linjc16/ctgov huggingface dataset:
Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
Unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in this group. 65 women with unexplained infertility and 65 healthy controls will collect daily urine samples form the luteal phase. hCG and creatinine levels are measured in order to detect pregnancies and early pregnancy loss.

Official Title
-----------------
Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility Measured by hCG Rise in Urine

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unexplained infertility Exclusion Criteria: IVF treatment

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 |
| --- | --- |
| unexplained infertility<br>patients with unexplained infertility | |
| healthy controls<br>women who wish to conceive, no more tha 3 previous cycles, age above 18 | |
| references<br>lesbian women with a regular cycle without use of anticonception and not at risk of becoming pregnant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of early pregnancy loss |  | 3 mentrual cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pregnancies |  | 3 menstual cycles | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unexplained infertility, hCG, early pregnancy loss
Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

Study Overview
=================
Brief Summary
-----------------
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.

Official Title
-----------------
A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Azithromycin plus Chloroquine
* Drug: Mefloquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following: Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours. Exclusion Criteria: Severe or complicated malaria. Pregnant or breast-feeding women.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Azithromycin plus Chloroquine<br>* Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)<br>* Other names: Zithromax;|
| Experimental: 2<br> | Drug: Mefloquine<br>* Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa. |  | duration of trial | 
| The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population. |  | duration of trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary objective is to assess the efficacy of azithromycin plus chloroquine. |  | duration of trial | 
| Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens. |  | duration of trial |
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (USA)

Study Overview
=================
Brief Summary
-----------------
This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post- implementation of an Alarm Advisor software.

Detailed Description
-----------------
In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded. In an interim period an Alarm Advisor software will be introduced to the unit. In a second phase (post-implementation) the same set of alarm data will be recorded. The Alarm Advisor Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits). The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

Official Title
-----------------
Nurses' Customization of Physiologic Monitor Alarms: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software

Conditions
-----------------
Clinical Alarms

Intervention / Treatment
-----------------
* Device: Alarm Advisor Software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients admitted to the intensive care units during the study periods Exclusion Criteria: - none

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Phase (Control)<br>no Alarm Advisor Software installed | |
| Post-Phase (Observation)<br>Alarm Advisor Software implemented | Device: Alarm Advisor Software<br>* Providing advice on alarm limits as part of routine medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Alarms | red and yellow alarms with subgroups | 2 month per phase with 2 month washout (6 month overall) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alarm Nuisance, Alarm Reduction, Patient Monitoring, Intensive Care, Alarms, Alarm Fatigue
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy

Study Overview
=================
Brief Summary
-----------------
The study will include data from a nationwide Danish cohort of postmenopausal women and the United States of America (US) cohort of postmenopausal women. The Danish nationwide cohort will be established through linkage of Danish national patient registries. The US cohort will be established based on data from US claims database, Truven. The aim of this study is to evaluate whether exposure to Vagifem® increases the rate of endometrial cancer in postmenopausal women.

Official Title
-----------------
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy: A Register-based Cohort Study in Postmenopausal Women

Conditions
-----------------
Postmenopausal Vaginal Atrophy

Intervention / Treatment
-----------------
* Drug: Vagifem®
* Drug: Non-Vagifem® LDVE, Estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 50-75 years at entry Exclusion Criteria: Endometrial cancer prior to entry Any use of vaginal estrogen products prior to entry Hysterectomy prior to entry

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Danish cohort<br>Danish cohort starts on 1 January 2000 and ends on 31 December 2019. It consists of new users of low dose vaginal estrogens (LDVE) (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy. | Drug: Vagifem®<br>* According to local clinical practice - independent of inclusion in this study<br>Drug: Non-Vagifem® LDVE, Estradiol<br>* According to local clinical practice - independent of inclusion in this study<br>|
| US cohort<br>US cohort starts on 1 January 2007 and ends on 31 December 2019. It consists of new users of low dose vaginal estrogens (LDVE) (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy. | Drug: Vagifem®<br>* According to local clinical practice - independent of inclusion in this study<br>Drug: Non-Vagifem® LDVE, Estradiol<br>* According to local clinical practice - independent of inclusion in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First time occurrence of endometrial cancer (yes/no) during time in cohort from entry (start of treatment) to exit (end of study period, occurrence of any other cancer (except non-melanoma skin cancer), date of emigration or date of death) | Yes/no | From entry (day 0) to exit (upto 19 years) |
Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

Study Overview
=================
Brief Summary
-----------------
A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

Official Title
-----------------
A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: IDX21459
* Drug: Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects Subjects are in good general health. Subjects have provided written informed consent form. All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects Documented clinical history compatible with chronic hepatitis C without cirrhosis. Treatment-naïve HCV Genotype 1 Exclusion Criteria: All subjects Pregnant or breastfeeding Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV). Decompensated liver disease Other clinically significant medical conditions or laboratory abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days | Drug: IDX21459<br> <br> Drug: Matching Placebo<br> <br> |
| Experimental: Group B<br>HCV subjects genotype 1, IDX21459 capsules, once for 1 day | Drug: IDX21459<br> <br> |
| Experimental: Group C<br>HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days | Drug: IDX21459<br> <br> Drug: Matching Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessment | Proportion of subjects experiencing adverse events. | up to 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic | Plasma and urine concentrations of IDX21459 and its metabolite/s. | Up to 120 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C virus, HCV
Model-Free Time Curves for Longitudinal Data Analysis

Study Overview
=================
Brief Summary
-----------------
To enhance statistical methods for epidemiological studies by extending the Disturbed Highest Derivative Polynomial (DHDP) to models for binary-logistic and Poisson data and by including random subject effects in the Gaussian model.

