linjc16/ctgov huggingface dataset:
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum

Study Overview
=================
Brief Summary
-----------------
Patients with epithelial ovarian cancer, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Relapse more than 6 months following first line chemotherapy is regarded as platinum/taxane sensitive disease. Reinduction chemotherapy with platinum/taxane is known to be an effective treatment option. Therapy induced anemia is a common problem resulting in decrease of quality of life. The rationale of this trail is to evaluate the effects of epoetin alpha on reduction of therapy induced anemia, rate of transfusions and on quality of life.

Official Title
-----------------
Reinduction Chemotherapy Containing Carboplatin and Paclitaxel With or Without Epoetin Alpha in Recurrent Platinum Sensitive Ovarian Cancer, Cancer of the Fallopian Tube or Peritoneum

Conditions
-----------------
Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum, Platinum Sensitve Relapse, Anemia

Intervention / Treatment
-----------------
* Drug: paclitaxel, carboplatin, epoetin alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapse longer than 6 months after termination of platinum/taxane based first line chemotherapy Previously histologically confirmed cancer of: ovary, fallopian tube, peritoneum measurable and evaluable lesions by ultrasound, computer-tomography or MRI Performance status ECOG < 2 or karnofsky index > 60% normal organ function Exclusion Criteria: more than 1 chemotherapy prior enrollment ongoing treatment with epoetin alpha or related drugs history of thrombosis or embolism during the past 12 months prior enrollment ileus left ventricular failure > NYHA classification > 2 Ongoing toxicity of any kind (> CTC Grad II)

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

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

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 |
| --- |
|Drug: paclitaxel, carboplatin, epoetin alpha|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of anemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Overall survival |  |  | 
| Progression free survival |  |  | 
| Toxicity |  |  |
Inflammatory Markers and Resistant Depression

Study Overview
=================
Brief Summary
-----------------
This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.

Official Title
-----------------
Inflammatory Markers and Resistant Depression

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

Intervention / Treatment
-----------------
* Procedure: blood sample
* Behavioral: psychometric scales


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: group 1: Patients with resistant MDD (at least 2 failed treatments for the current episode) ,current treatment with IRS or IRSNA, group 2: patients with MDD remission after response to an antidepressant treatment. Exclusion Criteria: comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection

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: Screening
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: resistant depression<br>patients suffering from resistant unipolar depression (at least 2 failed antidepressant treatments for the current episode) | Procedure: blood sample<br>* blood sample for concentration levels of inflammatory markers<br>Behavioral: psychometric scales<br>* Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD<br>|
| Other: non resistant depression<br>patients in remission from unipolar depressive disorder | Procedure: blood sample<br>* blood sample for concentration levels of inflammatory markers<br>Behavioral: psychometric scales<br>* Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasmatic concentration of Interleukin 6 |  | at patient inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of proinflammatory cytokine | Expression intensity of monocytes costimulation molecules | at patient inclusion | 
| concentration of antiinflammatory cytokine |  | at patient inclusion | 
| functional polymorphisms of expression genes of inflammatory proteins |  | at patient inclusion | 
| plasmatic concentration of Retinoid X receptor signaling pathway |  | at patient inclusion | 
| Expression rate of monocytes costimulation molecules |  | at patient inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistant depression, inflammation
Post-market Assessment of Biodesign Dural Repair Grafts

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.

