linjc16/ctgov huggingface dataset:
Monitoring Patients for Developing Communicable and Opportunistic Infections and for Responding to Therapy

Study Overview
=================
Brief Summary
-----------------
Patients are exposed to infectious agents regularly, regardless of their immunologic status. Traditionally clinicians have decided to institute prophylaxis based on epidemiologic factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method that is non-invasive, such as quantitative PCR, would be desirable to more precisely define those who would benefit from prophylaxis. Similarly, when patients develop disease and are being treated, quantitative, non-invasive techniques are needed to assess response to therapy. This project is designed to develop and test quantitative tests using blood, urine, or sputum samples.

Detailed Description
-----------------
Patients are exposed to infectious agents regularly, regardless of their immunologic status. Traditionally clinicians have decided to institute prophylaxis based on epidemiologic factors, skin test (i.e. PPD), or immunologic parameters. A quantitative and specific method that is non-invasive, such as quantitative PCR, would be desirable to more precisely define those who would benefit from prophylaxis. Similarly, when patients develop disease and are being treated, quantitative, non-invasive techniques are needed to assess response to therapy. This project is designed to develop and test quantitative tests using blood, urine, or sputum samples.

Official Title
-----------------
Monitoring Patients for Developing Communicable and Opportunistic Infections and for Responding to Therapy

Conditions
-----------------
Communicable Diseases, Opportunistic Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients older than 18 years of age. Ability to give informed consent. No medical contraindication to phlebotomy. Epidemiologically at risk for tuberculosis or for an opportunistic infection. Patients who can identify a responsible health care provider as someone willing to provide clinical information and to receive medically important information.
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
-----------------
Communicable Infection, Monitoring, Non-Invasive Tests, Opportunistic Infection
Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression

Study Overview
=================
Brief Summary
-----------------
We investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG) infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we hypothesize that this chronic persistent infection might play a role for depressive and psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti TG medication might further improve psychiatric symptomatology in affected patients. This is investigated in a double-blind, placebo-controlled, randomized treatment trial.

Official Title
-----------------
Effect of Add-on Anti-Toxoplasmosis Treatment on Parameters Defining Toxoplasma Gondii Infection and on Psychopathology in Patients With Schizophrenia or Major Depression Serologically Positive for Toxoplasma Gondii - Phase 3 Study

Conditions
-----------------
Schizophrenia, Major Depression

Intervention / Treatment
-----------------
* Drug: daraprim
* Drug: pyrimethamine
* Drug: folinic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia or Major Depression Both genders Adult Patients are able to give informed consent Exclusion Criteria: Additional diagnosis of substance abuse/dependency Continuous treatment with medication not compatible with study medication Medical status not compatible with study medication Any condition that increases study risk considerably Pregnancy, nursing

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: daraprim|nan|
|Drug: pyrimethamine|nan|
|Drug: folinic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychopathology ratings |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TG infection parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Psychosis, Depression, Affective Disorder
A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine pilot safety and efficacy data for a topical formulation of EM-1421 applied to the cervix of patients with CIN 1, 2, or 3.

Detailed Description
-----------------
This was an open-label, pilot Phase I/II dose evaluation and pharmacokinetic evaluation study to compare the safety and efficacy of terameprocol (45mg or 90mg/application)administered once per week for 3 weeks to the cervix uteri in patients with biopsy-proven CIN. Patients who met eligibility criteria visited the clinic weekly for terameprocol application. Patients kept a daily diary card record of genitourinary symptoms.

Official Title
-----------------
A Pilot Translational Study of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) for the Treatment of Cervical Intraepithelial Neoplasia Induced by Human Papilloma Virus

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Drug: EM-1421


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Negative pregnancy test Biopsy confirmed CIN 1, 2, or 3 Exclusion Criteria: Pregnancy or breast feeding

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

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

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: EM-1421<br>Administration of EM-1421 intravaginally once per week for 3 weeks Dose level of 45 mg/application (1% w/w) or 90 mg/application (2% w/w) | Drug: EM-1421<br>* EM-1421 administered intravaginally every 3 weeks as 45 mg (1% w/w) EM-1421 or 90 mg (2% w/w) EM-1421<br>* Other names: Tetra-O-Methyl Nordihydroguaiaretic Acid;|

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
-----------------
cervical intraepithelial neoplasia, CIN, HPV
Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

Study Overview
=================
Brief Summary
-----------------
This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard press-and-breathe inhaler.

Detailed Description
-----------------
This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.

Official Title
-----------------
Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Albuterol HFA-BOI
* Drug: Albuterol HFA-MDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening Poor inhaler coordination as assessed at screening Reversible bronchoconstriction (≥ 12% increase in FEV1) Exclusion Criteria: Albuterol allergy Investigational drug within 30 days Injected corticosteroid within 6 weeks Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled Other criterial 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albuterol HFA-BOI<br> | Drug: Albuterol HFA-BOI<br>* Albuterol HFA breath operated inhaler, 90 mcg/sprau<br>|
| Active Comparator: Albuterol HFA-MDI<br> | Drug: Albuterol HFA-MDI<br>* Albuterol HFA multi-dose inhaler<br>* Other names: Proair HFA-MDI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs) |  | Pre-dose and +120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area-under-the-effect curve of change in SGaw from basline over time |  | Pre-dose and +120 minutes | 
| The maximum increase in SGaw from baseline over two hours |  | Baseline through +120 minutes | 
| Time in hours to the maximum increase in SGaw from baseline |  | Baseline through +120 minutes post-dose |
The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment

