linjc16/ctgov huggingface dataset:
Dorsal Splint or Circular Cast for Colles' Fracture?

Study Overview
=================
Brief Summary
-----------------
At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast after 10 days. According to individual factors such as age, general health and radiological results after 10 days, some patients with severe redisplacement are readmitted to hospital for surgery. The main purpose of this study is to determine whether, during the first 10 days of immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the two methods.

Official Title
-----------------
Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures

Conditions
-----------------
Colles' Fracture

Intervention / Treatment
-----------------
* Procedure: plaster cast
* Procedure: dorsal splint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 50 years and older Colles' fracture due to low energy trauma Exclusion Criteria: high energy trauma age under 50 years dementia

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: complete plaster cast<br>reduction and a complete plaster cast, | Procedure: plaster cast<br>* complete circular plaster cast<br>|
| Active Comparator: dorsal plaster splint<br>reduction and a dorsal plaster splint. | Procedure: dorsal splint<br>* dorsal plaster splint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| redisplacement | dorsal angulation, radial tilt and radial shortening - radiographs | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | pain during past 24h on a VAS | 10 days | 
| number of analgesic tablets | number of analgesic tablets taken during the 10 days after reduction. | 10 days |
Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.

Official Title
-----------------
Stepped Surgery in Uveitic Cataract: A Novel Approach to a Quiet Eye

Conditions
-----------------
Outcome of Stepped Cataract Surgery in Uveitis

Intervention / Treatment
-----------------
* Procedure: cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement Exclusion Criteria: the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: stepped cataract surgery<br> | Procedure: cataract surgery<br>* stepped surgery in the form of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visulal acuity | overall improvement in vision using LogMAR | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular inflammation | flare up of inflammation after surgery USING SUN classification | 6 months |
Study on Energy Cost Prediction of Cycle Ergometer

Study Overview
=================
Brief Summary
-----------------
This study purpose is (1) to develop the new energy expenditure equation; (2) to increase accuracy of energy cost prediction of cycle ergometer; (3) to find out some dependent factors.

Detailed Description
-----------------
Oxygen consumption (ml/min) was measured while subjects were at rest and exercised at four submaximal workloads in steady state on cycle ergometer. Bioelectrical impedance analysis was used to estimate the body fats and skeletal muscle mass.

Conditions
-----------------
Healthy, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female Never received bicycle training Exclusion Criteria: Exercise testing contraindications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy female
Dexmedetomidine and Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia. The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered

Official Title
-----------------
The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.

Conditions
-----------------
Anesthesia Complication

Intervention / Treatment
-----------------
* Drug: Normal saline
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective gynaecological laparoscopic surgery Age 20-45 yrs Suspected surgery time 30 minutes Inflation pressure <13 Cm H20 Exclusion Criteria: Contraindications to regional block (infection at the needle insertion site) Altered conscious level. Pregnancy Body mass index >35 Height <155 cm Patients who have difficulty understanding the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control group<br>will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline | Drug: Normal saline<br>* intravenous flluid<br>|
| Other: Dexmedetomidine group<br>will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic) | Drug: Dexmedetomidine<br>* anaesthetic adjuvants and pain killer medication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence shoulder tip pain |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative haemodynamic stability, et co2, sao2. |  | 2 hours |
Treatment of Malignant Glaucoma by Anterior Vitrectomy From Two Different Approaches

Study Overview
=================
Brief Summary
-----------------
To compare the surgical outcomes of treating phacoemulsification with intraocular lens implantation combined with goniosynechialysis (Phaco-IOL-GSL) associated malignant glaucoma (MG), using different incision sites in anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).

Official Title
-----------------
Treatment of Malignant Glaucoma Secondary to Cataract Surgery Combined With Goniosynechialysis by Anterior Vitrectomy From Two Different Approaches

Conditions
-----------------
Glaucoma Secondary

Intervention / Treatment
-----------------
* Procedure: anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MG was diagnosed based on the presence of a central and peripheral shallow anterior chamber with normal or elevated intraocular pressure (IOP). Exclusion Criteria: The diagnosis was made only after confirming the absence of choroidal detachment or hemorrhage and posterior segment mass lesion, using B-scan ultrasonography or ophthalmoscopy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomy|First, a 23-G incision was made at the peripheral inferior temporal sector of the cornea and connected with an anterior chamber infusion cannula. Another corneal incision was made at the superior temporal sector or superior nasal sector, and Viscoat® (Bausch & Lomb, Shandong, China) was infused though the incision to fill the anterior chamber. Iridotomy was performed through the incision using Wescott scissors and toothed forceps. Hyaloidectomy and zonulectomy were performed through a peripheral iris defect using an anterior chamber approach to set up a pathway between the anterior chamber and the vitreous cavity. We repeatedly carried out vitrectomy around the pathway to reduce the risk of postoperative re-obstruction of the tunnel created.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of MG | MG relapse after the anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI). | follow up: 3 to 31 months |
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above the muscle or below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with reconstruction. A secondary purpose is to learn whether there are differences in complications and costs between the two locations.

