linjc16/ctgov huggingface dataset:
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

Study Overview
=================
Brief Summary
-----------------
Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in the plasma cohort compared to watchful waiting in the control cohort. Primary endpoint after 3-6 months: Pathological remission. Secondary endpoint: HPV remission.

Official Title
-----------------
Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Procedure: CAP treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for CAP: Histologically confirmed CIN I / II Reliable assessment of the radius of the portio and marginal borders of the lesions Written consent for treatment with low temperature plasma after reconnaissance Inclusion Criteria for Control-Group: Histologically confirmed CIN I / II Reliable assessment of the radius of the portio and marginal borders of the lesions Patients who want a waiting procedure and a control examination after 3-6 months Exclusion Criteria: Histologically confirmed CIN III Not fully visible transformation zone An indication of invasive disease Expected lack of compliance of the patient or incapacity of the patient to understand the meaning and purpose of the clinical trial Severe cardio-vascular disease Lack of patient consent

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAP cohort<br>Cold Atmospheric plasma intervention | Procedure: CAP treatment<br>* Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.<br>|
| No Intervention: Control cohort<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological remission of cervical intraepithelial neoplasia | Biopsy, Histopathological examination | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human papilloma virus remission rate | Smear testing | 3-6 months | 
| Comfort / Dyscomfort during intervention | Freiburger Index of patient comfort | Immediately, 2 week, 3-6 months |
Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.

Official Title
-----------------
Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase

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

Intervention / Treatment
-----------------
* Drug: micronized progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 36 years Body mass index between 18 and 29 Presence of both ovaries Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L Patients can enter the study only once. Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study) Normal HSG (maximum 3 months prior starting the stimulation). Donor sperm can be included Exclusion Criteria: Polycystic ovarian syndrome (Rotterdam criteria) Endometriosis(≥AFS III)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

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

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 |
| --- | --- |
| Experimental: micronized progesterone<br> | Drug: micronized progesterone<br>* 600mg in 3 separate doses per day<br>* Other names: utrogestan;|
| No Intervention: no utrogestan<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate,clinical pregnancy rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IUI, clomiphene citrate, utrogestan
The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids

Study Overview
=================
Brief Summary
-----------------
The metabolic syndrome is associated with hyperdynamic circulation and sympathetic activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free fatty acids are responsible for this association. The investigators hypothesize that in patients with obesity and the metabolic syndrome, an increased intracellular concentration of long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and sympathetic activation. The investigators aimed to assess this effect of free fatty acids on the adenosine system in healthy volunteers.

Official Title
-----------------
The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids

Conditions
-----------------
Obesity, Metabolic Syndrome X

Intervention / Treatment
-----------------
* Drug: Intravenous infusion of Intralipid/heparin
* Drug: Intravenous infusion of Glycerol/heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Pregnancy Asthma Use of medication Cardiovascular/pulmonary disease and diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous infusion of Intralipid/heparin|nan|
|Drug: Intravenous infusion of Glycerol/heparin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forearm blood flow |  |  | 
| Vasoactive effect of caffeine |  |  | 
| Sympathetic activity (noradrenaline spillover, spectral analysis) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
free fatty acids, vasodilation, sympathetic activity
A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency

Study Overview
=================
Brief Summary
-----------------
To determine: The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency (PAD or SAD). The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency. The half-life of Vigam® Liquid after 4 months of treatment. The subclass and total gammaglobulin concentrations after each infusion of Vigam® Liquid.

Official Title
-----------------
A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.

Conditions
-----------------
Primary or Secondary Antibody Deficiency

Intervention / Treatment
-----------------
* Biological: Vigam® (Human Normal Immunoglobulin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18-80 years) with PAD or SAD With a low serum IgG (<6 g/l) and a history of recurrent infections Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement therapy Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than twice upper limit of normal prior to entry into the trial Exclusion Criteria: -

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vigam® Liquid<br> | Biological: Vigam® (Human Normal Immunoglobulin)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG half-life |  | Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose |
Management of the Sprained Ankle by Help of NSAID-Plaster

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the management of the sprained ankle by help of NSAID-plaster. A questionnaire. The effect of RICE and RICE + NSAID-plaster in the treatment of the sprained ankle, compared by pain-score.

Official Title
-----------------
Optimation of Treatment of the Sprained Ankle by Help of NSAID-Plaster (Flector). A Questionnaire.

Conditions
-----------------
The Sprained Ankle

Intervention / Treatment
-----------------
* Procedure: flector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A sprained ankle, less than 24 hours old, understanding Danish, 18 years or older Exclusion Criteria: Fracture of the ankle, wound around the ankle, allergy of NSAID- pregnancy, daily use of NSAID, GI-bleeding

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: flector|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-score |  |  |
Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System

Study Overview
=================
Brief Summary
-----------------
Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.

Official Title
-----------------
Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System.

