linjc16/ctgov huggingface dataset:
Meniere Disease and Hearing Aids

Study Overview
=================
Brief Summary
-----------------
Patients with unilateral Meniere Disease often a distortion that causes difficulties to provide hearing aids to these patients. Those patients have two main problems: disorders in noise comprehension due to interaural threshold difference and increase in the distortion during dizziness crisis. Due to these problems, some people cannot be fitting with hearing aids because the compression needed is too high or the discomfort in noise is not bearable for patients. Our aim is to evaluate and to propose a way to adjust hearing aids to restore binaural hearing with comfort.

Official Title
-----------------
Meniere Disease and Hearing Aids

Conditions
-----------------
Meniere Disease, Hearing Loss, Sensorineural

Intervention / Treatment
-----------------
* Device: Hearing aids fitting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 y.o Meniere disease as define by the Barany Society Unilateral deafness with a threshold over 50dB Normal ear with a threshold above 30dB Interaural threshold difference of at least 30dB Patient who has already an hearing aids and satisfied with it Exclusion Criteria: Absence of consent of the patient or not able to give it Patient with hearing aids well fitted

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: cohort followed up
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hearing aids fitting|Fitting hearing aids and evaluating the results at 6 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the comprehension in noise | Evaluation with the FrMatrix test of the noise comprehension at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the ear recruitment and the settings of the hearing aids | Correlation between the fowler test and the MPO modifications | 6 months |
Determination of Residual Anticoagulatory Effects of Fondaparinux

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.

Official Title
-----------------
Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux

Conditions
-----------------
Anticoagulant Prophylaxis/Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fondaparinux therapy for at least 3 days Exclusion Criteria: Age < 18 years Hemodialysis

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 |
| --- | --- |
| Fondaparinux Prophylaxis group<br> | |
| Fondaparinux Therapy group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antiXa-levels (peak- and through-levels) |  | between day 3 and day 14 after start of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thromboembolic or bleeding episodes, HIT |  | day 14 after start of therapy |
Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.

Official Title
-----------------
Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction

Conditions
-----------------
Skin Laxity

Intervention / Treatment
-----------------
* Procedure: Neck Liposuction and Ultrasound Treatment
* Procedure: Sham Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 35-60 years old Exhibit mild to moderate neck skin laxity on clinical examination No other serious health problems, including psychiatric illness. Exclusion Criteria: Prior neck surgery or face lift. Bleeding disorders or coagulopathy. Botulinum toxin or filler injections to neck area within past 6 months. Severe neck skin laxity or sagging Other serious medical conditions that in the opinion of the surgeon could compromise safety

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neck Liposuction and Ultrasound Treatment<br>Subject will receive neck liposuction and ultrasound treatment. | Procedure: Neck Liposuction and Ultrasound Treatment<br> <br> |
| Sham Comparator: Sham<br>Subject will receive sham treatment | Procedure: Sham Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in photo ratings at 8 weeks. | Two blinded raters will compare baseline and 8 week photos of subjects that received the combined treatments or the sham treatments. | Baseline and 8 weeks |
Standardized Management of Complex Twins

Study Overview
=================
Brief Summary
-----------------
At present, the incidence of monochorionic twins in all pregnancies is around 3-5‰ worldwide.In 2019, the twin Committee of China Maternal and Child Health Association conducted statistics from 48 medical units all over the country, showing that there were 4,876 cases of monochorionic twins, accounting for 10.2‰ of all pregnancies.In addition to increased incidence of preterm delivery, miscarriage, and maternal complication, the unique placental vascular structure of monochorionic twins is associated with complex fetal complication such as twin-twin transfusion syndrome, selective intraurine growth restriction, twin anaemia-erythrocytosis sequence, twin reversed arterial perfusion sequence, one of twin with dysplasia, twins with single amniotic sac and conjunctions are common. At present, there is no unified standard for the diagnosis and treatment of these complicated twins, and various treatment methods have a great impact on the pregnancy outcome and fetal prognosis.Therefore, the standardized management of complex twins benefits diagnosis and treatment of complex twins and improves fetal prognosis.

Official Title
-----------------
Standardized Management of Complex Twins

Conditions
-----------------
Twins

Intervention / Treatment
-----------------
* Other: standardization management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complex twin disease 18-45 years Exclusion Criteria: single pregnancy normal twin pregnancy
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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: standardization management|Apply standardization management to improve the outcomes of pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized management system of twin pregnancy clinic | S/D score and Apgar score of complex twin pregnancy assessed by clinical doctors | 1 year |
Multi Breath Nitrogen Washout (MBNW) as a Measure of Small Airway Function in Patients With Respiratory Disease

Study Overview
=================
Brief Summary
-----------------
The researchers are investigating a novel technique, the multi breath nitrogen washout technique, to measure airway changes in various respiratory diseases.

Detailed Description
-----------------
It is well documented that there are significant ventilatory changes in respiratory diseases such as cystic fibrosis, asthma and the onset of bronchiolitis obliterans syndrome (BOS) following chronic rejection of lung transplantation. At present, we use measures such as spirometry and lung biopsies to determine the changes of airway function and disease severity. Our aim is to develop a novel technique called the multi breath nitrogen washout (MBNW) which we believe is able to measure the inhomogeneity of ventilation in both the larger airways (conductive region, generation 1 - 16) as well as the smaller airways (acinar region 17 - 23). Our belief is that these measurements are much more subtle than current techniques and will be more sensitive in measuring large and small airway changes in disease. The MBNW can also give us an insight as to which particular zones of the lung are affected in differing respiratory disease. For example, it is believed that BOS begins at the distal portion of the lung (acinar region) and proceeds towards the proximal zone (conductive). However, at present no current techniques can differentiate between damage to the acinar zone and the conductive zone or indeed accurately measure small airway (acinar zone) function. We believe the the MBNW has the capacity to do so.