Official Title
-----------------
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction

Conditions
-----------------
Breast Reconstruction Following Mastectomy

Intervention / Treatment
-----------------
* Procedure: Subcutaneous placement
* Procedure: Submuscular placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women at least 18 years of age, who will undergo immediate unilateral or bilateral implant-based breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy. Women at least 18 years of age, who will undergo immediate bilateral implant-based breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy. Exclusion Criteria: Subjects who are unable to read or speak English. Patients desiring autologous reconstruction. BMI >40. History of radiation therapy to the breast(s), e.g. history of breast conservation therapy. Current nicotine and/or tobacco use. Documented diagnosis of chronic pain. Women who are pregnant or breast-feeding * Women who decline the use of acellular dermal matrix (ADM). Surgeon decision not to proceed with tissue expander reconstruction. Women undergoing single stage (straight to implant) reconstruction.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subcutaneous<br>Subcutaneous placement of tissue expander | Procedure: Subcutaneous placement<br>* The tissue expander will be placed above the muscle.<br>|
| Active Comparator: Submuscular<br>Submuscular placement of tissue expander | Procedure: Submuscular placement<br>* The tissue expander will be placed below the muscle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient satisfaction | Difference in patient satisfaction between the two groups using the physical well being scale. | Baseline, Year 3 |
The Outcome of the Transobturator Tape (TOT) Procedure

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to report the subjective and objective outcome of outside-in transobturator technique (TOT) (Monarc®) in long-term follow-up. This is a follow-up study concerning 191 patients operated on in Turku University Hospital between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS), a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an absence of reoperation for SUI during the follow-up period.

Official Title
-----------------
The Outcome of the Transobturator Tape (TOT) Procedure During the Follow-up of 6.5 Years

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Other: Gynaecological examination, a supine stress test, questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 191 patients operated on with the TOT procedure between May 2003 and December 2004 at the Department of Obstetrics and Gynecology in the Turku University Hospital. Exclusion Criteria:
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients operated on with the TOT<br> | Other: Gynaecological examination, a supine stress test, questionnaires<br>* Gynaecological examination, a supine stress test, questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective outcome of the TOT operation, which was evaluated with stress test and need for reoperation for urinary incontinence. |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective outcome of the TOT operation which was assessed with evaluated questionnaires. |  | 8 years |
Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).

Official Title
-----------------
A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: neratinib
* Other: Placebo
* Drug: Moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of nonchildbearing potential, 18-50 years old. Healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HKI-272 | Drug: neratinib<br>* HKI-272<br>|
| Placebo Comparator: 2<br>Placebo | Other: Placebo<br>* Placebo<br>|
| Active Comparator: 3<br>Moxifloxacin | Drug: Moxifloxacin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thorough QTc study
Montelukast for Prevention & Treatment of OHSS

Study Overview
=================
Brief Summary
-----------------
montelukast & dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

Detailed Description
-----------------
patients with high risk for ovarian hyperstimulation will undergo a freeze-all protocol then montelukast & dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

Official Title
-----------------
Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles

Conditions
-----------------
Ovarian Hyperstimulation Syndrome

Intervention / Treatment
-----------------
* Drug: dydrgesterone 10 mg( tab)/12hs/14 days
* Combination Product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS high responders high numbers of ovum retrieved Exclusion Criteria: hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 37 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>dydrgesterone 10 mg( tab)/12hs/14 days | Drug: dydrgesterone 10 mg( tab)/12hs/14 days<br>* Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup<br>* Other names: progesterone only;|
| Experimental: study<br>montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days | Combination Product: montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days<br>* montelukast 10 mg(tab) once daily oral for 7 days & dydrgesterone 10 mg (tab) twice daily oral for 14 days &<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who develop ovarian hyperstimulation syndrome | incidence | 0-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants treated of ovarian hyperstimulation syndrome | treatment & resolution | 0-14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian hyperstimulation syndrome, Montelukast