linjc16/ctgov huggingface dataset:
Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy

Study Overview
=================
Brief Summary
-----------------
Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of patency, fixation of the PEG and possible leakage around the PEG. BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo device, which is inserted over the PEG and then is used to radially dissect the overgrowing tissue with a cutting wire. In this study both methods, the standard method using an ESD knife and the Flamingo device, are compared in a randomized controlled open-label trial. Primary endpoint is the time needed for PEG removal.

Official Title
-----------------
A Prospective Randomized Controlled Multicenter Trial for Evaluation of the Flamingo Device in Endoscopic Treatment of the Buried Bumper Syndrome.

Conditions
-----------------
Buried Bumper Syndrome

Intervention / Treatment
-----------------
* Device: Flamingo Device
* Procedure: Standard Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endoscopy proven Buried Bumper Syndrome PEG or Jet-PEG Exclusion Criteria: Major Coagulation disorder Percutaneous endoscopic jejunostomy or use of a ballon fixed device

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy<br>Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife. | Procedure: Standard Therapy<br>* Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife<br>|
| Experimental: Flamingo Device<br>The Flamingo device is used for treatment of Buried Bumper Syndrome. | Device: Flamingo Device<br>* Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Removal of PEG |  | Assessed at day 1 (day of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate |  | Assessed at day 1 | 
| Complications |  | Assessed during follow-up for up to ten days |
Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia

Study Overview
=================
Brief Summary
-----------------
In this scheme, TMS treatment of Primary dystonia is planned by precise magnetic resonance positioning.

Official Title
-----------------
Precision-targeted Transcranial Magnetic Stimulation in the Treatment of Primary Dystonia

Conditions
-----------------
Primary Dystonia, Transcranial Magnetic Stimulation

Intervention / Treatment
-----------------
* Device: Transcranial magnetic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary dystonia Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcranial magnetic stimulation|Transcranial magnetic stimulation (TMS) is a noninvasive biological stimulation technique born in the middle of 1980's.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burke-Fahn-Marsden dystonia rating scale | The BFMMS measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs) with scores ranging from 0 (minimum) to 120 (maximum).The higher scores mean a worse outcome. The BFMDS is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting,feeding, eating, swallowing, hygiene, dressing, and walking),with scores ranging from 0 (completely independent) to 30 (completely dependent). | Five days |
Epidural vs. Wound Catheter Following Liver Resection

Study Overview
=================
Brief Summary
-----------------
Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described. This study aims to compare postoperative pain control between patients with epidural analgesia versus the combination of continuous infiltration of local anaesthetic with wound catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The investigators expect that pain control will be similar between the two groups but that the utilization of wound catheters will confer benefit due to the lack of systemic side effects associated with epidural analgesia

Conditions
-----------------
Transplant Surgery

Intervention / Treatment
-----------------
* Procedure: This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients scheduled to undergo an open liver resection at this hospital will be eligible to participate. Exclusion Criteria: Patients with a contraindication to either epidural or wound catheter Inability to give written, informed consent Aged less than 18 years old Liver resection combined with a secondary surgical procedure Body mass index of <18 or >40 Pregnancy or lactation A history of chronic pain requiring regular opioid analgesia Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment<br> | |
| Active Comparator: Intervention arm<br> | Procedure: This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.<br>* This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of hospital stay following open liver resection |  | 6 months (or length of the study) |
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients

Study Overview
=================
Brief Summary
-----------------
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Detailed Description
-----------------
Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily. Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment. Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1. Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Official Title
-----------------
A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

Conditions
-----------------
Transplantation

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver transplant at least 12 months prior to enrollment. Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL. Exclusion Criteria: Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Tacrolimus<br>* Immunosuppression<br>* Other names: Advagraf, FK506E, MR4;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine clearance |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, HbA1c, Acute rejection episodes |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Liver Transplantation
Impact of Anti-Giardia and Antihelmintic Treatment on Infant Growth in Bangladesh

Study Overview
=================
Brief Summary
-----------------
This longitudinal study aimed to assess whether regular anti-Giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural Bangladeshi infants.

Detailed Description
-----------------
A randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of Dhaka, the capital of Bangladesh. Infants aged between 3 and 11 months were randomly assigned to either receiving anti-Giardia and antihelmintic treatment, or anti-Giardia treatment only, or a control group receiving placebos. Weight and supine length were recorded every 4 weeks. Every 12 weeks intestinal permeability (L/M ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin G and Giardia intestinalis specific IgM titre (GSIgM) and eggs of the three common geohelminths and Giardia intestinalis cysts were determined.

