linjc16/ctgov huggingface dataset:
Blood Pressure Monitor Clinical Test (Cuff Range: 22 cm-30 cm)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the blood pressure level of the patient using a cuff ranged 22 cm-30 cm.

Official Title
-----------------
Blood Pressure Monitor Clinical Test (Cuff Range: 22 cm-30 cm)

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: arm range: 22 cm-30 cm

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 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 |
| --- | --- |
| stethoscopy<br> | |
| BPM<br>blood pressure monitor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra [tocilizumab]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.

Official Title
-----------------
Retrospective Study on the Use of Biologicals in Monotherapy in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Diagnosis of rheumatoid arthritis Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted) Exclusion Criteria: Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis Patients that have started their current monotherapy before 01/01/2009

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice |  | approximately 1 year | 
| Type of biological agents used in monotherapy in routine clinical practice |  | approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores |  | approximately 1 year | 
| Quality of life: HAQ-DI score |  | approximately 1 year | 
| Safety of biologics used in monotherapy: Incidence of adverse events |  | approximately 1 year |
Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation

Study Overview
=================
Brief Summary
-----------------
Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous cannulation pain and anxiety

Detailed Description
-----------------
One hundred and fifty patients undergoing surgery were randomized to apply Valsalva's maneuver (the valsalva group) and music therapy(the music group) and a placebo (the control group) during peripheral venous cannulation (PVC). The patients' pain, anxiety, and satisfaction scores will be measured.

Official Title
-----------------
Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation Pain and Anxiety

Conditions
-----------------
Cannulation,Pain

Intervention / Treatment
-----------------
* Other: Music
* Other: Valsalva maneuver
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery Exclusion Criteria: Patients with a history of anxiety disorders or hearing problem and preoperative pain.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The music group<br>Participant will allow to listen any kind of music which they wish | Other: Music<br>* a kind of music which the participant likes will be listened using speakers<br>|
| valsalva maneuver<br>participants will be asked to take a deep breath and exhale the air out in 15 seconds | Other: Valsalva maneuver<br>* Participant will be asked to take a deep breath and exhale the air out in 15 seconds<br>|
| The control group<br>no intervention | Other: control<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | Pain intensity | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction scale | satisfaction level(worst,bad,none,good,better) | one month |
Dexamethasone Therapy for Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy of IV Dexamethasone in treatment low back pain as an adjunct to analgesics.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: IV Dexamethasone Therapy
* Other: IV Normal Saline (NaCl 0.9%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No red flags of serious spinal pathology Normal neurological examination Indication for opioid analgesia based on our pain management protocol No known hypersensitivity to the medication Ability to provide informed consent Exclusion Criteria: Pregnancy All others who do not meet inclusion criteria

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 |
| --- | --- |
| Active Comparator: Dexamethasone Therapy<br>Three consecutive doses of IV Dexamethasone with be administered over three days. The doses will be tapered according to the following: 1st dose, 26mg., 2nd dose, 20mg., and the third dose will be 10 mg. Each dose will be administered over 24 hours in a slow drip, in a 100cc. normal saline bag (0.9%). | Drug: IV Dexamethasone Therapy<br> <br> |
| Placebo Comparator: Placebo Therapy<br>Three consecutive doses of 100cc IV normal saline (0.9%), will be administered over three days. Each dose will be administered over 24 hours in a slow drip. | Other: IV Normal Saline (NaCl 0.9%)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | Pain will be measured according to the Visual Analog Scale throughout the treatment. | Four days |
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Detailed Description
-----------------
The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Official Title
-----------------
A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation

Conditions
-----------------
Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use, Loxapine Causing Adverse Effects in Therapeutic Use

Intervention / Treatment
-----------------
* Drug: Haloperidol + lorazepam
* Drug: Loxapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requires treatment for agitation in the judgment of a physician Patient either pre-consented, has surrogate consent, or able to consent (in cases of mild agitation). The patient is at least 18 years of age and less than 65 years of age. Patients with known or presumed schizophrenia or bipolar 1 disorder. Exclusion Criteria: Patients with acute respiratory signs/symptoms (eg, wheezing). Known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma or taking meds for asthma or COPD. Female patients who are obviously pregnant or breast-feeding. Medically unstable patients. Patients or surrogates who object to being in the study (even if previously pre-consented). Physician objection to patient enrollment in the study. Prisoners or incarcerated.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: haloperidol + lorazepam<br>IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler | Drug: Haloperidol + lorazepam<br>* Haloperidol + lorazepam + placebo<br>* Other names: Haldol + Ativan;|
| Experimental: loxapine<br>Inhaled loxapine 10mg + IM normal saline | Drug: Loxapine<br>* loxapine + placebo<br>* Other names: Adasuve;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS) | Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available | 120 minutes |
Health-Related Quality of Life for Thyroid Patients

Study Overview
=================
Brief Summary
-----------------
Background: Thyroid diseases are frequent. They include both metabolic changes and gland enlargement (goitre). Previous research and clinical suspicion indicate that the life quality of many patients is reduced despite successful treatment. Research methods are, however, weak, and a well-tested, disease specific quality of life questionnaire is especially needed. Several treatment possibilities exist for each thyroid disease. For example, hypermetabolism can be treated with either medication, radioactive iodine or by surgery. No comparative studies of quality of life using the different treatment modalities exist. Purpose: To develop and evaluate a questionnaire to measure health-related quality of life in patients suffering from thyroid diseases. Methods: To ensure that all relevant aspects are included, the questionnaire will be developed on the basis of a systematic examination of the scientific literature and interviews with 13 physicians and 100 patients. The questionnaire will then be tested by 100 new patients. After revision, the questionnaire will be answered by 1000 patients with a view to scientifically investigate the measuring capacity of the questionnaire. This will be done using traditional psychology methods (psychometry) as well as modern statistical methods (structural equations for categorical data and item response models). Relevance: The above-mentioned questionnaire is necessary for clarifying whether these diseases reduce quality of life and, in the long-term, whether a difference in quality of life exists using the different treatment alternatives and whether treatment can be improved. It should also be included in quality protection studies, in the evaluation of new treatment modalities and possibly also in the treatment of the individual patient.

