linjc16/ctgov huggingface dataset:
Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use a novel load monitoring technology to correlate limb loading to ankle fracture outcomes. This study will collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing.

Official Title
-----------------
Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of Ankle Fractures

Conditions
-----------------
Ankle Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years of age or older Patient has an ankle fracture Patient speaks English Patient weighs between 100 and 250 pounds Patient lives in close enough proximity to the hospital to return for all appointments ( 100 miles) Exclusion Criteria: Patient is younger than 18 years of age Patient has multiple fractures that would alter weight bearing protocol Patient does not speak English Patient weighs less than 100 pounds or more than 250 pounds Patient does not live in close enough proximity to the hospital to return for all appointments ( >100 miles) Patient has a traumatic brain injury that would make it so they cannot consent Patient has diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Patient Activity Measure (PAM-13) Questionnaire | A subjective evaluation of perceived compliance with physician instructions | Follow Up Visits up to 1-Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray (AP and Lateral) | Subjectively evaluate fracture healing | Follow Up Visits up to 1-Year |
Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion

Study Overview
=================
Brief Summary
-----------------
Laparoscopic surgery is now a well-established alternative to open surgery for many gynecological disorders owing to its faster wound healing, shorter hospital stay, less postoperative pain, and better cosmetic results. Postoperative scar cosmoses is a critical issue for women, especially for young women. These scars may have negative impacts, such as psychological consequences. The symptoms associated with the wound, such as pain, tenderness, and itching, can be induced by the scars

Official Title
-----------------
Perioperative Outcome of Infraumbilical Versus a Modified Intraumbilical Direct Trocar Insertion in Gynecologic Laparoscopy: A Randomized Controlled Trial

Conditions
-----------------
Gynecologic Disease

Intervention / Treatment
-----------------
* Procedure: infraumbilical transverse incision
* Procedure: intraumbilical incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women subjected to direct trocar application as a part of any gynecologic procedure performed Exclusion Criteria: Verres needle insertion. Patients with previous abdominal surgery and scar, umbilical hernia, previous laparoscopy or previous umbilical surgery, burns in the umbilical region; who have hyperpigmented skins.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>infraumbilical transverse incision will be done | Procedure: infraumbilical transverse incision<br>* a 10 mm infraumbilical transverse incision will be done to allow trocar to be inserted without undue resistance from the skin so that the trocar will pass through the fascia and the peritoneum with ease<br>|
| Active Comparator: control group<br>Direct intraumbilical transverse incision will be done | Procedure: intraumbilical incision<br>* right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean difference in the duration of surgery | calculated from the onset of surgery till the end | 30 minutes |
Duobrii in Combination With Biologics

Study Overview
=================
Brief Summary
-----------------
12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks

Detailed Description
-----------------
A single center, pilot study of 25 subjects to assess 12 weeks DUOBRII to patients with 2%-10% body surface area who are receiving biologic therapy for at least 24 weeks

Official Title
-----------------
Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Duobrii


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of chronic plaque-type Psoriasis affecting 2%-10% BSA Patient is being treated with biologic therapy for a minimum of 24 weeks Able and willing to give written informed consent prior to performance of any study-related procedures Exclusion Criteria: Psoriasis affecting ˂2% or >10% BSA Patient not receiving a biologic agent, or receiving biologic agent <24weeks Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit. Has previously used DUOBRII

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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Duobrii<br>Duobrii QD | Drug: Duobrii<br>* duobrii applied daily for 4 weeks followed by every other day for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body surface area improvement | body surface area determined by palm method where 1 palm is equivalent to 1% | 8 weeks |
Post Market Clinical Follow-up of EUROSTEM Femoral Stem

Study Overview
=================
Brief Summary
-----------------
EUROSSTEM is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

Detailed Description
-----------------
Post market observational study. This study is multicenter, prospective, non comparative.

Official Title
-----------------
Post Market Clinical Follow-up of EUROSTEM Femoral Stem

Conditions
-----------------
Hip Osteoarthritis, Hip Arthropathy, Hip Arthritis, Hip Necrosis, Hip Fractures, Hip Dysplasia

Intervention / Treatment
-----------------
* Device: hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who received EUROSTEM Patient informed of its participation to the study Patient aged over 18 to date of surgery Exclusion Criteria: Patient presenting a contraindication to EUROSTEM implantation. Patient who refused to participate to the study Vulnerable subjects

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 |
| --- | --- |
| EUROSTEM femoral stem<br>All patients who received EUROSTEM femoral stem whatever the version (cemented or cementless) | Device: hip arthroplasty<br>* Hip prosthesis surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of EUROSTEM Femoral Stem | Collect the safety of the device trought complications occurence rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological performances of EUROSTEM Femoral Stem | Collect the performances of the device trought radiological evaluation | 1 year | 
| Clinical performances of EUROSTEM Femoral Stem | Collect the performances of the device trought clinical scores | 1 year | 
| Survival of EUROSTEM Femoral Stem | Assess the survival rate of the device | 10 year |
Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.

