linjc16/ctgov huggingface dataset:
T Cell Function in Chronic Idiopathic Urticaria

Study Overview
=================
Brief Summary
-----------------
Chronic idiopathic urticaria (CIU) is a common form of chronic urticaria in which the cause is not detected after intensive clinical and laboratory investigation.In view of the current data, it was suggested that at least part of the patients with CIU have an autoimmune process.This study is designed to investigate the mechanisms involved in the regulation and activation of the immune cells in patients with CIU and corelate them with disease activity

Official Title
-----------------
T Cell Function in Chronic Idiopathic Urticaria

Conditions
-----------------
Chronic Urticaria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age above 18 chronic urticaria Exclusion Criteria: age below 18 pregnancy other severe chronic diseases

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

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

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 |
| --- | --- | --- |
An Unusual Association Between Pancreatic Cancer and Purtscher-like Retinopathy

Study Overview
=================
Brief Summary
-----------------
AN UNUSUAL ASSOCIATION BETWEEN PANCREATIC CANCER AND PURTSCHER-LIKE RETINOPATHY

Detailed Description
-----------------
Purtscher's retinopathy may cause sudden loss of vision of varying severity, secondary to head or chest injury. Its pathophysiology is unclear. Purtscher's-like retinopathy has more attenuated clinical and objective features and can be associated with many non-neoplastic pathologies. Otherwise, an association of this kind of retinopathy with malignancies has been described once in the Literature (multiple myeloma). We present a case report on a unique association between pancreatic cancer and Purtscher-type retinopathy.

Official Title
-----------------
An Unusual Association Between Pancreatic Cancer and Purtscher-like Retinopathy: Presentation of a Unique Case

Conditions
-----------------
Purtscher Retinopathy, Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NONE - Exclusion Criteria: NONE -
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methylprednisolone|1 g. of methylprednisolone in saline solution 250 cc once a day for 5 days, and one eye drops of Diclofenac per eye 3 times a day for 30 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| funduscopic examination | At the funduscopic examination the back of the eye showed large yellow spots and retinal hemorrhages in the superficial retina. In the early stages, fluorescein angiography showed hypofluorescence in the area of the yellow-white patches while the late stages showed hyperfluorescence | at the onset of symptoms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abdominal CT-scan | CT scan of the abdomen revealed a large mass in the tail of the pancreas with direct extension to the vessels of splenic hilum and splenic vein thrombosis. A secondary invasion of the gastric wall and left adrenal gland was also demonstrated. Percutaneous needle biopsy was performed and histopathology showed moderate to poorly differentiated mucinous pancreatic adenocarcinoma. | at the onset of symptoms |
Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient

Study Overview
=================
Brief Summary
-----------------
This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.

Official Title
-----------------
Compassionate Use Study to Assess the Long Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in One Patient Following Termination of the SHIELD Open-label Study 2001060

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Azimilide 2HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy Exclusion Criteria: Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval. Is unwilling or unable to give or understand informed consent.
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: 1<br>1 tablet of 125 mg/day of azimilide 2HCl, oral | Drug: Azimilide 2HCl<br>* One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There was no outcome measure in this compassionate use |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients, with ICD
Oxygen Toxicity of HBOT in Chronic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Hypothesis: That HBOT can be toxic in the low-pressure range.

Detailed Description
-----------------
The study is a retrospective review of the author's experience treating chronic brain injury with HBOT, supplemented by cases communicated to the author, who developed untoward effects during or after their HBOT. The object of the study was to affirm or refute the author's general impression that there was an optimal dose of HBOT in chronic brain injury which was lower than the traditional dose applied in chronic non-central nervous system wounding. Furthermore, when this lower dosage range was exceeded and approached the traditional doses for non-CNS wounding oxygen toxicity would result. To address these impressions the study seeks to review the author's medical records and other patient/doctor communications to the author where side effects of HBOT occurred in the treatment of chronic brain injury and abstract signs, symptoms, and the dose of HBOT employed.

Official Title
-----------------
Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury

Conditions
-----------------
Adult and Pediatric Chronic Cerebral Disorders

Intervention / Treatment
-----------------
* Drug: Hyperbaric oxygen therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral disorder of greater than one year's duration Exclusion Criteria: None
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 |
| --- | --- |
| Experimental: Hyperbaric oxygen therapy<br>Patients undergoing low pressure HBOT for chronic brain injury | Drug: Hyperbaric oxygen therapy<br>* Total body pressurized oxygen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen toxicity |  | After completion of hyperbaric oxygen therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain injury, brain disorders
Coenzyme Q10 in Older Athletes Treated With Statin Medications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Coenzyme Q10 in Improving Mitochondrial Function in Older Athletes Treated With Statin Medications

Conditions
-----------------
Muscle Weakness, Myalgia, Side Effects of Statins

Intervention / Treatment
-----------------
* Drug: Coenzyme q 10
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 50 years of age, male or female. Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study Self-Described Athletes with any of the following characteristics: Participation in a competitive athletic event within the past year or currently training for a competitive athletic event within the 6 months following enrollment Regular exercise activity of at least 45 minutes duration 5 times per week Exclusion Criteria: Use of coenzyme Q10 during the preceding two months. CPK level at baseline greater than two times the upper limits of normal LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 1 placebo q d during treatment period<br>|
| Active Comparator: Coenzyme Q10<br>200mg of coenzyme Q10 | Drug: Coenzyme q 10<br>* 200 mg of Coenzyme q 10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population |  | The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coenzyme q10, statins, myalgias, anaerobic threshold, athletic performance
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

