linjc16/ctgov huggingface dataset:
Evaluating In Vivo OCT Imaging for Periocular Basal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Optical coherence tomography (OCT) is an imaging technique which shows the internal structure of living tissue (in vivo). It is safe, quick and painless to perform, and does not damage the tissue in any way. Recent advances in the technology mean that it can now be used to take images of the internal structure of the skin. This is useful because certain conditions, such as skin cancers, alter this structure. At present a suspected skin cancer is identified by taking a sample (a biopsy) which is analysed under the microscope to confirm the diagnosis. The cancer is then excised including a margin of apparently healthy-looking skin around it to ensure that the entirety of the tumour is removed. The excised tumour is then analysed again under a microscope to confirm that it was indeed completely removed (histology), after which a further operation is required to repair the defect. The purpose of this study is to evaluate OCT imaging of a particular type of skin cancer called a basal cell carcinoma (BCC), and in particular BCCs affecting the skin around the eyes (periocular). The study will compare the ability of OCT to define the margin of the BCC with the current 'gold standard' of histology. OCT could potentially improve the investigators ability to define the margins of the tumour before surgery and become a guide for minimally invasive surgery. The preservation of healthy tissue represents a priority, particularly in the area of the skin surrounding the eye.

Official Title
-----------------
An Investigation of the Correlation Between OCT and Histology in Defining the Margins of Periocular Basal Cell Carcinoma

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Other: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults of any age or gender who have capacity to give informed consent, and who have periocular basal cell carcinoma requiring surgical excision Exclusion Criteria: Children, vulnerable adults, inability to give informed consent

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 |
| --- | --- |
| BCC<br>Adult of any age or gender with capacity to give informed consent who has a basal cell carinoma requiring surgical excision and involving the periocular skin | Other: OCT<br>* Optical coherence tomography of periocular basal cell carcinoma<br>|

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
-----------------
Basal cell carcinoma, Optical Coherence Tomography
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders

Study Overview
=================
Brief Summary
-----------------
The study is an epidemiological survey to find out the incidence of loss of appetite in Indian patients suffering from various health disorders. This survey will be conducted to obtain information on appetite from a total of 17500 subjects This study does not intend to study the effect of any drugs. The primary source of information will be the subjects themselves. The study will be conducted at 275 - 350 centres spread across India.This is a single visit study.The physician will conduct routine clinical, physical and general examination.

Official Title
-----------------
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders.

Conditions
-----------------
Appetite

Intervention / Treatment
-----------------
* Other: No Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Non-pregnant women ≥ 18 years of age recuperating from healthcare disorders like:Malaria fever, Typhoid or enteric fever Hepatitis Acute infections including respiratory, urinary tract infections etc treated with antibiotic Tuberculosis Patient discharged from hospital after general surgical procedures like acute appendectomy, etc. Any other condition Exclusion Criteria: Patients unwilling to provide informed consent & comply with the study procedure Patient using drugs which affect appetite like Cyproheptadine etc.

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 |
| --- | --- |
| Group 1<br> | Other: No Drug<br>* No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with loss of appetite |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with fatigue |  | 1 Day | 
| Distribution of fatigue among the patients with respect to disease |  | 1 Day | 
| Percentage of patients with moderate to very severe Fatigue. |  | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appetite
Outcomes of Anti-HIV Therapy During Early HIV Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if it is effective to give aggressive anti-HIV therapy to patients who have been infected recently with HIV. Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV treatment as soon as possible. However, early HIV infection is not yet completely understood, so it is not known if this is the best approach. This study will look at the effects of beginning anti-HIV treatment during early HIV infection.

