linjc16/ctgov huggingface dataset:
Cellular Scale Measures of Short-Term Retinal Atrophy Progression

Study Overview
=================
Brief Summary
-----------------
Our goal is to determine the cellular scale changes that occur in subjects who have disease progression due to pentosan polysulfate sodium toxicity

Detailed Description
-----------------
The aim of this study is to determine the formation and progression of retinal changes caused by pentosan polysulfate sodium toxicity. To do this, we will measure how single cone photoreceptors respond to light in regions of the retina that are affected by pentosan polysulfate sodium toxicity. We will also measure how the retinal pigment epithelium, a layer of cells vital to photoreceptor health, change in shape and size over time.

Official Title
-----------------
Cellular Scale Characterization of the Retinal Pigment Epithelium-Photoreceptor Complex in Pentosan Polysulfate Sodium Toxicity

Conditions
-----------------
Pentosan Polysulfate Sodium Maculopathy, Pigmentary Maculopathy, Toxic Maculopathy, Pigmentary Retinopathy, Interstitial Cystitis, Chronic

Intervention / Treatment
-----------------
* Device: Adaptive optics imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of pentosan polysulfate sodium (Elmiron) usage for 5+ years Documented retinal findings that are associated with pentosan polysulfate sodium toxicity Exclusion Criteria: Presence of cataract or ocular media opacity that impedes retinal imaging If standard pupil dilation imposes a risk to ocular health Documented severe dry eye on ocular exam High refractive error (more than -/+ 6 Diopters)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| toxic maculopathy<br>Subjects with a history of 5+ years of Pentosan Polysulfate sodium use and with retinal findings associated with Pentosan polysulfate sodium toxicity on fundus exam | Device: Adaptive optics imaging<br>* adaptive optics - optical coherence tomography (AO-OCT) retinal imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study is to develop new biomarkers of retinal atrophy progression due to pentosan polysulfate sodium toxicity. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elmiron, maculopathy, pentosan polysulfate sodium, retinal toxicity
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)

Study Overview
=================
Brief Summary
-----------------
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years

Official Title
-----------------
Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Hematopoietic Stem Cell Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Durie-Salmon stage IIA-IIIB multiple myeloma Age > 18 and ≤ 65 years Previously untreated myeloma Presence of a sibling (potential donor) Bilirubins < twice normal;ALAT and ASAT < four times normal Left ventricular ejection fraction > 40% Creatinine clearances > 40 mL/min Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) > 40% and/or need for continuous oxygen supplementation Karnofsky performance status > 60% Patients must give written informed consent Exclusion Criteria: Age > 65 years Previously treated myeloma Absence of a sibling (genetic randomisation cannot be applied) Karnofsky performance status score < 60% HIV-infection Pregnancy Refusal to use contraceptive techniques during and for 12 months following treatment Patients unable to give written informed consent PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Hematopoietic Stem Cell Transplantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event free survival |  | yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma, Newly diagnosed multiple myeloma, Tandem Auto-Allo Transplant, Overall survival, Event free survival, Disease response
Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and cost-effectiveness between purified CD34+ cells and peripheral blood mononuclear cells in treatment of critical limb ischemia

Official Title
-----------------
Randomized Control Trial on Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia

Conditions
-----------------
Thromboangiitis Obliterans, Arteritis, Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Other: autologous purified CD34+ cells
* Other: autologous peripheral blood mononuclear cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford scale of 4-5 thromboangiitis obliterans, peripheral arterial disease, or arteritis caused by other etiologies, such as collagen diseases surgical or endovascular procedures are considered unlikely to have successful long-term revascularization, or have failed more than 4 weeks of critical limb ischemia if present, a non-healing ulcer after more than 4 weeks of optimal care by a wound care physician and a nurse Exclusion Criteria: within 3 months of an acute myocardial infarction any contraindication for the administration of granulocyte colony stimulating factor (G-CSF)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous purified CD34+ cell<br>transplantation of autologous purified CD34+ cell | Other: autologous purified CD34+ cells<br> <br> |
| Active Comparator: autologous PB-MNC<br>transplantation of autologous peripheral blood mononuclear cells | Other: autologous peripheral blood mononuclear cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major-amputation-free survival rate |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement on transcutaneous partial oxygen pressure |  | at 3 months |
Amlodipine as add-on to Olmesartan in Hypertension

Study Overview
=================
Brief Summary
-----------------
Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.

Official Title
-----------------
Efficacy and Safety of Amlodipine Used as add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: olmesartan medoxomil
* Drug: amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization. Exclusion Criteria: Secondary hypertension of any aetiology; Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s); History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: olmesartan medoxomil|nan|
|Drug: amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment. |  |  | 
| Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment. |  |  | 
| Safety and tolerability |  |  |
Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis

Study Overview
=================
Brief Summary
-----------------
Waiting for a proof by mycological culture is usually necessary before starting a systemic antifungal therapy. It therefore seems to us interesting to evaluate the benefit of using dermoscopy in clinical diagnosis of Tinea Capitis.

