linjc16/ctgov huggingface dataset:
Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to evaluate the situation regarding ambulant therapy of cancer patients in different practices in Germany. It should provide insight into the implementation of schemes for cancer therapy predefined in the guidelines, the treatment of diverse adverse reactions and the counter measures taken. Thereby, potential differences in treatment and with that differences in quality amongst individual practices might be identified. The medium to long term aim is to contribute to positively influence the quality of medical care of cancer patients in Germany.

Official Title
-----------------
Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy

Conditions
-----------------
Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Tumor disease (carcinoma of either breast, ovary, lung, colon, stomach, pancreas, rectum or plasmacytoma) 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 |
| --- | --- |
| Cancer patients<br>Patients suffering from a carcinoma (either breast, ovarian, lung, colon, stomach, pancreas, rectum or plasmacytoma) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-cancer treatments (Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation) | Course of the disease and type of applied anti-cancer therapies. Assessment of guidelines' implementation | From date of ICF until date of cure/death/ICF withdrawal, up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions and their treatment (Number and type of adverse reactions and applied counter measures / therapies) | Number and type of adverse reactions and applied counter measures / therapies | From date of ICF until date of cure/death/ICF withdrawal, up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Ovarian cancer, Lung cancer, Colon cancer, Gastric cancer, Pancreatic cancer, Rectum cancer, Plasmacytoma
The Significance of Ambrosia in Allergic Rhinitis and Asthma in Israel

Study Overview
=================
Brief Summary
-----------------
Ambrosia is known for its allergenicity in the USA causing hay fever and asthma. Israel has always been considered clean of Ambrosia but over the past years growth of Ambrosia plants has been detected in several locations in Israel. In the proposed study, patients referred for routine allergic evaluation will also be skin tested with Ambrosia allergens, in addition to their regular prick skin tests with all other airborne allergens.

Conditions
-----------------
Allergic Rhinitis, Asthma, Allergic Conjunctivitis, Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with allergic rhinitis, asthma, allergic conjunctivitis or atopic dermatitis who undergo prick skin tests with airborne allergens

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

Study Overview
=================
Brief Summary
-----------------
Assess tolerability of different dosing formulations (adult versus pediatric).

Official Title
-----------------
A Randomized, Multicenter, Comparative Study To Assess Tolerability Of A Single Oral 60 Mg/Kg Dose Of Zmax (Pediatric Concentration) Vs. Zmax (Adult Concentration) In Pediatric Patients With Acute Otitis Media

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Drug: Zmax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have clinical signs/symptoms of AOM in at least 1 ear Exclusion Criteria: Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor Previously diagnosed disease(s) of immune function Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 48 Months

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1. |  |  | 
| Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population. |  |  | 
| Frequencies of occurrence, by day, of treatment-related vomiting. |  |  | 
| Investigator and Sponsor assessment of clinical response. |  |  |
Efficacy of Yoga Based Self-Management Program for Chronic Pain

Study Overview
=================
Brief Summary
-----------------
Chronic pain is a major health issue with substantial economic burden.To support chronic pain patients during the COVID-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. Project was designed as community-based program, creating new social networks for patients, health care providers and academics. Platform to deliver intervention and data collection was AiM COVID mobile app. Our objective was to determine the efficacy of Yoga based self-management intervention for people living with chronic pain pain intensity, disability and health related quality of life.

Official Title
-----------------
Efficacy of Yoga Based Self-Management Program for Chronic Pain: Community Based Clinical Efficacy Study

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Yoga Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic pain for at least 3 months Having access to internet and video calls Exclusion Criteria: Pregnant or breast-feeding women, Patients not willing to give written consent Patients with severe psychiatric or personality disorder Malignancy

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

| Intervention/Treatment |
| --- |
|Other: Yoga Therapy|Yoga based self managed practices personalised to chronic pain patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity and disability | Pain intensity and related disability was measured through Brief Pain Inventory | From baseline to 6 week post intervention | 
| Health Related Quality of Life | Quality of life was measured through 36-Item Short-Form Survey | From baseline to 6 week post intervention | 
| Self-efficacy of pain | Self efficacy was measure through Pain Self-Efficacy Questionnaire | From baseline to 6 week post intervention |
Iron Supplementation in Hip/Knee Surgery

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.