Official Title
-----------------
Development and Validation of a Thyroid-Specific Quality of Life Measure

Conditions
-----------------
Thyroid Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with benign thyroid disease. Exclusion Criteria: Unable to complete questionnaire: must be able to read and write Danish

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid disease, Quality of Life, Patient reported outcome, questionnaire, Quality of Life measurement
Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair

Study Overview
=================
Brief Summary
-----------------
Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few years peripheral nerve blocks have increased their popularity for this kind of operation. The investigators want to see how the type of anesthesia and postoperative analgesia effects the time required for patient mobilisation.

Official Title
-----------------
Comparison of Femoral - Sciatic - Obturator Nerve Block vs General Anesthesia in Combination With Continuous or Bolus Femoral Nerve Block for Arthroscopic ACL Repair Regarding the Time of Patient Mobilasation

Conditions
-----------------
Arthroscopic ACL Rerpair, Surgery, Anesthesia Care

Intervention / Treatment
-----------------
* Other: Ultrasound Guided Femoral Sciatic Obturator nerve blocks
* Other: General Anesthesia femoral bolus
* Other: General anesthesia femoral continuous


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 80 yrs ASA I - III ACL surgery Exclusion Criteria: Coagulopathy disorders Infection at the puncture site for the interscalene block Neurologic deficit in the arm that is going to be operated Allergy to local anesthetics BMI > 35 Psychiatric disorders Patient's refusal Problems with patient communication

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia Femoral continuous<br>General anesthesia plus continuous femoral nerve block | Other: General anesthesia femoral continuous<br> <br> |
| Active Comparator: General anesthesia Femoral bolus<br>General anesthesia plus single shot femoral nerve block | Other: General Anesthesia femoral bolus<br> <br> |
| Active Comparator: Femoral Sciatic Obturator Nerve block<br>Ultrasound guided femoral plus sciatic plus obturator nerve block | Other: Ultrasound Guided Femoral Sciatic Obturator nerve blocks<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery completed without pain for the patient | Use of VAS score | Completion of the surgery | 
| Postoperative pain | Use of VAS score | 1st postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilization of the knee | How many degrees can the patient bend the knee | 24 weeks postoperatively |
Safety of SPD465 in Treating Adults With ADHD.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.

Official Title
-----------------
A Phase III, Multi-center, 12-month, Open-label Safety Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events. Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods. Exclusion Criteria: Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol. Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders. History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder. Females who are pregnant of lactating.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of safety will be based on the occurrence of treatment emergent AEs and specific evaluation of vitals signs, ECG, laboratory and physical examination. |  | Throughout the study period of approximately 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-rating scale (ADHD-RS-IV) taken at the Visit 1 and all visits thereafter. |  | Baseline, Weekly for 4 weeks, and then Monthly for 5 months. | 
| Clinical Global Impression of Improvement scale assessed at Visits 1 through 15/Early Termination (ET). |  | Baseline, Weekly for 4 weeks, and then Monthly for 5 months. | 
| Pittsburgh Sleep Quality Index (PSQI) - assessed at Visits 1 through 15/ET. |  | Baseline, Weekly for 4 weeks, and then Monthly for 5 months. |
Clinical Study on the Effect of PTH on CYP3A4 Activity

Study Overview
=================
Brief Summary
-----------------
Parathyroid hormone (PTH) may play an important role in the down-regulation of CYP3A4 expression induced by Chronic kidney diseases (CKD). In the study of molecular mechanism, the research group found that the expression of CYP3A2 metabolic enzyme in rat liver decreased in the state of CKD.And PTH may down-regulate the expression of CYP3A4 metabolic enzyme by inhibiting the expression of Nuclear factor- Kilobuse (NF-kB) p65 subunit

Official Title
-----------------
Clinical Study on the Effect of PTH on CYP3A4 Activity

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Drug: Nifedipine controlled released tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese male or female subjects with an age of 18 or older were included; The clinical physician diagnosed CKD with hypertension; The physician decided that nifedipine controlled release tablets should be given. Subjects agree to the study protocol, clinical and follow-up time, and sign the informed consent after the approval of the ethics committee; Subjects will be able to communicate well with the investigator and will be able to complete the study as required. Exclusion Criteria: Patients with CKD requiring dialysis treatment; Other clinical reasons that may be considered inappropriate for inclusion by clinicians.

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 |
| --- | --- |
| XBDP1-<br> | Drug: Nifedipine controlled released tablets<br>* lower blood pressure<br>|
| XBDP2-<br> | Drug: Nifedipine controlled released tablets<br>* lower blood pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concentration of nifedipine | the concentration of nifedipine | at 5-7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour ambulatory blood pressure | mean blood pressure | at 1 day and 7day |