Detailed Description
-----------------
Although many researchers have recommended initiation of aggressive antiretroviral therapy as soon as possible after HIV infection occurs, the tolerability and efficacy of this approach has not been systemically evaluated. Many features of primary HIV pathogenesis are incompletely understood. A more complete understanding of immune dynamics and viral pathogenesis during primary HIV infection is critical to determine optimal treatment intervention strategies. This study will evaluate the outcomes of potent antiretroviral therapy initiated at different stages of primary HIV infection. Thirty-six of the study patients are coenrolled to ACTG 371 or another treatment protocol. All study drug treatment and toxicity management is performed according to guidelines in these treatment protocols. An untreated cohort of 12 patients is also followed on this study. Patients are stratified at enrollment according to their stage of acute or early HIV infection. Patients are evaluated for virologic, immunologic, and clinical parameters for 96 weeks. In addition, novel studies of source partner identification are proposed. An effort is made to determine the most likely source partner(s) for each study patient on the basis of patient recall of possible exposures. A separate study protocol will evaluate the source partner.

Official Title
-----------------
Outcomes of Antiretroviral Therapy During Primary HIV Infection

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are at least 13 years old. Have acute or early HIV infection. The stage of HIV infection will depend on the results from certain lab tests. Exclusion Criteria Patients will not be eligible for this study if they: Are pregnant or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 13 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
-----------------
Immunity, Cellular, Sexual Partners, Treatment Outcome, Anti-HIV Agents, Viral Load, Acute Infection
Lactoferrin Treatment in HIV Patients

Study Overview
=================
Brief Summary
-----------------
Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.

Official Title
-----------------
Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Recombinant Lactoferrin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values) Age >40 years Exclusion Criteria: Prior cardiovascular disease or stroke Diabetes Rheumatologic Diseases Pregnancy Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2) Cirrhosis or end-stage liver disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recombinant Lactoferrin<br>Recombinant lactoferrin will be administered by mouth twice daily | Drug: Recombinant Lactoferrin<br> <br> |
| Placebo Comparator: Placebo<br>Matched placebo will be administered by mouth twice daily | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event | Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious) | During 3 months on Lactoferrin or Placebo (and following washout period) | 
| IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8) | The IL-6 & D-dimer score is defined as: 0. 33*log2 IL-6 + 0.16*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 & D-dimer score are interpreted as HR(event) per doubling of IL-6 and D-dimer, or HR(event) per 20% increase in IL-6 and D-dimer; the score itself is unitless. Among the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5. Higher scores are worse. | 3 months (Baseline to Month 3 or Month 5 to Month 8) | 
| Number of Participants Taking Medication as Assigned | Number of participants taking medication as assigned at 3 months | 3 months |
Sensorimotor Based Brain Computer Interface

Study Overview
=================
Brief Summary
-----------------
Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. Often, the computer software that analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals when the training target location is known. The investigators want the BCIs to be more universal, and not depend on knowing the target location. Therefore, the investigators will test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.

Official Title
-----------------
Effect of Normalizer Adaptation on Accuracy in a Sensorimotor Based Brain-Computer Interface

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: Brain computer Interface Mu (SMR) rhythm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older. Able to read text on a computer screen Able to understand and remember instructions concerning participation. Exclusion Criteria: Unable give informed consent. Unable to understand and follow instructions. Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings. Known to have photosensitive epilepsy. Open head lesions or sores.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mu Rhythm with adaptation<br> | Other: Brain computer Interface Mu (SMR) rhythm<br>* Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 10 sessions.<br>|
| Experimental: Mu Rhythm without adaptation<br> | Other: Brain computer Interface Mu (SMR) rhythm<br>* Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 10 sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of a mu rhythm BCI using adaptation versus no adaptation. | Accuracy with which subjects can select one of two targets after a 3-second time period. The accuracy for a run is calculated as the % of the trials in which the correct target is selected. The average accuracy will be calculated for each of the 10 usage sessions and changes over the sessions will be tracked. | 10 times over 5 weeks |
Subthreshold Micropulse Laser Treatment of Acute Central Serous Chorioretinopathy

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of 532 nm green subthreshold micropulse laser (GSML) as a treatment for acute central serous chorioretinopathy (CSCR).

