linjc16/ctgov huggingface dataset:
Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in pediatric patients, by presenting the clinic-radiological outcome and complications.

Official Title
-----------------
Yulin Orthopedics Hospital of Chinese and Western Medicine

Conditions
-----------------
Bone Diseases

Intervention / Treatment
-----------------
* Procedure: free nonvascularized fibula autograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. This retrospective study included pediatric patients before epiphyseal closure with tumor-like lesions in femoral neck. Exclusion Criteria: pediatric patients with tumor-like lesions in femoral neck after epiphyseal closure; pediatric patients with benign bone tumors and malignant bone tumors in the femoral neck after epiphyseal closure; adult patients with benign or malignant bone tumors and tumor-like lesions in femoral neck.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 Years

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 |
| --- | --- |
| Experimental: Free nonvascularized fibula autograft<br>Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck. | Procedure: free nonvascularized fibula autograft<br>* Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck between Aug. 2012 and Sep. 2016. All the patients were given supplementary skeletal traction through supracondyle of femur for 4 weeks to 6 weeks after the resections.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of peri-implant bone level from baseline at 7 and 54 months | Mean follow-up of all the patients after primary surgery was 24 months, ranged 7 months to 54 months. | 7 months to 54 months |
GlobalSurg-CovidSurg Week

Study Overview
=================
Brief Summary
-----------------
Observational study to determine the optimal timing for surgery following SARS-CoV-2 infection and assess key global surgery indicators.

Detailed Description
-----------------
Prospective, observational international cohort study. Any hospital worldwide can participate (including hospitals that have not admitted SARS-CoV-2 infected patients). All patients undergoing a surgical procedure in an operating theatre will be included. All consecutive eligible patients should be included. 7-day data collection period, with follow-up at 30 days after surgery for each patient. However, no changes should be made to normal patient care/ follow-up pathways Primary outcome is 30-day mortality. All collaborators will be included as PubMed-citable co-authors on resulting publications.

Official Title
-----------------
GlobalSurg-CovidSurg Week: Determining the Optimal Timing for Surgery Following SARS-CoV-2 Infection

Conditions
-----------------
Surgery, Covid19, Post-Op Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Any operation (elective or emergency) done in an operating theatre by a surgeon. All surgical specialties including: acute care surgery, breast surgery, cardiac surgery, colorectal surgery, general surgery, gynaecology, hepatobiliary surgery, neurosurgery, obstetrics, oesophagogastric surgery, ophthalmology, oral and maxillofacial surgery, orthopaedics, otolaryngology, paediatric surgery, plastic surgery, thoracic surgery, transplant surgery, trauma surgery, urology, vascular surgery. Day case surgery and inpatient surgery included. Any SARS-CoV-2 status (positive at any time, negative, not tested). All ages including children and adults. Exclusion criteria: Minor procedures (full list will be available in the protocol).
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 |
| --- | --- | --- |
| Post-operative mortality | Mortality at 30 days after surgery | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-patient mortality | Mortality while the patient is admitted to hospital | 30 days after surgery | 
| Post-operative pulmonary complications | 30-day postoperative pulmonary complications (pneumonia [CDC definition], ARDS, unexpected ventilation) | 30 days after surgery | 
| Post-operative venous thromboembolism | 30-day venous thromboembolism (deep vein thrombosis/ pulmonary embolism) | 30 days after surgery | 
| Post-operative complications | 30-day Clavien-Dindo grade | 30 days after surgery |
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics/Pharmacodynamics and Safety of GK Activator (2) Following a Single Oral Dose Administration in Patients With Type 2 Diabetes.

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: GK Activator (2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2); normal renal function, or moderate or severe impairment. Exclusion Criteria: type 1 diabetes; treatment with insulin or PPAR gamma agonist within 6 months of screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GK Activator (2)<br>* 100mg po<br>|
| Experimental: 2<br> | Drug: GK Activator (2)<br>* 100mg po<br>|
| Experimental: 3<br> | Drug: GK Activator (2)<br>* 100mg po<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, adverse events, laboratory parameters. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, Tmax, Cmax, T1/2, CL/F, CLR for GK Activator (2) and metabolite. Glucose Cmax and Cmin, and percentage decrease in glucose from baseline. |  | Throughout study. |
Drug Combination on Exercise Performance at High Altitude

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to determine the effectiveness of using two FDA approved medications in concert to reduce the likelihood of sickness due to low oxygen levels and to reduce the decrement in physical performance at higher elevations. The investigators hypothesize that this drug combination will reduce the symptoms of acute mountain sickness and improve exercise performance at high altitude compared to placebo.

Official Title
-----------------
Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude

Conditions
-----------------
Acute Mountain Sickness

Intervention / Treatment
-----------------
* Drug: ambrisentan and theophylline
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males Exclusion Criteria: VO2max below 45ml/kg/min currently taking any medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ambrisentan and theophylline<br>ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days | Drug: ambrisentan and theophylline<br> <br> |
| Placebo Comparator: placebo<br>matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group | Drug: placebo<br>* placebo for comparison group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (Minutes) to Complete 2 Miles on a Treadmill |  | after arriving at high altitude (within 1 hour) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise performance
Minimal-Dose Resistance Training for Improving sIgA and Cortisol

Study Overview
=================
Brief Summary
-----------------
Whereas the role of endurance training on immune function has been widely studied, little is known about the role of resistance training (RT). In this cross-over randomized controlled study, it will be analysed the effects of three RT protocols which only differs in volume in improving secretory immunoglobulin A (sIgA) and cortisol in saliva among young, health and sedentary people

Official Title
-----------------
Minimal-Dose Resistance Training for Improving sIgA and Cortisol Among Young, Health and Sedentary People