Study Overview
=================
Brief Summary
-----------------
To evaluate whether treatment with Estradiol supplementation during the luteal phase improves IVF outcomes Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a GnRH analog will receive 4 mg estradiol valerate in the luteal phase.Patient's followup will include E2 progesterone and BHCG 14 days after embryo transfer and vaginal ultrasound on day 21 and 28 after embryo transfer

Detailed Description
-----------------
The study will include Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a daily GnRH analog in a long protocol,older then 18, .The women will be randomised to two groups.Both groups will be given vaginal tabs of natural micronized progesterone(Uterogestan) The study group will be given oral estradiol Valerate 4 mg.Prior to treatment, each patient will be signed on informed concent. Patients will be excluded if they are older than 40, have any systemic illnesses or a personal or family history of a thromboembolic event. Follow up: Verification of pregnancy status and hormonal profile will be carried out on day fourteen after embryo transfer by means of serum hCG,P and E2. clinical pregnancy will be defined as the presence of a gestational sac on ultrasonography on day 21 after embryo transfer and fetal heart will be evaluated on day 28

Official Title
-----------------
Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment

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

Intervention / Treatment
-----------------
* Drug: Treatment with estradiol valerate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women treated for infertility with controlled ovarian hyperstimulation using daily GnRH agonist Exclusion Criteria: Women younger then 18 or older then 40 Women with systemic disease Women with a family or personal history of thromboembolic event

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Treatment with estradiol valerate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E2 and progesterone levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
luteal, phase, estradiol, pregnancy, rate
High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion

Study Overview
=================
Brief Summary
-----------------
The study aims to verify if the association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, reduces the risk of miscarriage in patients at risk.

Official Title
-----------------
Efficacy of the Association of Hyaluronic Acid With High Molecular Weight, α-lipoic Acid (ALA), Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion in Patients at Risk

Conditions
-----------------
Abortion, Spontaneous

Intervention / Treatment
-----------------
* Other: high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: two or more previous spontaneous first trimester abortions without apparent risk factors (idiopathic polyabortion) Endocrinopathies Autoimmune diseases Thrombophililic or coagulation diseases Exclusion Criteria: Multiple pregnancies Presence of genetic abnormalities of one or both partners leading to increased risk of fetal aneuploidies Presence of Mullerian abnormalities in the uterus Symptoms present at recruitment such as pelvic pain or metrorrhagia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: Treatment group<br> | Other: high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D<br>* Patients will take an association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, from the first visit at the experimental center (within the 12th week of gestation) for 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of metrorrhagia and/or pelvic pain in the first trimester of gestation. |  | 3 months |
A Phase I Study of BR790 in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.

Official Title
-----------------
A Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Efficacy of BR790 Monotherapy in Subjects With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Drug: BR790


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent voluntarily. Age ≥18 and ≤75 years old. Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment. Had at least one measurable lesion. ECOG≤1. Expected survival period ≥ 3 months. Exclusion Criteria: Any previous treatment with SHP-2 inhibitor. Symptomatic brain metastases. Subjects with thoracic/ascites fluid that need drainage or intervention. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC<1.5×10^9/L PLT<100×10^9/L Hb<90g/L TBIL>1.5×ULN ALT, AST>2.5×ULN (without liver metastases) or ALT, AST>5×ULN (with liver metastases), Cr >1.5×ULN. With uncontrolled severe disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-65mg QD<br> | Drug: BR790<br>* Subjects will receive oral administration of BR790.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity (DLT) |  | up to 32 day | 
| maximum tolerated dose (MTD) |  | up to 32 day | 
| recommended phase II clinical study dose (RP2D) |  | up to 32 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | up to 32 day | 
| Cmax |  | up to 32 day | 
| t1/2 |  | up to 32 day | 
| pERK | the level of pERK in blood | up to 32 day | 
| AE | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | through study completion, an average of 3 years | 
| ORR |  | through study completion, an average of 3 years |
Vertical Distance Between Medial and Lateral Malleolus in Normal Population

Study Overview
=================
Brief Summary
-----------------
Determine variation in vertical distance between the medial and lateral malleolus in the normal population subjected to X-rays for any other causes than ankle fracture Determine the effect of weight bearing on this variation

Detailed Description
-----------------
There is gap of knowledge about determination of vertical distance between medial and lateral malleolus Our research will cover this gap of knowledge ,so our research question will be what is the normal variation of vertical distance between medial and lateral malleolus Fractures of ankle are common injuries,approximately 2% of the general population will sustain an ankle fracture during their life time .many can be successfully treated non operatively However,for those injuries that require surgical intervention ,restoration of the anatomy is the main principle The importance of anatomic restoration of the fibula ,specially in preserving normal length has been appreciated by several authors Data will be obtained from measuring the vertical distance between lateral and medial malleolus in AP view of ankle in traumatic non ankle fractured people in standing and non standing position

Official Title
-----------------
Radiological Assessment of Vertical Distance Between Medial and Lateral Malleolus in Normal Population

Conditions
-----------------
Ankle Fractures

Intervention / Treatment
-----------------
* Radiation: X rays


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non ankle fractured people Non arthritic ankle Age more than 18 years old Non diabetic people Normal ankle X-rays as determined by tibiocrural angle and tibiofibular overlap Exclusion Criteria: people with fracture ankle (United &non United) Arthritic ankle Diabetic people Abnormal ankle X-rays

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: X rays|Radiological assessment of vertical distance between medial and lateral malleolus in normal opulation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertical distance between medial and lateral malleolus Radiologically | •All ankle X rays will be collected periodically through the PAC system (in Emergency Room and out patient clinics )•Using talocrural angle and tabiofibular overlapping to verify normal ankle anatomy as well as exclusion of those X rays in exclusion criteria | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiological standard f ankle fixation