linjc16/ctgov huggingface dataset:
Diagnosis of Hemangiomas and Vascular Malformations

Study Overview
=================
Brief Summary
-----------------
To develop a non-invasive, simple and affordable, measurement technique to differentiate hemangiomas from subtypes of VMS. The purpose of this study is to determine the best office based diagnositc instrument for differentiating the subtype of vascular lesions. The instrument must be simple and affordable so it can be used by primary car physicians in the doctor office. The procedure will be based on non-invasive and unharmful measurements that will be compared to the diagnosis from specialized physicians in this field and the final pathology.

Official Title
-----------------
Diagnosis of Hemangiomas and Vascular Malformations Using Non-invasive Imaging Devices

Conditions
-----------------
Hemangiomas, Vascular Malformations, Venular Malformations, Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected Hemangioma, Vascular Malformations (VMS) including venular Malformations (port-wine stain, PWS), Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations or mixed malformations. Exclusion Criteria: All pregnant individuals will be excluded, since physiologic changes of pregnancy could alter characteristics of the vascular lesion.

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, Hemangiomas, Vascular Malformations, Venular Malformations, Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations
CGF Influence on Post-operative Complications.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the influence of CGF application into post-operative soft tissue and bone defects on post-operative complications and wound healing.

Detailed Description
-----------------
The research was conducted in twenty patients with symmetric single tooth qualified to extraction. On one side of dental arch, post-operative region was field with CGF material, while on the other side it was left to normal healing. In both cases pain, swelling, alveolar osteitis, antibiotics and analgesics intake in post-operative period were evaluated in the first, fourth and seventh day after surgery. Wound healing was assessed seven and thirty days after extraction.

Official Title
-----------------
The Influence of Concentrated Growth Factors (CGF) Application on Post-operative Complications.

Conditions
-----------------
CGF, Bone Loss, Post-operative Wound Healing

Intervention / Treatment
-----------------
* Procedure: CGF application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no known medical history of abnormal platelet counts, patients with symmetric teeth qualified for extraction, Exclusion Criteria: systemic diseases, pregnancy, lactation, drugs known to affect the number or function of platelets, abnormal platelet counts

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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 |
| --- | --- |
| Experimental: Study group<br> | Procedure: CGF application<br>* CGF application into post-operative soft tissue and bone defects<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain vs. CGF application | In order to evaluate the relationship between intensity of pain after surfery and filling the alveolus with platelet-rich plasma, , NRS (Numeric Rating Scale) pain scale is used. NRS scale, ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of swelling | The presence of swelling was evaluated using zero one system. | 24 hours |
Vactosertib and Durvalumab in Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This trial will test the efficacy and safety of durvalumab in combination with vactosertib in patients with metastatic gastric cancers who failed ≥ 2 lines of chemotherapy

Detailed Description
-----------------
Efficacy and safety of durvalumab (anti-PD-L1) via IV infusion Q4W, in combination with vactosertib (TGF-beta inhibitor) PO bid for 5 days a week for up to a maximum of 12 months, will be tested in patients with metastatic hypermutated gastric cancers as ≥ 3rd-line setting until confirmed disease progression, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Official Title
-----------------
Vactosertib in Combination With Durvalumab (MEDI4736) in Patients With Gastric Cancer

Conditions
-----------------
Stomach Neoplasm

Intervention / Treatment
-----------------
* Drug: durvalumab and vactosertib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have histologically- or cytologically-confirmed diagnosis of metastatic gastric adenocarcinoma in the stomach and gastroesophageal junction that are refractory to at least two lines of treatment. Have a performance status of 0-1 on the ECOG Performance Scale. Have measurable disease at least one investigator-assessed measurable disease per RECIST v1.1 Have adequate organ functions Exclusion Criteria: Prior ALK5 inhibitor treatment Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs Patients weighing <30kg

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vactosertib in combination with durvalumab<br>single arm study | Drug: durvalumab and vactosertib<br>* durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Objective response rate in 55 participants according to RECIST v1.1 | Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year |
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.

Official Title
-----------------
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

Conditions
-----------------
Bladder Cancer, Low Testosterone Levels

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bladder cancer Scheduled to undergo radical cystectomy Exclusion Criteria: Evidence of advanced metastatic disease, Undergoing cystectomy for non-bladder primary malignancy or bladder cancer type other than urothelial cell History of breast or prostate cancer Polycythemia, cardiovascular thromboembolism, untreated obstructive sleep apnea, uncontrolled heart failure, or acute coronary event in the past six months

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bladder Cancer Patients<br>Patients with bladder cancer scheduled to undergo radical cystectomy (RC). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hypogonadism in Participants Based on Serum Testosterone 90 Days Post Radical | The count of participants with hypogonadism (the level of serum testosterone used as a threshold). | 90 days post-RC surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Hypogonadism in Participants Based on Serum Testosterone 30 Days Post Radical Cystectomy | The count of participants with hypogonadism 30 days post radical cystectomy using the serum testosterone levels (the level of serum testosterone used as a threshold). | 30 days post-RC surgery | 
| The Number of Hypogonadism in Participants Based on Serum Testosterone Immediately Post Surgery Days Post Radical Cystectomy | The count of participants with hypogonadism immediately post radical cystectomy based on levels of testosterone (the level of serum testosterone used as a threshold). | Immediately post-operatively RC surgery | 
| The Number of Hypogonadism in Participants Based on Serum Testosterone at Baseline Days Post Radical Cystectomy | The count of participants with hypogonadism at baseline days post radical cystectomy (the level of serum testosterone used as a threshold). | Baseline, prior to RC surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radical cystectomy, hypogonadism
Interphase Gap in Biphasic Stimulation in DBS for ET

Study Overview
=================
Brief Summary
-----------------
Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.