Official Title
-----------------
Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts

Conditions
-----------------
Cerebrospinal Fluid Leak

Intervention / Treatment
-----------------
* Device: Biodesign Dural or Duraplasty Repair Grafts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Planned use of the Biodesign Dural or Duraplasty Graft. Exclusion Criteria: Age <18 years Unable or unwilling to provide informed consent Life expectancy <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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biodesign Dural or Duraplasty Repair Grafts|Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage | Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis). | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biodesign® Dural Repair Graft, dura mater repair, cerebrospinal fluid leak, CSF leak, Biodesign® Duraplasty Repair Graft
Steroids Added to Dithranol and Narrow Band UVB(Ultraviolet B) (UVBnb) in Psoriasis

Study Overview
=================
Brief Summary
-----------------
Objective(s): (i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment. (ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75). Trial with medicinal product

Detailed Description
-----------------
(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment. (ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75). Trial with medicinal product

Official Title
-----------------
A Phase IV, Randomized, Double Blind, Placebo Controlled, Single-center Study of the Impact of Topical Steroids on Narrow Band UVB (Ultraviolet B) and Dithranol Combination Treatment of Psoriasis (DIPSO)

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Steroid active treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Moderate to severe psoriasis of the chronic-plaque and / or guttata type Exclusion criteria: Participation in a Goeckerman therapy regimen within 6 months previous to the present study

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steroid active treatment<br>Triamcinolone acetonide 0.1% in unguentum leniens topically | Drug: Steroid active treatment<br>* Triamcinolone in unguentum leniens 0.1%<br>* Other names: Topical triamcinolone;|
| Placebo Comparator: Vehicle<br>unguentum leniens topically | Drug: Steroid active treatment<br>* Triamcinolone in unguentum leniens 0.1%<br>* Other names: Topical triamcinolone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse 50% PASI after treatment, time to PASI 75% on treatment | Relapse 50% PASI after treatment, time to PASI 75% on treatment | 2 years |
Assessment of Bone Mineral Density During Pregnancy

Study Overview
=================
Brief Summary
-----------------
BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.

Detailed Description
-----------------
Consecutive patients with singleton pregnancies between 36 and 39 weeks booked at a general obstetric clinic in a regional hospital will be recruited for the study. The obstetric department is a tertiary referral center in the region and part of a university teaching unit which catered to an annual delivery of around 10,000 women. A group of first trimester pregnant women with nearly the same age is recruited as controls.

Official Title
-----------------
Changes in Bone Mineral Density as Measured by Calcaneal Quantitative Ultrasound in Third Trimester of Pregnancy

Conditions
-----------------
Bone Mineral Density Quantitative Trait Locus 3

Intervention / Treatment
-----------------
* Radiation: calcaneal quantitative ultrasound assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. females during 3rd trimister Exclusion Criteria: Secondary causes of bone loss such as hyperparathyroidism. Co-morbidities that would interfere with bone metabolism as clinically significant liver or renal disease. Physical or orthopedic disabilities that would place the subject at risk or limit their ability to perform US. Taking medication known to affect bone including steroid hormones. Histories of smoking and use of oral contraceptives (OCs) are not exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthcare<br>QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester | Radiation: calcaneal quantitative ultrasound assessment<br>* QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density loss during pregnancy that is detectable by quantitative ultrasound at the os calcis. |  | 6 months |
Molecular Studies on Hereditary Haemorrhagic Telangiectasia Families

Study Overview
=================
Brief Summary
-----------------
This study will examine genes involved in the vascular dysplasia Hereditary haemorrhagic telangiectasia i(HHT)

Detailed Description
-----------------
Hereditary haemorrhagic telangiectasia (HHT) is a condition inherited as an autosomal dominant trait. Sequencing DNA from affected and unaffected family members allows us to identify disease-causal genes. Sequencing these genes allows us to identify what the precise DNA variants are which are causing disease, particularly if linked to functional assays in separate studies.

Official Title
-----------------
Molecular Studies on Hereditary Haemorrhagic Telangiectasia Families With Pulmonary Arteriovenous Malformations

Conditions
-----------------
Telangiectasia, Hereditary Hemorrhagic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of family affected by HHT Exclusion Criteria: Unable or unwilling to provide informed consent for DNA sample
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with HHT and their families<br>No intervention - blood or saliva sample only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey

Study Overview
=================
Brief Summary
-----------------
To determine if women can understand the instructions, carry out the test, and interpret the test results. Women will be recruited to complete a test instruction and comprehension assessment and a usability assessment.

