linjc16/ctgov huggingface dataset:
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.

Official Title
-----------------
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: diquafosol tetrasodium (INS365) Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: best corrected visual acuity in both eyes of at least +0.7 six-month documented history of dry eye disease at least mild severity in 2 of the 4 dry eye symptoms unanesthetized Schirmer score of less than or equal to 7mm corneal fluorescein staining of greater than or equal to 4 (out of 15) Exclusion Criteria: nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm ongoing contact lens wear current topical ophthalmic medication use

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: diquafosol tetrasodium (INS365) Ophthalmic Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dry eye testing measures and symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dry eye testing measures and symptoms |  |  |
EXercise Training for Reducing Anxiety in First-Time Inmates

Study Overview
=================
Brief Summary
-----------------
Clinical trial with 2 arms (interval exercise training or waiting list) aiming at evaluating the anxiolytic effects of a 6 weeks-long exercise training program in first-time prisoners with elevated anxiety symtpoms

Official Title
-----------------
Interval Exercise Training for Reducing Anxiety in First-Time Inmates

Conditions
-----------------
Anxiety State

Intervention / Treatment
-----------------
* Behavioral: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-time prisoners ; elevated state anxiety (> 40 on the state anxiety inventory) Exclusion Criteria: Symptoms of and/or known cardiovascular, metabolic, psychiatric, neurological or neurodevelopmental disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interval exercise training<br> | Behavioral: exercise training<br>* 6 weeks of physical exercise training. 3 sessions per week. Session duration : 40 minutes. Self-regulated exercise intensity using Borg's ratings of perceived exertion (RPE)<br>|
| No Intervention: waiting list<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in state anxiety | pre- to post-intervention change in the State Anxiety Inventory score (STAI; Spielberger et al., 1993). The STAI has 20 items assessed on a 4-point Likert scale ranging from 1 (not at all) to 4 (most intensive). Consequently, the range of possible scores is 20-80. | before and after the 6 weeks of intervention |
Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).

Official Title
-----------------
Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

Conditions
-----------------
Stage IB2 Cervical Cancer, Stage II Cervical Cancer, Adenocarcinoma, Squamous Cell Carcinoma, Adenosquamous Carcinoma

Intervention / Treatment
-----------------
* Procedure: hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operable Stage IB2/II Cervical Cancer adenocarcinoma, squamous cell or adenosquamous carcinoma Patient between 18 and 70 years old No lombo-aortic lymph node invasion at baseline Previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles) Followed by a 15 grays utero-vaginal brachytherapy, eventually combined with a 6th cycle of chemotherapy (cisplatin 40 mg/m2) with a pelvic boost if lymph node or parametrial invasion No macroscopic residual tumor after 6 to 8 weeks after brachytherapy. Exclusion Criteria: Other tumor histology (neuro-endocrine) Stage > II (FIGO 1995) at baseline Patient with remaining cervical cancer (after sub-total hysterectomy)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with hysterectomy<br> | Procedure: hysterectomy<br> <br> |
| No Intervention: without hysterectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse free survival | There is a follow-up period of 3 years. | from randomization to relapse or last contact (up to 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | There is a follow-up period of 3 years. | From randomisation to death or last contact (up to 3 years) |
German Adrenocortical Carcinoma Registry

Study Overview
=================
Brief Summary
-----------------
Basic objective of the German Adrenocortical Carcinoma Registry is to improve the care of patients with adrenocortical cancer. The registration of as many patients as possible helps to collect data for the prognosis and prospects of success regarding different treatment plans. This data will be taken into consideration for planning prospective studies. With this registry, the recruitment of patients for prospective studies will be significantly facilitated. In this way - and in cooperation with networks in other countries (e.g. in Italy and France) - a structure allowing systematic improvement of therapy will be developed.

Official Title
-----------------
Deutsches Nebennieren-Karzinom-Register - German Adrenocortical Carcinoma Registry

Conditions
-----------------
Adrenocortical Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of adrenocortical carcinoma
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adrenocortical carcinoma<br>Adrenocortical carcinoma | |

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
-----------------
Surgery, Adrenal cancer, Treatment, Mitotane
Trial of SAVVY Vaginal Gel and HIV in Nigeria

Study Overview
=================
Brief Summary
-----------------
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Detailed Description
-----------------
Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

Official Title
-----------------
Randomized Controlled Trial of SAVVY and HIV in Nigeria

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

Intervention / Treatment
-----------------
* Drug: 1.0% C31G SAVVY vaginal gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 35 year old women HIV negative More than one sexual partner in past 3 months Average 3 coital acts per week Willing to use vaginal gel and condoms for 12 months Exclusion Criteria: HIV positive Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 1.0% C31G SAVVY vaginal gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of HIV-1 and HIV-2 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity, HIV transmission
Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions

Study Overview
=================
Brief Summary
-----------------
RATIONALE: New diagnostic procedures, such as bioelectric field imaging, may help find and diagnose melanoma and other skin cancers. It may also be a less invasive way to check for skin cancer. PURPOSE: This phase I trial is studying bioelectric field imaging in diagnosing melanoma and other skin cancers in patients with skin lesions.

