linjc16/ctgov huggingface dataset:
Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the effectiveness of a workplace yoga intervention in reducing the frequency of pain involving the head and neck area.

Official Title
-----------------
Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers: Quasi Experimental Study

Conditions
-----------------
Headache, Cervical Pain, Musculoskeletal Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Office workers Willing to participate an give consent Exclusion Criteria: Secondary headache Neck injury Trauma Critically ill Cognitive impairment Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga@Work<br> | Other: Yoga<br>* Relaxation yoga exercises, yoga breathing, yoga sound and imagery practices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of headache, neck and shoulder pain | Pain Journal assessed the number of days with headache, neck and shoulder pain | From baseline to 6-week post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of head, neck and shoulder pain | Visual Analogue Scale was used to assess the severity of pain with 0 to 10 scale; 0 describe no pain and 10 worst pain. | From baseline to 6-week post intervention | 
| Analgesics use | Daily pain journal was used to assess analgesics use | From baseline to 6-week post intervention |
OCTA Analysis In Children After Lensectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to quantify and compare the foveal avascular zone (FAZ), the parafoveal and foveal vessel density of superficial (SCP) and deep capillary plexus (DCP) and retinal thickness in deprivation amblyopic eyes, fellow non-amblyopic eyes, and age-matched normal eyes, using optical coherence tomography angiography (OCTA). The FAZ, parafoveal and foveal SCP and DCP, and retinal thickness were measured in normal controls and at least 3 months postoperatively in children with unilateral cataract and compared between groups after adjusting for axial length and spherical equivalents.

Official Title
-----------------
Optical Coherence Tomography Angiography Analysis After Childhood Lensectomy

Conditions
-----------------
Deprivation Amblyopia

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children after cataract surgery and healthy volunteers Exclusion Criteria: presence of corneal opacity preventing detailed imaging nystagmus retinal disease, persistent fetal vasculature intraocular inflammation, glaucoma vitreoretinal surgery premature birth neurologic disease systemic disease that could alter microvasculature (including diabetes, hypertension, cardiovascular disease and renal disease)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eyes post-lensectomy<br>Eyes of children after cataract surgery | Device: Optical Coherence Tomography Angiography<br>* A device testing the vascular density in the retina<br>|
| No Intervention: Healthy Eyes<br>Eyes of healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foveal retinal thickness | Foveal retinal thickness in microns | up to 36 months | 
| Area of foveal avascular zone | Area of foveal avascular zone in square microns | up to 36 months |
ROTEM in Patients With Placenta Previa

Study Overview
=================
Brief Summary
-----------------
The rotational thromboelastogram (ROTEM) test can be performed on patients with placenta previa/accreta/increta/percreta who have a high likelihood of massive bleeding, and the predictors can be identified by comparing the patients who actually show massive bleeding with those who do not. Applying these predictive factors to pregnant women undergoing cesarean section after diagnosis of placenta previa/accreta/increta/percreta, it will be advantageous for the perioperative management because it is possible to select pregnant women with a factor of massive bleeding.

Official Title
-----------------
Rotational Thromboelastometry During Cesarean Section as a Predictive Evaluation for Progression of Intraoperative Massive Hemorrhage in Parturients With a Potential Risk of Perioperative Hemorrhage: a Prospective Observational Study

Conditions
-----------------
Placenta Previa, Placenta Accreta, Placenta Increta, Placenta Percreta

Intervention / Treatment
-----------------
* Diagnostic Test: ROTEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean section under spinal anesthesia Placenta previa Placenta accreta Placenta increta Placenta percreta Exclusion Criteria: Coagulopathy Medication with antiplatelets or anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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 |
| --- | --- |
| patients with risks of intraoperative massive bleeding<br>patients with risks of intraoperative massive bleeding | Diagnostic Test: ROTEM<br>* ROTEM including INTEM, EXTEM, APTEM, and FIBTEM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Volume of intraoperative blood loss | 1 min after finishing an operation | 
| Change of INTEM | intrinsic pathway component | 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation | 
| Change of EXTEM | extrinsic pathway component | 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation | 
| Change of APTEM | fibrinolytic component | 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation | 
| Change of FIBTEM | the level of fibrinogen | 10 min after spinal anesthesia, 5 min after baby delivery, 1 min after finishing operation |
Impact of COVID-19 on Psychological Status in Case of IVF Interrupted or Postponed

