linjc16/ctgov huggingface dataset:
Finhyst 2006: Study on Morbidity of Hysterectomies in Finland

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze prospectively all hysterectomies performed in Finland for benign indications including all 46 public hospitals performing hysterectomies and also 7 private clinics. Hypothesis is that vaginal and laparoscopic hysterectomies are safe and cost-effective methods of hysterectomy.

Detailed Description
-----------------
This Finhyst 2006 study evaluates nationwidely methods, indications, concomitant procedures, complications, hospital stay and convalescence time of all types of hysterectomies with questionnaires filled by doctors and patients. In addition, in the area of Helsinki University Central Hospital also the effect of quality of life and cost-effectiveness is studied.

Official Title
-----------------
Finhyst 2006: Incidence, Methods, Complications and Effect on Quality of Life of Hysterectomies in Finland in 2006

Conditions
-----------------
Morbidity of Hysterectomy

Intervention / Treatment
-----------------
* Procedure: laparoscopy
* Procedure: vaginal
* Procedure: abdominal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bening indications for hysterectomy Exclusion Criteria: Malignant indications for hysterectomy Postpartum hysterectomy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>laparoscopy | Procedure: laparoscopy<br>* laparoscopic hysterectomy<br>|
| Active Comparator: 2<br>vaginal | Procedure: vaginal<br>* vaginal hysterectomy<br>|
| Active Comparator: 3<br>abdominal | Procedure: abdominal<br>* abdominal hysterectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of hysterectomy |  | 1.1-31.12.2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness |  | 1.1.-31.12.2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterectomy, vaginal, laparoscopy, abdominal, complication, quality of life, cost-effectiveness, Morbidity of three types of hysterectomy
Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Study Overview
=================
Brief Summary
-----------------
Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct therapy for diabetic wounds. However, some patients have insufficient increase or even paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was to investigate the pathophysiology responsible for the different consequences of HBOT and to evaluate the effect of N-acetylcysteine (NAC) on these changes. Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete HBOT protocol.

Official Title
-----------------
The Relation Between Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation in Diabetic Patients Suffering From Foot Ulcers

Conditions
-----------------
Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patients, aged 18 years or older, with non-healing foot ulcers Exclusion Criteria: Patients with macrovascular disease amenable for revascularization with more than 70% obstruction in femoral artery (evaluated by US doppler) were excluded from the study. Similarly, patients with a documented allergy to NAC, liver cirrhosis or those receiving NAC for other indications were excluded. Finally, patients with chest pathology incompatible with pressure changes, patients with inner ear disease, or those suffering from claustrophobia were excluded.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-acetylcysteine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of the present study was to investigate whether changes in oxidative stress and NO bioavailability are responsible for the different effects of HBOT on tissue oxygenation in diabetic patients suffering from foot ulcers. |  |  |
Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.

Study Overview
=================
Brief Summary
-----------------
The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.

Detailed Description
-----------------
The Telephone Outreach for Therapy Trial was designed to test an intervention to assist new mothers or caregivers of HIV-exposed children with administering medication for the first 6 weeks of life to prevent mother-to-child HIV infection in the infants. To be eligible, mothers of infants were identified as HIV-infected in the Mother-Infant Rapid Intervention at Delivery Study. Mothers or caregivers of infants were randomized into two groups: the intervention group received a cellular phone and scheduled twice daily calls to assure infant medications were given, and the other group received the current standard of care. Enrollment into the study was completed and analysis of the study data is underway.

Official Title
-----------------
Mother-Infant Rapid Intervention at Delivery Telephone Outreach for Neonatal Therapy (TOT) Trial.

