linjc16/ctgov huggingface dataset:
Sample Size for Multivariate Time-to-event Data

Study Overview
=================
Brief Summary
-----------------
Most of randomized clinical trials (RCT) using time-to-event criteria as the primary endpoint are designed, powered and analyzed based on an hypothetical hazard ratio (HR) corresponding to the targeted effect size between experimental and control arms. Usually, one assumes that populations are homogeneous within each treatment arm, that is, within each arm, (i) the baseline risk is identical for all patients, and (ii) the treatment effect is identical for all patients. This assumption however may not hold in all circumstances. This project aims at providing a statistical method for the estimation of sample size in RCT, in the presence of heterogenous populations, such as assuming populations with distinct underlying baseline risks or assuming different treatment effects.

Official Title
-----------------
Sample Size Determination in Heterogeneous Populations for Multivariate Time-to-event Data

Conditions
-----------------
Clinical Trials

Intervention / Treatment
-----------------
* Drug: intervention treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: not applicable Exclusion Criteria: not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Control arm, i.e., as per standard procedures | |
| Experimental<br>Experimental arm, i.e. investigational product | Drug: intervention treatment<br>* intervention treatment (any)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | time from randomization to death | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sample size, survival, randomized clinical trials, statistical test
Characterization of Blood Drawn From the Pulp of Primary Molar Undergoing Pulpotomy or Pulpectomy.

Study Overview
=================
Brief Summary
-----------------
Following medical history and clinical examination the children which are scheduled for treatment with suspected pulpary involved primary teeth will be selected. During the regular treatment if a pulp of primary teeth is opened and before the regular pulpotomy procedure is performed the blood that is flowing out of the pulp will be collected and stored until analyzed for the present of inflammatory markers. Clinical and radiographic evaluation will be obtained in follow up appointments if the child will remain in regular treatments in our clinic.

Conditions
-----------------
Inflammatory Markers, Pulpotomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pulpal involved primary teeth with a vital pulp of which a certain amount of blood can be obtained. Exclusion Criteria: systemic disease pulp necrosis permanent teeth

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 13 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 |
| --- | --- |
| pulpotomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of specific inflammatory markers |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulpotomy failure |  | 1 year |
Non-Linear Imaging of Skin In Vivo

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to investigate the potential for Enspectra Investigational Device to display microscopic skin structure in people of different age, sex, race, and skin health.

Official Title
-----------------
Non-Linear Imaging of Skin In Vivo

Conditions
-----------------
Skin Cancer

Intervention / Treatment
-----------------
* Device: Vio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects, ages 2 - 90 years old. Subject, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements. Subject or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device. Subject and guardian, if applicable, must comply with the protocol requirements. Subject or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies. Exclusion Criteria: Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne) Any known allergies to any materials used in the preparation of skin and/or device use Has a temporary or permanent electrical implanted medical device -

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vio|Feasibility study looking at different types of healthy skin as well as skin with suspected skin conditions using Enspectra's skin imaging investigational device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging Performance | Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma | 1 hour | 
| Image Quality | Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type. | 1 hour |
Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Study Overview
=================
Brief Summary
-----------------
Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are commonly used for autologous hematopoietic transplants. PBSCs are also now being used for some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors. However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and the effects of filgrastim on healthy individuals. The purpose of this study is to determine the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving unrelated donors and to determine the effects of this donation process on unrelated stem cell donors.

Detailed Description
-----------------
This study establishes and evaluates a system to supply peripheral blood stem cell (PBSC)products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The protocol describes processes for donor identification, education and evaluation. Procedures for administration and monitoring of the stem cell mobilizing agent filgrastim are included. The study also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for indefinite donor follow-up.

Official Title
-----------------
Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Healthy adults Exclusion Criteria: Pregnancy or uninterruptible breastfeeding. Sensitivity to filgrastim or to E. coli-derived recombinant protein products. History of autoimmune disorders, including rheumatic disease and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable. History of deep vein thrombosis or pulmonary embolism. Thrombocytopenia <150 x 10(9)/L (<150,000/uL) at baseline evaluation. Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been full evaluated. Positive Hemoglobin-Solubility (e.g. SickleDex or equivalent) test. Donors receiving experimental therapy or investigational agents.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral blood stem cells, filgrastim-mobilized, allogeneic transplantation, Unrelated Donors for allogeneic transplantation
Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Study Overview
=================
Brief Summary
-----------------
This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.

Official Title
-----------------
Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer

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

Intervention / Treatment
-----------------
* Drug: Dacomitinib
* Drug: PD-0325901
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological proof of advanced non-small cell lung cancer Written documentation of KRAS (exon 2, 3 or 4) mutation At least 18 years of age or older Able and willing to give written informed consent WHO performance status of 0 or 1 Exclusion Criteria: Symptomatic or untreated leptomeningeal disease Symptomatic brain metastasis Impairment of gastrointestinal function Uncontrolled infectious disease Left ventricular ejection fraction < 50% Retinal degenerative disease or with history of uveitis, retinal vein occlusion or retinal detachment Other protocol-defined inclusion/exclusion criteria may apply

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: Dacomitinib + PD-0325901<br>Dacomitinib: oral tablets PD-0325901: oral capsules | Drug: Dacomitinib<br> <br> Drug: PD-0325901<br> <br> Drug: Docetaxel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of dose-limiting toxicities |  | 1.5 years | 
| Progression free survival |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | 2.5 years | 
| Plasma concentration |  | 2.5 years | 
| Overall response rate |  | 2.5 years | 
| Duration of response |  | 1.5 years | 
| Time to response |  | 2.5 years | 
| Overall survival |  | 3 years |
Clinical Study of Intermittent Positive Pressure Breathing (IPPB)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of long-term intermittent positive pressure breathing (IPPB) treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic obstructive pulmonary disease. The evaluation compared the use of IPPB with use of a powered nebulizer.

