linjc16/ctgov huggingface dataset:
Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes

Study Overview
=================
Brief Summary
-----------------
To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.

Official Title
-----------------
Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes

Conditions
-----------------
Postoperative Cognitive Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Between 60 to 85 years old; Undergoing non-cardiac and non-neurological surgery under general anesthesia; Expected hospital stay ≥5 days; American Society of Anesthesiologists class I or II. Exclusion criteria: Mental or neurodegenerative diseases; History of severe trauma or surgery within one year; History of nasal or sinus illness or surgery; Cold or influenza within 3 weeks; Significant history of organ dysfunction; Previous neuropsychological testing; Difficulty to perform tests (including severe visual or auditory disorders); Mini-Mental State Examination (MMSE) <24 points, <20 points if the participant only attended elementary school, or <17 points if the participant did not go to school.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 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 |
| --- | --- |
| study group<br>300 male and female patients undergoing non-cardiac surgery are enrolled at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. Patients will be divided into POCD and non-POCD groups according to the scores of neuropsychological tests. | |
| control group<br>30 healthy volunteers are enrolled for calculating the Z-scores of study group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the neuropsychological test battery to measure cognitive function |  | 1 day before surgery(baseline) | 
| olfaction test to measure the sense of smell |  | 1 day before surgery(baseline) | 
| the neuropsychological tests to measure cognitive function |  | within 5 to 10 days (average of 7 days) after surgery | 
| olfaction test to measure the sense of smell |  | within 5 to 10 days (average of 7 days) after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-cardiac surgery, Postoperative Cognitive Dysfunction
Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.

Official Title
-----------------
An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas

Conditions
-----------------
Pancreatic Cancer, Neoplasm Metastasis, Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: talabostat mesylate tablets
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women age ≥18 years Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas Measurable disease defined per RECIST Karnofsky Performance Status ≥50 Expected survival ≥12 weeks Provide written informed consent Exclusion Criteria: CNS metastases Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer Radiation therapy to >25% of the bone marrow Clinically significant laboratory abnormalities Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry. Pregnancy or lactation

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: talabostat mesylate tablets|nan|
|Drug: gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 
| progression-free survival (PFS) |  |  | 
| quality of life |  |  | 
| pain |  |  | 
| performance status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, cancer of the pancreas, adenocarcinoma of the pancreas, pancreatic neoplasms, Metastatic pancreatic cancer (Stage IV), Stage IV Adenocarcinoma of the Pancreas
Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of Neotrofin to Treat Patients With Sensory or Motor Neuropathy Caused by Chemotherapy for Cancer

Conditions
-----------------
Peripheral Nervous System Diseases, Chemotherapy-Induced Peripheral Neuropathy

Intervention / Treatment
-----------------
* Drug: leteprinim potassium (Neotrofin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient must have diagnosis of cancer and be receiving or have received chemotherapy that has resulted in sensory or motor neuropathy. Sensory or motor neuropathy must be >/= grade 2 per Common Toxicity Criteria at baseline. In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is acceptable. Patient must have normal hematological cell counts. Patient must have a life expectancy of >/= 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leteprinim potassium (Neotrofin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects Of Calisthenic Exercises On Physical Fitness Among School Going Children

Study Overview
=================
Brief Summary
-----------------
The study will be conducted to determine the effects of Calisthenic Exercise on Physical fitness among school going children .

