linjc16/ctgov huggingface dataset:
Energetics and Function in Older Humans

Study Overview
=================
Brief Summary
-----------------
The investigators have previously reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves concentrations of red-cell GSH. The investigators also found that when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an increase in intracellular GSH concentrations. The current proposal will investigate if cysteine and glycine supplementation for a duration of 24 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months after completing supplementation, measurement of GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be done to determine the effects of washout.

Detailed Description
-----------------
Data not available at present

Official Title
-----------------
Energetics and Function in Older Humans

Conditions
-----------------
Aging, Erythrocyte Glutathione Deficiency, Muscle Weakness

Intervention / Treatment
-----------------
* Dietary Supplement: Cysteine (as n-acetylcysteine) and Glycine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older subjects: age 70-80 years; Younger subjects: age 21-30 years Exclusion Criteria: No known diabetes, liver disease, kidney disease, coronary heart disease, stroke, or cancer; Any limitations in ability to walk; Triglyceride concentrations greater than 500 mg/dl (if lipid lowering medications are stopped); BMI less than 20.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycine and N-acetylcysteine<br>Older subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months | Dietary Supplement: Cysteine (as n-acetylcysteine) and Glycine<br>* Older subjects will be studied before and after receiving cysteine and glycine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell concentrations of Glutathione measured by HPLC |  | 8 months |
Acute Immunological Effects of Exercise in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals.

Official Title
-----------------
ACTIVE- Acute Effects of a Single Physical Exercise Intervention on Immune Cells and Inflammation in Cancer Patients and a Healthy Comparison Group

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: High intensity interval exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents and young adults >14 years of age undergoing acute cancer treatment (chemotherapy) signed informed consent Exclusion Criteria: Inability to follow and implement test instructions medical contraindication to HIIT on cycle ergometer chemotherapeutic treatment 48 h prior Hb <8g/dl; platelets < 20,000/ul.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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 |
| --- | --- |
| Experimental: Cancer patients<br>Single exercise intervention following a HIIT protocol, duration  20 mins | Behavioral: High intensity interval exercise training<br>* Endurance training adapted to age, resting heart rate<br>* Other names: HIIT, Exercise;|
| Active Comparator: Healthy adults<br>Single exercise intervention following a HIIT protocol, duration  20 mins | Behavioral: High intensity interval exercise training<br>* Endurance training adapted to age, resting heart rate<br>* Other names: HIIT, Exercise;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Natural Killer Cells | NK cells, subgroups and innate lymphoid cells | Change from pre Intervention to immediately after intervention and 1 hour post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Quality of Life | Quality of Life (EORTC QLQ-C30, questionnaire score from 0 - 100, higher score = better quality of life) | Once after intervention | 
| Fatigue | Fatigue (EORTC QLQ FA12 Fatigue questionnaire range 0 - 100, higher score = worse outcome) | Once after intervention | 
| Nutritional status | Mini Nutritional Assessment (MNA range 0 - 14 points), lower score = worse | Once after intervention |
Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: desvenlafaxine 50 mg
* Drug: desvenlafaxine 100 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A primary diagnosis of MDD Depressive symptoms for at least 30 days before the screening visit. Exclusion Criteria: Treatment with DVS SR at any time in the past. Known hypersensitivity to venlafaxine Significant risk of suicide based on clinical judgment

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: desvenlafaxine 50 mg|nan|
|Drug: desvenlafaxine 100 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Global Clinical Improvement will be the key secondary efficacy variable. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Adult, Outpatients
Quantification of Upper Extremity Hypertonia

Study Overview
=================
Brief Summary
-----------------
Dr. Sanger and the research team want to learn about upper extremity hypertonia (stiffness) in children and young adults with cerebral palsy. Specifically, they want to learn about ways to measure the stiffness in the joints of hypertonic arms. The information the research team will collect includes any physical exams or computer generated data about your arm movements.

Official Title
-----------------
Quantification of Upper Extremity Hypertonia

Conditions
-----------------
Dystonia, Muscle Hypertonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Dystonia in at least one arm Age 4 to no upper limit Exclusion Criteria:increased risk of participation botulinum toxin within 6 months

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- | --- |
| Observation |  | 1 hour |
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.

Detailed Description
-----------------
Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups: Awake: the LMA was left in place until the patient fully regained consciousness Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery. Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.

Official Title
-----------------
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?

Conditions
-----------------
Laryngeal Mask Airway Removal, Respiratory Complication

Intervention / Treatment
-----------------
* Other: LMA removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children scheduled for minor surgery Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anesthetised<br>LMA removal once the halogenated anesthetic turned off | Other: LMA removal<br>* According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.<br>|
| Active Comparator: Awake<br>LMA removal once the patient fully regained consciousness | Other: LMA removal<br>* According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of respiratory adverse events |  | from LMA removal to 20 minutes afterwards |
Pain Modality Treatment After Hemorrhoidectomy

Study Overview
=================
Brief Summary
-----------------
Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences. The objective is to corroborate which pain treatment modality is better in patients after hemorrhoidectomy.

