syndrome: a Prospective Study in a Single Institution

Conditions
-----------------
Superior Mesenteric Artery Syndrome

Intervention / Treatment
-----------------
* Procedure: Duodenojejunostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (at least 2 of the following): severe and frequent upper digestive symptoms (occurring at least once a week), associated to poor quality of life and refractory response to medical treatment; a condition of underweight (BMI <18.5 kg/m2) associated with difficulty eating; severe complications of SMAS (e.g. gastric perforation, acute pancreatitis, aspiration pneumonia); suggestive findings of SMAS at barium swallow; diagnostic aortomesenteric angle and distance at CT/MR angiography. Exclusion Criteria: inability to provide the informed consent; malignancies; bowel motility disorders; severe psychiatric illness; pregnancy; impossibility to perform the required diagnostic workup.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMAS patients<br> | Procedure: Duodenojejunostomy<br>* Duodenojejunostomy with or without duodenal resection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score | Severity (0-6) + frequency (0-5) x 5 symptoms (abd pain, nausea, vomiting, reflux, bloating) | 47 months (IQR 34-72) | 
| BMI | Body mass index | 47 months (IQR 34-72) | 
| Need for medical treatment | PPIs, prokinetic drugs | 47 months (IQR 34-72) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superior Mesenteric Artery Syndrome, Chronic duodenal obstruction, Duodenojejunostomy, Wilkie's syndrome
Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds

Study Overview
=================
Brief Summary
-----------------
To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry dressing in the treatment of open wounds after incision and drainage.

Official Title
-----------------
Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Other: Taliderm™
* Other: Taliderm™
* Other: standard wet to dry dressing with gauze


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients with soft tissue abscess that will result in an open surgical wounds greater than or equal to 4 cms in any dimension Wound will require serial dressing changes Greater than or equal to 18 years of age Ability to obtain informed consent Exclusion Criteria: Inability to obtain informed consent Pregnancy Prisoner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group II<br>Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing. Gauze dressing changes will continue per standard of care until the scheduled follow-up visits (first or second visit). At the scheduled follow-up visits, the subject will have a Taliderm™ dressing applied and left in place until the next scheduled dressing change (up to eight hours), then will continue standard of care wet to dry gauze dressing changes until next scheduled follow-up visit. | Other: Taliderm™<br>* Taliderm™ dressing application up to three applications<br>|
| Other: III<br>standard wet to dry dressing with gauze | Other: standard wet to dry dressing with gauze<br>* wet to dry dressing standard of care<br>|
| Active Comparator: group I<br>Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing | Other: Taliderm™<br>* taliderm™ dressing application once<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this study will be rate of wound healing (judged as per cent complete wound closure) at the two (2) and three (3) week follow-up visits. |  | two and three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of wound infection |  | two and three weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soft tissue abscess requiring incision and drainage
18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness

Study Overview
=================
Brief Summary
-----------------
Clinical examinations are difficult to discriminate between vegetative state and minimally conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not been established in a clinical setting. we will do a forward study of PET imaging in disorders of consciousness patients, and validate with clinical assessments with the coma recovery Scale-Revised(CRS-R).

Detailed Description
-----------------
Every patient need to be conducted the PET/CT scanning two times.The first time is resting state.The second time is stimulated state by watching a vedio.

Official Title
-----------------
18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness

Conditions
-----------------
Persistent Vegetative State

Intervention / Treatment
-----------------
* Radiation: 18F-FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of disorder of consciousness Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controls<br>The controls are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the controls sleep for an hour in a quiet room before scanning. | |
| Experimental: Patients<br>The patients are intravenous injected of 185 to 370 MBq 18F-FDG.Then,the patients sleep for an hour in a quiet room before scanning. | Radiation: 18F-FDG<br>* 18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standardized uptake value |  | 60 mins after injecting 18F-FDG |
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU). The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin

Official Title
-----------------
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Device: Fast gelling dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both gender ≥18 years old. Subjects with type 1 or 2 diabetes mellitus. Texas Grade A1 or 2, C1 or 2 Exuding diabetic foot ulcer Ulcer localisation; below the ankle Signed Informed Consent. Exclusion Criteria: Known allergy/hypersensitivity to the dressing. HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months) Wound infection requiring systemic treatment Subjects who will have problems following the protocol. Subjects included in other ongoing clinical investigation at present or during the past 30 days. Toe pressure less than 70 mmHg Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes) Dry wounds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fast Gelling Dressing<br> | Device: Fast gelling dressing<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peri-wound Skin | Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin | 12 weeks |