linjc16/ctgov huggingface dataset:
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening

Study Overview
=================
Brief Summary
-----------------
We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for skin tightening immediately post laser and 3 months follow up.

Detailed Description
-----------------
To study the efficacy on facial skin tightening and wrinkle reduction after a single pass of double stacking pulses of long pulse 1064nm laser on the face in skin types III-V immediately post procedure and at 3 months. The study is a split-face placebo-controlled single-blind study.

Official Title
-----------------
Randomized-controlled Split-face Treatment of Facial Rhytids and Laxity in Asians Using Long-pulse 1064nm Laser

Conditions
-----------------
Skin Tightening, Skin Laxity, Wrinkle Reduction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 35-60 years Exclusion Criteria: History of skin malignancy Patients on immunosuppression Patients with other known internal malignancy Patients with malnutrition, vitamin or mineral insufficiency Patients on colchicine, penicillamine Patients with weight loss 7.5% of usual body weight within 3 months history of botulinum toxin injection within 6 months history of facial filler injection within 1year

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 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 |
| --- | --- |
| 1064nm laser, laxity<br>split-face single-blind randomized placebo-controlled trial evaluating improvement in facial skin laxity of the side of the face with placebo versus laser | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1064nm YAG laser, laxity, rhytides, asian
Trial of the Use of Doxycycline After Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.

Detailed Description
-----------------
Basic Science small animal model data indicates that matrix metalloproteinase (MMP) inhibition via doxycycline results in improved early rotator cuff repair biomechanics and histology. Rotator cuff repair failure and retear is a significant clinical problem. The effects of MMP inhibition on human rotator cuff tear repair healing and outcomes is unknown, but may potentially improve healing rates and outcomes. Our purpose is to evaluate the effects of early oral doxycycline on healing and outcomes following arthroscopic rotator cuff repair.

Official Title
-----------------
Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair

Conditions
-----------------
Rotator Cuff Injury

Intervention / Treatment
-----------------
* Drug: Doxycycline
* Drug: sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: repair of rotator cuff age 18 and above able to swallow capsules Exclusion Criteria: less than 18 unable to read or understand consent form unable to swallow capsules allergy to doxycycline

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: Doxycycline<br>oral doxycycline, 2 weeks, twice a day, | Drug: Doxycycline<br>* antibiotic used to treat infection<br>* Other names: Alodox;|
| Placebo Comparator: sugar pill<br>sugar pill, same size, shape, and color as comparator, twice a day for 2 weeks. | Drug: sugar pill<br>* placebo with no pharmacologic effect<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rotator cuff ultrasound of post-operative shoulder | An ultrasound of the post-operative rotator cuff to assess level of healing or defect present. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeons score | The survey is a standardized assessment of shoulder pain and function from the patient's perspective. | 6 weeks, 3mos, 6mos, 1yr and 2 yr. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rotator cuff repair, Doxycycline
Influence of Exercise on Anemia in MDS Patients

Study Overview
=================
Brief Summary
-----------------
That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function.

Official Title
-----------------
The Influence of Exercise on Anemia in MDS Patients

Conditions
-----------------
Feasibility Pilot Study

Intervention / Treatment
-----------------
* Other: Stationary Exercise cycling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Have a confirmed diagnosis of MDS, Have approval of the study medical monitor, be able to read English, be 21 years of age or older, give informed consent - Exclusion Criteria: Have physical limitations, be identified in the active or maintenance stage of exercise behavior -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care monitoring | |
| Other: Exercise using stationary cycling<br>Stationary cycling exercise program | Other: Stationary Exercise cycling<br>* Stationary exercise cycling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility data on the effect of a stationary cycling program | Aim to provide preliminary feasibility data on the effect of a stationary cycling program on anemia and acrocytosis, fatigue, aerobic capacity, strength, and hematopoietic stem and progenitor cell mitochondrial function in MDS patients. |  |
Epidemiology of Sepsis in Turkish ICUs.

Study Overview
=================
Brief Summary
-----------------
The prevalence and mortality of sepsis in Turkey is not know at large. Turkish Society of Intensive Care Medicine, Sepsis Study Group conducted a multi-centre,point prevalence survey to determine the prevalence, causative micro-organisms and outcome of sepsis in Turkish ICUs.

Official Title
-----------------
Epidemiology of Sepsis in Turkish ICUs :a National Point Prevalence Multi-centre Study.

Conditions
-----------------
Sepsis, Septic Shock, Severe Sepsis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:All patients present on or admitted to participating ICU on study day. Exclusion Criteria: Age<18 years Patients who underwent cardiovascular surgery.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infection only<br>The patients have only infection | Other: No intervention<br> <br> |
| Infection + SIRS<br>Patients have infection plus systemic inflammatory response syndrome (SIRS) | Other: No intervention<br> <br> |
| Severe sepsis<br>Septic patients with newly developed organ dysfunctions | Other: No intervention<br> <br> |
| Septic shock<br>Sepsis plus sepsis related hypotension | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sepsis | The prevalence of sepsis,Severe sepsis and septic shock on study day | Up to 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate of sepsis | Mortality rate of septic shock | Mortality at 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, ICU, Point prevalence
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptom Patients Who Completed the Protocol 25543 (25544)(P05777)

Study Overview
=================
Brief Summary
-----------------
This is an extension study to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.

Official Title
-----------------
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed the Protocol 25543 (NCT 00212836; P05817)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: asenapine
* Drug: olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continue to meet all demographic and procedural inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into this extension trial. Have demonstrated an acceptable degree of compliance and completed the 25543 trial, and would benefit from continued treatment according to the investigator. Exclusion Criteria: Have an uncontrolled, unstable clinically significant medical condition. Have been judged to be medically noncompliant in the management of their disease.

