linjc16/ctgov huggingface dataset:
Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block

Study Overview
=================
Brief Summary
-----------------
Our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in Hip joint surgeries. Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative. Our secondary outcome of the study: mean arterial blood pressure, heart rate, respiratory rate, adverse effects, block related complication, sedation score (by Ramsay sedation scale) and pain score (by Visual Analog Scale)

Official Title
-----------------
Effect of Adding Magnesium Sulphate to Bupivacaine in Ultrasound Guided Pericapsular Nerve Group Block for Post Operative Analgesia in Hip Joints Surgeries

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Drug: Pericapsular nerve group block using bupivicaine and magnesium sulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients aged 18 years or more. Patients with American society of anesthesiologists (ASA) classification class I or II Patients weight range from 50 to 90 Kgs Exclusion Criteria: • Patient refusal of peripheral nerve block Patient with infection at the site of injection Patient with coagulopathy Patients with known allergy to used medications.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group C (control)<br>will have Peng block using 20mg bupivacaine 0.25% | |
| Active Comparator: Group M<br>will have PENG block with 2mg magnesium sulphate 10% as an adjuvant to 20mg of bupivacaine 0.25% | Drug: Pericapsular nerve group block using bupivicaine and magnesium sulphate<br>* This technique involves the deposition of the local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain management | total amount of postoperative morphine consumption in the first 24 hours postoperatively. | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | It's a scale from 0 to 10 where 0 means no pain and 10 means worst pain imaginable | 24 hours postoperatively |
Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
CKD is a strong risk factor for cardiovascular disease and mortality , As in adults, cardiovascular disease occurs in some children with CKD before they reach ESRD as well as after

Detailed Description
-----------------
This work aims to study the electrophysiological changes in cardiovascular system in children with predialytic CKD. ECG is important in detection of cardiac rhythm abnormalities, cardiac conduction defects and detection of myocardial ischemia

Official Title
-----------------
Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease

Conditions
-----------------
Predialytic Chronic Kidney Disease

Intervention / Treatment
-----------------
* Device: Holter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1 to 15 year children with predialytic chronic kidney disease GFR.>15 ml\min per 1.73m2 , stages 1, 2, 3, 4 according to (KDOQI stages). Exclusion Criteria: Age >15 year On regular dialysis GFR<15 ml\min per 1.73m2, Stage 5 according to (KDOQI stages). Children with known cardiovascular disease or known arrhythmia Patients on the potential medication affecting ECG result as B-blocker, antipsychotics , antidepressant

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Holter|24 hour electrocardiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Sinus tachycardia or bradycardia | One year | 
| changes in QT interval | Prolonged QT interval in ECG | One year | 
| QRS duration | Increase or decrease in ECG | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease
Study of CM326 Injection in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.

Detailed Description
-----------------
The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects

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

Intervention / Treatment
-----------------
* Biological: CM326
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years and ≤ 65 years, healthy male. With normal or abnormal laboratory test results without clinical significanceat screening period and baseline. Subjects can communicate well with investigators and comply with protocol requirements. Exclusion Criteria: Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period. Major surgery is planned during the study period. The average daily smoking volume is more than 5 cigarettes within 3 months before screening. Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL. There are any reasons that the investigator believes will prevent the subject from participating in the study.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM326 Low Dose<br>CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose | Biological: CM326<br>* CM326 Injection<br>Other: Placebo<br>* Subcutaneous injection<br>|
| Experimental: CM326 Medium Dose<br>CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose | Biological: CM326<br>* CM326 Injection<br>Other: Placebo<br>* Subcutaneous injection<br>|
| Experimental: CM326 High Dose<br>CM326 220mg/2mL or matched placebo, subcutaneous at high dose | Biological: CM326<br>* CM326 Injection<br>Other: Placebo<br>* Subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency adverse events during treatment | By assessing the number and severity of adverse events during the study. | Up to week 12 |
ND-YAG Laser Iris Depigmentation for Cosmoses

Study Overview
=================
Brief Summary
-----------------
Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study

