linjc16/ctgov huggingface dataset:
Ph1 Marinol Interaction Study - Part 2 - 1

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.

Official Title
-----------------
Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers

Conditions
-----------------
Marijuana Dependence

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Dronabinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between 18 and 45 years of age Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence Must be seeking treatment at time of study entry Must be able to understand and provide written informed consent Must provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period If female and of child bearing potential, agrees to use birth control. Exclusion Criteria: Please contact site for more information

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dronabinol<br> | Drug: Dronabinol<br> <br> * Other names: Medication intervention;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> * Other names: Placebo comparator arm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. | Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects. | Day 9 and 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Marijuana dependence
Calcium DXA: Impact of Calcium Supplements on Lumbar Spine Bone Mineral Density

Study Overview
=================
Brief Summary
-----------------
We, the investigators at the University of Wisconsin, hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by dual energy x-ray absorptiometry (DXA).

Detailed Description
-----------------
We hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by DXA. To test this, 36 subjects ingested various calcium supplements after a spine DXA scan and were then scanned again 15, 30 and 45 minutes after ingestion. Subsequently a subset of 15 subjects had three spine scans performed for instrument precision and subsequently ingested a calcium tablet with scans 15 and 30 minute intervals after ingestion.

Official Title
-----------------
Impact of Calcium Supplements on Lumbar Spine Bone Mineral Density

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women 18 years or older Exclusion Criteria: Internal spinal hardware

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether exercise training leads to changes in the blood that are produced by exercised muscles and if these changes produce new hormones that affect the body's regulation of sugar and body weight.

Official Title
-----------------
Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Exercise Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age between 18-35. Body mass index (BMI) must be ≥18.5 and ≤27 kg/m2. HbA1c values ≤5.7% Exclusion Criteria: Age <18 and >50 HbA1c ≥ 5.7%; heart or lung disease acute systemic infection accompanied by fever, body aches, or swollen lymph glands BMI > 27 kg/m2 current dieting or weight loss efforts current pregnancy or breastfeeding known history of HIV/AIDS; cancer biochemical evidence of renal or hepatic dysfunction; renal or liver disease demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis recent blood donation clinical history of stroke hypertension (systolic > 140 mmHg or diastolic > 90 mmHg) type 1 or 2 diabetes; inability to exercise at 50% of predicted heart rate (HR) reserve at baseline Participants taking beta-blockers Participants who screen positive for The American Heart Association's contraindications to exercise testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Exercise-Training Intervention<br>Subjects will undergo a 10-week aerobic exercise protocol. | Other: Exercise Intervention<br>* 10 Week aerobic exercise training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in circulating proteins in the blood. |  | Baseline vs. Post 10 Week Training. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise
GARDASIL Reexamination Study (V501-059)

Study Overview
=================
Brief Summary
-----------------
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Gardasil through collecting the safety information according to the Re-examination Regulation for New Drugs.

Official Title
-----------------
Re-examination Study for General Vaccine Use to Assess the Safety Profile of GARDASIL in Usual Practice

Conditions
-----------------
Human Papillomavirus (HPV) Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females and males 9-26 years of age who Are Vaccinated With The First Dose Of Gardasil For The Prevention Of Any Disease Caused By Human Papillomavirus (e.g., Cervical Cancer, Genital Warts, etc.) Within Local Labeling Exclusion Criteria: Participant Who Has A Contraindication To Gardasil According To The Local Label Participants Who Are Vaccinated With Gardasil Before Study Start

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 26 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Korean Participants Vaccinated with GARDASIL<br>Females and males 9-26 years old who are vaccinated with GARDASIL in usual practice. The GARDASIL vaccination series consists of three 0.5-mL intramuscular injections. The second and third doses are to be administered 2 months and 6 months after the first dose, respectively. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Any Adverse Experience | An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. | Up to 14 days after any GARDASIL vaccination | 
| Percentage of Participants With Any Adverse Drug Reaction | An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out | Up to 14 days after any GARDASIL vaccination |
Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19

Study Overview
=================
Brief Summary
-----------------
Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.

