linjc16/ctgov huggingface dataset:
A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients

Study Overview
=================
Brief Summary
-----------------
Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but conflicting. Previous clinical studies mostly used experimental or non-standardized surgical stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized, clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.

Conditions
-----------------
Cancer Patients

Intervention / Treatment
-----------------
* Procedure: The local anesthetic injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20-80 cancer patient patient whom receiving opioid treatment, any acute or chronic pain condition amenable to a diagnostic/therapeutic nerve block or neuromodulation,and a regular analgesic regimen. Exclusion Criteria: patient who has any change in opioid or other analgesic medications less than 14 days prior to the scheduled procedure an inability to understand English or adequately respond to the relevant questions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The local anesthetic injection group<br> | Procedure: The local anesthetic injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-injection pain intensity | The local anesthetic injection before main procedure was performed by one pain physician using a 25-gauge needle and 1 ml of 1% lidocaine to raise a small skin wheel. Before and immediately following the injection, patients were asked to rate injection-specific pain and unpleasantness intensity on a 0 to 10 numerical rating scale (NRS). | 1 min after lidocaine anesthetic injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid induced hyperalgesia
Sun Protection Factor (SPF) Assay

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Official Title
-----------------
Sun Protection Factor (SPF) Assay

Conditions
-----------------
Sunscreen Agents

Intervention / Treatment
-----------------
* Drug: BAY 987517
* Drug: SPF 15 Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of an age of 18 to 70 years inclusive; Fitzpatrick Skin Type I, II and/or III for SPF testing; Good health as determined from the CRO Subject History Form (SHF); Signed and dated Informed Consent Form; Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form; An unambiguous minimal erythema dose (MED).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were considered for SPF testing. | Drug: BAY 987517<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>Drug: SPF 15 Control<br>* Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of water resistant SPF in accordance to 21 CFR (Code of Federal Regulations) 207.327 |  | 16-24 h post exposure |
Early Screening and Identification for Panvascular Diseases

Study Overview
=================
Brief Summary
-----------------
Identify the pathogenic factors involved in the occurrence and development of panvascular disease and its pathogenesis.

Detailed Description
-----------------
Identify the pathogenic factors involved in the occurrence and development of panvascular disease and its pathogenesis by a multi-omics study.

Official Title
-----------------
Early Screening and Identification for Panvascular Diseases

Conditions
-----------------
Panvascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients with panvascular diseases; 2. Patients or guardians who agreed to join the study; 3. Patients who can complete the relevant examinations involved in this study; Exclusion Criteria: patients with coagulation dysfunction.
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 |
| --- | --- |
| Panvascular disease group<br>patients with panvascular diseases | |
| Healthy controls<br>Healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any new stroke events | Incidence of any new ischemic or hemorrhagic stroke | Up to 48 months |
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures

Study Overview
=================
Brief Summary
-----------------
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given. The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: GnRH agonist trigger
* Drug: hCG trigger


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF patients with at least 4 consecutive failures. On trigger day, no more than 10 follicles of 12 mm and up Exclusion Criteria: History of moderate or severe OHSS.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 44 Years

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

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: hCG trigger<br>Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. | Drug: hCG trigger<br> <br> * Other names: Luteal support with daily progesterone gel = Crinone 8%;|
| Experimental: GnRH agonist trigger<br>ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. | Drug: GnRH agonist trigger<br> <br> * Other names: Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Heart Activity 1 Month After Oocyte Retrieval | Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval | 1 month after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Comfort During the Luteal Phase |  | During 2 weeks from day of oocyte retrieval |
Discomfort Score Identifies Painfulness During Unsedated Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However, unsedated colonoscopy was thought to be an option for some but not for all. If we could able to identify which patients at high risk for painful colonoscopy in preoperational stage, targeted administration of sedatives or special techniques to these patients would be an attractive option.

Detailed Description
-----------------
Here we prospectively collected the data during colonoscopy and investigated the possible risk factors associated with painful colonoscopy by using a step-wise multivariate regression model. Furthermore we developed a novel point score to predict whether the patients at high risk for painful colonoscopy and targeted offer an appropriate method of colonoscopy or with the aid of special techniques to help the completion of procedure.

Official Title
-----------------
A New Intubation Discomfort Score Identified Patients' Painfulness During Unsesated Colonoscopy

Conditions
-----------------
Risk Factors Associated With Painful Colonoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent unsedated colonoscopy Exclusion Criteria: (1) no bowel preparation or colon cleansing by enema only; (2) no need to reach cecum; (3) prior finding of severe colon stenosis or obstructing tumor; (4) history of colectomy; (5) unstable hemodynamics; (6) pregnant; (7) unable to give informed consent.

