linjc16/ctgov huggingface dataset:
Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.

Official Title
-----------------
Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)

Conditions
-----------------
Post-solid Organ Transplant, Skin Neoplasms

Intervention / Treatment
-----------------
* Drug: Difluoromethylornithine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney Adequate organ function Hearing age/gender appropriate At high risk for developing skin cancer Immunosuppressant levels and doses show stable graft function Exclusion Criteria: Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA) Systemic therapy for cancer treatment or prophylaxis Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs [NSAIDs] (other than cardioprotective doses of aspirin)

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability |  | for 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50% |  | for the 12 months of therapy | 
| To determine if DFMO will be able to decrease polyamine levels in skin biopsies |  | for the 12 months of treatment |
Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients

Study Overview
=================
Brief Summary
-----------------
There has been an increase in incidence in sexually transmitted infections in HIV infected patients in the last years. In this study the investigators will prospectively evaluate the prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients attending the clinic for infectious diseases at the Berne University Hospital. In addition, participants will be asked to fill out a questionnaire on sexual behaviour and sexual health. Study hypothesis: STI prevalence is high in certain risk-groups to justify screening in regular intervals.

Official Title
-----------------
Prevalence of Asymptomatic and Symptomatic Infection of N. Gonorrheae and C. Trachomatis and Seroprevalence of HSV Typ 2 and Sexual Health Seeking Behaviour in People With HIV Infection in Bern

Conditions
-----------------
HIV Infections, Neisseria Gonorrhoeae, Chlamydia Trachomatis, Herpes Simplex

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infection Attending the Clinic for Infectious Diseases from May 09 to November 09 Sexually active during the last 12 months Written informed consent Exclusion Criteria: None

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 |
| --- | --- |
| HIV-infection<br>All HIV-infected patients attending the Clinic for Infectious Diseases at Berne university hospital, having been sexually active during the past 12 months and having given written informed consent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-infection, Neisseria gonorrhea, Chlamydia trachomatis, Herpes simplex virus, prevalence
Prediction of Pain in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.

Detailed Description
-----------------
The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale. Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Official Title
-----------------
Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Preoperative heat stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty. Exclusion Criteria: Bilateral / revision arthroplasty Disease affection central or peripheral nerve function Alcohol and medical abuse Daily use of opioids or glucocorticoids Malignancy BMI > 40 Depression Dementia or other cognitive dysfunction

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 |
| --- | --- |
| Patiens operated with TKA<br> | Procedure: Preoperative heat stimulation<br>* Preoperative short and long tonic heat stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulated pain (from 0-24 hours after surgery) | Pain during walk 5 m (VAS) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulated pain (from day 1 to day 7 after surgery) |  | 7 days | 
| Pain at day 14 after surgery |  | 14 days | 
| Pain at day 30 after surgery |  | 30 days |
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
A multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG)

Detailed Description
-----------------
A multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG) to infertile female patients undergoing assisted reproductive technology to controlled ovarian hyperstimulation

Official Title
-----------------
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer After Ovarian Hyperstimulation (Administration of rFSH or HP-hMG Alone or Co-administration of rFSH and HP-hMG)

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Drug: rFSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First IVF-ET cycle patients Exclusion Criteria: Poor ovarian responder - At least two of the following three features must be present: (i) Advanced maternal age (≥ 40 years) or any other risk factor for Poor ovarian response (POR); (ii) A previous POR (≤ 3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5-1.1 ng/mL)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 39 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 |
| --- | --- |
| fresh embryo<br>fresh embryo transfer after ovarian hyperstimulation | Drug: rFSH<br>* rFSH or HP-hMG or rFSH and HP-hMG<br>* Other names: rFSH and HP-hMG;|
| frozen embryo<br>frozen embryo transfer after ovarian hyperstimulation | Drug: rFSH<br>* rFSH or HP-hMG or rFSH and HP-hMG<br>* Other names: rFSH and HP-hMG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Oocytes | Counting number of Oocytes | average of 14 days |
Oxidative Stress and Vitamin E Requirements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if oxidative stress derived from cigarette smoking increases vitamin E requirements. The study will also assess the role of vitamin C in modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring vitamin E in plasma as well as by measuring the excreted vitamin E metabolite in the urine.

Detailed Description
-----------------
We will be investigating the fractional disappearance rate of tocopherols in cigarette smokers compared to nonsmokers. This will be accomplished by supplementing individuals with deuterium labeled alpha- and gamma-tocopherols. Quantification of plasma tocopherols as well as urinary metabolites, alpha- and gamma-carboxy ethyl hydroxychromanol, will be determined using liquid chromatography/mass spectrometry analysis. In addition, the role of vitamin C as it pertains to its influence on the fraction disappearance rate of vitamin E will also be evaluated.

