linjc16/ctgov huggingface dataset:
Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3

Study Overview
=================
Brief Summary
-----------------
Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Detailed Description
-----------------
Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Official Title
-----------------
Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Carboplatin and Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC Stages IB, IIA, IIB, IIIA/T3 Lung function test allowing surgery Age 18-75 years Exclusion Criteria: Poor lung function Performance status 3-4 Mediastinal lymph node involvement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carboplatin and Paclitaxel|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 |
| --- | --- | --- |
| Time to progression |  |  | 
| Complete resection rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small cell lung cancer, neoadjuvant, resection
Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women. II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients. III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years. Participants in the placebo group may be removed from study if bone loss exceeds 5% per year. A study duration of 3 years is anticipated.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: conjugated estrogens
* Drug: Medroxyprogesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Women postmenopausal for at least 2 years At least 10 teeth for which radiographic measurements can be obtained, i.e.: Not severely tilted Not so closely spaced that interproximal bone is thin Not in positions of restricted access

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: conjugated estrogens|nan|
|Drug: Medroxyprogesterone|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
-----------------
disease-related problem/condition, osteoporosis, rare disease
Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.

Detailed Description
-----------------
Continuous glucose monitoring (CGM) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. Successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. This proposal will test the hypothesis that intermittent CGM will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.

Official Title
-----------------
Real-Time Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes

Conditions
-----------------
Weight Loss, PreDiabetes

Intervention / Treatment
-----------------
* Device: CGM
* Other: Dietitian


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight/obese (BMI 25-40 kg/m2) Prediabetes (fasting glucose 100-125 mg/dL and/or HbA1c 5.7-6.4%) Exclusion Criteria: On glucose-lowering medications (e.g., metformin) On weight-loss medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM plus dietitian<br>Intermittent use of a continuous glucose monitor (CGM) plus dietitian support | Device: CGM<br>* Intermittent use of a continuous glucose monitor (CGM)<br>Other: Dietitian<br>* Monthly meetings with a dietitian<br>|
| Other: Dietitian only<br>Dietitian support only | Other: Dietitian<br>* Monthly meetings with a dietitian<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Weight Lost (kg) | Weight lost during the study | Baseline to end of study (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More |  | Baseline to end of study (3 months) |
Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre

Official Title
-----------------
Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Conditions
-----------------
Cleft Lip and Palate

Intervention / Treatment
-----------------
* Procedure: Cleft lip and palate repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborn patients with complete unilateral cleft lip and palate Exclusion Criteria: with associated syndrome previous lip/ palate repair previous presurgical orthopaedics other than passive palatal plate

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cleft lip and palate repair|The intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleft size measurement | Cleft size is measured before and after passive palatal plate therapy | Measured on a model after birth and at surgery with 8 month of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Full primary healing of the former cleft, no fistula formation, no oronasal leaking | 1, 3 and 6 month after surgery | 
| Adverse events | Surgical and anaesthesia-relate adverse events | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cleft lip, cleft palate, cleft lip and palate, orofacial cleft
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.

Detailed Description
-----------------
The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.

Official Title
-----------------
Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma, Primary Liver Cancer, Bile Duct Cancer, Pancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma, Liver Metastases

Intervention / Treatment
-----------------
* Other: Collaborative Care
* Other: Enhanced usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy, radiological, and/or biological evidence of hepatobiliary carcinoma age 18 years or older fluency in English. Exclusion criteria included: Exclusion Criteria: current suicidal or homicidal ideation current psychosis or thought disorder

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention versus standard of care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care Intervention<br>Care coordinator facilitates the assessment and treatment of cancer-related symptoms | Other: Collaborative Care<br>* Collaborative care intervention to manage cancer-related symptoms<br>|
| Active Comparator: Enhanced Usual Care<br>Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated | Other: Enhanced usual Care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Center for Epidemiological Studies-Depression scale | Change from baseline at 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Functional Assessment of Cancer Therapy-Fatigue | Change from baseline at 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma, Cholangio carcinoma, Primary Liver Cancer, Bile Duct CancerPancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma, Other Primary Cancers with Liver Metastases
Spine Registration Using 3D Scanning

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.

