linjc16/ctgov huggingface dataset:
The Role of Massage in Increasing Total Motile Sperm Count of IUI

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, randomized study, was to determine if neck and shoulder massage performed within 15 minutes of semen sample collection will increase the semen volume, and therefore increase the total motile sperm available for insemination as a result of decreased stress.

Official Title
-----------------
The Role of Massage in Increasing Total Motile Sperm Count of Intrauterine Insemination

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

Intervention / Treatment
-----------------
* Behavioral: Massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertility, initiating clomiphene + IUI therapy signed study consent Exclusion Criteria: Severe male infertility (baseline semen concentration < 10 million total motile sperm) female bilateral tubal occlusion failure to ovulate with clomiphene failed clomiphene + IUI therapy (three prior cycles with no conception) unable to tolerate clomiphene unable or unwilling to follow study protocol

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage<br>Professional Swedish massage less than 15 minutes prior to semen collection for intrauterine insemination. | Behavioral: Massage<br> <br> |
| No Intervention: No massage<br>Normal protocol for semen collection prior to intrauterine insemination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Motile Sperm Count | The primary outcome variable is total motile sperm count, which is determined based on the semen volume, concentration, and motility. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Pregnancy rate per cycle with intrauterine insemination. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Intrauterine insemination, Male factor infertility, Massage, Total motile sperm count
Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions

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

Intervention / Treatment
-----------------
* Drug: Imipramine Pamoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to imipramine pamoate or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First Imipramine Pamoate, then Tofranil-PM<br>First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period) | Drug: Imipramine Pamoate<br>* 75 mg capsule<br>* Other names: TOFRANIL-PM;|
| Active Comparator: First Tofranil PM, then imipramine pamoate<br>First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period) | Drug: Imipramine Pamoate<br>* 75 mg capsule<br>* Other names: TOFRANIL-PM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence Determined by Statistical Comparison Cmax | Blood samples were collected pre-dose and at intervals over 120 hours after each dose | 33 Days |
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
The long-term goal is to reduce stress and improve pain control with less opioid use in patients with sickle cell disease by promoting an intervention with self-management relaxation/distraction exercises, named You Cope, We Support (YCWS).

Official Title
-----------------
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
* Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with diagnosis of SCD (e.g., HbSS, HbSC, HbS-beta-0 thalassemia, and HbS-beta+ thalassemia); (b) reports moderate to severe level of pain (>3 on 0-10 scale) related to SCD within previous 24 hours; (c) uses opioid analgesics on as needed or continuous basis (d) who speaks and reads English; and (e) is 18 years of age or older Exclusion Criteria: are legally blind; (b) physically unable to complete procedures; (c) previously participated in our relaxation/distraction intervention feasibility study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br> | Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders.<br>* Self-monitoring of pain, stress, and opioid use + alerts/reminders.<br>|
| Experimental: Experimental Group<br> | Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).<br>* Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress intensity scale | This 3-item scale asks patients to report their current, least, and worst stress intensity in the past 24 hours, on a scale of 0 (no stress) to 10 (stress as bad as it could be) | Baseline through Week 8 |
Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.

Detailed Description
-----------------
This is a prospective study including patients presenting in aggregate primary lesions affected by nodular BCC of the eyelid (all subjects were submitted to incisional biopsy at 2 mm punch) at the commencement of this study. All were submitted to a local treatment with Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average). All subjects were submitted to a new incisional biopsy at 2 mm punch, after 12 weeks of treatment, and all of them were monitored monthly up to now.If positive biopsy (residue tumor) cases will managed with surgery.

Official Title
-----------------
Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma

Conditions
-----------------
Carcinoma, Basal Cell

Intervention / Treatment
-----------------
* Drug: Imiquimod 5% cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose injuries were confirmed by anatomical and pathological study (periocular superficial basal cell carcinoma). Patients with clinical counter indication for reconstructive surgery (high surgical risk). Patients who have refused a restorative surgery. (aesthetic reasons) Patients who have signed the free and informed consent. Exclusion Criteria: Patients who have a hypersensitivity reaction to the formula components. Children under 12 years of age. Pregnant and breastfeeding women. Patients whose injury was not confirmed by anatomical and pathological study. Individuals with previous autoimmune or inflammatory disease. Patients who have refused to sign the free and informed term of consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: nodular BCC of the eyelid<br>Patients with nodular BCC of the eyelid | Drug: Imiquimod 5% cream<br>* Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)<br>* Other names: immunomodulator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-treatment biopsy |  | post-treatment biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunomodulator, Carcinoma, Basal Cell
Thiamine as a Metabolic Resuscitator in Septic Shock

Study Overview
=================
Brief Summary
-----------------
The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.