Official Title
-----------------
Effects of Anti-Giardia and Antihelmintic Treatment on Infant Nutritional and Biochemical Status and Intestinal Permeability in Rural Bangladesh

Conditions
-----------------
Giardiasis

Intervention / Treatment
-----------------
* Drug: Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)
* Drug: Anti-Giardia treatment only (secnidazole or albendazole)
* Drug: Control group (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants living in the study area

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 15 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Anti-Giardia and antihelmintic treatment (secnidazole or albendazole)<br>* Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) or a placebo was administered Every 12 weeks: Albendazole (syrup, 200mg)<br>Drug: Anti-Giardia treatment only (secnidazole or albendazole)<br>* Every 4 weeks: Secnidazole (70mg/ml suspension, 0.5ml per kg of body weight) Every 12 weeks: placebo of Albendazole<br>Drug: Control group (placebo)<br>* Every 4 weeks: Secnidazole placebo Every 12 weeks: Albendazole placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional status |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal permeability |  | 9 months |
Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of potential irritation (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Delicata (new fragrance of Dermacyd)

Official Title
-----------------
Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) of Dermacyd Delicata (New Fragrance)

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: lactoserum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin I,II, III and IV Integral skin test in the region; Exclusion Criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs Personal history of atopy; History of sensibilization or irritation for topic products; Active cutaneous disease; Use of new drugs or cosmetics during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lactoserum|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG) |  |  |
Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries

Study Overview
=================
Brief Summary
-----------------
Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.

Detailed Description
-----------------
Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group. In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping. In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table. Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Device: Bair Hugger
* Device: VitaHeat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing orthopaedic outpatient surgeries over 18 years old Exclusion Criteria: allergic to material of bair hugger

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Forced Air<br>Bair Hugger | Device: Bair Hugger<br> <br> |
| Active Comparator: Conductive Warming<br>VitaHeat | Device: VitaHeat<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature | Measured by temporal artery thermometer | Intra-Operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthopaedics, post-operative warming
Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
To study the effects of an 8-week combined inspiratory muscle training and exercise (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak) (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in children with Cystic Fibrosis (CF) (secondary outcomes).

Detailed Description
-----------------
The investigators hypothesized that the combined training program would significantly benefit most of the aforementioned variables (especially, primary outcomes).

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Other


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: boy/girl aged 6-17 years living in the Madrid area Exclusion Criteria: severe lung deterioration [forced expiratory volume (FEV1) <50% of expected] unstable clinical condition (hospitalization within the previous 3 months) Burkholderia cepacia infection any disorder (e.g. muscle-skeletal) impairing exercise.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Other: intervention<br>Exercise training | Other: Other<br>* inspiratory muscle training (IMT) + aerobic and strength training 8-week duration IMT twice a day (mostly at home) + 3 weekly sessions of inhospital resistance + aerobic training<br>* Other names: Exercise training;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiorespiratory fitness (VO2peak) | maximum oxygen uptake (VO2peak), which is the best indicator of aerobic fitness in humans and an independent mortality predictor in children with cystic fibrosis | this outcome will be assessed up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | children's QoL with the Spanish Version (1.0) of the Cystic Fibrosis Questionnaire-Revised (CFQ-R). | this outcome will be assessed up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, exercise, children, cardiorespiratory fitness, muscle strength, pulmonary function, quality of life
Near Infrared Transillumination of the Paranasal Sinuses

Study Overview
=================
Brief Summary
-----------------
This research project designed to diagnose sinusitis using a simple and low-cost optical tool. Healthy sinuses are typically filled with air, and show up as bright spots on the camera. Infected sinuses are filled with fluid and show up dark spots on the camera. Images of infected sinuses could be used to diagnose sinusitis, or to check if surgical treatments on the sinuses have been successful.

Detailed Description
-----------------
This device consists of a specialized flashlight that uses mostly non-visible light, and a small camera to record the light. The tool is the size and shape of spoon. The technique of shining light into the mouth, face, and sinuses is known as transillumination and has been used for nearly a century to aid in the diagnosis of sinusitis. The tool described in this study is a custom made device that uses light that is invisible to the eye.

Official Title
-----------------
Near Infrared Transillumination of the Paranasal Sinuses

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Device: Optical Measurement transillumination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female age of 15 years or older. Has diagnose of sinusitis, nasal allergies,nasal breathing problem, and tumors. Exclusion Criteria: Age less than 15 year sold

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Optical Measurement transillumination<br>Optical Measurement of sinus | Device: Optical Measurement transillumination<br>* Optical Measurement of sinus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Sinus |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sinusitis