Official Title
-----------------
Pre-pilot Study of Spine Registration Using 3D Scanning

Conditions
-----------------
Spinal Fusion, Spinal Stenosis, Scoliosis, Spondylolisthesis

Intervention / Treatment
-----------------
* Device: Optical 3D Scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that require exposure of bony posterior spine anatomy for localization as standard of care. Clinically planned for spine surgery. Able to provide written informed consent from subject or subject's legal representative, using IRB approved consent form, and ability for subject to comply with the protocol requirements of the study. Exclusion Criteria: Language problems that would prevent from properly understanding instructions. Requirement of an interpreter. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study. Special populations: pregnant women, prisoners. Minimally invasive spine surgery that does not expose the necessary bone/s. Spine surgery without posterior exposure.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Optical 3D Scanner|An optical 3D scanner used to register spine anatomy to surgical computer navigation systems.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spine Registration | Closely match the Advanced Scanners optical scan of the partially exposed surface of the patient vertebra to the corresponding patient's preoperative MRI and/or CT scan, thereby learning the position of the rest of the vertebra. This endpoint includes registration of the relevant preoperative MRI or CT scan portion to the portion scanned by Advanced Scanners. | Throughout the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertebral Shift Measurement | Use the intraoperative x-ray (typically O-arm) measurements taken at various times in the procedure to validate the capability of our scanner to determine relative shifts between vertebra as a function of time. | Throughout the surgical procedure | 
| Determination Of Bony Exposure Requirements | Measure the area of the exposed vertebra of registered adjacent segments. Bone regions will be identified in the scan mesh, segmented from the rest of the scan, and their areas determined directly from that surface region by integrating the area of the relevant mesh faces, in units of square millimeters or square centimeters. | Throughout the surgical procedure |
Radial and Focused ESWT in the Treatment of Coccydynia According to Age and Body Mass Index

Study Overview
=================
Brief Summary
-----------------
To date, focused and radial types of ESWT have been effectively used in the treatment of coccydynia. However, studies directly addressing a comparison between radial and focused types of ESWT in coccydynia have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on coccydynia.

Official Title
-----------------
Comparation of Radial and Focused Extracorporeal Shock Wave Therapies According to Age and Body Mass Index in the Treatment of Coccydynia.

Conditions
-----------------
Coccyx Disorder

Intervention / Treatment
-----------------
* Device: ESWT (wave type: focused)
* Device: ESWT (wave type: radial)
* Device: ESWT (wave type: sham)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of coccydynia by clinical examination and X-ray imaging. be aged ≥18 at the time of diagnosis be give informed consent Exclusion Criteria: Malignancy Those who have received ESWT treatment before Pediatric patients Patients with infection.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Focused extracorporeal shock wave therapy<br> | Device: ESWT (wave type: focused)<br>* Extracorporeal Shock Wave Therapy, device: Electronica, Pagani, Italy<br>|
| Active Comparator: Radial extracorporeal shock wave therapy<br> | Device: ESWT (wave type: radial)<br>* Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy<br>|
| Sham Comparator: Sham extracorporeal shock wave therapy<br> | Device: ESWT (wave type: sham)<br>* Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | pain evaluation, higher scores mean a worse outcome. | 1 minute | 
| Oswestry Disability Index | functional status of low back pain, higher scores mean a worse outcome. | 5 minutes |
Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Study Overview
=================
Brief Summary
-----------------
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

Detailed Description
-----------------
The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.

Official Title
-----------------
Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: candidate for primary CRS histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer Exclusion Criteria: history of previous malignancies within 5 years prior to inclusion FIGO stage IV disease complete primary cytoreduction is impossible prior treatment for the current malignancy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled, open-label, multicenter phase III trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional surgery<br>Primary cytoreductive surgery without HIPEC | |
| Experimental: HIPEC<br>Primary cytoreductive surgery with HIPEC with cisplatin | Drug: cisplatin<br>* HIPEC with cisplatin after cytoreductive surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1 year after last patient last visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence-free survival |  | 1 year after last patient last visit | 
| adverse events | toxicity of extra treatment compared standaard treatment | 30 days after end of treatment | 
| cost evaluation | cost evaluation based measured by quality adjusted life year | 1 year after lplv | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, HIPEC, OVHIPEC, primary debulking
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.

Official Title
-----------------
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study

Conditions
-----------------
Time to Progression

Intervention / Treatment
-----------------
* Drug: gemcitabine + cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract signed written informed consent age > 18 WHO PS 0 or 1 at study entry measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria adequate renal (serum creatinin<1.5x upper reference range), liver (total bilirubin<2x upper reference range) and hematopoietic functions (PMN>1,5x109/L, platelets>100x109/L) life expectancy of at least 12 weeks effective contraception throughout the study for both male and female patients if the risk of conception exists Exclusion Criteria: uncontrolled concurrent CNS, cardiac, infectious diseases previous exposure to epidermal growth factor targeting therapy known hypersensitivity to any components of study treatments previous chemotherapy for this cancer previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix pregnancy or breast feeding medical or psychological conditions that would not permit the patient to complete the study or sign informed consent

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 |
| --- | --- |
| Experimental: 1<br>gemcitabine+cetuximab | Drug: gemcitabine + cetuximab<br>* gemcitabine 1g/m² 3weeks/4 cetuximab 400 mg/m² the first week, then 250 mg/m², every week Every cycle is 8 weeks treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival, objective response, safety |  | 12 months |