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: Telephone Outreach for Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother-infant pairs in which the mother was identified as HIV-infected in the MIRIAD Study Exclusion Criteria: Mother-infant pairs in which the infant is expected to be hospitalized for >2weeks after birth

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 2 Weeks

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Telephone Outreach for Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal adherence to zidovudine syrup measured as self report of the mother or caregiver AND drug level measured in heel stick specimens collected at 2, 4 and 6 weeks of life. |  |  |
Familial Aggregation of Stress Response

Study Overview
=================
Brief Summary
-----------------
To perform data analyses on the familial aggregation of the stress response as it relates to hypertension.

Detailed Description
-----------------
BACKGROUND: Given recent advances in the analyses of genetic epidemiologic data, the database presented a unique opportunity to address timely issues pertinent to the contribution of genetic and environmental factors to individual differences in cardiovascular reactivity. DESIGN NARRATIVE: Secondary data analyses were performed on family data obtained in an ongoing hypertension genetic study conducted at the University of Utah with Roger R. Williams as principal investigator. The available data represented one of the largest studies of cardiovascular reactivity among genetically related individuals. During 1981-83, a total of 2,548 subjects, members of 98 extended families (multiple generations and multiple nuclear families) participated in an extensive cardiovascular examination and were assessed on a comprehensive battery of cardiovascular tests. Annual follow-up questionnaires obtained information about the onset of hypertension and new medication prescribed. In 1991-92, a follow-up exam was conducted on 1,500 subjects. The data analysis attempted to confirm or refute hypotheses postulating a reactivity-hypertension association; investigated whether there was a sex limitation in the genetic and environmental determinants of reactivity; explored genotype-by-age interactions in the control of reactivity;and determined whether there was shared genetic and/or environmental variance between reactivity and other recognized cardiovascular risk factors such as obesity or lipids. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Healthy Environments Partnership

Study Overview
=================
Brief Summary
-----------------
The Healthy Environments Partnership was established in October 2000, as a part of the National Institute of Environmental Health Sciences Health Disparities Initiative. The Healthy Environments Partnership seeks to expand the knowledge base of how social and economic inequalities are linked to disparities in cardiovascular health among residents of Detroit. The Healthy Environments Partnership is a project of the Detroit Community-Academic Urban Research Center. The partners are: Brightmoor Community Center, Butzel Family Center, the Detroit Health Department, Friends of Parkside, Henry Ford Health System, Southwest Counseling and Development Services, Southwest Detroit Environmental Vision and University of Detroit Mercy and the University of Michigan School of Public Health, School of Nursing, and the Institute for Social Research.

Official Title
-----------------
Social and Physical Environments and Health Disparities

Conditions
-----------------
Cardiovascular Health

Participation Criteria
=================
Eligibility Criteria
-----------------
Age 25 and older Resident of three designated areas of Detroit, MI

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 95 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
health disparities, social environment, physical environment, racial health disparities
Courses Emergency Psychiatric Strasbourg

Study Overview
=================
Brief Summary
-----------------
Describe and analyze routes and modes of care for patients in emergency consultant in various emergency care and public psychiatric outpatient devices to provide useful information to optimize trajectories taken into psychiatric load on the Eurométropole territory upstream and downstream of where they viewed urgently.

Official Title
-----------------
ROUTE PATIENT CONSULTANT in OUTPATIENT CARE PSYCHIATRIC EMERGENCY SERVICES AND PUBLIC OF EUROMETROPOLE STRASBOURG

Conditions
-----------------
Psychiatric Emergency

Intervention / Treatment
-----------------
* Behavioral: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients, men and women, adults and minors of 11 years and more, seen for psychiatric consultation request emergency (unscheduled and requiring specialized psychiatric consultation within 72 hours) Exclusion Criteria: Will not be included in the study psychiatric consultations requested by internal hospital services other than emergency services, patients with psychiatric emergencies revised for post-emergency consultations

Ages Eligible for Study
-----------------
Minimum Age: 11 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: questionnaires|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| management of emergency patients consulting |  | follow-up of 1 month |
Efficacy Study of EVT 201 to Treat Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).