Official Title
-----------------
Measurements of Inhomogeneity of the Small Airway With Patients With Cystic Fibrosis, Asthma and Bronchiolitis Obliterans Syndrome (Post Transplant) Using the Multi Breath Nitrogen Washout Technique

Conditions
-----------------
Cystic Fibrosis, Asthma, Bronchiolitis Obliterans, Lung Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Doctor diagnosed cystic fibrosis, asthma Lung transplant recipient Exclusion Criteria: Smoke history of less than 10 pack years

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?
-----------------
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
-----------------
MBNW, Ventilation, small airways, Lung Transplant recipients (Bronchiolitis Obliterans syndrome)
Mode of Delivery on Newborn Hearing Test

Study Overview
=================
Brief Summary
-----------------
Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. The effect of the type of delivery to hearing screening is not yet clear. The first automated mode of delivery of babies born in Turkey auditory brainstem response (SAD's), the authors aimed to evaluate the effects of the test results and false positive rate. newborns were evaluated with brainstem response test. The AABR test was performed before patients were discharged. Perinatal and neonatal variables and AABR test results were recorded retrospectively.

Official Title
-----------------
The Effect of Mode of Delivery on Automated Auditory Brainstem Response (AABR) Test

Conditions
-----------------
Hearing Loss, Neonatal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: records of birth process and pregnancy test results of newborns. Exclusion Criteria: newborn; She was in a neonatal intensive care, congenital / chromosomal anomaly, undergoing congenital cmv infection, facial / ear deformity, families with hearing problems, those with hyperbiliromyemia, <12 hours after delivery, maternal infection, dm, recurrent abortion, smoking, plesanta previa,

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| newborn hearing screening results | hearing test results of newborns. The test results will be grouped according to the type of birth. The effect of the type of delivery on hearing test results will be investigated. The relationship between vaginal route and cesarean section and hearing test will be the first results. hearing test results were evaluated separately for the right and left ear as 'passed the test' and 'left test'. | 1 week after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Newborn Hearing Screening, Automated Auditory Brainstem Response, Mode Of Delivery
Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Study Overview
=================
Brief Summary
-----------------
To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.

Official Title
-----------------
Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: Subcutaneous immunotherapy - Recombinant birch pollen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA. Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen) Compliant patients Written consent. Exclusion Criteria: Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA. Patients treated with beta-blockers or under continuous oral corticosteroids. Pregnant women

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

| Intervention/Treatment |
| --- |
|Biological: Subcutaneous immunotherapy - Recombinant birch pollen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of symptom and medication scores. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, major allergen, birch
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.

Official Title
-----------------
A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Conditions
-----------------
Metastases, Cancer

Intervention / Treatment
-----------------
* Drug: ALIMTA
* Drug: folic acid
* Drug: multi-vitamins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic diagnosis of metastatic or locally advanced cancer Prior chemotherapy is allowed Adequate bone marrow, liver and kidney function Exclusion Criteria: Prior treatment with ALIMTA Brain metastasis Pregnancy or breast feeding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALIMTA|nan|
|Drug: folic acid|nan|
|Drug: multi-vitamins|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
-----------------
metastatic cancer, chemotherapy
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Official Title
-----------------
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Restasis, Optive Tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Males or females > 18 years old Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye. Likely to complete all study visits and able to provide informed consent Exclusion Criteria: · Patients using Restasis® for less than 3 months. Known contraindications to any study medication or ingredients Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females. Other active uncontrolled ocular diseases or uncontrolled systemic disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br> | Drug: Restasis, Optive Tears<br>* Restasis and Optive Tears use twice daily more frequently if needed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | 1 yr 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dry eye symptoms |  | 1 yr 3 months |
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The SCOPE-ITSCC Metastases Study

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a low number of SCC in OTR will metastasize.

Detailed Description
-----------------
In a large international multicenter prospective observational study a total number of 1000 OTR (organ transplant recipients) with a histologically proven cutaneous SCC (squamous cell carcinoma) will be included in 10 centers and followed during 2 years to establish the cumulative incidence of metastases in OTR with cutaneous SCC.

Official Title
-----------------
Metastases of Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients. The SCOPE-ITSCC Metastases Study

Conditions
-----------------
Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Other: SCC metastasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Organ-transplant recipients (OTR). Histologically proven cutaneous invasive SCC at time of inclusion Exclusion criteria: Lack of consent. History of metastases of cutaneous SCC

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 |
| --- | --- |
| SCC metastasis<br>organ transplant recipients | Other: SCC metastasis<br>* occurrence of SCC metastasis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCC metastasis detection |  | two years |
Non-Interventional Study of Zoladex in Endometriosis

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open label NIS, which is to assess the efficacy of Zoladex in adjuvant setting after operation in moderate to severe endometriosis patients.

Official Title
-----------------
A Non-interventional Study of Postoperative Treatment With Goserelin Acetate (Zoladex) in Moderate to Severe Endometriosis Patient

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced endometriosis confirmed histologically (r-AFS score III-IV) with conservative laparoscopy or laparotomy. Patient who has the indication of Zoladex and has been prescribed Zoladex according to physician's judgement, irrespective of the inclusion in the study. Patient has been already prescribed Zoladex within 1 month after operation. Exclusion Criteria: Have used hormone treatment prior to 3 months of recruitment. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site). Previous enrolment in the present study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Symptom recurrence rate and total recurrence rate |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 18 months | 
| Zoladex administration time |  | 6 months | 
| Add-back therapy information |  | 18 months |