linjc16/ctgov huggingface dataset:
Case Control Study: Determinants of Osteoporosis in GOLD II COPD Patients.

Study Overview
=================
Brief Summary
-----------------
Patients with COPD have been found to have an increased risk of osteoporosis. The underlying mechanism is not clear yet. This case control study aims to identify risk factors for osteoporosis in GOLD II COPD patients. COPD GOLD II patients with osteoporosis (cases) will be matched by gender and age to COPD GOLD II patients without osteoporosis(controls). Possible risk factors for osteoporosis are: BMI/VVMI (body composition) emphysema vs chronic bronchitis physical capacity Use of certain medication (eg corticosteroids, SSRI's) Nutritional status Infectious parameters Outpatients from the pulmonary ward of the Catharina Hospital Eindhoven with GOLD II COPD according to the ATS and GOLD-guidelines will be included in the study (after written informed consent). A DEXA-scan will be made, if patients are osteoporotic or have a normal BMD they will be included in the study. A HRCT will be made, a six minutes walking distance will be performed, blood will be drawn for lab. analysis, an X-ray of the vertebral collum will be made, impedance will be measured and hight and weight will be measuered. Also patients will fill in a questionaire. By univariate and multivariate analysis the collected data will be analysed to determine possible risk factors for th development of osteoporosis in COPD GOLD II patients.

Official Title
-----------------
Determination of Risk Factors for Developing Osteoporosis in COPD GOLD II Patients. A Case Control Study to Identify Possible Risk Factors for Developing Osteoporosis in COPD GOLD II Patients.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 40 years GOLD II COPD Written permission Exclusion Criteria: Age < 40 years No COPD or COPD GOLD I, III or IV no written permission

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| 1<br>GOLD II COPD patients with osteoporosis | |
| 2<br>GOLD II COPD patients with a normal bone mineral density | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for osteoporosis in GOLD II COPD patients |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Osteoporosis, BMD, DEXA-scan
Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Study Overview
=================
Brief Summary
-----------------
Interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial

Official Title
-----------------
Interest of a Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area: a Multicentric Phase III Randomized Trial

Conditions
-----------------
Recurrence of Head and Cancer in Irraiated Area

Intervention / Treatment
-----------------
* Procedure: Reirradiation with concomitant chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: head and neck squamous cancer both sexes >=18 years recurrence treated by surgery and initially treated by radiotherapy with written informed consent at entry time Exclusion Criteria: -

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Reirradiation with concomitant chemotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 3 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local event-free survival |  |  | 
| Toxicity |  |  |
Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years

Study Overview
=================
Brief Summary
-----------------
Evaluation of the learning and encouragement effect on six minutes walking test in children under 12 years

Official Title
-----------------
Learning and Encouragement Effect on 6 Minute Walking Test in Children Between 6 and 12 Years

Conditions
-----------------
Healthy Children

Intervention / Treatment
-----------------
* Other: six minute walking test
* Other: six minute walking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: acute or chronic lung, cardiac or neuromuscular disease at risk of- or overweight (BMI higher than 85th percentile for children of the same age and sex) a motor disability

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: test 1<br>six minute walking test | Other: six minute walking test<br>* six minute walking test<br>|
| Experimental: test 2<br>six minute walking test | Other: six minute walking test<br>* six minute walking test<br>|
| Experimental: test with encouragement<br>six minute walking test | Other: six minute walking test<br>* six minute walking test with encouragement<br>|
| Active Comparator: test without encouragement<br>six minute walking test | Other: six minute walking test<br>* six minute walking test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distance | walked distance | six minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | heart rate | six minutes | 
| pulsed oxygen saturation | pulsed oxygen saturation | six minutes |
Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort study enrolling ulcerative colitis patients who initiate tofacitinib therapy. Investigators will collect clinical data, blood and stool samples prior to initiation of tofacitinib and, at minimum, monthly after the start of therapy. They will collect tissue from colonoscopies prior to initiation of therapy and within 6 months on therapy. Clinical characteristics and response to treatment will then be associated with genotype, blood immune profiles, stool microbiota, and cellular and molecular profiles of the biopsies to generate a treatment response model. Using predictors identified in our model, we will then attempt to validate the model and findings with the OCTAVE (Pfizer), SPARC (CCF), and RISK (CCF) data.

Official Title
-----------------
Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Diagnostic Test: GWAS analysis by Illumina BeadChip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total mayo score between 6 and 12 Endoscopic subscore of 2 or 3 Exclusion Criteria: Recent use of antibiotic therapy (<4 weeks) Current extreme diet (parenteral nutrition, specific carbohydrate diet). Active infection or malignancy. Significant underlying liver or renal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Patients Treated with Tofacitinib<br>Microbiota profiling by 16S sequencing RNA-seq transcriptional profiling of the blood and biopsy samples Immunological profiling by multi-parameter flow cytometry | Diagnostic Test: GWAS analysis by Illumina BeadChip<br>* will generate comprehensive genotype data for patients. Samples will be used for transcriptional profiling, microbiota profiling by 16S analysis and immunological profiling by flow cytometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GWAS analysis pretreatment | GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients. | 1 Day |
Impact of Treatment Induced Premature Menopause on Quality of Life

Study Overview
=================
Brief Summary
-----------------
To understand the impact of treatment induced menopause on quality of life and sexuality following blood and marrow transplantation.