Official Title
-----------------
Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults of age 18-80 years tested positive for SARS-CoV-2 reverse-transcriptase - polymerase chain reaction (rt-PCR) and presented within 7 days of symptom(s) onset Exclusion Criteria: Pregnancy Sepsis Malignancy Patients on immunosuppressant therapy Chronic inflammatory conditions Cases lost to follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| PROGRESSION<br>Cohort A with patients who progressed to next stage of illness or continue to remain in the same stage | Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO<br>* Absolute lymphicyte and absolute monocyte counts are recorded on admission of COVID -19 positive patient and ratio is derived. the patients are followed up for any progression of disease stage.<br>|
| NON PROGRESSION<br>Cohort B with those who improved by two points on the ordinal scale without any further progression | Diagnostic Test: LYMPHOCYTE MONOCYTE RATIO<br>* Absolute lymphicyte and absolute monocyte counts are recorded on admission of COVID -19 positive patient and ratio is derived. the patients are followed up for any progression of disease stage.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression | disease progression equal or more than 2 stages | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | end outcome of the patients diagnosed of COVID-19 infection | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LYMPHOCYTE MONOCYTE RATIO, COVID-19, DISEASE PROGRESSION
Adverse Events in Dry Needling

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective cohort survey study is to further explore the incidence of adverse events with dry needling by physical therapists - as well as any differences or similarities between patient-reported vs therapist-reported incidence of AEs.

Detailed Description
-----------------
The study design will comprise of an observational study, where practicing clinicians will log data from dry needling sessions and patients will report via online surveys. Clinician logs will be collected weekly via an online REDCap survey . Patients will be instructed to complete an online REDCap survey in the event that an adverse event occurs. Data will be collected for a period of 4 mo. Descriptive statistics will be used to calculate frequencies of various AE's and rates of occurrence per 100 treatments. Adverse events will be classified on how frequently they occur, ranging from very common (>1/10 treatments) to very rare (<1/10,000 treatments). The investigators will then examine for differences between patient-reported and clinician-reported incidences and also explore for any correlations between adverse events and other various reported factors.

Official Title
-----------------
Clinician-Reported and Patient Reported Incidence of Mild and Significant Adverse Events Associated With Dry Needling by Physical Therapists

Conditions
-----------------
Muscle Soreness, Headache, Knee Osteoarthritis, Back Pain, Neck Pain, Needle Stick, Shoulder Pain, Hip Osteoarthritis

Intervention / Treatment
-----------------
* Other: Observational dry needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient that receives dry needling as a part of their care by a physical therapist and consents to provide information Exclusion Criteria: Does not receive dry needling or does not consent to provide information

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Dry needle<br>Dry needling is provided as a part of a comprehensive treatment program by a physical therapist. The patient and the therapist will record any adverse events that occur. | Other: Observational dry needle<br>* No intervention provided by the study. Observation of any adverse events that occur surrounding dry needling by a physical therapist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | adverse events are recorded by the patient and therapist | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry needling, adverse event, physical therapy
I VACCIN Hospitalization of COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
A REALLIFE evaluation of rate of hospitalized patients in Intensive Care Units and in medical Units of non -vaccinated patients vs vaccinated patients

Detailed Description
-----------------
Transversal National multicenter non interventional on the COVID-19 vaccines Period of hospitalization: from January 1st to March 3rd, 2022 Recruitment duration: 37 days Total study duration: 44 days

Official Title
-----------------
Impact of Vaccination on Medical and Intensive Care Hospitalization of COVID-19 Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female ≥ 18 years Confirmed COVID-19 patients hospitalized in ICU and Medical Units during the period of the study from January 1st to March 3rd. Exclusion Criteria: Subjects vaccinated outside Tunisia Subjects <18 years Not confirmed COVID-19 Not hospitalized patients