Official Title
-----------------
Sideral Forte in Prosthetic Hip and Knee Surgery

Conditions
-----------------
Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy, Anemia, Iron Poor Blood

Intervention / Treatment
-----------------
* Dietary Supplement: Sucrosomial iron plus ascorbic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ASA 1, 2, or 3 No neuropsychiatric conditions Acceptance of informed consent Elective prosthetic hip or knee surgery Exclusion Criteria: ASA 4 Present or past neuropsychiatric conditions Hip or knee revision surgery Use of iron as dietary supplement Known erythrocytosis Incompatible hypersensitivities Iron metabolism disorders Lymphoproliferative disorders

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (group A)<br>Patients who are subjected to the intervention, being iron plus ascorbic acid, other than the standard of care. | Dietary Supplement: Sucrosomial iron plus ascorbic acid<br>* A number of 41 subjects are supplemented with 30 mg of iron plus 70 mg of ascorbic acid daily for 30+/-5 days before orthopedic surgery.<br>|
| No Intervention: Control (group B)<br>Patients who are not subjected to the intervention and follow the standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of blood hemoglobin levels | CHange of hemoglobin concentration (g/dl) from baseline and after 30 days +/- 5 days | Baseline and 30 days +/- 5 days |
Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the: Natural history of calcification posttransplantation Natural history of BMC following renal transplantation Reverse correlation between calcification score and aortic calcifications following renal transplantation Correlation of IMT, BMC, PWV and biochemical variables Correlation of IMT, BMC, PWV, biochemical variables and outcome Predictors of CV disease after transplantation Predictors of IMT progression, BMC loss and PWV progression after renal transplantation

Official Title
-----------------
Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients

Conditions
-----------------
Renal Transplant, Atherosclerosis, Arterial Stiffness

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incident renal transplant patients or combined renal/pancreas transplant patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| A<br>incident renal transplant patients | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular outcome |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
calcification, bone lesions
Flavoring Oral Contrast for MR Enterography

Study Overview
=================
Brief Summary
-----------------
To determine if patient satisfaction, participation, and image quality improves with flavored oral contrast for MR enterography.

Detailed Description
-----------------
Volumen is an oral contrast agent used in MR imaging of the bowel. It has an unpleasant taste which makes it difficult for pediatric patients, especially sick pediatric patients, to drink. There are other contrast materials used in the department that are flavored to improved patient participation. The investigators hope to determine a way to flavor Volumen to improve patient participation. In doing so, the investigators hope to also improve patient satisfaction as well as imaging quality.

Official Title
-----------------
Flavoring Oral Contrast for MR Enterography

Conditions
-----------------
Taste, Altered

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients having a MR enterography Exclusion Criteria: sedated patients

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 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 |
| --- | --- |
| Flavored contrast<br>This group of patients will have the choice to flavor their contrast. | |
| Unflavored contrast<br>This group of patients will drink the contrast without flavoring. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients that prefer flavored contrast | the number of patients that prefer flavored contrast will be evaluated by a questionaire | one year | 
| bowel diameter measurements on MR Enterography | bowel diameter measurements will be made by two radiologists on MR Enterography | one year |
Measurement of the Folate Receptor in Blood

Study Overview
=================
Brief Summary
-----------------
The folate receptor (FR) is a cell marker that is over expressed on the cell surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues the FR is usually located on the tissue surface that is inaccessible to circulating drugs. As such, drugs which target the FR may potentially be used to achieve anti-tumour efficacy whilst reducing toxicity to normal tissues. Therefore the ability to measure FR levels from different cancer types may help to select patients who are most likely to benefit from treatment with FR targeted therapies. One such drug BGC 945 is currently being tested in preclinical study at The Institute of Cancer Research

Detailed Description
-----------------
A method has been developed in the laboratory which has been able to measure FR obtained from cancer cells in culture that has been added into blood. We would like to study if this method can measure FR in plasma and serum obtained from patients with ovarian cancer. We would also like to analyse plasma and serum samples obtained from healthy volunteers to determine if they have any appreciable levels of FR, which can then be compared to the measurements obtained from cancer patients.