Official Title
-----------------
Oxidative Stress and Vitamin E Requirements

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: Vitamin E with and without Vitamin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: non-smoking status or smokers (more than 1 pack per day) age: 18-35 y stable body weight, ranging between 80% and 130%, maintenance of normal exercise and activity patterns total cholesterol ≤ 7.758 mmol/L (300 mg/dl) triglyceride concentration ≤ 3.387 mmol/L (300 mg/dl) Subjects will be excluded if they fulfill any one of the following: antioxidant supplement users resting blood pressure above 160/105 mm Hg engaged in aerobic activity more than five hours per week vegetarian or other restrictive dietary requirements fasting blood glucose concentration of ≥ 7.77 mmol/L (140 mg/dl) history of diabetes or uremia other known metabolic disease or medication use known to affect lipid metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitamin E with and without Vitamin C|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cigarette smoking, tocopherol, bioavailability, metabolism, oxidative stress
National Breast Cancer and Lymphedema Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the National Breast Cancer Lymphedema Registry is to collect health information in order to study the lymphedema as a complication of breast cancer treatment. The investigators hope to learn whether early diagnosis will help to prevent lymphedema or, if it does occur, to reduce the severity.

Detailed Description
-----------------
Historically, breast cancer-associated lymphedema has been relatively ignored, with mis-diagnosis, late diagnosis, and failure to treat. The condition has a measurable, substantial impact on patient function and perceived quality of life (QOL). Recent pilot studies suggest that interventions that are designed to facilitate early diagnosis and preventive strategies have a major impact on the incidence and severity of disease burden. This registry is designed to prospectively capture the relevant data to document the impact of preemptive diagnostic and treatment strategies.

Official Title
-----------------
National Breast Cancer and Lymphedema Registry

Conditions
-----------------
Breast Cancer, Lymphedema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer survivorship Exclusion Criteria: Age < 18 years old

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 |
| --- | --- |
| Breast cancer survivors<br>Patients who have undergone breast cancer treatment (e.g. surgery, node dissection, chemotherapy and/or radiation therapy), and what affect this has had on their arm health. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preemptive diagnostic and treatment strategies | The methods for lymphedema surveillance and detection will be correlated to the new appearance of lymphedema in this cohort of breast cancer survivors. We will also assess severity of lymphedema and responsiveness to treatment strategies. | Each enrolled patient will be followed for an average of 1 year |
Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

Detailed Description
-----------------
cPTFEi s a mesh-like product designed to reduce associated post surgical complications.

Official Title
-----------------
A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Device: MotifMESH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired Exclusion Criteria: Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study. For subjects with Diabetes Mellitus, HbA1C <12% BMI ≤ 40 kg/m²

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MotifMesh<br>Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh | Device: MotifMESH<br>* Polytetrafluoroethylene (cPTFE) macroporous mesh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh | Hernia occurrence at one year after surgery | 1 year |
Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Official Title
-----------------
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: Premarin®/MPA formulation A
* Drug: Premarin®/MPA formulation B
* Drug: Premarin®/MPA formulation C
* Drug: Premarin®/MPA currently marketed product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Healthy postmenopausal women aged 35 to 70. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg. Nonsmoker or smoker of fewer than 10 cigarettes/day. Exclusion History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control. History within 1 year of study day 1 of alcohol or drug abuse. Use of any investigational drug within 30 days before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Premarin®/MPA formulation A<br> <br> |
| Experimental: 2<br> | Drug: Premarin®/MPA formulation B<br> <br> |
| Experimental: 3<br> | Drug: Premarin®/MPA formulation C<br> <br> |
| Active Comparator: 4<br> | Drug: Premarin®/MPA currently marketed product<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcome |  | No time frame | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premarin®
Gender Differences in the Tolerance to Stretch

Study Overview
=================
Brief Summary
-----------------
The effect of stretching on range of motion is believed to rely upon an increased tolerance to stretch. This suggests, that pain modulation has significance in regards to the effect of stretching.

Detailed Description
-----------------
Given that there may be differences in the way men and women perceive a painful stimulus, this suggests that there may be potential gender differences in the tolerance to stretch following stretching.

Official Title
-----------------
The Effect of Stretching on Pain Sensitivity - Potential Gender Differences?

Conditions
-----------------
Range of Motion, Articular, Muscle Stretching Exercises

Intervention / Treatment
-----------------
* Other: Muscle stretching exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Absence of any pain or other conditions which might affect the somatosensory system and pain perception Exclusion Criteria: Substance abuse, History of neurological or mental disabilities, Lack of ability to comply with instructions, Delayed onset of muscle soreness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Male<br>Static Muscle stretching exercises of the knee flexors | Other: Muscle stretching exercises<br>* Muscle stretching exercises consisting of static stretching exercises of the knee flexors<br>|
| Female<br>Static Muscle stretching exercises of the knee flexors | Other: Muscle stretching exercises<br>* Muscle stretching exercises consisting of static stretching exercises of the knee flexors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Passive knee extension Range of motion | Passive knee extension range of motion was measured at baseline just prior to Muscle stretching exercises | 
| Range of Motion | Passive knee extension Range of motion | Passive knee extension range of motion was measured 30 seconds after Muscle stretching exercises | 
| Pain Thresholds | Pressure Pain Thresholds | Pressure pain Thresholds were measured at baseline just prior to muscle stretching exercises | 
| Pain Thresholds | Pressure Pain Thresholds | Pressure pain Thresholds were measured 30 seconds after muscle stretching exercises | 
| Torque | Passive Resistive Torque | Passive resistive torque was measured at baseline just prior to muscle stretching exercises | 
| Torque | Passive Resistive Torque | Passive resistive torque was measured 30 seconds after muscle stretching exercises |