Conditions
-----------------
Immune System, Resistance Training

Intervention / Treatment
-----------------
* Behavioral: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-30 years Sedentary Exclusion Criteria: to have had COVID-19 during the last 3 months to have been vaccinated against COVID-19 during the last 3 months physical limitations or health problems

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance exercise for 10 min<br>Resistance circuit training of 10 min | Behavioral: Resistance training<br>* Resistance circuit training<br>|
| Experimental: Resistance exercise for 20 min<br>Resistance circuit training of 20 min | Behavioral: Resistance training<br>* Resistance circuit training<br>|
| Experimental: Resistance exercise for 30 min<br>Resistance circuit training of 30 min | Behavioral: Resistance training<br>* Resistance circuit training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of secretory immunoglobulin A (sIgA) | Secretory Immunoglobulin A in saliva | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of salivary cortisol (Scortisol) | Cortisol in saliva | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistance training, immune system, cortisol
Far Infrared Radiation Treatment for Uterine Fibroids

Study Overview
=================
Brief Summary
-----------------
A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.

Detailed Description
-----------------
Uterine fibroids are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape and often highly vascular. On MR imaging exams, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. We are postulating that energy specific electromagnetic radiation of the uterus will shrink the benign tumors.

Official Title
-----------------
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids

Conditions
-----------------
Leiomyoma

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation (5μm to 20μm wavelength)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18 or older with symptomatic fibroids Exclusion Criteria: Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment Metallic implants that are incompatible with MRI or ultrasound Known intolerance to the MRI contrast agent (e.g. Gadolinium)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Radiation: Far Infrared Radiation (5μm to 20μm wavelength)<br>* Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.<br>* Other names: Far infrared radiation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids |  | 2 years and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related uterine conditions, for example, bleeding. |  | Two years and nine months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroid Tumor, Fibroid Uterus, Fibroids, Uterine, Fibromyoma, Uterine Neoplasms
FitMi PD Home Therapy for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The investigators will run an at-home usability study of a newly developed home exercise device (FitMi PD) for individuals with Parkinson's disease. FitMi PD uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer.

Official Title
-----------------
FitMi PD: an Affordable Home Therapy Device for Individuals With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: FitMi PD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate PD (Hoehn and Yahr stage I to III) Mini-Mental State Examination greater than 28 Exclusion Criteria: Age less than 18 years old

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: At home exercise therapy with FitMi PD<br>Participants will be instructed to use FitMi PD exercise system for three hours per week over 3-week period. | Device: FitMi PD<br>* Exercise using the motion sensing devices and a tablet computer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Successfully Used FitMi PD to Exercise at Home | Number of participants who were successfully able to use the device at home to exercise over 3 week period. | Immediately Post-Treatment, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental State Examination (MMSE) | A screening tool for assessing cognitive impairment. A maximum possible score of 30 is used to provide a picture of an individuals' present cognitive performance. A score of < 24 is the generally accepted cutoff indicating the presence of cognitive impairment. Levels of impairment have been classified as: None: score = 24-30 Mild: score = 18-24 Severe: score = 0-17 | Baseline |
Women With Asymptomatic Endometrial Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical meaning of an endometrial hyperplasia diagnosed using a vaginal ultrasound during routine gynecological examination.

Official Title
-----------------
Women With Asymptomatic Endometrial Hyperplasia

Conditions
-----------------
Endometrial Hyperplasia

Intervention / Treatment
-----------------
* Other: vaginal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asymptomatic women with endometrial hyperplasia diagnosed using a vaginal ultrasound Exclusion Criteria: postmenopausal bleeding
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with endometrial hyperplasia<br> | Other: vaginal ultrasound<br>* vaginal ultrasound performed at a routine gyn examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of invasive endometrial cancers |  | Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women with atypical endometrial hyperplasia |  | Participants will be followed for the duration of hospital and until the results of the final histology from the endometrial biopsy are completed, for an expected average of 10 days |
A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the VFIX device).

Detailed Description
-----------------
In this study, the surgeon will not use the actual V-Fix device. Instead, the surgeon will use a routine operating room instrument, which is similar to the size and shape of the V-Fix device to mimic the placement of the VFIX device by using the routine operating room instrument to push the top of your vagina towards the ligament.

Official Title
-----------------
A Prospective, Observational Surgical Simulation Study to Evaluate the Safety of the VFIX Device Mechanism as Treatment for Vaginal Apical Prolapse

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years. Subjects with apical support prolapse in whom the surgeon may consider a surgical procedure to correct level 1 support, with C or D descent at least halfway down the vaginal length (i.e. uterus and cervix or the vaginal vault in hysterectomised subjects), and having laparoscopy or abdominal surgery (additional surgery e.g. tubal ligation or ovarian cystectomy is also allowed). Vaginal examination during the screening visit confirms that the lateral fornix of the vagina can reach both the left and right SSL and therefore the surgical simulation can be performed. The investigator considers that the subject is medically fit enough to receive extended anaesthesia of approximately 15 minutes, to complete the additional anatomical observation study procedures. Subjects agree to participate in the study and document this agreement by signing the Ethics Committee approved informed consent. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Incidence of subjects without any bowel entrapment between the vagina and the right SSL in subjects that the surgeon declares he would have deployed the V-Fix device |  | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of subjects without any bladder entrapment or traversing of the peritoneal cavity between the vagina and the right or left SSL in subjects that the surgeon declares he would have deployed the V-Fix device |  | Intraoperative | 
| Incidence of subjects without any bowel entrapment between the vagina and the left SSL in subjects that the surgeon declares he would have deployed the V-Fix device |  | Intraoperative |