Detailed Description
-----------------
Patients who have undergone a hemorrhoidectomy are included in the study, the pain treatment modality is conceived by the treating surgeon or anesthesiologist. The first modality is to administer pain killers on-demand depending on visual analog scales of pain and the second modality to give pain killers on determined hours.

Official Title
-----------------
Around the Clock Pain Treatment Modality Offer Better Pain Control and Less Opiates Drugs Use

Conditions
-----------------
Pain, Acute, Pain, Procedural

Intervention / Treatment
-----------------
* Other: Pain scale registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery for hemorrhoids Exclusion Criteria: Mental retardation Incapacitated patient Under 18 years old
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Around the clock analgetic treatment<br>Patients that underwent hemorrhoidectomy and pain killers are prescribed every specific hour independent of pain degree, if necessary drugs can be administered on demand. | Other: Pain scale registry<br>* The nurses ask the patient about the pain filling every two hours during the hospitalization.<br>|
| On demand analgetic treatment<br>A pain killers list is prescribed by the physician and the nurse decides which drug to administer depending on a protocol of treatment based on the visual analog scale. | Other: Pain scale registry<br>* The nurses ask the patient about the pain filling every two hours during the hospitalization.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain medition | The pain registred is analyze as maximum, mean and on discharge. | Immediately after the intervention/procedure/surgery | 
| Drugs Administred | The amount of drugs administred to each patients is analyzed | Immediately after the intervention/procedure/surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain killers
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).

Official Title
-----------------
Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On Demand Treatment and Control of Bleeding Episodes in Subjects With Hemophilia A or Hemophilia B, With Inhibitors: The Crimson 1 Study

Conditions
-----------------
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor

Intervention / Treatment
-----------------
* Biological: MarzAA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of congenital hemophilia A or B with inhibitors Male or Female, age 12 or older History of frequent bleeding episodes Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities Exclusion Criteria: Previous participation in a clinical trial evaluating a modified rFVIIa agent Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect Known hypersensitivity to trial or related product Known positive antibody to FVII or FVIIa detected by central lab at screening Have a coagulation disorder other than hemophilia A or B Be immunosuppressed Significant contraindication to participate

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MarzAA<br>Coagulation Factor VIIa variant, 60 µg/kg by subcutaneous route, administered on-demand during bleeding episodes for a maximum of 3 doses as needed for hemostasis | Biological: MarzAA<br>* A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes.<br>|
| Active Comparator: Standard of Care<br>Standard of care administered on-demand during bleeding episodes | Biological: MarzAA<br>* A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding episode treatment success | Proportion of bleeding events treated with MarzAA achieving hemostatic efficacy based on a four-point scale according to the Investigator's assessment compared with standard of care. | 24 hours after the first administration of study drug |
Vidéolaryngoscopy Study of the LPEC in Obese Patients

Study Overview
=================
Brief Summary
-----------------
Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position

Detailed Description
-----------------
Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position

Official Title
-----------------
Evaluation of the Impact of Sellick's Manoeuvre or Para-tracheal Compression of the Cervical Esophagus on Laryngeal Mass Movement and Vocal Cord Visualization in Obese Patients.

Conditions
-----------------
Videolaryngoscopy

Intervention / Treatment
-----------------
* Procedure: mobilization of the larynx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients with BMI > 35 undergoing general anaesthesia Exclusion Criteria: pregnant women people with facial oropharyngeal abnormalities

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Videolaryngoscopy<br>Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in 2 groups: patient in dorsal decubitus or Rapid Airway Management Positioner. | Procedure: mobilization of the larynx<br>* Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in 2 groups: patient in dorsal decubitus or Rapid Airway Management Positioner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance between oesophagus and trachea | Distance between oesophagus and trachea | During laryngoscopy |
Evaluation of EMI in Patients With Micra Leadless Pacemaker

Study Overview
=================
Brief Summary
-----------------
Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).

Detailed Description
-----------------
Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers. Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.

Official Title
-----------------
Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker

Conditions
-----------------
Electromagnetic Interference

Intervention / Treatment
-----------------
* Other: surgical procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: subjects with an implanted Micra pacemaker who required a surgical procedure Exclusion Criteria: no Micra pacemaker

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 |
| --- | --- |
| Micra subjects<br>Surgical procedure | Other: surgical procedure<br>* Surgical procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMI | Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms | up to 6 months next postop interrogation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device reset | Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms | up to 6 months next postop interrogation |