linjc16/ctgov huggingface dataset:
Impact of Exercise Medicine on Lower Limb Amputees According to the International Classification of Functioning

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.

Detailed Description
-----------------
Exercise medicine in lower limb amputees has a positive impact on physical condition and on some cardiovascular aspects (first domain of ICF). But as the investigators know, there is no evidence that this improvement is connected with a significant benefit on the performance of daily live activities and social participation (second and third domains of the ICF). The investigators want to determine benefits of exercise medicine on all of these domains.

Official Title
-----------------
Impact of Exercise Medicine on Lower Limb Amputees According to the Three Domains of the International Classification of Functioning

Conditions
-----------------
Lower Limb Amputees

Intervention / Treatment
-----------------
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral lower limb amputation amputees with prothesis after learning how to walk with the prothesis walking with or without technical aids Exclusion Criteria: previous exercise training

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy<br>Comparing the patients to themselves (spontaneus evolution) before intervention. | Other: Physiotherapy<br>* Physiotherapy three times a week for 8 weeks according to a well-defined protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 minutes walk test |  | at -1, 0, 2 and 4 mounths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Timed Up and Go |  | at -1, 0, 2 and 4 mounths | 
| Change in Satisfaction towards prothesis questionnaire (SAT-PRO) | questionnaire | at -1, 0, 2 and 4 mounths | 
| Change in Flexibility test | measurement of distance between fingers and floor | at -1, 0, 2 and 4 mounths | 
| Change in Isokinetic strength testing |  | at -1, 0, 2 and 4 mounths | 
| Change in Prosthetic Profile of the Amputee |  | at -1, 0, 2 and 4 mounths | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sequelae of; Amputation, Traumatic, Limb, Lower
Acute Beetroot Juice Supplementation in Amateur Climbers

Study Overview
=================
Brief Summary
-----------------
Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in endurance activities, its benefits in neuromuscular function and strength performance has been barely studied. In this cross-over randomized placebo-controlled study, we investigated the effects of BJ acute supplementation in improving neuromuscular performance in amateur climbers

Official Title
-----------------
Acute Effects of Beetroot Juice Supplementation Among Neuromuscular Performance in Amateur Climbers

Conditions
-----------------
Dietary Supplement, Sport Performance

Intervention / Treatment
-----------------
* Dietary Supplement: Beetroot Juice (BJ) acute supplementation
* Dietary Supplement: Placebo Juice (PLA) acute supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years active climbing for, at least, last 6 months Exclusion Criteria: smoking contraindications to BJ diet physical limitations, health problems, or musculoskeletal injuries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BJ supplementation<br> | Dietary Supplement: Beetroot Juice (BJ) acute supplementation<br>* One serving of 70 mL of BJ (6.4 mmol of NO3) 3h before initiating the testing session<br>|
| Placebo Comparator: PLA supplementation<br> | Dietary Supplement: Placebo Juice (PLA) acute supplementation<br>* One serving of 70 mL of juice (0.005 mmol of NO3) 3h before initiating the testing session<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in rate of force development (N/s) at 50, 100 and 200 ms; and at 95% of maximal force | Using a force sensor | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nitrites and nitrates levels in saliva (μmol/L) | Using specific kit ELISA analysis | 1 week | 
| Changes in maximal number of pull-ups |  | 1 week | 
| Changes in maximal isometric handgrip strength (kg) | Using a dynamometer | 1 week | 
| Changes in maximal jump height (cm) | Maximal jump height using a contact platform | 1 week |
The Use of Reminders in Implementing an E-learning Program in General Practice

Study Overview
=================
Brief Summary
-----------------
To evaluate General Practitioners use and reuptake of an e-learning programme in diagnostic evaluation of dementia after an intervention consisting of three mailed reminder letters. There is no direct patient involvement in this study.

Detailed Description
-----------------
The three mailed reminder letters will be mailed to the General Practitioners (GPs) in January 2007. The Periods where the e-learning programme will identify GPs using the programme are: Period before: November 1. and 6 weeks forward. Period after: Medio marts and 6 weeks forward. All log files are kept anonymous for the principal study investigator by the Danish Medical Association.

