linjc16/ctgov huggingface dataset:
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand

Study Overview
=================
Brief Summary
-----------------
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.

Official Title
-----------------
A Phase 2 Proof-of-concept Study of Gevokizumab in Subjects With Inflammatory Erosive Osteoarthritis of the Hand

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hand osteoarthritis Joint tenderness and/or redness At least one erosion by X-ray (as determined by the central reader) Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia History of gout, pseudogout, or hemochromatosis History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent or chronic systemic infections Known allergy to acetaminophen Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Solution for subcutaneous injection<br>|
| Experimental: gevokizumab<br> | Drug: gevokizumab<br>* Solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in AUSCAN pain score at Day 84 | The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis. | Baseline and Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erosive Osteoarthritis, Osteoarthritis, Osteoarthritis of the Hand
Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ability of a non-invasive monitor that measures how much fluid is in the body as well as various blood tests for their ability to predict worsening kidney function in patients with heart failure.

Detailed Description
-----------------
Our specific aims are to: Evaluate the individual and collective ability of pro-B type natriuretic peptide (NT-pro-BNP), soluble (s)ST2, neutrophil gelatinase-associated lipocalin (NGAL), and bioelectrical impedance vector analysis (BIVA) for predicting in-hospital worsening renal function (WRF) in patients evaluated in emergency department (ED)with acutely decompensated heart failure (ADHF)compared to a model of clinical variables alone. Evaluate the individual and collective ability of NT-proBNP, sST2, NGAL, and BIVA for identifying the correct cause of in-hospital WRF in patients evaluated in the ED with ADHF. Evaluate the individual and collective ability of NT-pro-BNP, sST2, NGAL, and BIVA for predicting outcomes (all-cause death, all-cause re-hospitalization, initiation of renal replacement therapy by 180 days) in patients with ADHF.

Official Title
-----------------
Biomarkers Plus Bioimpedance Vector Analysis to Predict Cardiorenal Syndrome Onset and Prognosis in Patients With Acutely Decompensated Heart Failure: Biomonitoring and Cardiorenal Syndrome in Heart Failure(BIONICS-HF) Trial

Conditions
-----------------
Cardiorenal Syndrome, Acute Decompensated Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyspnea thought to be due to ADHF NYHA class III or IV symptoms Exclusion Criteria: renal failure requiring renal replacement therapy rior to enrollment unable or unwilling to participate > 6 hours from first dose of intravenous diuretic

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 |
| --- | --- |
| ADHF patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the onset of Worsening renal function following admission |  | From beginning of hospitalization to a follow up of 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the initiation of renal replacement therapy |  | From beginning of hospitalization to a follow up of 60 days | 
| all cause mortality |  | From beginning of hospitalization to a follow up of 60 days |
Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic Tumors

Study Overview
=================
Brief Summary
-----------------
This study is based on the finding that tumor cells that are grown in the laboratory can be modified in such a way that, when injected to the patient, they will stimulate his/her immune response. This approach will be evaluated in patients with melanoma and colorectal, gastric, ovarian, breast, lung and kidney epithelial cancer. Tumor cells grown in the laboratory will be modified to make them stimulatory to the immune system, irradiated to kill them, and injected to the patient eight times at two-week intervals. This protocol is expected to prolong survival of metastatic cancer patients.

Conditions
-----------------
Colorectal Cancer, Ovarian Cancer, Gastric Cancer, Breast Cancer, Lung Cancer, Kidney Cancer, Melanoma

Intervention / Treatment
-----------------
* Biological: Autologous or Allogeneic tumor cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One of the following metastatic cancers: Melanoma, breast, ovary, colorectal, gastric, lung or kidney Above 18 years of age Failure of at least one chemotherapy protocol Clinical performance status of ECOG 0,1 Absolute neutrophil count greater than 1000/mm3 Serum ALT/AST less than three times the upper limit of normal Serum creatinine less than or equal to 1.6 mg/dl. Must be able to understand and sign the Informed Consent document Exclusion Criteria: Below 18 years of age Women who are pregnant Life expectancy of less than three 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous or Allogeneic tumor cells<br>Intervention: 5 vaccine doses, 3 weeks apart, injected subcutaneously. | Biological: Autologous or Allogeneic tumor cells<br>* Five vaccine doses, injected subcutaneously at 3-week intervals. Each dose is composed of irradiated and DNP-conjugated tumor cells.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

Official Title
-----------------
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018

Conditions
-----------------
Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
-----------------
* Drug: NX-1207
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide signed informed consent prior to enrolment in the study AUASI ≥ 15 Prostate Volume ≥ 30 mL ≤ 70 mL Qmax < 15 mL/sec based on a minimum void of 125 mL Agree not to use any other approved or experimental BPH or OAB medication anytime during the study Exclusion Criteria: History of illness or condition that may interfere with study or endanger subject Use of prescribed medications that may interfere with study or endanger subject Presence of a median lobe of the prostate Previous surgery or MIST for treatment of BPH Post-void residual urine volume > 200 mL PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL Participation in a study of any investigational drug or device within the previous 90 days Prostate cancer

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

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

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: NX-1207<br> | Drug: NX-1207<br>* Single intraprostatic injection of 2.5 mg NX-1207<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single intraprostatic injection of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Urological Association Symptom Index (AUASI) |  | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Urological Association Symptom Index (AUASI) |  | 90 days | 
| American Urological Association Symptom Index (AUASI) |  | 180 days | 
| American Urological Association Symptom Index (AUASI) |  | 270 days | 
| Peak urine flow rate (Qmax) |  | 365 days | 
| Peak urine flow rate (Qmax) |  | 90 days | 
| Peak urine flow rate (Qmax) |  | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign prostatic hyperplasia, BPH, Enlarged prostate
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)

Study Overview
=================
Brief Summary
-----------------
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin D serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin D during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.

