linjc16/ctgov huggingface dataset:
Microwave Ablation for Leiomyoma

Study Overview
=================
Brief Summary
-----------------
This prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment of symptoms related to uterine fibroids. We will include 200 women.

Official Title
-----------------
Prospective Observational Trial of Microwave Ablation for Leiomyoma (MYOMIC2)

Conditions
-----------------
Uterine Fibroid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premenopausal no future child wish acceptable risks for general anestesia or sedation willing to comply with protocol Exclusion Criteria: current or future child wish bleeding disorder with increased risk of bleeding

Ages Eligible for Study
-----------------
Minimum Age: 25 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 severity of uterine fibroids | Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire. minumum 0, maximum 100 where higher scores indicate higher symptom severity | 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life score | Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire.minumum 0, maximum 100 where higher scores indicate higher quality of life | 6 months post treatment | 
| menstrual bleeding | Score on validated Pictorial Bleeding assessment chart. minimum 1, no maximum. higher scores indicate more bleeding. | 6 months post treatment | 
| acceptability | Answer to question: if you were to recommend the treatment to a friend on a scale from 1-7 where 7 is the highest rating- what would you say. | 2 hours post treatment and 6 months post treatment (+/- 2 weeks) |
NewBreez Safety and Efficacy Evaluation

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.

Official Title
-----------------
Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis

Conditions
-----------------
Swallowing Disorders

Intervention / Treatment
-----------------
* Device: NewBreez ILP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation Must be able to understand and be willing to provide written informed consent Exclusion Criteria: Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device Major swallowing disorder Existing coagulation disorder Previous esophageal stenting Life-expectancy < 12 months Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NewBreez ILP<br>Implantation of a NewBreez ILP | Device: NewBreez ILP<br>* NewBreez ILP implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration score at 1 month | Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Swallowing disorders, Aspiration
Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project

Study Overview
=================
Brief Summary
-----------------
Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.

Official Title
-----------------
Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Imaging study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven colorectal cancer Unresectable stage IV disease K-Ras wild type tumour Patients scheduled to undergo chemotherapy with irinotecan and cetuximab Exclusion Criteria: Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study Poorly controlled diabetes Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection Symptomatic brain metastases Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception

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 |
| --- | --- |
| PET-CT<br>Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab | Other: Imaging study<br>* PET-CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET response on day 7 |  | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6 |  | week 6 | 
| To define the optimal cutoff value of SUVmax and their predictive value |  | at day 7 and week 6 | 
| To explore the test/retest reliability of PET/CT in this setting |  | 2 weeks | 
| To assess the value of PET/CT at day 7 in predicting overall survival |  | up to 1 year | 
| To asses the correlations between biomarkers and PET changes after Cetuximab |  | up to 6 months |
Baby Formula and Health

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.

Official Title
-----------------
Formula - Understanding Nutrition (FUN)

Conditions
-----------------
Pancreas Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers ≥ 19 years of age Singleton birth Healthy Infants Infant between 3-6 months at the time of visit and exclusively fed one of the formulas for a minimum of 3 months Exclusion Criteria: Delivery before 35 weeks Infant birth weight <2500g Infants exhibiting growth faltering (loss of more than 25 percentile points) between 1 month to the time of study visit for either weight or length. Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns. Infant consumption of more than two servings of complementary foods per day before the study visit.

Ages Eligible for Study
-----------------
Minimum Age: 5 Months

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 |
| --- | --- |
| Standard formula<br>Participants receiving intact protein lactose-based formula, exclusively for at least 3 months. | |
| Sensitive<br>Participants receiving intact protein glucose/sucrose- based formula, exclusively for at least 3 months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change in blood glucose | change in blood glucose from fasting to 1 hour post glucose challenge | baseline to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean endogenous insulin secretion | change in mean insulin collected at baseline and 1 hour post glucose challenge | baseline to 1 hour |
Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long. To see if patients feel better while taking Pemetrexed plus Gemcitabine.