Official Title
-----------------
Impact of Treatment Induced Premature Menopause on Quality of Life Following Blood and Marrow Transplantation

Conditions
-----------------
Menopause, Premature

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premenopausal sexually active women able to read and write English Exclusion Criteria: - postmenopausal females

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

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

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 |
| --- | --- | --- |
| Quality of life | To describe the impact of premature menopause on sexuality and quality of life. | 1 year | 
| Sexuality | To describe the impact of premature menopause on sexuality and quality of life. | 1 year |
Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment

Study Overview
=================
Brief Summary
-----------------
Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common symptom whereas life-threatening anaphylaxis is rather rare. A recently published study (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients, disregarding their penicillin skin test results. In the proposed study the investigators will similarly challenge beta-lactam allergic patients, both children and adults for an extended (5 days) period of time. The study will include patients with a history of a skin rash following beta-lactam administration as well as patients who cannot provide any data on their presumed allergic reaction, disregarding their penicillin skin test results.

Conditions
-----------------
Beta-lactam Allergy

Intervention / Treatment
-----------------
* Drug: Beta-lactam oral challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of skin rash following the administration of beta-lactam antibiotic Patients with a diagnosis of penicillin allergy who have no data on the nature of the symptoms that have eventually resulted in establishing this diagnosis Exclusion Criteria: Patients in whom the rash appeared within 1 hour after the last dose of the drug Patients who also developed other anaphylactic symptoms Patients who had a life-threatening rash such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis or DRESS. Pregnancy
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

| Intervention/Treatment |
| --- |
|Drug: Beta-lactam oral challenge|Oral daily dose, according to patient's weight, of amoxicillin or other suspected beta-lactam will be administered for 5 consecutive days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy | In case of the development of any adverse reactions throughout the 5-day challenge patients will notify the investigators over the phone. If assessed necessary by the investigators, patients will return to the Allergy Clinic for repeated evaluation. After completion of the 5-day challenge all patients will be contacted by the investigators and will be inquired about any adverse reactions throughout the challenge. The number of participants with adverse reactions to the challenge will be reported. | 5 days |
Comparison of INVOS and FORE SIGHT Cerebral Oximeter

Study Overview
=================
Brief Summary
-----------------
Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. The investigators hypothesize that these positions influence cerebral oxygenation. Further the investigators presume that the two cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.

Official Title
-----------------
Assessing Cerebral Oxygenation During Different Surgical Procedures - Comparison of INVOS and ForeSight Cerebral Oximeter

Conditions
-----------------
Changes in Cerebral Oxygenation During Different Patient Positioning, Coparison of Two Cerebral Oximeters

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 and <80 years written informed consent Exclusion Criteria: cerebrovascular disease coronary heart disease severe organ failure hemoglobin < 10mg/dl injury of forehead pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Beach chair<br>Patients scheduled for surgical procedure in beach chair position (Shoulder surgery) | |
| Sitting position<br>Patients scheduled for surgical procedure in sitting position (Neurosurgery) | |
| Head down position<br>Patients scheduled for surgical procedure in head down position (daVinci robotic surgery) | |
| Prone position<br>Patients scheduled for surgical procedure in prone position | |

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
-----------------
NIRS, cerebral oxygenation
Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following arthroscopic knee surgery.

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain

Conditions
-----------------
Pain, Postoperative Arthroscopy

Intervention / Treatment
-----------------
* Drug: MK0966 / Duration of Treatment: 1 Days
* Drug: Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days
* Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia Patients must experience moderate to severe pain following surgery Patient must be in general good health as judged by the primary investigator Exclusion Criteria: Osteoarthritis; rheumatoid arthritis Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen Asthma associated with nasal polyps Any arthroscopic knee surgery in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0966 / Duration of Treatment: 1 Days|nan|
|Drug: Comparator: acetaminophen (+) hydrocodone bitartrate / Duration of Treatment: 1 Days|nan|
|Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Pain Relief over 6 hours following a single oral dose compared to placebo. |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen. |  | 6 hours |
An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: Radafaxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Major Depressive Disorder (MDD) Duration of current depressive episode 12 weeks - 24 months Patients can read and write at a level sufficient to provide a signed consent If female, patients must be practicing an acceptable method of birth control Exclusion Criteria: Patients have other psychiatric disorders that would affect patient's response to treatment Patients have not responded to two or more adequate courses of antidepressant therapy Patients cannot be currently abusing illicit drugs or alcohol Patients are not currently receiving psychotherapy Patients have received electroconvulsive therapy within 6 months prior to screening Patients are pregnant or lactating

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Radafaxine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the MADRS score at other timepoints; change in the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW353162,, Major depressive disorder,, flexible
Primary Immunodeficiency in Kuwait

Study Overview
=================
Brief Summary
-----------------
Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity. Study hypothesis: PIDD is relatively common in Kuwait compared to populations from different geographic areas. The distribution of PIDD in Kuwait is different from other geographic areas with more severe forms being more frequent. Brief inclusion and exclusion criteria of study participants: PIDD patients presented at different clinics/hospital in Kuwait. Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect), will be excluded Estimated sample size of the study: All patients who were registered in KNPIDR since 2004 will be included in the study along with the new patients who will be recruited during the study period. Primary objectives: Determine the prevalence and frequency of different PIDD in Kuwait Identify clinical presentation patterns for PIDD in Kuwait Identify natural history of PIDD in Kuwait Help to asses epidemiology of PIDD in Kuwait Determine particularities about PIDD affecting the population in Kuwait Determine the health impact of PIDD in Kuwait Development of strategies to improve the care and the quality of life of patients with PIDD

Official Title
-----------------
Kuwait National Primary Immunodeficiency Registry (KNPIDR)

Conditions
-----------------
Primary Immune Deficiency Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PIDD patients presented at different clinics/hospital in Kuwait Exclusion Criteria: Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect)
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 |
| --- | --- | --- |
| Number of Participants With Different Epidemiological Features |  | 15 years | 
| Number of Overall and New Cases of PID Per 100,000 Kuwaitis |  | 15 years |