Official Title
-----------------
Cytochalasin D Supplementation to ICSI Handling Medium

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Medium Supplemented with Cytochalasin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICSI indicated participants Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handling Medium Supplemented with Cytochalasin D<br> | Other: Medium Supplemented with Cytochalasin D<br>* A medium with in-house supplementation of Cytochalasin D to decrease oocyte degeneration after ICSI and improve the survival rate<br>|
| No Intervention: Handling Medium as it is.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocyte survival rate |  | 6 days of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate |  | 6 days of culture | 
| Blastocyst formation rate |  | 6 days of culture | 
| Embryo utilization rate |  | 6 days of culture | 
| Clinical pregnancy rate |  | three months | 
| Implantation rate |  | 7 weeks | 
| Ongoing pregnancy rate |  | 12 weeks |
Interpersonal Psychotherapy for Severely Depressed Inpatients

Study Overview
=================
Brief Summary
-----------------
We examined the hypotheses that severely depressed inpatients treated for 5 weeks with IPT-S plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher response- and remission rates compared to pharmacotherapy plus CM. For the follow-up period (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower rates of relapse for patients initially treated with combination therapy.

Detailed Description
-----------------
A randomized controlled trial was conducted in 124 hospitalized patients with a DSM IV diagnosis of Major Depressive Disorder comparing 5 weeks of Interpersonal Psychotherapy modified for depressed inpatients (IPT-S) plus pharmacotherapy versus medication plus intensive Clinical Management (CM). The study included a prospective, naturalistic follow-up 3- and 12 months after acute treatment in 97 of 105 treatment completers. The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure.

Official Title
-----------------
An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Behavioral: Interpersonal Psychotherapy
* Drug: sertraline or amitriptyline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depression (single episode, recurrent or bipolar II) according to the Structured Clinical Interview for DSM IV (SCID)and a score of ≥ 16 on the 17-item version of the Hamilton Rating Scale for Depression (HAMD) Exclusion Criteria: (1) concurrent diagnosis of bipolar I disorder, primary substance abuse or dependency, mental disorder due to organic factors, and borderline or antisocial personality disorder, (2) psychotic symptoms, (3) severe cognitive impairment, (4) contraindications to the study medication, and (5) being actively suicidal

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Interpersonal Psychotherapy|nan|
|Drug: sertraline or amitriptyline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  |  |
Total Xenoestrogen Body Burden in Relation to Mammographic Density, a Marker of Breast Cancer Rlisk

Study Overview
=================
Brief Summary
-----------------
Mammographic density is sensitive to estorgen exposure and constitutes a strong intermediate maker of breast cancer risk. We hypothesize that women with higher serum xenoestrogen levels will have greater mammographic density.

Official Title
-----------------
Total Xenoestrogen Body Burden in Relation to Mammographic Density, a Marker of Breast Cancer Risk

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 55-70 years of age, Post menopausal Exclusion Criteria: If they have ever used hormone replacment therapy or have ever used Tamoxifen or Raloxifene, Diag. with breast cancer have had breast implants or have had a mastectomy/

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Characterize the distribution of total xenoestrogen burden and identify important source of xenoestrogen exposure among a clinic-based sample of postmenopausal women. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the association of total xenoestorgen exposure with mammographic density. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast, Estrogens, Mammography
Chronic Pain After Inguinal Herniorrhaphy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads to a lower incidence of chronic pain compared to open herniorrhaphy.

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Inguinal herniorrhaphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary inguinal hernia Exclusion Criteria: History of severe mental illness or chronic pain elsewhere

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Inguinal herniorrhaphy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of the hernia |  |  |
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.

Detailed Description
-----------------
Inclusion Criteria: Duodenal or ampullary adenoma greater than or equal to 10mm. Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection. Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female Exclusion criteria: Duodenal or ampullary adenoma <10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide Informed Consent Less than 18 years old Allergy to Octreotide

Official Title
-----------------
Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Conditions
-----------------
Adenoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duodenal or ampullary adenoma greater than or equal to 10mm Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female Exclusion Criteria: Duodenal or ampullary adenoma <10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide informed consent Less than 18 years old Allergy to Octreotide

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide<br>Octreotide 100mcg subcutaneous every 8 hours for 5 days | Drug: octreotide<br>* Octreotide 100mg subcutaneous every 8 hours for 5 days<br>* Other names: Study drug;|
| Other: no octreotide<br>No Octreotide | Other: No Octreotide<br>* No drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post endoscopic mucosal resection bleeding | clinical evidence of a bleed, including melena, hematochezia, hematemesis | 3 days |