Detailed Description
-----------------
Nd-YAG Laser for changing iris coloration by the principle of depigmentation for cosmoses Is that procedure safe or not a prospective study safety will be assessed by measuring IOP using Goldman applanation tonometry pre and post-session. visual acuity assessment in Log-Mar pre and post-session. Refraction assessment pre and post-session. Lens and fundus assessments on slit-lamp and using auxiliary lens 78D

Official Title
-----------------
ND-YAG Laser Iris Depigmentation for Cosmoses

Conditions
-----------------
Iris Depigmentation

Intervention / Treatment
-----------------
* Device: Nd-YAG Laser for iris depigmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clear cornea clear lens normal IOP < 20 mmHg adults aged more than 18 years old normal fundus dark pigmented iris (black or brown) Exclusion Criteria: Glaucomatous patients and those receiving anti-glaucoma treatment. corneal or lens opacity. any fundus abnormality

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ND-YAG Laser for iris depigmentation<br>ND-YAG Laser for iris depigmentation | Device: Nd-YAG Laser for iris depigmentation<br>* Nd-YAG Laser for iris depigmentation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring intra-ocular pressure (IOP) by the standard Goldman applanation tonometer before and after ND-YAG Laser for iris depigmentation | Session of Nd-YAG Laser targeting the iris using power less than that used for peripheral iridotomy causing pigment bleaching to change the iris colour for cosmoses, which may cause pigmentary glaucoma (secondary open angle glaucoma). | one year | 
| Safety of ND-YAG Laser, by visual acuity assessment in log-mar subjectively by using Snellen chart before and after ND-YAG Laser | If ND-YAG LASER could affect visual acuity. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nd-YAG Laser, Iris, Cosmoses
Low Energy Availability and Pituitary Function (LEAP Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.

Official Title
-----------------
A Randomized Cross-over Study of Low Energy Availability on Pituitary Function in Women

Conditions
-----------------
Hypogonadotropic Hypogonadism

Intervention / Treatment
-----------------
* Behavioral: 5-day controlled metabolic dietary intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18-30 Body mass index between 18.5-24.9 OR 30-45 Have regular menstrual cycles between 18-40 days over the past 6 months Weight stable (not gained or lost 5kg) in the past 3 months Exclusion Criteria: Using hormonal birth control currently or within the past three months Polycystic ovary syndrome (current or past diagnosis) Pregnant, lactating, planning to become pregnant in next 6 months Engaging in regular intentional aerobic exercise Significant medical issues (e.g.,cardiovascular disease or diabetes)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Energy balanced metabolic diet (5-days)<br>45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate | Behavioral: 5-day controlled metabolic dietary intake<br>* Over 5-days, all food will be provided from the metabolic kitchen and participants will be instructed to eat all of the food provided each day and only the food provided each day.<br>|
| Experimental: Low energy availability metabolic diet (5-days)<br>20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate | Behavioral: 5-day controlled metabolic dietary intake<br>* Over 5-days, all food will be provided from the metabolic kitchen and participants will be instructed to eat all of the food provided each day and only the food provided each day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate | Within-participant changes in response to both conditions will be measured, with lower LH AUC indicating a blunted pituitary response to stimulation. | Baseline,  4-weeks,  8-weeks (visits timed to to days 1-5 of the menstrual cycle) |
Evaluation Treatment Outcomes of Anterior Open Bite Treated by Temporary Anchorage Devices

Study Overview
=================
Brief Summary
-----------------
The present study will be performed to Evaluate the treatment outcome of anterior open bite by temporary anchorage device on buccal and palatal mini screws

Official Title
-----------------
Evaluation Treatment Outcomes of Anterior Open Bite Treated With Maxillary Intrusive Force by Temporary Anchorage Devices

Conditions
-----------------
Anterior Openbite Malocclusion

Intervention / Treatment
-----------------
* Other: Temporary Anchorage Devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age range 13-18 years old. Patients have anterior open bite. Normal healthy patient. Patient have healthy oral tissues. Patient have class I or II jaw relationship. Patient have complete set of permanent teeth except the wisdom tooth. Exclusion Criteria: Uncooperative patient and parents. patient who had undergo previous orthodontic treatment. Patient with class III jaw relationship.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Temporary Anchorage Devices|intrusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| open bite closure | the change in amount of open bite detected by mm. which measured from the cast model and from cephalometric x ray. | 1 year |
Effects of Lidocaine Bolus and Infusion on Bispectral Index Values and Spectrum During Anesthesia Maintenance