Official Title
-----------------
Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis. Prospective, Multicenter Study (ETDT)

Conditions
-----------------
Tinea Capitis

Intervention / Treatment
-----------------
* Device: Dermoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with clinically diagnosed tinea capitis Patient has signed informed consent Exclusion Criteria: Patient with kerion or tinea favosa Antifungal treatment within 15 days prior to inclusion
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tinea capitis<br> | Device: Dermoscopy<br> <br> * Other names: Trichoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of several hair with at least one dermoscopic appearance specific of tinea capitis | The presence of several hair with at least one dermoscopic appearance Specific of tinea capitis ( corkscrew hair , comma hairs, interrupted (Morse code-like) hairs, hair shafts covered by whitish sheaths, zig-zag shaped hairs) correlating with The growth of a dermatophyte in the fungal culture. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermoscopic appearance (corkscrew hair, comma hairs, interrupted (Morse code-like) hairs, hair shafts covered by whitish sheaths, zig-zag shaped hairs) according to microscopic pathogenic species. |  | baseline | 
| Concordance of dermoscopic appearance for each of the two operators. | Concordance between dermoscopic interpretation (corkscrew hair, comma hairs, interrupted (Morse code-like) hairs, hair shafts covered by whitish sheaths, zig-zag shaped hairs) of the dermatologist during the initial consultation and dermoscopic interpretation on the photographs by a blinded trained practitioner. | baseline | 
| Presence of a green fluorescence or not under the light of a Wood's lamp by comparing it with the result of the fungal culture. |  | baseline | 
| Introduction or not of a local or general presumptive treatment by the clinician while waiting for the result of the fungal culture. |  | baseline |
Enhancing Gluteus Maximus Recruitment

Study Overview
=================
Brief Summary
-----------------
Can participants enhance gluteus maximus recruitment during a single-leg squat test following a neuromuscular training program?

Official Title
-----------------
Enhancing Gluteus Maximus Recruitment: a Randomized Controlled Pilot Trial

Conditions
-----------------
Muscular Weakness

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria female healthy, active individuals age 18-36 walk without assistive device able to run, jump, squat without difficulty show evidence of hip muscle dysfunction on screening exam Exclusion criteria history of knee ligament injury, knee surgery, patella dislocation knee pain traversing stairs, squatting or after prolonged sitting within 6 months of test joint line tenderness suggestive of meniscus pathology positive knee ligament stress tests

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention | |
| Experimental: Exercise<br>Exercise to improve gluteus maximus recruitment | Other: Exercise<br>* Exercise to improve gluteus maximus recruitment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee valgus angle |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Hip, Muscle Strength, Electromyography, Biomechanical Phenomena
Culturally Sensitive Cognitive Behavioural Therapy for the Survivors of Intimate Partner Violence (IPV)

Study Overview
=================
Brief Summary
-----------------
Women experience negative psychological outcomes long after the violent relationship has ended. Women suffer constant trauma and psychological distress being in emotional and mentally abusive relationship. Present study developed Culturally sensitive cognitive-behaviour therapy (CBT) to fit the client's cultural identity, context, and preferences.

Official Title
-----------------
The Effects of Culturally Sensitive Cognitive Behavioural Therapy on Women Experienced Intimate Partner Violence

Conditions
-----------------
Mental Abuse of Adult, Emotional Abuse, Domestic Violence

Intervention / Treatment
-----------------
* Other: CS-CBT
* Other: CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women victim of intimate partner violence Still in relationship with abuser Willing to attend 16-weeks sessions Exclusion Criteria: In need of clinical supervision or treatment Severe mental disorders Cognitive disorders Refused to give written consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-CBT<br>Culturally sensitive-CBT intervention was comprised of 16 sessions of cognitive behavioral therapy focused on culturally-specific beliefs and attitude. | Other: CS-CBT<br>* Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.<br>|
| Active Comparator: CBT<br>CBT intervention was comprised of 16 sessions of cognitive behavioral therapy. | Other: CBT<br>* CBT was delivered at an individual level, dealing with thoughts, feelings and behaviours in the present. Thoughts are identified and then challenged, to make them more objective and rational.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological symptoms | Brief Symptom Inventory (BSI) was used to assess psychological complaints | Change from baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self esteem | Rosenberg Self-Esteem Scale was used to assess self esteem | Change from baseline to 16 weeks | 
| Forgiveness | Heartland Forgiveness Scale was used to assess forgiveness to oneself, to other and to situation | Change from baseline to 16 weeks |
Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH

Study Overview
=================
Brief Summary
-----------------
CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity. CP-945598 is also being considered as a potential treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH patients and underwrite the safety of this compound prior to any further studies in NASH patients.

Official Title
-----------------
A Multiple Dose, Randomized, Double-Blind (3rd Party Open), Placebo-Controlled Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of CP-945598 In Subjects With Nonalcoholic Steatohepatitis (NASH)

Conditions
-----------------
Non-Alcoholic Steatohepatitis(NASH)

Intervention / Treatment
-----------------
* Drug: Active treatment
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) of 25 to 40 kg/m2 Subjects with biopsy evidence of NASH in the 2 years prior to the screening visit. Hemoglobin ≥11 g/dL, platelet count ≥100,000 cells/mm3, neutrophil count ≥1,500cells/mm3. Exclusion Criteria: Other forms than NASH liver disease. Decompensated or severe liver disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-945598 20 mg<br> | Drug: Active treatment<br>* 20 mg CP-945598 as 15 and 5 mg tablet once daily for 3 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo as two tablets once daily for three weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine 6-β-hydroxycortisol:cortisol ratio |  | 3 weeks | 
| Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments. |  | 8 weeks | 
| PK for CP-945598 and its primary circulating metabolite |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath ID® tests (methacetin and octanoate) |  | 6 weeks | 
| Soluble and exploratory biomarkers |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetic safety NASH patients
Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.

Official Title
-----------------
Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel

Conditions
-----------------
Systemic Infection

Intervention / Treatment
-----------------
* Other: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity) Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED) Specimen is at least 500 µL (1.5 mL collection desired) Exclusion Criteria: Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity) Physician determines that participation in the study is an unacceptable health risk Minimum volume requirement is not met

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Specimens that meet inclusion criteria<br> | Other: Observational Study<br>* Exclusion from the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays) |  | 12 months |