linjc16/ctgov huggingface dataset:
Assessment of Functional Ability and Follow-up at Home for Older Medical Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effect of an intervention that consist of assessment of functional ability, rehabilitation plan and follow-up at home for older medical patients. The hypothesis is that assessment of functional ability, development of rehabilitation plan and follow-up at home reduce the older medical patient's risk of readmission. Also the intervention is expected to reduce mortality, number of contacts to general practitioners and emergency physician

Official Title
-----------------
Assessment of Functional Ability and Follow-up at Home for Older Medical Patients

Conditions
-----------------
Geriatric Disorder

Intervention / Treatment
-----------------
* Other: Assessment of functional ability and follow-up at home


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to Medical Visitations Section (MVA) Aarhus University Hospital Aged 65+ Resident in City of Aarhus Exclusion Criteria: Patients admitted from nursing home Patients transferred to other hospital departments Patients terminally ill

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Usual care | |
| Experimental: Assessment of functional ability<br>Assessment of functional ability and follow-up at home | Other: Assessment of functional ability and follow-up at home<br>* Assessment of functional ability and follow-up at home<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission |  | Readmission in 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission |  | Readmission in 30 days | 
| Mortality |  | Mortality in 26 weeks | 
| Number of contacts with GP |  | 26 weeks | 
| Number of contacts with emergency Physician |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute care, older medical patients, Functional assessment, readmission
Pilot Study Investigating the Use of the ReBuilder to Treat Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of the ReBuilder in the treatment of individuals with breast cancer and chemotherapy induced peripheral neuropathy.

Conditions
-----------------
Peripheral Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with breast cancer referred to Physical Therapy for CIPN Physical Therapy Examination indicates use of Rebuilder for CIPN At least 18 years of age Signed informed consent for study population Willingness to complete study according to protocol Exclusion Criteria: Patients who do not have CIPN Patients <18 years of age Inability to or unwilling to sign informed consent Unable to read and understand the English language Preexisting sensory peripheral neuropathy from other comorbid conditions such as diabetes or alcoholism More than three (3) prior ReBuilder treatments; OR ReBuilder within the last 30 days, for sensory peripheral neuropathy

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in touch and sensory by way of change in the Semmes-Weinstein Monofilament Testing |  | one year | 
| Changes in touch and sensory by way of changes in Functional Gait Assessment |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ReBuilder, breast cancer, chemotherapy induced
Ankle Fracture Treatment in the Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to track surgical outcomes and post-operative course in patients 55 years of age or older treated for ankle fractures.

Detailed Description
-----------------
This study seeks to describe and track surgical outcomes associated with the use of a minimally invasive surgical technique used to treat ankle fractures in at-risk patients 55 years of age or older

Official Title
-----------------
Ankle Fracture Treatment in the Elderly, at Risk Population

Conditions
-----------------
Ankle Fracture

Intervention / Treatment
-----------------
* Other: Fracture union


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 55 years of age at time of surgery receiving treatment for ankle fractures Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- |
| Ankle Fracture<br>Patients aged 55 years at time of surgery undergoing treatment for ankle fractures. | Other: Fracture union<br>* Retrospective records review post-operatively until fracture resolved.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of Fracture Union | Retrospective records review tracking ankle fractures post-operatively until fracture heals. | Post-operatively until documentation of fracture healing, assessed up to seven months following surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Complications | Retrospective record review tracking complications post-operatively until resolved. | Post-operatively until documentation that complications resolved, assessed up to seven months following surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle, Fracture, Elderly, At-risk Population, Ankle Fracture in at-risk elderly population
Comparison of Three Techniques for Analgesia After Abdominoplasty

Study Overview
=================
Brief Summary
-----------------
This study was conducted to demonstrate post-abdominoplasty analgesic duration consequent to three different surgically infiltrated LA techniques; bilateral TAPB, bilateral RSB and subcutaneous infiltration using the same volume of 0.25% bupivacaine (40 ml). Pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were also recorded.