Study Overview
=================
Brief Summary
-----------------
Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenance delivered with target controlled infusion (TCI) with stable Concnetration at the effector site of Propofol (CeP)

Detailed Description
-----------------
Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenence delivered with target controlled infusion (TCI) with stable concentration at the effector site of Propofol (CeP). Aim of this study is to analyze BIS values and power spectrum before and after a lidocaine bolus (1,5 mg/kg delivered in 10 minutes) and a subsequent continuous infusion (1,5 mg/kg/min for 30 minutes) delivered at anesthetist's discretion for postoperative analgesia.

Official Title
-----------------
Effects of Lidocaine Bolus and Continuous Infusion on Bispectral Index Values and Spectrum During Maintenance of Total Intravenous Anesthesia With Target Controlled Infusion (Schnider Model)

Conditions
-----------------
Anesthesia Brain Monitoring, Lidocaine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergo general anesthesia with Target Controlled Infusion of Propofol (Schnider model) and Remifentanil (Minto model) and Lidocaine bolus and continuous infusion for a total of 40 minutes. Exclusion Criteria: Neurological disease Psychiatric disease Obesity

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between BIS values and power spectrum before and after lidocaine administration | Patients will receive during anesthesia maintenance a lidocaine bolus of 1,5 mg/kg delivered in 10 minutes and a lidocaine continuous infusion of 1,5 mg/kg/h for 30 minutes | We collect data about propofol concentration (ng/ml)and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start o anesthesia until the emergence from anesthesia |
Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation

Study Overview
=================
Brief Summary
-----------------
Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years. Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.

Official Title
-----------------
Prospective Evaluation of Patients Undergoing Surgical Treatment for Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for the Treatment of Flexible Flatfoot in the Growth Age

Conditions
-----------------
Flat Feet, Subtalar Arthrorisis, Growth Age

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic, flexible, symptomatic flatfoot Patients aged between 8 and 14 years Exclusion Criteria: Joint laxity Neuromuscular disorders Neurological conditions Traumatic sequelae Iatrogenic flatfoot Congenital flatfoot due to tarsal synostosis

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 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 |
| --- | --- | --- |
| Meary's angle |  | At baseline (day 0) | 
| Meary's angle |  | After 1 month | 
| Meary's angle |  | After 3 months | 
| Meary's angle |  | After 6 months | 
| Meary's angle |  | After 12 months | 
| Meary's angle |  | After 24 months | 
| Meary's angle |  | After 36 months | 
| Meary's angle |  | After 48 months | 
| Meary's angle |  | After 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS Score |  | At baseline (day 0) | 
| AOFAS Score |  | After 1 month | 
| AOFAS Score |  | After 3 months | 
| AOFAS Score |  | After 6 months | 
| AOFAS Score |  | After 12 months | 
| AOFAS Score |  | After 24 months | 
| AOFAS Score |  | After 36 months | 
| AOFAS Score |  | After 48 months | 
| AOFAS Score |  | After 72 months |
Sensor Technology Assessments of Reproductive Target Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to better understand female reproductive health in the context of using wearable technology. Participants were provided and wore an Oura Ring, tracked their menstrual cycles, provided at-home ovulation test results, and had their cycles monitored via trans-vaginal ultrasounds. The study aimed to collect data from females with regular menstrual cycles.

Official Title
-----------------
Sensor Technology Assessments of Reproductive Target Study

Conditions
-----------------
Menstrual Cycle, Ovulation, Menstruation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women age 18-42 years Regular menstrual cycles every 25-32 days Own an iPhone or Android mobile device Agree to follow study protocol such as wearing the Oura Ring for the duration of the study, at-home ovulation testing, present for frequent ultrasounds Exclusion Criteria: Non-English speaking Current use of hormonally active medications History of infertility History of recurrent pregnancy loss Current circadian disruptions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective ovulation day |  | 6 months | 
| Prospective ovulation day |  | 6 months |