linjc16/ctgov huggingface dataset:
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Official Title
-----------------
A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

Conditions
-----------------
Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: ALKS 3831


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give informed consent/assent as per local requirements Agrees to use an acceptable method of contraception during the study, and for 30 days after any study drug administration, unless surgically sterile or post-menopausal Has the potential to benefit from the administration of ALKS 3831, in the opinion of the investigator Subject met the eligibility criteria of the antecedent study at the time of enrollment in the antecedent study and completed the treatment period in one of the following antecedent studies within 7 days: ALK3831-A304, ALK3831-A306, or ALK3831-A307 Additional criteria may apply Exclusion Criteria: Has any finding that, in the view of the investigator or medical monitor, would compromise the safety of the subject or affect their ability to fulfill the protocol visit schedule or visit requirements Has a positive drug screen for drugs of abuse at study entry Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration Additional criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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
Interventional Model Description: Open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 3831<br>Coated bilayer tablet | Drug: ALKS 3831<br>* Olanzapine + samidorphan, daily oral dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be measured by frequency of serious and non-serious adverse events |  | Up to 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alkermes, ALKS 3831, Olanzapine, Samidorphan, Schizophrenia, Schizophreniform, Bipolar I
Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19

Study Overview
=================
Brief Summary
-----------------
The aim of this possible study is to identify if SARS-CoV-2 can be found in the tear film and conjunctiva of a patient with COVID-19.

Official Title
-----------------
Conjunctival Swab vs Nasopharyngeal Swab in Patients With COVID-19

Conditions
-----------------
COVID-19, SARS-CoV 2

Intervention / Treatment
-----------------
* Diagnostic Test: Conjunctival swab and nasopharyngeal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years A confirmed COVID-19 disease Signed and dated declaration of consent The patient fell ill in Tyrol Exclusion Criteria: none

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Swab<br>Conjunctival swab and nasopharyngeal swab for SARS-COV 2 | Diagnostic Test: Conjunctival swab and nasopharyngeal swab<br>* Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV2 positive conjunctival swabs | The primary endpoint is the number of conjunctival swabs tested positive for SARS-CoV2. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival swab vs nasopharyngeal swab | The secondary target is the difference between the conjunctival swab tested positive for SARS-CoV2 and the nasopharyngeal swab. | 1 year |
Neonatal Microbiome Validity Study

Study Overview
=================
Brief Summary
-----------------
This is a validation study to compare proposed field collection methods with a gold standard collection technique for microbiome analysis of stool and breast milk samples.

Detailed Description
-----------------
In order to conduct a future study of the gut microbiome in a population living in a rural, low income setting, this validation study will be conducted to verify the validity of our proposed field collection methods for stool and breast milk samples. We will compare the microbial diversity and abundance in the biologic samples using various proposed field collection methods to an immediately frozen sample. The proposed field collection methods are feasible for use in a community-based study in a low income setting with limited access to cold storage.

Official Title
-----------------
The Neonatal Microbiome Study: Validity of Biologic Sample Collection Methods

Conditions
-----------------
Gut Microbiome

Intervention / Treatment
-----------------
* Other: Microbiome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lactating women (for breast milk sample) Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Microbiome|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in intestinal microbiome between gold standard and proposed field protocol | Comparison of microbiome from snap-frozen sample (gold standard) to proposed field collection methods to determine which field method best correlates with the snap-frozen sample. | Baseline | 
| Difference in breast milk microbiome between gold standard and proposed field protocol | Comparison of microbiome from snap-frozen sample to proposed field collection methods to determine which field method best correlates with the snap-frozen sample. | Baseline |
Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Single-institutional Cancer Registry

Study Overview
=================
Brief Summary
-----------------
Real-world studies on long-term prognosis in patients who underwent anti-tumor treatments during hospitalization from a hospital-based cancer registry in china.

Detailed Description
-----------------
This is a single-center continuous enrollment cohort study. The overall survival and disease-free survival of patients with malignant tumors in the target tumor hospital undergoing surgery, radiotherapy, chemotherapy, and immunotherapy were observed. Follow-up methods include medical records review, telephone call interview, and data linkage to the related provincial death certificate registries. This study will provide real world data-sets for researches on long-term survival and prognosis of cancer patients, and expend exploration on the cancer survival determinants both from clinical and social-economic prospective.

Official Title
-----------------
Studies on Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Fudan University Shanghai Cancer Center Registry（FUCaRe）

Conditions
-----------------
Neoplasms, Survival, Surgery, Radiotherapy, Drug Therapy

Intervention / Treatment
-----------------
* Procedure: hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period. Exclusion Criteria: Patients who have not been treated during hospitalization; Patients with non-malignant tumors.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Cancers<br>subgroups according to cancer sites | Procedure: hospitalization<br>* Including various treatments such as surgery, radiotherapy, chemotherapy and immunotherapy during hospitalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Death from any cause | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | the time from treatment to recurrence of cancer, second primary cancer or death | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Survivorship
Female Sexual Function and Socioeconomic Status

Study Overview
=================
Brief Summary
-----------------
In an urban gynecology practice serving patients with publicly and privately funded insurance, female sexual dysfunction was associated with low income, depression, urinary incontinence, and sexual inactivity.