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 COVID-19 not vaccinated patients hospitalized in ICU | Rate of non vaccinated patients who were hospitalized in ICU due to COVID-19 compared to all patients hospitalized due to COVID-19 | From January 1st to February 15th | 
| Rate of COVID-19 not fully vaccinated patients hospitalized in ICU | Rate of not fully vaccinated patients who were hospitalized in ICU due to COVID-19 compared to the total number of Hospitalized patients | From January 1st to February 15th | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of COVID-19 not vaccinated patients hospitalized in Medical Units | Rate of non vaccinated patients who were hospitalized in Medical units due to COVID-19 compared to all patients hospitalized due to COVID-19 | From January 1st to February 15th | 
| Rate of COVID-19 not fully vaccinated patients hospitalized in Medical Units | Rate of not fully vaccinated patients who were hospitalized in Medical units due to COVID-19 compared to all patients hospitalized due to COVID-19 | From January 1st to February 15th | 
| Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine | Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine received | From January 1st to February 15th | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Vaccination, Hospitalization
Early Child Care and Risk of Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine risk factors associated with infant growth and the development of obesity in the first year of life. The investigators plan to establish a racially and ethnically diverse southern cohort of 800 mother/infant dyads, followed regularly from birth to 12 months of age. The cohort will be residents of Durham, North Carolina (NC) and the immediate surrounding area. The proposed longitudinal study will examine factors contributing to the development of obesity, including dietary behaviors, physical activity and inactivity, stress, and sleep duration and quality. Frequent in-home assessments throughout infancy and contact with other care providers will help pinpoint exactly when children begin to gain weight excessively and will identify risk factors related to energy intake, energy expenditure, stress, and sleep associated with obesity.

Official Title
-----------------
Nurture: Early Child Care and Risk of Obesity

Conditions
-----------------
Child Adiposity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mother over 18 in 2nd or 3rd trimester of pregnancy with singleton speak and read English planning to stay in area for the first year of baby's life Exclusion Criteria: baby born with conditions that may affect weight, feeding or motor activity

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment (observational study)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child adiposity | In-person assessments of infant weight, length, and skinfold thicknesses at birth, 3, 6, 9, and 12 months of age | birth - 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child adiposity, Infancy, Motor activity, Feeding behavior, Sleep, Stress, Physiological
Retroperıtoneal Soft-Tıssue Sarcomas

Study Overview
=================
Brief Summary
-----------------
: Soft Tissue Sarcomas are rare mesenchymal tumors with many subtypes. Clean margin-wide resection is recommended for treatment. The guidelines recommend that sarcoma treatments be carried out in sarcoma centers. In this study, the location, histopathological features, clinical and demographic features, recurrence, and prognosis of retroperitoneal sarcomas were investigated.

Detailed Description
-----------------
The demographic, histopathological, and immunohistochemical data of the patients who were operated on with the diagnosis of intraabdominal mass at Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital from March 2016 to December 2020 were retrospectively evaluated. Ethical approval was obtained from Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital Ethics Committee. Patients diagnosed with pathological sarcoma subclass were included in the study. Patients younger than 18 years were excluded from the study. Visceral organ-origin sarcomas and extremity sarcomas were also excluded from the study. GIST's were included in sarcoma subtypes by WHO in 2013. However, they were not included in the study due to their solid organ origin. The data of 18 patients' whore remained after the exclusion criteria were analyzed retrospectively. Pathology samples of the patients were re-examined by a single pathologist. The demographic analysis was used for statistics.

Official Title
-----------------
Retroperıtoneal Soft-Tıssue Sarcomas: Retrospectıve Clınıcal Study

Conditions
-----------------
Retroperitoneal Sarcoma, Margin, Tumor-Free

Intervention / Treatment
-----------------
* Procedure: retroperitoneal mass excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated with the diagnosis of intra-abdominal mass patients diagnosed with pathological sarcoma subclasses Exclusion Criteria: Patients younger than 18 years Visceral organ-origin sarcomas extremity sarcomas GIST

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Margin, Tumor-Free<br> | Procedure: retroperitoneal mass excision<br>* retroperitoneal mass excision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clean margin wide resection | effect of clean surgical margin on recurrence | 63 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft tissue sarcoma, Surgery, Multidisciplinary Sarcoma Team