linjc16/ctgov huggingface dataset:
Postoperative Gastrointestinal Dysfunction After Cardiac Surgery - Occurrence and Search for Biomarkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the frequency and grade of gastrointestinal dysfunction in patients after thoracic cardiovascular surgery, and to search for biomarkers of gastrointestinal dysfunction. All adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. The first three postoperative days the function of the gastrointestinal tract is scored according to a rating scale (grade 0-4), along with other clinical parameters. Plasma blood samples are collected from each patient preoperatively and the first three postoperative days. The plasma samples are stored in a biobank for later determination of plasma proteins. In the analysis, the patients are divided according to the gastrointestinal rating scale and the plasma protein expression, gastrointestinal complications and all-cause mortality are compared between the groups.

Official Title
-----------------
Gastrointestinal Dysfunktion Efter hjärtkirurgi - förekomst Samt sökande Efter Nya biomarkörer

Conditions
-----------------
Thoracic Surgical Procedures, Gastrointestinal Tract, Cardiopulmonary Bypass, Biomarkers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepted for an elective thoracic cardiovascular surgical procedure requiring cardiopulmonary bypass >18 years old Exclusion Criteria: Present and severe symptoms from the gastrointestinal tract Previous major/extensive abdominal surgery Presence of astomy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute gastrointestinal injury score | Acute gastrointestinal injury score from Reintam Blaser et al (2012) modified for postoperative patients. | Postoperative days 1-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma protein expression |  | Postoperative days 1-3 | 
| Gastrointestinal complications |  | 30 days postoperative | 
| All cause mortality |  | 30 days postoperative |
Flap Sliding to Treat Post-LASIK Striae

Study Overview
=================
Brief Summary
-----------------
This study assessed the efficacy and safety of a simple, noninvasive flap sliding technique for managing flap striae following laser in situ keratomileusis (LASIK). Included eyes underwent flap sliding 1-2 days after surgery, which involved using a cellulose sponge to gently slide the flap perpendicular to the striae. The flap was not lifted during the procedure. Thirteen of 14 eyes were successfully managed with flap sliding. Uncorrected distance visual acuity (DVA) improved in all patients 1 day after flap sliding, with 11 eyes having a corrected DVA of 20/25 or better. Complications following flap sliding occurred in 2 eyes. We believe that our study makes a significant contribution to the literature because it demonstrates a simple, noninvasive technique for managing flap striae that develop during early post-LASIK epithelial healing.

Official Title
-----------------
Flap Sliding Technique for Managing Flap Striae Following Laser in Situ Keratomileusis

Conditions
-----------------
LASIK Complication Management

Intervention / Treatment
-----------------
* Procedure: Flap sliding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Significant flap striae in the visual zone within 2 days following microkeratome LASIK. Exclusion Criteria: striae 2 days after surgery visually insignificant striae

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Flap Sliding<br>noninvasive flap sliding technique for managing flap striae following laser in situ keratomileusis (LASIK). | Procedure: Flap sliding<br>* All subjects underwent the flap sliding technique, which was performed at the Alforsan Eye Centre in Assiut, Egypt. Prior to surgery, all subjects underwent corneal imaging with anterior segment optical coherence tomography to confirm the presence of striae. All surgical procedures were performed by the same surgeon 1 or 2 days following LASIK. Subjects were administered a topical anesthetic. Striae location and orientation were then determined after drying the corneal surface with a cellulose sponge. The sponge was used to push the LASIK flap over the stromal bed in a direction that was perpendicular to the striae. The flap was pushed from the proximal side of the striae toward the flap edge. The ultimate goal was to move striae and put the flap into its proper place. Following surgery, OCT imaging was repeated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UDVA | Uncorrected distance visual acuity | 1 day |
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Study Overview
=================
Brief Summary
-----------------
This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.

Official Title
-----------------
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Conditions
-----------------
Port-Wine Stain

Intervention / Treatment
-----------------
* Drug: Hemoporfin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range: 14 to 65 years-old； Clinically diagnosed of Port-wine Stain; Patients receiving hemoporfin based upon the clinical judgment of the investigator; Written informed consent signed and agreed to receive periodic follow-up Exclusion Criteria: Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution; Scar diathesis; Pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application; Be judged not suitable to participate the study by the investigators

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 65 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: Hemoporfin<br> | Drug: Hemoporfin<br>* Hemoporfin mediated photodynamic therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | 96 weeks after hemoporfin application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction rating of the overall treatment by subjects |  | 8, 24 and 96 weeks after hemoporfin application | 
| Satisfaction rating of the overall treatment by investigators |  | 8 weeks after hemoporfin application | 
| Response rate | proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%) | 8 weeks after hemoporfin application |
Uroflowmetry Results and Vitamin D Levels

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluate the relationship between LUTS and vitamin D with uroflowmetry parameters in female patients. They found no relation between vitamin D levels and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with urologic problems. The investigators believe that there is a need for studies emphasizing serum Ca levels in addition to vitamin D levels in patients with LUTS.