Study Overview
=================
Brief Summary
-----------------
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability

Official Title
-----------------
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Histological confirmed diagnosis of carcinoma of the prostate Current or previous evidence of metastatic disease to the bone Receiving currently or not, hormonal therapy ECOG performance status of 0, 1, or 2 Exclusion Criteria: Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less. Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L). WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L. Liver function tests >2.5 ULN, serum creatinine >1.5 ULN. Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol. Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula. Other protocol-related inclusion / exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcomes/objectives planned |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Bone Metastases, Zoledronic acid
Why Are Fertility Preservation Patients Not Coming Back?

Study Overview
=================
Brief Summary
-----------------
This is a single-center retrospective study carried out with a phone call follow-up to investigate women's decision not to return for criopreserved ovocytes use after cancer treatment. The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center from January 2001 to December 2017. Patients were asked a set of standardized questions whose purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for embryo transfer. All data were recorded anonymously in our dataset.

Detailed Description
-----------------
All women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy, were contacted. The survey's purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for oocytes use.

Official Title
-----------------
Why Are They Not Coming Back? A Single-center Follow-up Study in Fertility Preservation in Oncological Women.

Conditions
-----------------
Fertility Issues, Cancer

Intervention / Treatment
-----------------
* Other: Follow up survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fertility preservation population<br>all women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy | Other: Follow up survey<br>* phone call follow-up to investigate women's decision not to return for embryo transfer after cancer treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| return rate | return rate of cancer patients who underwent fertility preservation | from January 2001 to December 2021 |
Occipital Transcutaneous Stimulation in Chronic Migraine

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect in chronic migraine patients of daily 20 minute-transcutaneous sub occipital neurostimulation using the occipital Cefaly° device.

Detailed Description
-----------------
Chronic migraine is a disabling neurological condition affecting 0.5-2% of the population. CM is difficult to treat and preventive treatment options are limited. Due to the inefficiency of available and the lack of new preventive anti-migraine drug, neurostimulation methods have raised great interest in recent years. The ONSTIM study showed a reduction in headache frequency in 39% of patients treated with active ONS during 12 weeks, compared to no improvement in the non-effectively stimulated or medically treated groups.

Official Title
-----------------
Transcutaneous Suboccipital Neurostimulation for the Treatment of Chronic Migraine

Conditions
-----------------
Chronic Migraine

Intervention / Treatment
-----------------
* Device: Cefaly Kit Arnold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse Exclusion Criteria: other diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefaly Kit Arnold<br>Occipital transcranial stimulation is implemented in occipital region at 16 mA of intensity, for 20 minutes, everyday for 3 months, in 20 chronic migraine patients. | Device: Cefaly Kit Arnold<br>* Occipital neurostimulation can have a therapeutic effect in chronic migraine treatment, thus representing a possible therapeutic option in patients that do not respond to any medication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly frequency of migraine days |  | 2 months treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly frequency of headache days |  | 2 months | 
| Monthly frequency of total headache days |  | 2 months | 
| Cumulative monthly headache hours |  | 2 months | 
| Monthly acute drug intake |  | 2 months |
Psychosocial Determinants of Nutrient Intake in Girls

Study Overview
=================
Brief Summary
-----------------
To better understand the determinants of nutrient intake in black and white adolescent girls and to examine the effects of nutrient intake and eating behaviors on obesity, a significant risk factor for CVD.

Detailed Description
-----------------
BACKGROUND: Studies have documented the importance of eating behavior as a modifiable risk factor for the development of obesity and cardiovascular disease (CVD). The burden of obesity and CVD is not equally distributed in the population; women from ethnic minority populations are particularly likely to be obese and to have higher rates of CVD and stroke than white women. DESIGN NARRATIVE: The study determines the extent to which psychological and familial factors contribute to nutrient intake in black and white girls, beyond the well-established effects of ethnicity and socioeconomic factors. Specifically, the aims of the project are the following: 1) to provide a detailed developmental description of eating behaviors and nutrient intake in black and white girls and to examine the clustering of certain eating behaviors (e.g., skipping meals and snacking) into eating patterns; 2) to determine the clinical significance of eating behaviors and eating patterns by examining their contribution to nutrient intake and the development of obesity; 3) to examine the role of psychological and familial factors as determinants of eating behaviors, eating patterns, nutrient intake, and obesity in black and white girls. Capitalizing upon the availability of extensive data collected prospectively among an exceptionally well-maintained cohort of 2,379 black and white females over a 12-year period (from ages 9-10 to ages 21-23), the study applies innovative analytic procedures to further the scientific understanding of the determinants of nutrient intake and eating behaviors in adolescent girls. Participants were assessed annually for ten years as part of the National Heart, Lung and Blood Institute Growth and Health Study (NGHS) with measurements of anthropometry, food intake, eating and weight related attitudes and behaviors and family cohesion. Parents also provided information about weight, eating, and family environment at two assessments. In a subsequent study with the same sample, structured clinical interviews were conducted to determine history of psychiatric disorders and risk factors for eating disorders. Adult weight was also measured.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

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

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 23 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 |
| --- | --- | --- |