Official Title
-----------------
A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension

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

Intervention / Treatment
-----------------
* Drug: valsartan plus hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed severe hypertension Exclusion Criteria: Inability to discontinue all prior antihypertensive medications Heart failure of any kind History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease Diabetes with poor glucose control Allergy to certain medications used to treat high blood pressure Other protocol-defined exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan plus hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure less than 140/90 mmHg after 4 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure less than 140/90 mmHg after 6 weeks |  |  | 
| Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks |  |  | 
| Systolic blood pressure less than 140 mmHg after 4 and 6 weeks |  |  | 
| Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks |  |  | 
| Adverse events and serious adverse events at each study visit for 6 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, high blood pressure, valsartan/hydrochlorozide, severe hypertension
An Extension Study to Assess the Safety, Tolerability, Efficacy, and Treatment Adherence of Dapsone in Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Dapsone Formulation A
* Drug: Dapsone Formulation B
* Drug: Dapsone Formulation C
* Drug: Dapsone 5% Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in Allergan study 225678-004 Exclusion Criteria: Anticipates the need for surgery or hospitalization during the study

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapsone Formulation A<br>Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug: Dapsone Formulation A<br>* Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.<br>|
| Experimental: Dapsone Formulation B<br>Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug: Dapsone Formulation B<br>* Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.<br>|
| Experimental: Dapsone Formulation C<br>Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug: Dapsone Formulation C<br>* Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.<br>|
| Active Comparator: Dapsone 5% Gel<br>Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks. | Drug: Dapsone 5% Gel<br>* Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.<br>* Other names: ACZONE®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Inflammatory Lesion Count |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Non-Inflammatory Lesion Count |  | Baseline, Week 12 | 
| Change from Baseline in Total Lesion Count |  | Baseline, Week 12 | 
| Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1 |  | Week 12 |
Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece

Study Overview
=================
Brief Summary
-----------------
ADMIRE was a prospective, observational cohort study of patients with diabetic macular edema (DME). Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to months 12, 24 and 36 after treatment with intravitreal aflibercept in treatment-naïve patients and previously treated patients. Safety was evaluated by recording any patients-reported events.

Official Title
-----------------
Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece: The ADMIRE Study

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with DM, able to give written informed consent Patients with DME>320 μm, who need treatment Exclusion Criteria: Patients with other retinal diseases than DME Intraocular surgery within the last 6 months

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aflibercept|Intravitreal aflibercept as used in the routice clinical practice|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best-corrected visual acuity |  | 12 months |
Collection of Outcomes Data for Pregnant Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
This study collects treatment and outcomes information on pregnant patients who are or were pregnant with cancer. Gathering and storing health information on pregnant patients with cancer, may provide data for future research studies and improve patient care.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To collect, both prospectively and retrospectively, data on disease characterization, treatment and outcome for pregnant patients with malignancies seen at M. D. Anderson Cancer Center. II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and pregnancy outcome data and to facilitate correlation of these characteristics with patient outcome. III. To have a single data repository, kept on a secure platform, that will integrate clinical information and research findings and serve as a secure archive for future research. OUTLINE: Patients' medical records are reviewed prospectively and retrospectively.

Official Title
-----------------
Collection of Outcomes Data for Pregnant Patients With Cancer

Conditions
-----------------
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Other: Medical Chart Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant patients with cancer and patients known to have been pregnant with a diagnosis of cancer are eligible, regardless of their diagnosis or treatment plan Patients may receive prenatal care from any obstetrician, but a consult with Maternal Fetal Medicine is encouraged
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (medical chart review)<br>Patients' medical records are reviewed prospectively and retrospectively. | Other: Medical Chart Review<br>* Medical records are reviewed<br>* Other names: Chart Review;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of data repository for patient characteristics, treatment, and pregnancy outcome data |  | Up to 15 years |
Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain

Study Overview
=================
Brief Summary
-----------------
the aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section.

Detailed Description
-----------------
pregnant females scheduled for cesarean section under spinal anesthesia will be enrolled . two groups of patents will be recruited . the study group will receive paracetamol pre operative .

Official Title
-----------------
Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial.

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Drug: paracetamol
* Drug: Saline Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women (ASA II) having singleton pregnancy at term (≤ 37 weeks of gestation) aged between 18 and 40 years. Exclusion Criteria: Patients having allergy to study drug, gestational diabetes cardiovascular or biliary disorders asthma renal impairment preeclampsia any chronic pain condition or trauma in the shoulder, forearms or upper limbs patients with any contraindication to SA were excluded from the study.
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>will receive 100 ml of saline | Drug: Saline Solution<br>* 100ml<br>|
| Experimental: paracetamol group<br>will receive 1gm paracetamol (100ml) | Drug: paracetamol<br>* 1gm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence shoulder tip pain | presence of shoulder tip pain | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale | severity of shoulder tip pain (0-10) where 0 is no pain and 10 is the worst pain ever | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder tip pain