Detailed Description
-----------------
This retrospective cohort study included 186 female patients who admitted to LUTS. Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate (Qav), and voided volume (V) were recorded. Patients were divided into two groups according to age (18-50 and ≥51) and vitamin D levels (<20 and ≥20). Laboratory parameters, uroflowmetry results, were compared between groups. The study was approved by the local ethics committee (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the Helsinki Declaration and Good Clinical Practices Guidelines.

Official Title
-----------------
The Relationship Between Vitamin D Level and Lower Urinary Tract Symptoms in Women

Conditions
-----------------
Lower Urinary Tract Symptoms, Vitamin D Deficiency, Calcium Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of low urinary tract symptom Exclusion Criteria: Urinary tract infection, Diabetes mellitus, Neurological disorder, Pregnancy Stone disease Other urinary system disorders.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflowmetry Results | There was no significant relationship between age, creatinine, Qmax, Qav, V and vitamin D level (P>0.05). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D Levels | The mean D vitamin level was 21.19ng/ml. D vitamin was <20 ng/ml in %55.9 patients. There was no difference in the levels according to the age of all patients. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower Urinary Tract Symptoms, Vitamin D Deficiency, Calcium Deficiency
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

Study Overview
=================
Brief Summary
-----------------
This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

Detailed Description
-----------------
Phase one : A double blind randomized placebo controlled trial of rosiglitazone 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year. after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis Phase II extension open label trial All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.

Official Title
-----------------
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

Conditions
-----------------
Non Alcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven NASH with steatosis >= 20% Increased serum ALT Exclusion Criteria: bland steatosis daily alcohol > 20/30 g (women/men) any other cause of liver disease secondary NASH including drug-induced steatohepatitis treatment with insulin or glitazones cardiac insufficiency Hb < 10 g/dl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in steatosis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
steatosis,, fibrosis,, diabetes,, obesity
Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation <= 12%. The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.

Official Title
-----------------
Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery

Conditions
-----------------
Surgery, Colorectal

Intervention / Treatment
-----------------
* Drug: balanced 6% hydroxyethylstarch 130/0.4
* Drug: balanced crystalloid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective colorectal surgery minimum age 18 years informed consent Exclusion Criteria: patients with severe cardiomyopathy or severe heart failure history of coagulation disorders intracranial hemorrhage patients with severe cardiovascular or respiratory disorders renal insufficiency severe liver diseases

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>A balanced hydroxyethyl starch 130/0.4 will be used | Drug: balanced 6% hydroxyethylstarch 130/0.4<br>* Fluid administration and optimization based on cardiac output findings during surgery.<br>|
| Active Comparator: Group 2<br>A balanced crystalloid will be used | Drug: balanced crystalloid<br>* Fluid administration and optimization based on cardiac output findings during surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of administered fluids | Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgery related complications |  | day 28 and 90 postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colloid, goal-directed fluid optimization, hemodynamic optimization, crystalloid
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)

Study Overview
=================
Brief Summary
-----------------
This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study.

Official Title
-----------------
A Prospective, Multicentric, Open Label, Bio-Interventional, Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For Treatment of Facial Wrinkles (Nasolabial Folds)

Conditions
-----------------
Facial Wrinkles (Nasolabial Folds)

Intervention / Treatment
-----------------
* Other: Autologous Human Platelet Lysate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects (male and female), aged 18 to 40 years (both inclusive). Subjects willing to refrain from any other treatment for Nasolabial Folds. Subjects who are willing to give informed consent and adhere to the study protocol. Exclusion Criteria: Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc Subjects with history of Connective tissue disease Subjects with autoimmune diseases Subjects unwilling to or unable to comply with the study protocol. Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Other: Study Group<br>All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region | Other: Autologous Human Platelet Lysate<br>* All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkle Severity Rating Scale as per ATLAS photographic grading at rest & on full smile |  | Day 0, End of Study - 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement Scale |  | Day 0, End of study - Month 3 |
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
To determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.

Official Title
-----------------
Natural Orifice Translumenal Endoscopic Surgery: Laparoscopic-Assisted Transvaginal Cholecystectomy

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Procedure: Laparoscopic-assisted transvaginal cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females who are postmenopausal or who no longer wish to bear children Females >25 years old and <65 years old Diagnosis of biliary disease requiring cholecystectomy American Society of Anesthesiology (ASA) Class I or II Females who are able to understand and willing to sign an informed consent document Exclusion Criteria: Pregnancy BMI >= 30 Patients who are still interested in childbearing Patients taking immunosuppressive medications or who are immunocompromised Patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid) Patients with suspicion of gallbladder cancer Patients with history of previous open abdominal surgery Patients with untreated common bile duct stones

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 64 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic-assisted transvaginal cholecystectomy|Trans-vaginal Cholecystectomy with Laparoscopic Assistance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and efficacy of the procedure |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain |  | one year | 
| Time to return to work |  | one year | 
| Time to return to daily activities |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female, Cholelithiasis, Natural Orifice Surgery, Laparoscopic- Assisted, Transvaginal