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>asenapine | Drug: asenapine<br>* 5-10 mg sublingually twice daily for 26 weeks<br>|
| Active Comparator: 2<br>olanzapine | Drug: olanzapine<br>* 5-20 mg by mouth once daily for 26 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale | Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst]. | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Measured by Quality of Life Scale (QLS) | Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best]. | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) |
Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours

Study Overview
=================
Brief Summary
-----------------
A study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. The study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function.

Detailed Description
-----------------
No patients will receive any medical or procedural treatments in this study, since these have been administered in a previous trial. The previous trial participants will be contacted and asked to attend a clinic or to have a telephone interview, where they will answer a questionnaire. They will be assessed clinically for visual fields, as well as undergoing an MRI scan of their head to assess tumour size (unless they have had a scan anyway in the previous 12 months), these tests would ordinarily form part of the routine outpatient workup for patients with pituitary tumours. There is no significant risk to the physical well-being of the patients with any of the methods to be used.

Official Title
-----------------
Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours

Conditions
-----------------
Pituitary Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were previously included in the initial pituitary PDT trial, in addition to those who were randomised as part of the RCT arm of the study. These patients have already participated in phase I/II trials. Of note, these patients all have pituitary tumours. Exclusion Criteria: Patients who were not included in the above mentioned trials. Patients included in the original trials who have subsequently died (of any cause).

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour size on MRI scan. |  | 6 months |
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more potent when compared to morphine. Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low dose patches are recommended for treatment of moderate pain for example osteoarthritis pain. It is known that well treated pain even preoperatively may prevent prolonged postsurgical pain. In the present study the effects of low dose buprenorphine on postoperative pain and recovery were assessed.

Official Title
-----------------
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty

Conditions
-----------------
Pain, Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Buprenorphine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no pregnancy/lactation, reliable contraception before menopause elective knee or hip arthroplasty surgery BMI (=body mass index) 18-35 kg/m2 obtained informed consent Exclusion Criteria: buprenorphine medication allergy to study drugs• ikä < 18 tai >75 years BMI <18 tai>35 kg/m2 weight below 50 kg Other contraindication for the study drug

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine<br>Buprenorphine 5 microg/h/7days patch | Drug: Buprenorphine<br>* Buprenorphine 5 microg/h/7 days<br>|
| Placebo Comparator: Placebo<br>Placebo patch | Drug: Placebo<br>* Placebo patch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Brief pain inventory | time from drug patch administration up to five weeks | 
| Prolonged pain after arthroplastic surgery | Brief pain inventory | from time from drug patch administration up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Arthroplasty, Buprenorphine
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

Study Overview
=================
Brief Summary
-----------------
The prospective clinical trial PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response.

Detailed Description
-----------------
The prospective clinical trial PDA-MAPS - Pancreatic ductal adenocarcinoma - Microbiome as Predictor of Subtypes aims to investigate the prognostic and predictive power of the orointestinal and tumoral microbiome in PDAC patients and associate findings with genetic, transcriptional and clinical data, in particular with treatment response. Patients with histologically confirmed PDA are enrolled at primary diagnosis and prior to oncological or surgical treatment. Rectal and buccal microbiome swabs as well as detailed clinical records are obtained from all patients. Following DNA extraction, both 16S rRNA and metagenomic sequencing will be performed using ONT sequencing platform. All data and clinical records are centrally stored, visualized and integrated via tranSMART and SEEK platforms.

Official Title
-----------------
Pancreatic Ductal Adenocarcinoma - Microbiome as Predictor of Subtypes

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Other: Oral and rectal swabs for microbiome sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with pancreatic mass suspicious of pancreatic ductal adenocarcinoma Exclusion Criteria: < 18 years patients that cannot give informed consent pregnant and breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Oral and rectal swabs for microbiome sequencing|Oral swabs and rectal swabs are collected non-invasively.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Progression free survival of patients measured in months | 12 months upon study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular subtypes of pancreatic cancer | Basal and classical subtype via RNAseq from tissue samples | within 3 months of histological diagnosis | 
| Response to chemotherapy | reponse, partial response and progress according to RECIST within 6 months of therapy initiation | up to 6 months after start of therapy |
Detection of Microplastics in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The exponential growth in plastic production/use translates into a parallel increase in environmental plastic waste, which is constantly degraded into microplastics and nanoplastics. Information on the effects of microplastics on human health is still preliminary. Cardiac surgery patients is a population high exposed to plastics. This observational study will obtain biological samples of cardiac surgery patients as a reference and vulnerable group of individuals highly exposed to microplastics and potentially more susceptible. The objective of this research is to be able to detect microplastics on blood and operation samples of cardiac surgery patients as well as their potential genotoxic and immunological damage.

Official Title
-----------------
Detection of Microplastics in Cardiac Surgery Patients: Its Metabolic Pathways and Toxic Effects

Conditions
-----------------
Cardiac Surgery, Microplastics, Nanoplastics, Cardiovascular Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Elective cardiac surgery Exclusion Criteria: Emergency surgery or limited-term surgery Previous cardiac surgery Previous severe liver disease Pregnant or planning to become pregnant Have a malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Detection of microplastics/nanoplastics in heart tissue and the blood of patients undergoing cardiac surgery | Other: Microplastics<br>* Detection of microplastics as a yes/no value<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of microplastics in human heart tissue and the blood | Detection of microplastics in human heart tissue and the blood undergoing cardiac surgery | perioperative: preoperative and pro-/postoperative blood and intraoperative heart tissue |