Official Title
-----------------
Measurement of the Folate Receptor in Blood

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stage III/IV ovarian cancer healthy volunteers who are staff at the ICR and RMH Exclusion Criteria: patients or healthy volunteers who are unable to give informed consent pregnancy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gynaecological Cancer<br>Gynaecological Cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the levels of folate receptor in blood samples obtained from patients with ovarian cancer and from healthy volunteers |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
folate receptor, blood samples, ovarian cancer, development of measure of folate receptor in blood samples, possible selection of patients for treatment with FR targeted agents
PRP Use in Treatment of Fistula Ano

Study Overview
=================
Brief Summary
-----------------
In treatment of perianal fistula several methods are described. However, since the Hippocrates basics of surgical treatment has not changed very much. the aim of this study is to evaluate the effectiveness of PRP gel in treatment of perianal fistula.

Detailed Description
-----------------
Perianal fistula is a chronic condition that seriously affects the patients' quality of life. There are different treatment modalities used in treatment. Recently sphincter preserving methods are becoming more popular with low complication rates. Most of this methods aiming the closure of fistula tract by different pathways. Platelet rich plasma (PRP) is used in a wide range of conditions in medicine. The investigator's team showed the effective treatment of pilonidal disease by use of PRP gel. In the recent study, aim to evaluate the effectiveness of PRP gel in treatment of perianal fistula. Patients with perianal fistula will be evaluated for the study. After taking permission with informed consent; cases will be included in the study. Cases with inflammatory bowel disease, platelet function disorders or connective tissue disorders that may alter wound healing will be excluded from the study. After, PRP application to the fistula tract patients will be taken to follow up. Perianal fistulas will be followed by magnetic resonance imaging 1 month after the application. Pre-application and post-application scans will be used for the evaluation of the treatment success.

Official Title
-----------------
Use of Platelet Rich Plasma in Treatment of Perianal Fistula

Conditions
-----------------
Fistula in Ano

Intervention / Treatment
-----------------
* Other: platelet rich plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with perianal fistula signing the informed consent form above the age of 18 Exclusion Criteria: inflammatory bowel disease previous radiation therapy having connective tissue disorders

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
Interventional Model Description: PRP gel will be applicated to all cases
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP gel application<br>PRP application for perianal fistula | Other: platelet rich plasma<br>* platelet rich plasma prepared from the patients' own blood will be applied to the fistula tract<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of the cure rate | closure of the fistula tract will be evaluated by physical examination and magnetic resonance imaging | 1 month |
Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

Study Overview
=================
Brief Summary
-----------------
Still not well resolved access, execution and interpretation of spirometry in primary care medicine. This seriously affects the quality of care of chronic respiratory diseases. OBJECTIVE: To compare the effectiveness of two methods for quality control in performing spirometry in primary care teams (EAP) participating in the Healthcare Process Chronic Obstructive Pulmonary Disease (COPD ) (multidisciplinary program between primary care medicine and hospital for improved care COPD). METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality control of spirometry in each EAP randomize into three branches: Supervision from the pulmonary function laboratory of the Hospital ; computer. Program incorporated into automated spirometer. Spirometric usual practice (control group without any support on the quality ). Spirometry EAP participants include year follow-up study . All sites use the same model spirometer and have received the same previous training . In a 2nd phase results implementing the most effective method shown in the 1st phase was studied. EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the quality spirometry. POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early detection (secondary prevention ) , the diagnosis of the severity and developmental control of COPD.

Official Title
-----------------
Effectiveness of Two Methods for Quality Control in Primary Care Spirometry

Conditions
-----------------
Spirometry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients seen in the participating primary care, requiring spirometry for both the diagnosis and control of any disease will be included. Exclusion Criteria: Patients under 15 years

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Spirometry, quality control, Pulmonary Function Laboratory<br>Performing spirometry, with control over the quality of the same, made from the pulmonary function laboratory of the Hospital de la Santa Creu i Sant Pau. | |
| Spirometry, quality control, software<br>Performing spirometry, with the support of software self-management quality of spirometry maneuvers incorporated therein | |
| Spirometry, quality control, control group<br>Performing spirometry in the way that is currently working in primary care (control group without any support). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of two methods for quality control in primary care spirometry |  | Basal |