Detailed Description
-----------------
This prospective study included 42 eyes of 42 patients with acute CSCR treated with IRIDEX™ IQ 532 nm GSML. The study was conducted at Minia University Hospital and Genaidy Ophthalmology Center, Minia, Egypt between October 2019 and May 2022. All patients were subjected to a complete ophthalmological examination, fluorescein angiography (FA) and optical coherence tomography (OCT) at baseline and each follow-up visit 1, 3 and 18 months after laser treatment

Official Title
-----------------
Subthreshold Micropulse 532 nm Green Laser Treatment of Acute Central Serous Chorioretinopathy: 18-month Results

Conditions
-----------------
Acute Central Serous Retinopathy With Subretinal Fluid

Intervention / Treatment
-----------------
* Procedure: Micropulse laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute CSCR Exclusion Criteria: chronic CSCR Previously treated case of Acute CSCR
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 |
| --- |
|Procedure: Micropulse laser|532 nm green subthreshold micropulse laser (GSML) as a treatment for acute central serous chorioretinopathy (CSCR).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual acuity | resolution of subretinal fluid | 18 months |
Quantitative Magnetic Resonance Imaging (MRI) Sub-Study of MS PATHS

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the performance of a new magnetic resonance imaging (MRI) metrics software prototype when used in radiological practice in multiple sclerosis (MS).

Official Title
-----------------
Performance and Feasibility of Quantitative MRI Metrics in Routine Radiology Practice: A Sub-Study of MS PATHS

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Board-certified neuroradiologists or experienced neuroradiology fellows. Employed at a participating MS PATHS institution. At least 3 years of experience in interpreting brain MRI scans of MS participants. Key Exclusion Criteria: Inability to comply with sub-study procedures. Other unspecified reasons that, in the opinion of Biogen or the MS PATHS Radiology Lead at the institution, make the radiologist unsuitable for participation.
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 |
| --- | --- | --- |
| Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision | MRIs from participants will be analyzed by the prototype. The radiologist will view the brain segmentation results and the new or enlarging T2 lesion detection results. The radiologist will either Approve or Reject the results. | Baseline up to 6 weeks | 
| Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of False-Positive and False-Negative Lesions | MRIs from participants will be analyzed by the prototype. The radiologist will view the new or enlarging T2 lesions to determine false-positive or false-negative results. | Baseline up to 6 weeks |
Follow-up of Patients After 4-row Arthrodesis or Proximal Row Carpectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to follow-up on patients who underwent different types of wrist surgery: 4-row arthrodesis or proximal row carpectomy.

Official Title
-----------------
Follow-up of Patients After 4-row Arthrodesis or Proximal Row Carpectomy

Conditions
-----------------
Wrist Surgery

Intervention / Treatment
-----------------
* Procedure: Anamnesis and clinical examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent wrist surgery (4-row arthrodesis or proximal row carpectomy) between 1998 and 2004

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wrist surgery<br> | Procedure: Anamnesis and clinical examination<br>* Anamnesis and clinical examination to follow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of both types of wrist surgery |  | 5 to 10 years follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wrist surgery: 4-corner arthrodesis or proximal row carpectomy
Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis

Study Overview
=================
Brief Summary
-----------------
This study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. Hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer

Official Title
-----------------
Tumor Response Prediction in Neoadjuvant Chemoradiation of Locally Advanced Rectal Cancer Using Metabonomics Analysis

Conditions
-----------------
Locally Advanced Rectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of primary rectal cancer with distance from anal verge being less than 12 cm; histologically confirmed adenocarcinoma; initial pathological stage of T3 or T4 and/or N+; no history of initial distant metastases; Karnofsky Performance Status score of ≥75 ≥18 years;≤75 years sign the inform consent Exclusion Criteria: pregnancy or breast-feeding women serious medical illness baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRG | Tumor regression grade | Surgery scheduled 6-8 weeks after the end of chemoradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response |  | Surgery scheduled 6-8 weeks after the end of chemoradiation | 
| Local Control rate | Number of participants with pelvic failure after surgery, evaluated using Kaplan-Meier Curve | From date of randomization until the date of first documented pelvic failure, assessed up to 10 years | 
| Disease-free Survival |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years | 
| Overall Survival |  | From date of randomization until the date of death from any cause, assessed up to 10 years | 
| Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0 | Number of participants with chemoradiation-related adverse events as assessed by CTCAE v4.0 | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoadjuvant Chemoradiation, treatment effect prediction, metabonomics