Detailed Description
-----------------
BACKGROUND: Intermittent positive pressure breathing may be a useful adjunct therapy for patients with chronic obstructive pulmonary disease. It is, however, quite expensive; moreover, in 1976 its treatment efficacy had not been determined. Although the effectiveness of IPPB had been previously studied, the influence of long-term treatment was not known for the following reasons: The individuals studied had been too few and were not randomly assigned to treatment groups, the patient groups were not homogeneous and their clinical and functional status were not well-documented, and precise descriptions of the manner in which IPPB was administered were not recorded. Based on these facts, a conference on the Scientific Basis of Respiratory Therapy, co-sponsored by the American Thoracic Society and the Division of Lung Diseases, issued a recommendation to develop a controlled clinical study of IPPB. Contracts were awarded to five clinical centers and a data center in November 1976. Planning of the trial ended in November 1977. Recruitment began in April 1978 for the 985 individuals who took part in this trial and ended in October 1980. Patients enrolled after March 31, 1980, were followed for 30 months instead of 36 months. Follow-up was completed in May 1983. DESIGN NARRATIVE: Randomized, fixed sample of 985 patients. Eligible patients were assigned to a treatment group using intermittent positive pressure breathing or to a control group using a powered nebulizer for treatment 3-4 times a day. Treatments continued for 3 years. Endpoints related to quality of life and respiratory function and capability.

Conditions
-----------------
Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: intermittent positive-pressure breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intermittent positive-pressure breathing|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Early Prediction of Sepsis in ICU

Study Overview
=================
Brief Summary
-----------------
Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.

Official Title
-----------------
The Early Prediction of Sepsis Occurrence in ICU

Conditions
-----------------
Prediction of Sepsis in Critical Patients

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who met all of the following criteria were included in the case group: At least 14 years old. Sepsis onset at least 5 hours after ICU admission. Sepsis onset is the first instance since admission to the hospital. Exclusion Criteria: Patients meeting all of the following criteria were included in the control group: At least 14 years old. Patients staying in ICU for at least 5 hours and have not had sepsis in this time. Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92). SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| non-sepsis<br> | Other: no intervention<br>* no intervention<br>|
| sepsis<br> | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| confidence index of sepsis occurrence |  | sepsis occurrence in five hours |
Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients

Study Overview
=================
Brief Summary
-----------------
Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients

Detailed Description
-----------------
To find out the better type of intevention in Static Stretching and Deep Kneading Massage for the betterment of Plantar Fasciitis Patients

Official Title
-----------------
Comparison of Static Stretching and Deep Kneading Massage Among Plantar Fasciitis Patients

Conditions
-----------------
Plantar Fasciitis

Intervention / Treatment
-----------------
* Behavioral: Static Stretching
* Behavioral: Deep Kneading Massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A person with phytoplitis by a doctor, physiotherapist or orthopedic surgeon. Determine the patient's age between 40 and 60 years. The patient's fracture, fracture, most cancers and various metabolism disorders are not used. Male and female victims can be involved. Exclusion Criteria: Inflammatory arthritis patients. Nerve distortions Another disease caused in the case of March. Patients with various basic muscle problems and the effects of red science Does not use the patient's latest records and footprint.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Static Stretching Among Plantar Fasciitis Patients<br>Using Static Stretching exercises | Behavioral: Static Stretching<br>* Using Static Stretching exercises<br>|
| Experimental: Deep Kneading Massage Among Plantar Fasciitis Patients<br>Using Deep Kneading Massage technique | Behavioral: Deep Kneading Massage<br>* Using Deep Kneading Massage technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static Stretching Among Plantar Fasciitis Patients | 32 participants in Static stretches are those in which you stand, sit or lie still and hold a single position for a period of time, up to about 45 seconds with Visual Analogue Scale | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep Kneading Massage Among Plantar Fasciitis Patients | 32 participants in Deep-kneading massage is a technique which is used in relaxing relieving muscle strain and neck, back, shoulder, abdominal, leg and foot pain with Foot and Ankle Ability Measure (FAAM) | 6 Months |
Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution

Study Overview
=================
Brief Summary
-----------------
This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA). About 24 subjects will take part in this study. Each subject's participation in this study will last for about 10 weeks. During this study, each subject will receive 3 different types of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA oral solution. In addition, information will also be learned about the safety and tolerability of these dosage forms given to healthy postmenopausal women.

Official Title
-----------------
An Open-label, Single-dose, Randomized-to-sequence, 4-period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women.

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Drug: bazedoxifene/conjugated estrogens combination tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day) Postmenopausal women aged 35 to 70 years At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL Women 55 years of older must have at least 12 months of amenorrhea Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg Exclusion Criteria: A history or active presence of clinically important medical disease. History or alcoholism or drug abuse within 1 year before study start. Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bazedoxifene/conjugated estrogens combination tablet|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
-----------------
Health