Detailed Description
-----------------
To determine if women can understand the instructions, carry out the test, and interpret the test results. Women will be recruited to complete a test instruction and comprehension assessment and a usability assessment. Study participants will be a convenience sample of women seeking health services. Participants will first be asked to review the instructions for the Congo Red Dot Test and complete a short written questionnaire that assesses their comprehension of the test instructions. Participants will then be asked to perform the test using a test control and to interpret the results obtained by answering a second written questionnaire. After the woman performs the test, a healthcare provider will use a matched control to perform a second test.

Official Title
-----------------
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Device: Congo Red Test (GV-005)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible to consent for research Able to read Spanish well enough to read the test instructions Able to give informed consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 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 |
| --- | --- |
| Women<br>Women seeking health services will perform the Congo Red Dot test (GV-005) individually by following the the test instructions | Device: Congo Red Test (GV-005)<br>* The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRD Test Comprehension | proportion of women who demonstrated various levels of understanding of the instructions for the CRD Test | within 5 minutes of reading test instructions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRD Test Usability | the proportion of women able to correctly use the CRD test | within 5 minutes of performing test | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congo Red Dot Test
Effect of Loading of Midazolam or Dexmedetomidine on Hemodynamics

Study Overview
=================
Brief Summary
-----------------
Loading dose of dexmedetomidine is related hemodynamic instability such as bradycardia and hypertension.

Detailed Description
-----------------
The investigators hypothesized substitution of loading of dexmedetomidine for midazolam could reduce hemodynamic instability during spinal anesthesia for knee arthroscopy.

Official Title
-----------------
Hemodynamic Change Between Loading of Dexmedetomidine or Midazolam as a Sedative Agents During Knee Arthroscopy

Conditions
-----------------
Knee Injuries

Intervention / Treatment
-----------------
* Drug: dexmedetomidine group
* Drug: midazolam group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were planned to undergo knee arthroscopy under spinal anesthesia Exclusion Criteria: age < 20 years underlying heart, liver or kidney disease hypersensitivity to midazolam or dexmedetomidine

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine group<br>dexmedetomidine 1 mcg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr | Drug: dexmedetomidine group<br>* intravenous loading of dexmedetomidine for 1 mcg/kg<br>* Other names: dexmedetomidine;|
| Experimental: midazolam group<br>midazolam 0.1 mg/kg intravenous loading followed by dexmedetomidine continuous infusion at the rate of 0.5 mcg/kg/hr | Drug: midazolam group<br>* intravenous loading of midazolam for 0.1 mg/kg<br>* Other names: midazolam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of heart rate |  | from 1 minute before anesthesia to 1 hr after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of bispectral index |  | from 1 minute before anesthesia to 1 hr after anesthesia |
Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women

Study Overview
=================
Brief Summary
-----------------
The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.

Official Title
-----------------
Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women. A Double Blind Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Mefenamic acid or Hyoscine or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertility female no history of HSG or Hysteroscopy Exclusion Criteria: vaginal or pelvic infection abnormal Pap smear contraindications for Mefenamic acid including upper and lower GI ulcers, bleeding disorder, Asthma or allergies, renal disease, using Warfarin,Aspirin, Lithium, history of Mefenamic acid or Hyoscine allergies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyoscine, Mefenamic acid, Placebo<br>Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group | Drug: Mefenamic acid or Hyoscine or placebo<br>* Mefenamic acid 500 mg. single oral use 30 minutes before SIS Hyoscine 10 mg. single oral use 30 minutes before SIS Placebo single oral use 30 minutes before SIS<br>* Other names: Buscopan (Hyoscine-N-butylbromide);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography |  | Before, during and after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction during saline infusion sonohysterography |  | After the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Saline infusion sonohysterography, Pain, Hyoscine, Mefenamic acid, women