Official Title
-----------------
Thiamine as a Metabolic Resuscitator in Septic Shock

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: D5W
* Drug: Thiamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years old Suspected or confirmed source of infection Hypotension (systolic pressure <90 mmHg) after a minimum 2 liter fluid bolus followed by vasopressor-dependence. Lactic Acidosis > 3 mmol/dl Exclusion Criteria: Competing cause of lactic acidosis including: seizures within 3 hours of enrollment, use of linazolid metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders Liver dysfunction specifically defined as AST or ALT elevation greater than 240 Current Thiamine supplements or usage Competing indication for thiamine administration Cardiac Arrest DNR/DNI or comfort care status (DNR status in an intubated patient receiving full care is eligible)

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>50 ml D5W | Drug: D5W<br>* Dextrose 5%<br>|
| Experimental: 2<br>200mg Thiamine in 50ml D5W | Drug: Thiamine<br>* Thiamine 200mg in 50ml D5W<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate Level 24 Hours After the First Study Medication Dose |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Shock Reversal | Shock reversal was defined as > 24 hours off all vasopressors | Hospital stay, average 2 weeks | 
| APACHE II Score at 24 Hours | APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Septic Shock
Drug Observance and Side Effects of Cytoreductive Drugs in PV and ET Patients

Study Overview
=================
Brief Summary
-----------------
Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential thrombocythemia completed an unique paper questionnaire in order to describe their observance, the side effects and their own appreciation of the taken drug.

Detailed Description
-----------------
During one year, all patients with PV or ET followed in our centre, and who took a drug to treat their MPN, were identified. The investigators submitted by mail or directly at the consultation a unique questionnaire containing 25 questions concerning patients characteristics, evaluation of observance, identification of side effects and own appreciation of the drug. After completion of the questionnaire, the patients were identified and followed to collect new data about thrombotic events or phenotypic evolution.

Official Title
-----------------
Etude de l'Observance thérapeutique et Des Effets Secondaires Des Traitements Chez Les Patients traités Pour Polyglobulie de Vaquez et thrombocytémie Essentielle

Conditions
-----------------
Polycythemia Vera, Essential Thrombocythemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PV or ET or SMF Patients who took oral or sub-cutaneous drugs to treat their MPN. Patients who agreed to complete the questionnaire Exclusion Criteria: Patients with low risk PV or ET who do not take treatment Patients unable to complete the questionnaire

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

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 |
| --- | --- | --- |
| Rate of adherence to drug prescription | prospective evaluation in a one shot questionnaire given to each treated patient seen at the consultation distributed between december 2014 and december 2015 | At inclusion |
Post Partum Thyroiditis 2: Long Term Observations

Study Overview
=================
Brief Summary
-----------------
The study tries to determine if post partum thyroiditis has marked long term (20 years after partum) risk for developing hypothyroidism.

Detailed Description
-----------------
This is study where we follow up women who in 1985 were checked for the occurrence of post partum thyroiditis 6 week after labour. The former patients have been invited to participate by answering a questionnaire and by providing results from blood tests.

Official Title
-----------------
Observations of Leng Term Effects From Post Partum Thyroiditis.

Conditions
-----------------
Hypothyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Defined group of women who tested positive for post partum thyroiditis in 1985. Control group randomly picked from those who tested negative. Exclusion Criteria: -
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
-----------------
Hypothyroidism
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.

Official Title
-----------------
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Randomised, Open-label, Parallel-group, Multi-centre Trial (FE 999905 CS07) in Which the Efficacy and Safety of 12 Months' Treatment With One Daily Dose of ZOMACTON Were Compared to One Daily Dose of GENOTROPIN

Conditions
-----------------
Idiopathic Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Procedure: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in trial FE 999905 CS07 and presence of anti-hGH antibodies at any post-dosing visit throughout the 12-month treatment period Signed informed consent and obtained assent according to local rules and practice Information on medical history, concomitant medications, and growth hormone therapy since completion of trial FE 999905 CS07 Exclusion Criteria: There are no pre-defined exclusion criteria in this study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sampling|Blood sample will be collected at a single visit|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anti-human Growth Hormone (hGH) antibodies | Measured as percentage of patients with positive anti-hGH antibodies. | At visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples | Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples. | At visit 1 | 
| Binding capacity levels in confirmed anti-hGH antibody positive samples | Measured as percentage of patients with binding capacity <2 mg/L in patients with confirmed positive anti-hGH antibody samples. | At visit 1 |
Expression of Hypoxia-Inducible Factor-α in Oral Precancers and Cancers

Study Overview
=================
Brief Summary
-----------------
Expression of hypoxia-inducible factor-α in oral precancers and cancers

Detailed Description
-----------------
Expression of hypoxia-inducible factor-α in oral precancers and cancers

Conditions
-----------------
Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oral cancer specimens Exclusion Criteria: not oral cancer specimens

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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
-----------------
oral precancers, oral cancer, hypoxia-inducible factor
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy

Conditions
-----------------
Diabetic Neuropathy, Painful

Intervention / Treatment
-----------------
* Drug: AGN 203818
* Drug: AGN 203818
* Drug: AGN 203818
* Drug: placebo capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of diabetic peripheral neuropathy Moderate to severe neuropathic pain Exclusion Criteria: Any other uncontrolled disease Pregnant or nursing females

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3 mg | Drug: AGN 203818<br>* 3 mg Capsule twice daily for 4 weeks<br>|
| Experimental: 2<br>20 mg | Drug: AGN 203818<br>* 20 mg Capsule twice daily for 4 weeks<br>|
| Experimental: 3<br>60 mg | Drug: AGN 203818<br>* 60 mg Capsule twice daily for 4 weeks<br>|
| Placebo Comparator: 4<br>Placebo | Drug: placebo capsule<br>* Capsule twice daily for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Daily Pain Score |  | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sleep interference score |  | Week 4 | 
| Beck depression inventory |  | Week 4 | 
| Quality of Life questionnaires |  | Week 4 |