Detailed Description
-----------------
DESIGN NARRATIVE: In previous work the investigator had developed the Disturbed Highest Derivative Polynomial (DHDP) as a model-free time curve and had published the theoretical development for its use as the overall time curve in a linear Gaussian model for longitudinal data with fixed covariate effects and autocorrelated errors but without subject effects. For the logistic model, the DHDP would replace the constant which appeared in the log odds in the non-longitudinal case. The first-order DHDP was a straight line whose slope received random disturbances over time. As such, it was capable of fitting a rich variety of arbitrarily changing time curves. The second-order DHDP would generally provide a fit with smaller high frequency variation. There are a number of longitudinal data analysis methods currently available for Gaussian and binary-logistic data. They all have in common the requirement to explicitly model the overall time curve--usually by a low order deterministic polynomial. The main significance of this proposal was to represent the overall time curve by a DHDP, thereby allowing the possibility for fitting arbitrarily changing time curves without explicitly modeling the form of the change over time. The order of the DHDP can be selected by a modification of the Akaike Information Criterion. The Poisson model should be useful in fitting the periodic reported incidence of a rare disease. The relationship of the DHDP to the Smoothing Polynomial Spline (SPS) was shown and methods were developed for using a SPS instead of a DHDP in analysis. Robustness of the methods were examined by computer simulation studies which evaluated and compared the ability of the DHDP and SPS models to estimate covariate effects and time curves when the time curves were generated by processes other than DHDP. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Visceral Obesity and Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
While perirenal fat measurement is an easy reproducible surrogate of visceral fat, its value as independent parameter in predicting postoperative complications after colorectal resection remains poorly investigated. The investigators want to test the value of perirenal fat as surrogate of visceral obesity as risk factor for morbidity in colorectal surgery and to compare it to the effect of Body mass index (BMI) and Waist- Hip ratio (WHR).

Official Title
-----------------
Value of Perirenal Fat Surface as a Risk Factor for Morbidity After Elective Colorectal Surgery

Conditions
-----------------
Visceral Obesity, Colorectal Surgery, Risk Factor

Intervention / Treatment
-----------------
* Procedure: Colorectal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective colorectal resection Exclusion Criteria: age under 18 emergency condition immunosuppression

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perirenal fat<br> | Procedure: Colorectal surgery<br>* Colorectal surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications (Clavien-Dindo classification) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the operation |  | From incision to dressing of the wound | 
| Rate of conversion |  | From incision to dressing of the wound |
Biopsychosocial Factors' Influence on Shoulder Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability.

Detailed Description
-----------------
The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability. Previous studies have suggested that specific genes influence pain perception. Other studies have suggested that specific psychological factors influence pain perception. We plan to investigate both of these factors to see if they contribute to the development of chronic shoulder pain and disability.

Official Title
-----------------
Biopsychosocial Factors' Influence on Shoulder Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: pain perception


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic shoulder pain and disability Exclusion Criteria: none

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exercise induced pain perception<br> | Behavioral: pain perception<br>* pain perception<br>|
| Surgical pain perception<br> | Behavioral: pain perception<br>* pain perception<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Measurement using the quick DASH | Baseline to 12 months | 
| Pain intensity | Measured by the Brief Pain Inventory | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical impairment | Measured shoulder range of motion | Baseline to 12 months | 
| Activity evoked pain | Measured by Numerical Rating Scale with shoulder movement | Baseline to 12 months |
Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram

Study Overview
=================
Brief Summary
-----------------
Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET).

Detailed Description
-----------------
Regional metabolic changes associated with response to 6 weeks of citalopram treatment, using 18-Fluorodeoxyglucose Positron Emission Tomography imaging, will be characterized (FDG PET). The following hypothesis will be tested: Antidepressant response or remission in depressed BPD patients will be associated with changes in cortical (prefrontal, parietal, premotor) and paralimbic (hippocampus, anterior cingulate, subgenual cingulate, posterior cingulate, and anterior insula) regions, consistent with SRI antidepressant response in unipolar depressed patients.

Official Title
-----------------
Neuroimaging Studies of the Treatment of Bipolar Depression With Citalopram

Conditions
-----------------
Bipolar Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current age 18-64 years; DSM-IV diagnosis of BPD, type-I, or type-II; Enrolled in the Citalopram Study at Tufts Medical Center Exclusion Criteria: Current pregnancy, or inability to utilize contraception, The presence of any metallic implants, History of claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Citalopram<br>Patients with bipolar disorder | |
| Placebo<br>Patients with bipolar disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rCMRglu | regional glucose metabolism | pre and post-treatment |