Official Title
-----------------
The Efficacy of Three Different Surgically Infiltrated Local Anesthetic Techniques in Abdominoplasty

Conditions
-----------------
Abdominoplasty Patients

Intervention / Treatment
-----------------
* Drug: Transevrsus abdominus plane block
* Drug: Rectus sheath block
* Drug: local anesthesia infiltartion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients listed for abdominoplasty Exclusion Criteria: allergy to bupivacaine

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transevrsus abdominus plane block group<br> | Drug: Transevrsus abdominus plane block<br>* a blunt needle was advanced in the midaxillary line to reach the fascial layer between the internal oblique and transverse abdominis muscles detected by facial click sensation. The LA was slowly injected so as to detect any sign of toxicity or incorrect needle tip position (as resistance) requiring needle repositioning then TAPB was repeated on the opposite side.<br>|
| Active Comparator: Rectus sheath block group<br> | Drug: Rectus sheath block<br>* In RSB group, 2-3 cm from midline, about 3-5 cm above the umbilicus, the needle was advanced at right angle to the skin. The needle reaches the space between the posterior layer of the rectus sheath and rectus abdominis muscle detected by firm resistance of the posterior wall, The LA was slowly injected then the same steps were repeated on the other side.<br>|
| Active Comparator: local infiltration group<br> | Drug: local anesthesia infiltartion<br>* 40 mls of 0.255 bupivacaine will be infiltrated at skin incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption (mg) | postoperative morphine consumption in milligrams in the 1st 24 hours postoperatively | up to 24 hours |
Role of Gut Microbiome in Cancer Therapy

Study Overview
=================
Brief Summary
-----------------
This study examines how gut microbiome can affect cancer therapy in cancer patients undergoing cancer therapy or stem cell transplant. The human microbiome affects the way some cancer drugs are metabolized in the human body. Information from this study may help doctors improve the way cancer treatment is delivered, and increase its effectiveness and success.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To correlate gut microbiome with specific cancer diagnoses and the clinical response (efficacy), and adverse effects of cancer therapy (single or multiple) and stem cell transplant. OUTLINE: Patients undergo collection of blood and stool samples and have their medical records reviewed.

Official Title
-----------------
Role of Gut Microbiome in Cancer Therapy

Conditions
-----------------
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection
* Other: Electronic Health Record Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-99 Diagnosis of cancer and undergoing cancer therapy or scheduled to start cancer therapy or undergoing stem cell transplant for any hematological condition Exclusion Criteria: Unable to provide informed consent Vulnerable adults

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Observational (biospecimen collection, medical record review)<br>Patients undergo collection of blood and stool samples and have their medical records reviewed. | Procedure: Biospecimen Collection<br>* Undergo collection of blood and stool samples<br>* Other names: Biospecimen Collected;Other: Electronic Health Record Review<br>* Review of medical records<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiome associations with cancer diagnoses | Will be done using Shogun pipeline for metagenomics data followed by analysis using QIIME 2.0. | Through study completion, average of 1 year | 
| Associations between microbial community abundances and clinical outcomes | Will use a linear multivariate regression model specifically developed for microbiome data (MaAsLin, Multivariate microbial Association by Linear models. | Through study completion, average of 1 year |
Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling

Study Overview
=================
Brief Summary
-----------------
X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens.

Official Title
-----------------
Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling (GPS)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: X-ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females of all races and ethnicities ≥ 18 years of age Must be scheduled for breast cancer surgery which includes a sentinel lymph node biopsy and/or axillary dissection Exclusion Criteria: • Any person whose final pathology could be compromised in any way by the X-ray procedure

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 |
| --- | --- |
| Surgery followed by x-ray assessment<br>After nodes are removed they are taken to radiology to be x-rayed | Procedure: X-ray<br>* surgical specimen taken to radiology and contents x-rayed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of lymph nodes | To determine if plain x-ray films obtained from the sentinel node/axillary dissection specimen can facilitate the identification of the lymph nodes and increase the average number of lymph nodes recovered by the pathologist. | Within the first 30 minutes after specimen is removed from the body | 
| Identification of affected area in node | To determine whether plain x-ray films obtained from the sentinel node/axillary dissection specimen can help direct the pathologist to the correct part of the node (the portion containing disease) to sample. | Within the first 30 minutes after specimen is removed from the body | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sentinel lymph node dissection, radiology, X-ray identification of nodes in a surgical specimen
Conservative Treatment of Proximal Humeral Fractures

Study Overview
=================
Brief Summary
-----------------
Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?