Detailed Description
-----------------
Callisthenic Exercises has proven effective in gaining strength, endurance and balance in adults and children age (11 to 17 years) but still evidence is less as compared to children age (8 to 13 years). calesthenics can be perform in door so for children who mostly stay t home or on gadget if perform these activities may improve their physical fitness

Official Title
-----------------
Effects Of Calisthenic Exercises On Physical Fitness Among School Going Children

Conditions
-----------------
Healthy Life Style, Physical Fitness

Intervention / Treatment
-----------------
* Other: Calisthenic Exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male school going children (8-13 year of age) Participants who are able to perform 11-12 repetitions of Calisthenic Exercises mentioned in my Study. BMI of school going children (8-13 year of age) Exclusion Criteria: • Children with any disability. Children with any acute illness. History of any fracture.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calisthenic Exercises<br>The participants of this group perform calisthenic exercises. | Other: Calisthenic Exercises<br>* Bunny Jumps, Bear Crawls, Bear Crawls, Bird Dog . these intervention were used<br>* Other names: Calisthenic Exercises (Animal Style);|
| No Intervention: Conventional Training<br>The participants of this group perform activities of daily routines like playing cricket, taking swings etc | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euro fit Fitness Testing Battery |  | 8 weeks |
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to (1) determine whether local injection of lidocaine used during Mohs surgery will elevate serum lidocaine concentrations to a level that could cause systemic symptoms and (2) determine whether sustained high levels of serum lidocaine occur after intralesional anesthesia on the face and neck. This study is a cross-sectional study of 10 subjects with basal cell carcinoma or squamous cell carcinoma of the face or neck requiring Mohs micrographic surgery. The study will consist of a brief questionnaire and blood draws during their Moh's surgical procedure.

Official Title
-----------------
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery

Conditions
-----------------
Basal Cell Carcinoma, Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Blood Draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age: 18-75 Basal cell carcinoma or squamous cell carcinoma of the head or neck Subjects are in good health Subjects that have the willingness and the ability to understand and provide informed consent for the use of their blood and communicate with the investigator Exclusion Criteria Lidocaine sensitivity Bleeding disorder Pregnancy Medical conditions which would impair hepatic blood flow: congestive heart failure, liver dysfunction, peripheral vascular disease. Subjects who are unable to understand the protocol or to give informed consent Subjects with mental illness

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lidocane<br>Patients undergoing Mohs micrographic surgery of the face or neck will have their blood drawn before, during, and after the procedure. | Procedure: Blood Draw<br>* Serum levels were measured<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw. |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squamous cell carcinoma of the head or neck
Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice

Study Overview
=================
Brief Summary
-----------------
Patients in Pisa will undergo thyroid gland surgery. In the protocol group anesthesia will be performed using an automated anesthesia delivery system; preoperative and intra-operative assessment of patients will be performed via video-conferencing from Montreal, which will also monitor and control anesthesia delivery via distant Internet connection - as supervision of functioning of the automated anesthesia delivery system. In the control group anesthesia will be performed in a standard fashion with manual control of the syringe pumps infusing anesthetics drugs. The hypothesis is that Tele-anesthesia, considered as preoperative assessment and anesthetic control of an automated anesthesia delivery system is feasible and reliable via standard means of internet communication (distant control via virtual network) and performed as well or even better than manual control of the anesthetic drugs infusion.

Official Title
-----------------
Tele-Anesthesia - Trans-Continental Anesthesia Compared to Standard Practice

Conditions
-----------------
Thyroid Gland Resection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective patients Patient scheduled for surgery under spinal anesthesia Patients aged 18 to 85 years Exclusion Criteria: Unable to provide informed consent Comatose patients Patients with dementia Allergy to Propofol

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Anesthetic drugs manually administrated<br> | |
| Automated anesthesia delivery system<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of closed-loop system for propofol administration, controlled remotely, compared with the performance of propofol manually administered to maintain in both case the level of hypnosis close to the BIS target. | Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS). A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be determined clinically by recording the % of sedation time during which the actual BIS is within 10% of the target BIS (excellent control), within 11 -20% (good control), between 21-30% (fair control) and beyond 30% of target (inadequate control). | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid gland resection surgery, total intravenous anesthesia
Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique

Study Overview
=================
Brief Summary
-----------------
study proposes an alternative atraumatic tooth extraction procedure; Apically achieved exodontia, which might offer an alternative to the conventional incisal exodontia, whilst providing minimum tissue trauma and subsequently maximum marginal tissue preservation.