Official Title
-----------------
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients

Conditions
-----------------
Sleep Initiation and Maintenance Disorders

Intervention / Treatment
-----------------
* Drug: EVT 201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have a diagnosis of primary insomnia over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period must be willing and able to complete a sleep diary and questionnaires Exclusion Criteria: must not have a clinically significant or unstable medical condition that may interfere with sleep must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants must not intentionally nap 3 (or more) times per week must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 64 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EVT 201|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time |  |  | 
| Wake after sleep onset |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency to persistent sleep |  |  | 
| Number of awakenings |  |  | 
| Total wake time |  |  | 
| Minutes of stages 1-4 and REM sleep |  |  | 
| REM latency |  |  | 
| Patient reported sleep variables |  |  | 
| Residual sedation measures |  |  | 
| Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments. |  |  |
To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.

Study Overview
=================
Brief Summary
-----------------
this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.

Conditions
-----------------
Diabetic Neuropathies, Insomnia Due to Medical Condition

Intervention / Treatment
-----------------
* Other: NeuropAWAY
* Other: Microcystalline cellulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Females aged ≥ 40 and ≤ 65 years of age. Participants with primary complaints of lower limb pain. History of Diabetes mellitus for more than one year. Participants with HbA1c ≥ 7.1 and ≤ 9.5% Exclusion Criteria: Diagnosed with severe cardiac disease Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85. Type II DM with history of foot ulcers in the last six months prior to the study History of nerve damage not due to Painful Diabetic Neuropathy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neuropaway<br> | Other: NeuropAWAY<br>* 2 capsules thrice daily to be taken half an hour prior to meal.<br>|
| Placebo Comparator: Microcystalline cellulose<br> | Other: Microcystalline cellulose<br>* 2 capsules thrice daily to be taken half an hour prior to meal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale. | pain intensity will be assessed by 11 point numeric rating scale where 0 indicates no pain and 10 indicates worst possible pain | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory. |  | 42 days | 
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index. |  | 42 Days | 
| effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 . |  | 42 Days |
Contact Allergies to Dental Metal as a Possible Risk Factor for Oral Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gathering information about allergies to metals may help doctors learn whether having an allergy to metal used in dental work increases the risk of developing oral cancer. PURPOSE: This clinical trial is studying contact allergies to dental metal as a possible risk factor for oral cancer.

Detailed Description
-----------------
OBJECTIVES: Identify the relationship between intraoral metal contact allergy and epithelial carcinogenesis in patients with newly or previously diagnosed intraoral squamous cell carcinoma. Compare the prevalence of metal contact allergy in these patients with control data from other existing study populations. OUTLINE: This is a multicenter study. Participants undergo metal patch testing using 27 metals* commonly used in dental repairs that are part of the Mayo metal series. Metal patches are applied to the patient's back for 3 days and the back is read on days 3 and 5. Relevant patient data obtained from their medical and dental history, physical exam, laboratory values and treatment are documented. NOTE: *Healthy volunteers (control) undergo metal patch testing using 8 metals most commonly positive for contact allergens.

Official Title
-----------------
Oral Metal Contact Allergy: A Cause of Oral Squamous Cell Carcinoma?

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: metal patch tests


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Newly or previously diagnosed oral squamous cell carcinoma Recruited from the otorhinolaryngology departments of Mayo Clinic Rochester and Mayo Clinic Arizona Healthy volunteer (control) No history of intraoral squamous cell carcinoma Employed at Mayo Clinic Rochester or Mayo Clinic Arizona PATIENT CHARACTERISTICS: No immunosuppression No other conditions that interfere with patch testing PRIOR CONCURRENT THERAPY: Not specified

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: metal patch tests|Twenty - seven (27) metal patch tests will be applied to the patient's back and left in place for 3 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between intraoral metal contact allergy and epithelial carcinogenesis |  | one year | 
| Prevalence of metal contact allergy comparison to study control data |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lip and oral cavity squamous cell carcinoma, oropharyngeal squamous cell carcinoma