Study Overview
=================
Brief Summary
-----------------
Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments. This study times to understand the changes in the psychological status of infertile patients who had in vitro fertilization (IVF) treatment interrupted or postponed because of the COVID-19 pandemic.

Official Title
-----------------
Impact of COVID-19 Pandemic on the Psychological Status of Infertile Patients Who Had in Vitro Fertilization Treatment Interrupted or Postponed

Conditions
-----------------
Infertility, Female, ART, IVF, COVID-19

Intervention / Treatment
-----------------
* Behavioral: Generalized Anxiety Disorder-7 (GAD-7)
* Behavioral: Patient Health Questionnaire-9 (PHQ-9)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with IVF treatment interrupted or delayed during COVID-19 pandemic patients with signed informed consent patients with more than 18 years Exclusion Criteria: patients with already diagnosed psychiatric disorders

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 |
| --- | --- |
| Infertile women who had the IVF treatment postponed or delayed<br> | Behavioral: Generalized Anxiety Disorder-7 (GAD-7)<br>* The GAD-7 is useful in primary care and mental health settings as a screening tool and symptom severity measure for the four most common anxiety disorders.<br>Behavioral: Patient Health Questionnaire-9 (PHQ-9)<br>* The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of anxiety |  | 1-4 weeks after communication of interrupted or delayed IVF | 
| Severity of depression |  | 1-4 weeks after communication of interrupted or delayed IVF |
The Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find a correlation between function of cytomegalovirus -specific T cells and the probability for intrauterine transmission.

Detailed Description
-----------------
Fetal infection with CMV is the most common cause of intrauterine infection. Only 40% of pregnant women with primary CMV transmit the virus to their fetus. Many of these women are referred to amniocentesis and many elect to terminate pregnancy without knowledge about fetal infection or damage. Currently it is assumed that transmission is dictated by variety of factors including maternal and fetal immune system. Efforts to find correlation between maternal immune system and fetal infection which can be used as a diagnostic marker were unsuccessful. Our hypothesis is that there is a correlation between cellular immune response of the mother to CMV infection and viral transmission to the fetus. Pregnant women with primary CMV infection (40% of whom are expected to be transmitters)and with pre-conception immunity will participate in this study. Blood from these women will be incubated with CMV peptides and T cell activation will be measured by the secretion of various cytokines.

Official Title
-----------------
The Relation Between the Maternal Cellular Immune System and Cytomegalovirus Intrauterine Infection

Conditions
-----------------
Pregnant Women, Cytomegalovirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women CMV IgG sero-conversion or the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies. Exclusion Criteria: Underlying immune deficiencies Other pregnancy complications

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pre-conception immunity<br>pre-conception immunity- pregnant women with CMV seropositive | |
| primary CMV infection<br>primary CMV infection- pregnant women with primary CMV infection (defined as CMV IgG sero-conversion, the presence of low avidity IgG antibodies or the presence of IgM with no previous IgG antibodies). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal-Fetal transmission of CMV |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cytomegalovirus Infections, Pregnancy, T-Lymphocytes, Transmission
Infrared Photomodulation Therapy for Seasonal Affective Disorder

Study Overview
=================
Brief Summary
-----------------
During winter months in northern latitudes use of Joovv device on self-reported non-clinical mental health (aka mood), sleep and energy levels. Participants will also submit Withings and Oura activity and sleep data.