Official Title
-----------------
ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

Conditions
-----------------
Mesothelioma

Intervention / Treatment
-----------------
* Drug: Pemetrexed
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mesothelioma that can be treated with chemotherapy Have received no prior chemotherapy for mesothelioma Have at least one measurable lesion Have an adequate performance status Sign an informed consent Exclusion Criteria: Previous treatment with chemotherapy for mesothelioma Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed Treatment with radiation therapy within the last 4 weeks Brain metastasis that is uncontrolled Active infection or other serious condition

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

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|
|Drug: Gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the objective tumor response rate for pemetrexed plus gemcitabine every 21 days in patients with malignant pleural mesothelioma who have not received prior chemotherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess time to objective tumor response for responding patients;To assess duration of response for responding patients;To assess time to treatment failure;To assess time to progressive disease |  |  | 
| To assess progression-free survival;To assess overall survival;To determine toxicities of pemetrexed in combination with gemcitabine in this population |  |  |
Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH

Study Overview
=================
Brief Summary
-----------------
A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. In this study, however, the authors did not trace the above questions due to analytical and methodological deficits. Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals

Detailed Description
-----------------
To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH (5 mg) and its formed glucuronide in healthy individuals in order to improve the possibilities for the assessment of unfitness to drive. For these purposes the following criteria will be studied: THCCOOH Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2) Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc) Formed THCCOOH-glu Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2) Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)

Official Title
-----------------
Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol (THCCOOH) and Its Acyl-glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects

Conditions
-----------------
THCCOOH, Pharmacokinetics, Metabolism, Cannabis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good state of health (physically and mentally) Exclusion Criteria: Any regular drug treatment within the last two months Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life Any acute or chronic illness or clinically relevant findings in the pre-study examination Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions Smoking (regular or irregular) Excessive alcohol drinking (more than approximately 30 g alcohol per day) Positive drug screening especially THC or known or admitted drug abuse

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy<br>healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.

Official Title
-----------------
Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia

Conditions
-----------------
Plasmodium Falciparum Malaria

Intervention / Treatment
-----------------
* Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man and non-pregnant women aged between 15 and 50. P.falciparum mono-infection of at least 1,000 parasites/µl. Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs. Consent from patient obtained. Exclusion Criteria: Pregnancy. Severe P. falciparum malaria . Documented intake of SP or Coartem two weeks or less prior recruitment. Other cause(s) of fever. Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition). History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR corrected clinical and parasitological outcome at day 45 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 
| Clinical recovery |  |  |
Radiotherapy for Malignant Astrocytomas in the Elderly

Study Overview
=================
Brief Summary
-----------------
A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status > 70.

Conditions
-----------------
Primary Brain Tumor, Anaplastic Astrocytoma, Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Drug: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glioblastoma and anaplastic astrocytoma, supratentorial, histologically confirmed Brain CT scan or MRI within 28 days before surgery Age: 70 years or older Karnofsky performance status, 70 or more. Life expectancy over 12 weeks Informed consent Exclusion Criteria: Brain radiotherapy Chemotherapy Severe systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 70 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: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  |  | 
| Quality of life |  |  | 
| Cognitive functions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
malignant gliomas
Diffusion Study on Patients With Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR Imaging in evaluating response to chemotherapy in osteosarcoma.

Detailed Description
-----------------
Dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging have the potential to measure early cellular and vascular changes that occur in response to chemotherapy and could therefore be early predictors of therapeutic response. Aim of our study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR imaging in evaluating response to chemotherapy during the preoperative treatment of osteosarcoma. Patients will undergo dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging before, during and after chemotherapy. Our long-term goal is to use these imaging techniques to develop non-invasive methodologies that would be better predictors of tumor response than the current clinical standard and earlier predictors than histological evaluation of the whole tumor.

Official Title
-----------------
Monitoring the Response of Osteosarcoma Under Neoadjuvant Chemotherapy: The Value of Dynamic Contrast Enhancement and Diffusion-weighted MRI

Conditions
-----------------
Osteosarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of osteosarcoma of all entities Written informed consent of patient Exclusion Criteria: No written informed consent Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia) Severe, active co-morbidity Major medical illnesses or psychiatric impairments
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Osteosarcoma patients<br>Patients with an histologically proven osteosarcoma will be entered into the study. | |

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
-----------------
Osteosarcoma, Response of chemotherapy, Dynamic contrast medium examination, Diffusion-weighted MR imaging