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 |
| --- | --- |
| Training Cohort<br>In the training cohort, we evaluated the impact of patient-related factors on the pain during the colonoscopy. In univariatelogistic regression analysis, All factors associated with the pain during colonoscopy (p<0.1) were included in multivariate analysis. | |
| Validation group<br>The validation cohort was used to verify the intubation discomfort score. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The anxiety status | Hospital Anxiety and Depression Scale (HAD) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain | Abdominal pain evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain) | 1 year |
Liraglutide in Newly Onset Type 1 Diabetes.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.

Conditions
-----------------
Diabetes Mellitus, Type 1

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0 Age 18 - 40 years - both inclusive Postprandial C-peptide > 0.2 nmol/l following sustacal meal test Able to understand the written patient information and to give informed consent Exclusion Criteria: Type 2 diabetes Body mass index <20 kg/m2 Pregnancy or unwillingness to use safe contraceptives Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0 Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at visit 0

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liraglutide<br>1.8 mg | Drug: Liraglutide<br> <br> * Other names: Victoza;|
| Placebo Comparator: Saline<br> | Drug: Placebo<br>* Saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-cell function | To investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucagon | To investigate the effect of liraglutide as compared to placebo for 52 weeks as an adjunctive therapy to insulin treatment on change in Postprandial glucagon levels following sustacal meal test. | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
c-peptide, insulin, hypoglycemia, Newly onset, Diabetes, Type 1, Beta cell, Autoimmune, Glucagon, Meal test
Continuous Tremor Assessment During Daily Activities

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone.

Official Title
-----------------
ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Device: Kinesia HomeView


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with essential tremor Currently taking medication to control tremor Exclusion Criteria: Cognitive limitations that prevent comprehension or execution of study protocol
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tremor reports provided<br>Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician | Device: Kinesia HomeView<br> <br> |
| Active Comparator: Tremor reports not provided<br>Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician | Device: Kinesia HomeView<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Change Scale score | Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment | End of Month 1, End of Month 2, End of Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression-Severity Scale Score | Utilized to measure overall tremor severity | Enrollment, End of Month 1, End of Month 2, End of Month 3 | 
| Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale | Utilized to measure overall tremor severity | Enrollment, End of Month 1, End of Month 2, End of Month 3 | 
| Quality of Life in Essential Tremor Questionnaire | Utilized to measure the impact tremor has on overall quality of life | Enrollment, End of Month 1, End of Month 2, End of Month 3 |
The Use of Ligasure (r) for Hydrocelectomy Surgery

Study Overview
=================
Brief Summary
-----------------
Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy.

Detailed Description
-----------------
Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.

Official Title
-----------------
The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery

Conditions
-----------------
Hydrocele

Intervention / Treatment
-----------------
* Device: Ligasure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 81 males Diagnosed with unilateral hydrocele Exclusion Criteria: Bilateral hydrocele infected hydrocele hydrocele secondary to tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 81 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients suffering from hydrocele, underwent treatment using Ligasure device. | Device: Ligasure<br>* Using ligasure to treat hydrocele<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resolution of hydrocele | The patients will undergo full urological physical exam to screen for signs of hydrocele. The testes size and manual palpation will be included in the assessment. | Three weeks after the surgery |
Pregnancy and Fibrinogen Disorders

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

Detailed Description
-----------------
Women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. Data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. In this observational study will be include adult women with pas obstetrical history. A general questionnaire on demographics and clinical data will be filled out by the patient's physician. A detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data.

Official Title
-----------------
Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

Conditions
-----------------
Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital, Dysfibrinogenemia, Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) At lest one past pregnancy Adult Exclusion Criteria: No past pregnancy Not confirmed fibrinogen disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Prevalence of normal issue pregnancy | All pregnancy not resulting in miscarriage, stillbirth or abortion | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pregnancy without complications | All pregnancy not resulting in intrauterine growth retardation, preterm labor, pregnancy-induced hypertension, gestational diabetes, preeclampsia, abruption placenta, anamniota, vaginal bleeding requiring medical intervention | At inclusion | 
| Modalities of delivery | Vaginal versus caesarean cut | At inclusion | 
| Modalities of delivery | Instrumental delivery vs none | At inclusion | 
| Post-partum complications | Post-partum haemorrhage and/or thrombotic event within 3 months after the delivery | At inclusion | 
| Fibrinogen variations | Fibrinogen levels throughout the pregnancy | At inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, obstetric, miscarriage, haemorrhage, fibrinogen