Official Title
-----------------
Implementation of an E-learning Program in Diagnostic Evaluation of Dementia by Reminders: A RCT Among General Practitioners in Copenhagen

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Behavioral: Reminder letters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General Practitioners working in Copenhagen Municipality October 1st 2006 Exclusion Criteria: General Practitioners stopping to work in study period

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Reminder letters and usual implementations vs. usual implementation | Behavioral: Reminder letters<br>* 3 mailed reminder letters<br>|
| No Intervention: Control group<br>usual implementations | Behavioral: Reminder letters<br>* 3 mailed reminder letters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of General Practices using the e-learning programme at least once in periods monitored. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of logins in the periods monitored. |  |  | 
| The time og logins in the periods monitored. |  |  | 
| The number of logins in working hours in the periods monitored. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heading Health Plan Implementation, Computer-Assisted Instruction, General Practice, Dementia, education
Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19

Study Overview
=================
Brief Summary
-----------------
Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested. In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.

Official Title
-----------------
Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: Ivermectin Oral Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants eligible for inclusion will include non-pregnant adult (>18 years old) with molecular confirmation of COVID-19. [Participants will be eligible in a period of no longer than 72 hours after exposure]. Exclusion Criteria: Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support). Weight below 40Kg or above 100Kg Unable to take oral medication Known allergy to the drugs Pregnancy or breast feeding Participating in another RCT for treatment of COVID-19.

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
Interventional Model Description: Double blind randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: IVERMECTIN<br> | Drug: Ivermectin Oral Product<br>* 3mg Capsules, 12-15mg/ day for 3 days<br>|
| Active Comparator: PLACEBO<br> | Drug: Ivermectin Oral Product<br>* 3mg Capsules, 12-15mg/ day for 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral clearance at day 6 | The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo. | Outcome will be determined till 6 days post intervention | 
| Viral shedding duration | Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests) | Outcome will be determined till 14 days post intervention | 
| Symptoms clearance time | Time between drug treatment and symptoms resolution | Outcome will be determined till 14 days post intervention |
Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Study Overview
=================
Brief Summary
-----------------
The aim of this study is examining the combination of two FDA approved drugs, Opipramol and baclofen, which may increase rehabilitation from psychoactive substances. Previous studies have indicated a connection of sigma-1 receptor to cocaine abuse and raised the possibility that these receptors as mediators of drug craving . However previous studies showed partial efficacy with no significant relapse in relapse rates. The same is true for the use of GABAb-1 receptor antagonist. Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent. Moreover, previous open and controlled trials indicated that the GABAb-1 antagonist baclofen partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine. Our studies in an animal model for addiction have shown a significant effect of the combine treatment of the indicated medications both in decreasing relapse and increase of -number of respondents.

Official Title
-----------------
Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction: Medical and Cognitive Effects

Conditions
-----------------
Drug Abuse

Intervention / Treatment
-----------------
* Drug: Opipramol
* Drug: Baclofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age will be 60-18, both sexes, seeking treatment in order to stop the consumption of materials Exclusion Criteria: Did not include trial addicts with co-morbidity, kidney, heart, metabolic, neurological and psychiatric disorders (psychosis, chronic depression).

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug-A<br>opripramol 150 mg per day (3*50) Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent. | Drug: Opipramol<br>* PO<br>Drug: Baclofen<br>* PO<br>|
| Active Comparator: Drug-B<br>baclofen 90 mg per day (3*30) Baclofen is a GABAb-1 antagonist and has shown partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine. | Drug: Opipramol<br>* PO<br>Drug: Baclofen<br>* PO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased craving | Lower withdrawal symptom will be measured by questionnaires | 1 month |
SIBO & SIFO After Colectomy

Study Overview
=================
Brief Summary
-----------------
After subtotal colectomy, 40% of patients report abdominal pain, gas and diarrhea, and poor quality of life; whose etiology is unknown. The investigators determined whether small intestinal bacterial (SIBO or fungal overgrowth SIFO) could cause these sympotoms (> 1 year).

