linjc16/ctgov huggingface dataset:
Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

Study Overview
=================
Brief Summary
-----------------
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Detailed Description
-----------------
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Official Title
-----------------
Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

Conditions
-----------------
Breast Cancers, Ovarian Cancers

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over. Woman with or without breast cancer or ovarian cancer at baseline. Man with or without breast cancer at baseline. Signed consent to participation Affiliation to a social security regimen, or beneficiary of such a regimen. Exclusion Criteria: A person of legal age subject to a legal protection measure, or unable to express consent. Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subjects carrying a BRCA gene mutation<br>subjects carrying a BRCA gene mutation | Other: Questionnaires<br>* standardized data collection and 10-year prospective follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of breast and / or ovarian cancer during subject lifetime | risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events). | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BRCA gene mutation
A Double Blind Clinical Trial of DCS for Food Anxiety

Study Overview
=================
Brief Summary
-----------------
This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.

Detailed Description
-----------------
This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.

Official Title
-----------------
A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa

Conditions
-----------------
Anorexia and Bulimia Nervosa

Intervention / Treatment
-----------------
* Drug: Placebo vs Setraline
* Drug: Setraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified Exclusion Criteria: Pregnant or planning on becoming pregnant Psychotic or Manic

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Setraline<br>250 mg DCS (setraline) versus placebo plus exposure | Drug: Setraline<br>* 250mg DCS<br>|
| Placebo Comparator: placebo<br>Placebo group plus exposure | Drug: Placebo vs Setraline<br>* Placebo<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition. Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced. | Twice a week for two weeks | 
| Body Mass Index | BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome. | twice a week for two weeks and at initial assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia, Bulimia, Anxiety, Exposure
Darbepoetin Alfa in Patients With Poor Prognosis Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)

Study Overview
=================
Brief Summary
-----------------
The aim is to determine the frequency of RBC transfusion in patients with metastatic poor prognosis germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa

Official Title
-----------------
Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic Poor Prognosis Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)

Conditions
-----------------
Dysgerminoma

Intervention / Treatment
-----------------
* Drug: Darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Poor prognosis according IGCCCG-criteria: Primary mediastinal tumor Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung Poor marker: AFP > 10.000 ng/ml or beta-HCG > 10.000 ng/ml (50.000 IU/l) andd LDH >10 x upper normal limit No previous chemotherapy Age > 18 years Performance-Status: WHO =< 2 Written informed consent Ability to give informed consent Exclusion Criteria: Hemolysis Hematological disease with insufficient erythropoiesis Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency Uncontrolled arterial hypertension Treatment with rh-Erythropoetin during trial Creatinin clearance < 50 ml/min Insufficient bone marrow function (WBC count < 3.000/ml or platelets < 100.000/µl) Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease Second malignancy, except of completely resected basal cell carcinoma of the skin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Darbepoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of transfusions (reduction from 90% to 65%) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with no transfusions |  |  | 
| developing of hemoglobin levels |  |  | 
| objective remission rate |  |  | 
| progression-free- and overall-survival (pfs, os) |  |  | 
| quality of life |  |  |
Prevalence of Facial Asymmetry Among Orthodontic Patients

Study Overview
=================
Brief Summary
-----------------
To estimate the prevalence of facial asymmetry

Detailed Description
-----------------
The objectives of the present study are: To estimate the prevalence of facial asymmetry among Egyptian population, according to type, sex, and age. To provide an insight into the key aspects to be taken into consideration while accomplishing an accurate diagnosis and formulation of rational integrated orthodontic-surgical treatment plan that considers correction of all aspects of the asymmetry.

Official Title
-----------------
Prevalence of Facial Asymmetry Among PreOrthodontic Adult Patients: A Crosssectional Retrospective Study

Conditions
-----------------
Facial Asymmetry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18-40 years old of both sexes who asked for orthodontic treatment Exclusion Criteria: • No previous orthodontic treatment. photographs of poor quality. Any hereditary diseases or syndromes such as Down's syndrome or cleidocranial dysostosis. Any disease of the jaw that might have affected the normal growth of permanent dentition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| 18-40 years old of both sexes<br>patient from 18 to 40 years old seeking orthodontic treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of facial asymmetry | chin deviation,deviation of the nasal pyramid and degree of occlusal plane cant and the relation between each type and existing malocclusion. | Just before the orthodontic treatment |
Patient-Reported Outcomes in Adults With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the differences in perceived health, psychosocial functioning, behavioral outcomes and quality of life of adults with congenital heart disease who are living in different areas of the world, and how these differences can be understood (e.g., differences in sense of coherence or illness perceptions).

Official Title
-----------------
Assessment of Patterns of Patient-reported Outcomes in Adults With Congenital Heart Disease - International Study

Conditions
-----------------
Heart Defects, Congenital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with congenital heart disease, defined as: a gross structural abnormality of the heart or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and severe heart defects) 18 years of age or older Diagnosed under the age of ten, i.e. before adolescence Continuing follow-up at an adult congenital heart disease center or included in a national/regional registry Physical, cognitive, and language abilities to complete self-report questionnaires Exclusion Criteria: Prior heart transplantation Isolated pulmonary hypertension Syndromes affecting cognitive abilities

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 |
| --- | --- |
| Adults with congenital heart disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported health status (EuroQol-5D) |  | Baseline | 
| Patient-reported psychosocial functioning (Hospital Anxiety and Depression Scale) |  | Baseline | 
| Patient-reported behavioral outcomes (Health Behavior Scale - Congenital Heart Disease) |  | Baseline | 
| Patient-reported quality of life (Linear Analog Scale Quality of Life;Satisfaction with Life Scale) |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported sense of coherence (Sense of Coherence scale 13 items) |  | Baseline | 
| Patient-reported illness perceptions (Brief Illness Perception Questionnaire) |  | Baseline | 
| Patient-reported socio-demographic variables (e.g. age, educational level) |  | Baseline | 
| Medical variables by chart review (e.g. cardiac surgeries, frequency of follow-up) |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart defects, congenital, Patient-reported outcomes, Health status, Factors, psychosocial, Health behavior, Quality of life, Sense of coherence, Illness perceptions, Depression, Anxiety
Evaluation of Corneal Epithelial Thickness Mapping

Study Overview
=================
Brief Summary
-----------------
Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.