Detailed Description
-----------------
Introduction: Female sexual dysfunction is common, and the effect of socioeconomic status in an urban population is unknown. The objective is to determine socioeconomic and clinical factors associated with female sexual dysfunction for patients with publicly and privately funded health insurance in an urban outpatient gynecology clinic. Methods: We performed an observational, IRB approved, cross-sectional study of 238 sexually-active, non-pregnant women reporting to two urban gynecology clinics, representing patients with publicly funded (n=70) or privately funded health insurance (n=168). The participants completed validated questionnaires measuring sexual function (Female Sexual Function Index or FSFI), depression (Center for Epidemiologic Studies Depression Scale), urinary incontinence (Questionnaire for Urinary Incontinence Diagnosis), and demographic variables. Data was analyzed with non-parametric t-tests, chi-squared tests, and linear regression models.

Official Title
-----------------
Female Sexual Function and Socioeconomic Status

Conditions
-----------------
Sexual Dysfunction

Intervention / Treatment
-----------------
* Behavioral: assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women age 18 or older, presenting for an annual routine gynecology appointment, and were sexually active in the past six months Exclusion Criteria: pregnant women, women who were less than six weeks post-partum, women reporting for a gynecologic problem visit, non-English speakers, incomplete survey questionnaires, or refusal to consent to participate in the study.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: assessment|assessment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSF Index | Questionnaire | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Information Assessment | Questionnaire | Day 1 |
Influenza Vaccine Postpartum Questionnaire

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess the knowledge and attitudes of post-partum women regarding influenza and the use of the influenza vaccine in pregnancy.

Detailed Description
-----------------
Women on our post-partum floor will be approached to complete a questionnaire which will assess their knowledge and attitudes regarding influenza and the use of the influenza vaccine in pregnancy. The study will take place over a 2-month period during influenza season, and at the time when the influenza vaccine becomes available.

Official Title
-----------------
Acceptability and Feasibility of Influenza Vaccine Administration on the Post-partum Floor Prior to Discharge Home During Flu Season

Conditions
-----------------
Vaccine, Influenza, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women admitted to the postpartum floor during the study period Exclusion Criteria: inability to read or understand English
Sexes Eligible for Study
-----------------
Female

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

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
-----------------
influenza, influenza vaccine, pregnancy
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes

Official Title
-----------------
Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: PL2200 Aspirin Capsules
* Drug: Enteric-coated aspirin caplets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-Insulin-Dependent Diabetes Mellitus Adults 21 to 79 years, inclusive Body mass index between 30 and 40 kg/m2, inclusive Exclusion Criteria: Currently prescribed aspirin or anti-coagulants Contraindications to aspirin Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus Patient requires insulin

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 79 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PL2200 Aspirin Capsules<br>PL2200 Aspirin Capsules | Drug: PL2200 Aspirin Capsules<br>* 325 mg aspirin; once per day for 10 days<br>|
| Active Comparator: Enteric-coated aspirin caplets<br>Enteric-coated aspirin caplets | Drug: Enteric-coated aspirin caplets<br>* 325 mg aspirin; once per day for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to 99% Inhibition of Serum Thromboxane | Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy. | 11 days |
Clinical Outcomes From NOCD Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention

Study Overview
=================
Brief Summary
-----------------
This is a naturalistic, observational study of individuals with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy, augmented with between-session support with text messaging and an online community forum.

Official Title
-----------------
Clinical Outcomes From NOCD Digital Behavioral Health Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention

Conditions
-----------------
Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Behavioral: Exposure and response prevention therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obsessive-compulsive disorder Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Obsessive-Compulsive Disorder<br>adults, adolescents, and children with obsessive-compulsive disorder | Behavioral: Exposure and response prevention therapy<br>* Exposures and response prevention therapy (a type of cognitive-behavioral therapy for obsessive-compulsive disorder), delivered in real-time by licensed therapists remotely via video. The treatment was augmented by between-session text messaging and online community support.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimensional Obsessive-Compulsive Scale | self-rated psychometric instrument to measure symptom severity of multiple OCD subtypes | change from pre-treatment to post-treatment (after 11 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) OCD severity scale | clinician-rated psychometric instrument to measure overall OCD symptom severity | pre-treatment, after 4 weeks, and post-treatment (after 11 weeks) | 
| Depression Anxiety and Stress Scale (DASS-21) | self-rated psychometric instrument to measure depression, anxiety, and stress | pre-treatment, after 4 weeks, and post-treatment (after 11 weeks) | 
| Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (QLES-Q) | self-rated psychometric instrument to measure quality of life | pre-treatment, after 4 weeks, and post-treatment (after 11 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exposure and response prevention, digital behavioral health, remote treatment, video therapy
Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract

Study Overview
=================
Brief Summary
-----------------
Is a combination of Ribose, Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract helpful in CFS and FIbromyalgia?

Detailed Description
-----------------
Ribose has been shown to be very helpful in CFS and fibromyalgia. Many studies have also shown benefit for the symptoms of these conditions from Ashwagandha, Rhodiola, Schisandra, licorice, and green tea extract. The study is undertaken as an early open label study to check for the efficacy of a proprietary combination of these

Official Title
-----------------
Treatment of Fibromyalgia and CFS With Ribose, Ashwagandha, Rhodiola, Licorice, Schisandra and Green Tea Extract

Conditions
-----------------
Fibromyalgia, CFS

Intervention / Treatment
-----------------
* Dietary Supplement: Smart Energy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be diagnosed with CFS and/or fibromyalgia live in the United States 3 - be over 18 years of age Exclusion Criteria: pregnancy Diabetes Hypertension

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: Treatment of CFS/FMS with the nutritional combination<br> | Dietary Supplement: Smart Energy System<br>* A nutritional /herbal combination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | A composite VAS of Fatigue, Pain, Sleep, Cognition and overall well-being. These are each on a 1-10 scale with the same units, with 10 being healthy. The composite sum total of all of these (0-50) will be used as a single outcome measure | 4-6 weeks |