Official Title
-----------------
Investigating the Use of an Interphase Gap in Biphasic Pulses in DBS for ET Patients

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Device: Study Tool Computer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential tremor treated with Vim-DBS Normal impedances of DBS circuit Signed written informed consent Exclusion Criteria: Active psychiatric disease or active alcohol or drug abuse Dementia History of recurrent or unprovoked seizures Relevant comorbidities that influence objective clinical assessment Pregnancy

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: Crossover Assignment
Interventional Model Description: The patient will be allocated to the both arms in a cross-over design (no interphase gap and interphase gaps of different lenghts). The order of the pulses will be delivered in a random order, and with a double-blind design. Of all pulses, the therapeutic window will be assessed acutely (3 times per pulse shape).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biphasic pulse without interphase gap<br> | Device: Study Tool Computer<br>* Nonconventional pulses delivered with custom-ware designed by Boston Scientific<br>|
| Experimental: Biphasic pulse with interphase gap<br> | Device: Study Tool Computer<br>* Nonconventional pulses delivered with custom-ware designed by Boston Scientific<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic threshold (mA) | Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA) | During uptitration of the amplitude (entire process takes 3-4 minutes) | 
| Side effect threshold (mA) | Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA) | During uptitration of the amplitude (entire process takes 3-4 minutes) |
Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.

Official Title
-----------------
A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1

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

Intervention / Treatment
-----------------
* Drug: Lopinavir/ritonavir
* Drug: Efavirenz
* Drug: Lamivudine
* Drug: Tenofovir DF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have HIV Infection. Age 18 to 65 years old. Show no signs of recent illness other than HIV infection. Agree to use a barrier method of birth control during the study and for 30 days after study. Exclusion Criteria: Are unable to follow study requirements (in the opinion of the investigator). Are pregnant or breast-feeding. Are unable to take medications by mouth. Have chronic nausea or vomiting. Have cancer other than Kaposi's sarcoma or basal cell carcinoma. Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening. Are taking any medications that are not allowed with ABT-378/r and efavirenz. Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor. Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor. Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements. Have a history of kidney or bone 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lopinavir/ritonavir|nan|
|Drug: Efavirenz|nan|
|Drug: Lamivudine|nan|
|Drug: Tenofovir DF|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Safety Study of CTS21166 to Treat Alzheimer Disease

Study Overview
=================
Brief Summary
-----------------
This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers

Official Title
-----------------
A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: CTS21166 (ZPQ-21166)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult male > age 21; non-smoker (minimum 6 months); Exclusion Criteria: History or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease History or evidence of intravenous illicit drug use, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; Participation in another clinical trial within 30 days prior to dosing

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort<br> | Drug: CTS21166 (ZPQ-21166)<br>* Cohort 1: (7.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 2: (22.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 3: (45 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 4: (90 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 5: (150 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 6: (225 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days,proceed to Part B. Cohort 7: (225 mg): Up to 10 subjects, open label, 3 hour infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma |  |  |
HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at a program for women in drug abuse treatment designed to reduce Human Immunodeficiency Virus/Sexually Transmitted Disease (HIV/STD) risk behaviors and reduce unprotected sexual risk behavior.

Detailed Description
-----------------
The proposed trial is intended to test the effectiveness of a proven, manual driven, five-session safer sexual skills building group (SSB) intervention (Schilling et al., 1991; El Bassel and Schilling, 1992) for female patients in MMTP or in drug-free outpatient treatment. The effects of SSB will be compared to a standard group HIV education session (HE). This study uses a 2-group, randomized, parallel-group design to compare a five-session safer sexual skills building group to a single 60-min HIV education session (control condition). The control condition is designed to standardize and simulate the usual care at community clinics.

Official Title
-----------------
HIV/STD Safer Sex Skills Groups for Women in Drug Treatment Programs

Conditions
-----------------
Behavior Therapy

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult females (18 years of age or older) in drug abuse treatment at participating Community Treatment Programs are invited to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AIDS risk behavior |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavioral intervention
Diagnosis of Depression Among Adolescents

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to improve general practitioners' diagnoses of adolescent depression. Major depression is ranked fourth in the worldwide disability impact. The proportion of adolescents suffering from depressive disorders also seems to be increasing worldwide. Early interventions are known to reduce this illness. Therefore, the earlier depression can be identified in adolescents, the greater the advantage.

Official Title
-----------------
Diagnosis of Depression Among Adolescents - a Clinical Validation Study of Key Questions and Questionnaire

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: Validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age (14-16) Exclusion Criteria: not fluency in the Norwegian and Danish language

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Validation|nan|

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
-----------------
Depression, Validation, Adolescent, Validation of three key questions and questionnaire