Official Title
-----------------
Evaluation of Corneal Epithelial Thickness Mapping

Conditions
-----------------
Dry Eye and Contact Lens Wear

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Able and willing to provide consent Able and willing to complete the required examinations DRY EYE GROUP ONLY: Clinical diagnosis of dry eye CONTACT LENS GROUP ONLY: Regular contact lens wear Exclusion Criteria: History of ocular surgery History of laser refractive surgery History of cataract surgery DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye CONTACT LENS GROUP ONLY: Corneal pathology including dry eye NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dry Eye<br>clinical diagnosis of dry eye | |
| Contact Lens<br>routine wear of contact lens | |
| Normal<br>Not having history of dry eye or contact lens wear or corneal pathology or surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal epithelial thickness |  | Day 1 |
Early Rehabilitation of Patients With Posttraumatic Amnesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if a systematic intervention with early identifying of patients with posttraumatic amnesia using a reality orientation therapy can reduce the period with posttraumatic amnesia in order to get a better outcome for patients with traumatic brain injury

Detailed Description
-----------------
A systematic review with the latest investigation and treatment of patients with posttraumatic amnesia Investigate the effect of a systematic nursing programme on the length of posttraumatic amnesia Investigate the effect of a systematic nursing programme after 12 month Describe perspectives for the future within the early rehabilitation of patients with posttraumatic amnesia

Official Title
-----------------
Early Rehabilitation of Patients With Posttraumatic Amnesia. A Clinical Controlled Investigation of the Effect of a Nursing Programme in Patients With Traumatic Brain Injury in the Acute Care

Conditions
-----------------
Amnesia

Intervention / Treatment
-----------------
* Behavioral: Reality Orientation
* Behavioral: Reality Orientation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should be able to speak and understand danish Patients with traumatic brain injury A verified brain injury at the CT scanning Exclusion Criteria: Patients with medical illness Patients with other neurological illness Patients with neuroinfections meningitic, encephalitic Patients who does not understand and speaks danish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Reality Orientation|Two matched groups of patients diagnosed with TBI are selected from two university hospitals. In addition to conventional treatment, patients in one group are introduced to a reality- orientation programme consisting of systematic orientation, information, and systematic cooperation with the patient´s relatives.Patients in the other group receive conventional treatment only. All patients are tested on a daily basis in accordance with the RLAS and the GOAT test.|
|Behavioral: Reality Orientation|A quasiexperimental study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS |  | 12month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Posttraumatic amnesia, Early intervention, A systematic nursing programme in the ICU, Early identification of patients with posttraumatic amnesia
Serum Preptin and Amylin Levels in Polycystic Ovary Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
Preptin and amylin are pancreatic hormones which participate in glucose homeostasis. This study aims to evaluate how serum preptin and amylin levels are altered in polycystic ovary syndrome (PCOS) patients and healthy women based on BMI groups .

Detailed Description
-----------------
Materials and Methods: This is a cross-sectional review of 40 PCOS patients and 40 healthy women who were matched with respect to BMI (<25 kg/m2 and ≥25 kg/m2).

Official Title
-----------------
Serum Preptin and Amylin Levels With Respect to Body Mass Index in Polycystic Ovary

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: preptin and amylin level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients with PCOS Exclusion Criteria: Cushing's syndrome 21-hydroxylase deficiency Congenital adrenal hyperplasia Thyroid dysfunction Hyperprolactinemia Diabetes Chronic cardiovascular Hepatic, renal, and hematologic diseases Malignancies Using oral contraceptives, anti-androgens, glucocorticoids, anti-hypertensives, anti-diabetics, calcium supplements and anti-obesity drugs and those who smoke or consume alcohol -

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 35 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 |
| --- | --- |
| Polycyctic ovary sendrome (PCOS)<br>these women who have PCOS, we will use their blood samples | Diagnostic Test: preptin and amylin level<br>* we will take both of group blood samples to compare them serum preptin and amylin<br>|
| Healty groups<br>These women who have reguler menstrual cycle, no akne or hirsutism, we will use their boold samples | Diagnostic Test: preptin and amylin level<br>* we will take both of group blood samples to compare them serum preptin and amylin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Preptin and Amylin Levels with Respect to Body Mass Index in Polycystic Ovary Syndrome Patients | Serum Preptin and Amylin Levels will compare between groups | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amylin; obesity; polycystic ovarian syndrome; preptin
Characterization of Vascular Effects of Angiotensin II in Dorsal Human Hand Veins.

Study Overview
=================
Brief Summary
-----------------
The hypothesis is tested that stimulation with angiotensin II after blockade of the AT1-receptor results in venodilation in human healthy subjects in vivo.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: irbesartan (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: any relevant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irbesartan (drug)|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
-----------------
AT1-receptor, AT2-receptor, human pharmacology