Detailed Description
-----------------
There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.

Official Title
-----------------
Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study

Conditions
-----------------
Shoulder Fractures

Intervention / Treatment
-----------------
* Procedure: conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 60 yo and < 85 yo Acute fractures less than 1 week evolution Conservative treatment decided by orthopedic surgeon Contact between humeral head and humeral shaft. No gleno-humeral dislocation No previous surgery Exclusion Criteria: Cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 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
Interventional Model Description: prospective randomized without restrictions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-week<br>patients undergoing 1-week immobilization period | Procedure: conservative treatment<br>* immobilization on sling of the injured arm<br>|
| Experimental: 3-week<br>patients undergoing 3-week immobilization period | Procedure: conservative treatment<br>* immobilization on sling of the injured arm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain (analogical pain scale) | pain assessment through all the follow-up through the analogical pain scale | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fragment displacement assessed through X-Ray exam | displacement of the fractured fragments within 3 months period assessed through X-Ray exam | 3 months | 
| functional outcome | functional outcome measured through Constant Score | 1 year |
Efficacy of Pre- and Post-Operative Oral Dextromethorphan

Study Overview
=================
Brief Summary
-----------------
We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo (P)

Detailed Description
-----------------
One hundred patients were randomized to two groups. Group DEX was given 30 mg tablets of oral dextromethorphan with their pre-medication and three more times in the first 24 hours after surgery. Group P received the placebo following the same schedule. Post-operative analgesic requirements were assessed using a patient-controlled analgesia system. Pain was assessed at rest using a visual analog scale in the post anesthetic care unit(PACU), 6 and 24 hours after surgery.

Official Title
-----------------
Efficacy of Pre- and Post-Operative Oral Dextromethorphan for Reduction of Intra- and 24-Hr Post-Operative Morphine Consumption for Transabdominal Hysterectomy

Conditions
-----------------
Efficacy of Dextromethorphan, Morphine Consumption, Pain

Intervention / Treatment
-----------------
* Drug: pre-operatively followed by 30 mg three times per day after surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged between 30 and 60, with an ASA physical status of I or II, undergoing elective total abdominal hysterectomy under general anesthesia. Exclusion Criteria: Women with a history of significant renal or hepatic impairment, allergy to any of the study medications, antitussive or NSAID use (48 hours or 1 week, respectively) before surgery, chronic pain and regular analgesic use, were excluded. Patients taking medications that could interact with dextromethorphan, including quinidine, flecainide, mexiletine, fluoxetine, amitriptyline, nortriptyline, and propafenone

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pre-operatively followed by 30 mg three times per day after surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean morphine consumption |  |  | 
| Mean pain score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NMDAreceptor antagonist, dextromethorphan, pain, post-operative, opioid consumption, morphine
A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).

Detailed Description
-----------------
The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the safety of Xigris by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death.

Official Title
-----------------
A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis

Conditions
-----------------
Sepsis, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Infection

Intervention / Treatment
-----------------
* Drug: Drotrecogin Alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have Leukemia, Lymphoma or Myeloma. Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days. Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure. Participants must be on a breathing machine or require medication to maintain their blood pressure. Exclusion Criteria: Participants must not have increased bleeding risk due to medical conditions or medications.

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: 1<br>24 microgram/kg/hr for 96 hours (+ or - 1 hour) | Drug: Drotrecogin Alfa (activated)<br> <br> * Other names: Xigris;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 10 months | 
| Bleeding incidence |  | 10 months |