Detailed Description
-----------------
OBJECTIVES: To determine if the hand-held Bioelectric Field Imager can be used to measure the electric field in skin of various body surfaces, including face, neck, shoulders, arms, hands, chest, back, legs, and feet, during the course of examination and treatment of patients with suspected malignant skin lesions. To determine if there is a significant difference between the lateral electric field strength near benign and malignant skin lesions in the same individual. OUTLINE: Patients undergo scanning of their skin lesions and nearby healthy skin using the Bioelectric Field Imager (BFI). The lesions are then biopsied for histological diagnosis. Histological data from the biopsy is correlated with the electric field data from the BFI.

Official Title
-----------------
Development of an Electrical Diagnostic for Melanoma and Other Cutaneous Malignancies

Conditions
-----------------
Melanoma (Skin), Non-melanomatous Skin Cancer

Intervention / Treatment
-----------------
* Procedure: bioelectric field imaging
* Procedure: biopsy
* Procedure: histopathologic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Suspected malignant skin lesion Seeking treatment for skin lesion at the VA Medical Center PATIENT CHARACTERISTICS: Not pregnant No acute illness, including upper respiratory tract infection or flu that could result in fever No trauma to the skin lesion area No prisoners PRIOR CONCURRENT THERAPY: See Disease Characteristics

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: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bioelectric field imaging|nan|
|Procedure: biopsy|nan|
|Procedure: histopathologic examination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Bioelectric Field Imager (BFI) in measuring the electric field in skin of various body surfaces |  |  | 
| Use of BFI in detecting significant electric field differences between malignant and benign skin lesions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation

Study Overview
=================
Brief Summary
-----------------
to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor

Official Title
-----------------
Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnancy between 24-34 wees of gestation Exclusion Criteria: lack prenatal care fetal malformations stractural or genetical plcenta previa cerclage women who underwent conization of cervix polyhydramnious premature rupture of membranes induction of labor d/t medical condition preterm women with hypertension, diabetis or preeclampsia susp IUGR women with a chronic illness that may interupt pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>women without contraction at 24-34 weeks of gestation | |
| 2<br>women without contractions between 24-34 weeks of gestation with a history of preterm labor | |
| 3<br>women with preterm contractions 24-34 weeks of gestation | |

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
-----------------
preterm delivery, shory cervix, amniotic fluid sludge, uterine artery doppler, singeltone, normal amniotic fluid index, without rupter of membranes, 24-34 weeks of gestation
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Study Overview
=================
Brief Summary
-----------------
Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.

Official Title
-----------------
Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients

Conditions
-----------------
End Stage Renal Disease, Pruritus

Intervention / Treatment
-----------------
* Drug: cromolyn sodium
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis patients > 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs Willing and able to give informed concent Exclusion Criteria: Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus Lactase deficiency

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients on hemodialysis with pruritus, receiving cromolyn sodium | Drug: cromolyn sodium<br>* oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks<br>|
| Experimental: 2<br>patients on hemodialysis with pruritus, receiving placebo | Drug: placebo<br>* capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks<br>|
| No Intervention: 3<br>Patients on hemodialysis but without pruritus who do not receive any treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pruritus |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum tryptase level |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End Stage Renal Disease, Cromolyn Sodium, Pruritus, Tryptase
Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.

Detailed Description
-----------------
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. Doripenem or comparator is administered. The primary endpoint is the clinical response measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections

Conditions
-----------------
Bacterial Infections and Mycoses, Appendicitis, Cholecystitis, Pancreatitis, Peritonitis

Intervention / Treatment
-----------------
* Drug: doripenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a requirement for surgical intervention within 24 hours of study entry Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections Exclusion Criteria: Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control Any rapidly-progressing disease or immediately life-threatening illness

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: doripenem|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical response measured at late follow-up visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complicated Intra-Abdominal Infections, Appendicitis, Cholecystitis, Peritonitis