Conditions
-----------------
Knee Prosthetic Surgery, Robotic Assistance

Intervention / Treatment
-----------------
* Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Knee osteoarthritis requiring PS Knee Prosthesis Exclusion Criteria: Not meeting Inclusion Criteria Requiring Constrained Prosthesis Metal Allergy Neurological disorders. Cognitive impairment Not giving consent.

Ages Eligible for Study
-----------------
Minimum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Non-Robotic Assisted Knee Prosthetic Surgery<br> | |
| Active Comparator: ROSA® System Robotic Assisted Knee Prosthetic Surgery<br> | Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery<br>* Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery | Correct lower limb mechanical alignment | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility | Range of Motion in degrees | 1 year after surgery | 
| Technique reproducibility between surgeons | Reproducing mechanical alignment in degrees | Intraoperative | 
| Patient satisfaction | Patient satisfaction in a numeric scale from 1 to 10 | 1 year after surgery | 
| Time to Recovery | Time to feel patients themselves better than presurgery in months | 1 year after surgery | 
| Time to home discharge | Hospital stay in days between surgery and discharging home | 1 month | 
| Pain Control | Pain measurement with Visual Analogue Scale (VAS) | 1 year after surgery | 
| Technique Timing at Operating Room (OR) | Timing in minutes to measure reproducibility between surgeons | Intraoperative | 
| Implant Stability | Presence of varus / valgus instability | 1 year after surgery | 
| Complications | Major /Minor Complications | 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee prosthetic surgery robotic assistance
AVAdeno Study: An Observational Study of First-Line Avastin (Bevacizumab) in Patients With Adenocarcinoma of the Lung

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate the efficacy and safety of first-line Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups (<60, 60-69, 70-79, >80 years) in patients with inoperable advanced, metastatic or recurrent adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the start of first-line therapy.

Official Title
-----------------
AVAdeno: Non-interventional Study of Avastin 1st Line Therapy in Adenocarcinoma Patients of the Lung

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer Exclusion Criteria: Contraindications to Avastin treatment according to the Summary of Product Characteristics

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years) |  | approximately 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years) |  | approximately 4.5 years | 
| Clinical/demographic patient characteristics at initiation of treatment |  | approximately 4.5 years | 
| Avastin treatment schedule in routine clinical practice (dosage/duration) |  | approximately 4 years | 
| Concomitant anti-neoplastic therapy (dosage/duration) |  | approximately 4.5 years | 
| Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years) |  | approximately 4.5 years |
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.

Detailed Description
-----------------
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Official Title
-----------------
Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Other: Very low nicotine content cigarettes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Ages 18-44 years Gestational age ≤ 25 weeks Exclusion Criteria: Male Under 18 years old Over 44 years old Gestational age > 25 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very low nicotine content cigarettes<br> | Other: Very low nicotine content cigarettes<br>* Cigarettes containing 0.4 mg nicotine/g tobacco<br>|
| No Intervention: Usual Brand<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes per day |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Women, Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal, Pregnancy, Health disparities, Vulnerable populations
Gene Regulation by Thiazolidinediones

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon

Detailed Description
-----------------
The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia) therapy on T cell activation and cytokine expression in the absence of pathologic acute and chronic intestinal inflammation.

Official Title
-----------------
Gene Regulation by Thiazolidinediones

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable of giving informed consent Agrees to use a barrier method of birth control for the duration of the study Exclusion Criteria: History of inflammatory bowel disease Has taken prescription or over the counter medications in the two weeks prior to enrollment History of diabetes, heart failure, angina, hypertension, coronary heart disease, cancer, bleeding disorder, HIV, AIDS Fasting LDL >160 mg/dl History of smoking in the year prior to enrollment Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rosiglitazone<br>Rosiglitazone; 8mg tablet once a day for 14 days | Drug: Rosiglitazone<br>* 8mg tablet once a day for 14 days<br>* Other names: Avandia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDK4 mRNA |  | 14 days |
Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
There has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).

Detailed Description
-----------------
Adenocarcinoma (ADC) of the esophagus and gastroesophageal junction (GEJ) is an aggressive neoplasm and has a poor prognosis. Surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma. Signet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (SRC)). According to the World Health Organisation (WHO), a true signet-ring cell carcinoma (SRCca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of SRC in the stroma. If the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (ADC).

Official Title
-----------------
Signet Ring Cells in Esophageal and GE Junction Carcinomas Have a More Aggressive Biological Behavior

Conditions
-----------------
Adenocarcinoma, Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adenocarcinoma R0 resection Primary surgery Exclusion Criteria: - Other histology R1 or R2 resection Neoadjuvant therapy

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 |
| --- | --- |
| SRC<50%<br>Adenocarcinoma containing < 50% of signet ring cells | |
| SRC>50%<br>Adenocarcinoma containing > 50% of signet ring cells | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer specific 5 year survival in SRCC | Cancer specific 5 year survival classified into two groups according to WHO criteria (>50% SRC or <50% SRC) | from surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagectomy, Signet Ring Cells