Detailed Description
-----------------
A sample of 26 patients that received the extraction therapy For Group (A) patients, Atraumatic extractions using periotomes followed by conventional forceps were performed. For Group (B) patients, the novel technique of Vestibular Root Extraction was performed to the sample group's hopeless teeth.

Official Title
-----------------
Vestibular Extraction Technique (VET): a Novel Atraumatic Extraction Technique (Randomized Clinical Trial)

Conditions
-----------------
Tooth Extraction

Intervention / Treatment
-----------------
* Procedure: Vestibular Root Extraction
* Procedure: Atraumatic extractions using periotomes followed by conventional forceps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single non-adjacent hopeless maxillary anterior teeth Type II socket) Intact overlying soft tissues. Adequate palatal and at least 3 mm apical bone Exclusion Criteria: Smokers Pregnant females Patients with systemic diseases

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular Root Extraction<br> | Procedure: Vestibular Root Extraction<br>* a 1-cm long vestibular access incision was cut, 3-4 mm apical to the mucogingival junction of the involved tooth, then pushing the vestibular pouch in an incisal direction exposing the apical root area, and allowing direct undisturbed access to the root surface<br>|
| Active Comparator: Atraumatic extractions using periotomes followed by conventional forceps<br> | Procedure: Atraumatic extractions using periotomes followed by conventional forceps<br>* a sulcular releasing incision suing a micro scalpel was made to detach the surrounding tissues, followed by applying the periotome interproximally into the PDL space, widening the attached periodontal ligaments space.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in post restorative soft tissue height | identified midfacially and at the apex of the mesial and distal papillae by superimposing the STL (Standard Triangle Language) files of the models, obtained via IOS | at baseline and 12 months |
Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System

Study Overview
=================
Brief Summary
-----------------
This is a study to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxia.

Detailed Description
-----------------
The purpose of this study is to validate the efficacy of using a small portable oxygen source to mitigate altitude-induced hypoxic events. To do so, the invesitgators propose the following aims: Determine the ability of a portable oxygen storage device to reverse hypobaric hypoxemia in volunteers at altitude. Determine the duration of time that a single portable oxygen container can maintain normoxia in normal volunteers at altitude. Determine the optimum dose and timing of oxygen use to reverse hypobaric hypoxemia.

Official Title
-----------------
Enhancing Operability in a Hypobaric Hypoxic Environment With a Small Oxygen Storage System

Conditions
-----------------
Hypobaric Hypoxemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Altitude chamber qualified Previous agreement to be approached regarding altitude chamber research Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Elapsed time during which oxygen saturation by pulse oximetry (SpO2) remains above 90% I | Elapsed time during which subject's SpO2 remains above 90% after initially reaching or exceeding 94% following exposure to a simulated altitude of 14,000 and after receiving pulse-dosed oxygen | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of oxygen needed to return SpO2 to sea level value I | Amount of oxygen needed to return subject's SpO2 value to 94% (or higher) after exposure to a simulated altitude of 14,000 feet | 15 minutes | 
| Amount of oxygen needed to return SpO2 to sea level value II | Amount of oxygen needed to return subject's SpO2 value to 94% (or higher) after (i) reaching SpO2 value of 82-84% or (ii) attaining 85% of maximum predicted heart rate. This is following exercise on a stationary bicycle at a simulated altitude of 10,000 feet | 15 minutes | 
| Elapsed time during which SpO2 remains above 90% II | Elapsed time during which subject's SpO2 remains above 90% after initially following exposure to a simulated altitude of 14,000 and after initially (i) reaching SpO2 value of 82-84% or (ii) attaining 85% of maximum predicted heart rate. This is following exercise on a stationary bicycle at a simulated altitude of 10,000 feet and after receiving pulse-dosed oxygen. | 15 minutes |