Official Title
-----------------
Joovv for Seasonal Affective Disorder

Conditions
-----------------
Seasonal Affective Disorder

Intervention / Treatment
-----------------
* Device: Joovv Mini


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of mental health issues including clinical depression US based reasonably active individuals (self report run/gym 3x per week or more) Exclusion Criteria: average daily high temperature in zipcode above 60 degrees through end of March

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joovv Pilot Experimenta Arm<br>Individuals will receive 90 day access to the Joovv infrared mini light device. | Device: Joovv Mini<br>* the smallest photomodulation device in the Joovv infrared light product line.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change self report mood as assessed by Warwick Edinburgh sleep scale | non clinical measures of mood controlled for environmental temperature and daylight | Baseline to 90 day | 
| Change in Sleep Duration and Sleep Quality as measured by consumer connected health device | Measures of sleep and sleep quality as by a Withings or Oura Ring connected health device | Baseline to 90 day | 
| Change in activity levels as measured by consumer connected health devices | Measures of activity levels as by WIthings our Oura connected health devices | Baseline to 90 day |
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

Study Overview
=================
Brief Summary
-----------------
This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.

Official Title
-----------------
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males able to provide consent and complete a survey in English Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol) Exclusion Criteria: Previous participation in this study
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult PWH<br> | Other: No treatment given<br>* Subject will only fill out a questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of acute (bleed-related) pain (percentage) |  | At the first visit (only one study visit) | 
| Prevalence of chronic (arthritic) pain (percentage) |  | At the first visit (only one study visit) |
Vicryl Plus and Monocryl Plus in Breast Surgery

Study Overview
=================
Brief Summary
-----------------
This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.

Official Title
-----------------
Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery

Conditions
-----------------
Breast Cancer Surgery

Intervention / Treatment
-----------------
* Device: Vicryl plus and Monocryl plus
* Device: wound closure with Vicryl and Monocryl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over 18 years old who attend the Cardiff and Vale NHS Trust for elective breast cancer surgery Exclusion Criteria: patients unable to give consent or comply with follow up patients undergoing surgery for benign disease patients with inflammatory cancers or skin ulceration patients having neo-adjuvant chemotherapy or radiotherapy patients with known allergy to triclosan antiseptic patients with immune deficiency diseases

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vicryl plus/Monocryl plus<br>Vicryl plus and Monocryl plus is the active comparator arm. These are the active sutures, coated with triclosan antiseptic, being used in the closure of skin and subcutaneous tissues after breast cancer surgery. | Device: Vicryl plus and Monocryl plus<br>* closure of skin and subcutaneous tissues<br>|
| Placebo Comparator: vicryl/monocryl<br>Plain Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control. | Device: wound closure with Vicryl and Monocryl<br>* wound closure skin and subcutaneous tissues<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of surgical site infection |  | 6-7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimation time in hospital and return to work numbers of haematomas and seromas |  | 6-9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical site infection, wound complications, suture, antiseptic, wound closure
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.

Official Title
-----------------
An Open Label Extension Study (to Study DK143WS) Evaluating the Safety and Long-term Safety Follow-up of Biatain Ibu in Painful Chronic Venous Leg Ulcers

Conditions
-----------------
Leg Ulcers

Intervention / Treatment
-----------------
* Device: Biatain Ibu
* Device: Local best practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has participated in study DK143WS The patient is able to understand the treatment and is willing to comply with the treat-ment regimen. The patient is willing and able to give written informed consent Exclusion Criteria: Pregnant or lactating women Concomitant participation in other studies

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> | Device: Biatain Ibu<br>* Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.<br>* Other names: Coloplast Biatain Ibu;|
| Active Comparator: 2<br> | Device: Local best practice<br>* N/A - since intervention is local best practice<br>|
| No Intervention: No treatment<br>No treatment as wound was healed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Week 1, 6, 20, 33, 46 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical occurrences |  | Week 1, 6, 20, 33, 46 | 
| Ulcer area reduction |  | Week 1, 6, 20, 33, 46 | 
| Ulcer status |  | Week 1, 6, 20, 33, 46 | 
| Skin condition at healed ulcer location |  | Week 1, 6, 20, 33, 46 |