Official Title
-----------------
Does Colectomy Predispose to Small Intestinal Bacterial (SIBO) and Fungal Overgrowth (SIFO)

Conditions
-----------------
Small Intestinal Bacterial Overgrowth, Small Intestinal Fungal Overgrowth, Colectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were referred to a specialist motility center over 4 year period with: Unexplained gastrointestinal symptoms such as gas, bloating, belching, diarrhea, and abdominal discomfort history of colectomy patients with no history of colectomy patients included who had normal: upper endoscopy, colonoscopy, computerized abdominal tomography scan, and normal hematology, biochemical profiles, tissue transglutaminase antibody, thyroid stimulating hormone, and normal right upper quadrant ultrasound scan. patients with glucose breath test and/or duodenal aspirate Exclusion Criteria: patients with upper gut or small bowel surgery Patients who were hospitalized or with serious cardiac or pulmonary or neurologic comorbidities Patients with intestinal strictures or known intestinal motility disorders such as scleroderma or pseudo-obstruction syndrome

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 |
| --- | --- |
| Colectomy Group<br>Mean age 52.3 years (range:20-85), 82% females, and a mean duration of symptoms of 79.9 months in the colectomy group. The indication for colectomy was constipation (36%), diverticular disease (8%), bowel obstruction (8%), colorectal carcinoma (8%), colon polyps (6%), and other (34%). | |
| Control Group<br>Mean age of 49.9 years (range 18-88), 76% females, and mean duration of symptoms 77.6 months, | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of SIBO/SIFO | Patients with unexplained GI symptoms following colectomy and to compare this with a control group of patients with similar symptoms but without previous colectomy. | 4-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment with antibiotics and antifungals | Secondary aim was to assess the response to treatment with antibiotics and antifungals in colectomy patiens with SIBO/SIFO | 4-5 years |
Does Administration of Etomidate and Propofol of the Anesthetic Induction of Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngoscopy When Compared to Propofol or Etomidate Alone?

Study Overview
=================
Brief Summary
-----------------
This study will attempt to show that a combination of drugs, Etomidate and Propofol, provide a more stable blood pressure when used to put elderly hypertensive patients to sleep than either drug used alone.

Detailed Description
-----------------
Same as above.

Official Title
-----------------
Does Administration of Etomidate and Propofol if the Anesthetic Induction of the Elderly Hypertensive Patient Provide Superior Blood Pressure Stability in Response to Direct Laryngosacopy, When Compared to Propofol or Etomidate Alone?

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: propofol
* Drug: Etomidate
* Drug: Propofol and Etomidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 65 years old, with a history of hypertension. Exclusion Criteria: Patients less than 65 years old or without a history of hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Propofol alone will be used to put an elderly hypertensive patient to sleep for surgery. | Drug: propofol<br>* Propofol 1mg/kg will be given once to put the patient to sleep for surgery.<br>|
| Active Comparator: Etomidate<br>Etomidate alone will be used to put an elderly hypertensive patient to sleep. | Drug: Etomidate<br>* Etomidate 0.3mg/kg will be given once to put the patient to sleep for surgery.<br>|
| Active Comparator: Propofol and Etomidate<br>A combination of Etomidate and Propofol will be used to put an elderly hypertensive patient to sleep for surgery. | Drug: Propofol and Etomidate<br>* Etomidate 0.2mg/kg plus Propofol 0.5mg/kg will be given once to put the patient to sleep for surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure stability during anesthetic induction | Blood pressure will be measures every minute for 15 minutes following anesthetic induction | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthesia, elderly, hypertensive
Buprenorphine in Acute Renal Colic Pain Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.

Conditions
-----------------
Acute Pain Management, Renal Colic

Intervention / Treatment
-----------------
* Drug: Buprenorphine
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll. Exclusion Criteria: previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases; febrile patients (T > 38°C); hemodynamically unstable patients ( Systolic Blood Pressure < 90 mmHg); pregnant patients; patients with abdominal tenderness as a sign of peritoneal inflammation; any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection; patients with a history of drug addiction or known allergy to opioids; patients who had used analgesics 6 hours before arriving.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: Buprenorphine<br>Renal Colic Patients treated by 2 mg sublingual Buprenorphine. | Drug: Buprenorphine<br>* 2 mg sublingual tablet<br>|
| Active Comparator: Morphine<br>Renal Colic Patients treated by 0.1 mg/kg intravenous morphine. | Drug: Morphine<br>* 0.1 mg/kg IV morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain score | change in pain severity based on Numerical Rating Score | 20 and 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment side effects | experiencing any side effects by the patients as a result of treatment protocols. | 40 minutes |