linjc16/ctgov huggingface dataset:
Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)

Study Overview
=================
Brief Summary
-----------------
This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs).

Detailed Description
-----------------
Traditional systems of healing, such as shamanism, do not readily lend themselves to conventional research methods, yet studying their effectiveness is especially germane in the case of chronic conditions that involve an emotional component and that elude allopathic treatment regimens. Temporomandibular joint disorders (TMDs), which affect up to 10% of the adult population, are a prime example of such conditions. Traditional treatment outcomes for TMD pain are often unsatisfactory. Moreover, in women age 25-55 (the age-sex group most affected), TMD is often found in association with depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infection,and fibromyalgia. Because these multiple and complex symptoms suggest a loss of spirit or life energy, they may be particularly susceptible to treatment by shamanic (spiritual) healing, which aims to bring disturbed physical, mental, and emotional systems into balance. This phase I study will develop methods to evaluate shamanic healing as an intervention for TMD and will evaluate the feasibility of conducting randomized clinical trials of shamanic healing.

Conditions
-----------------
Temporomandibular Disorders

Intervention / Treatment
-----------------
* Procedure: shamanic healing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Females Age 25-55 TMD Research Diagnosis Criteria (RDC) clinical diagnosis of myofacial pain with or without disc displacement, arthralgia, arthritis, or arthosis Three or more significant systemic conditions, e.g. depression, fibromyalgia, GI or reproductive disturbances, upper respiratory problems, etc. in the preceding 2 years. Exclusion criteria: Diagnosed organic or medication induced major mental illness (e.g., schizophrenia, bipolar) Other neurological diagnoses (epilepsy, Parkinsons) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: shamanic healing|nan|

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
-----------------
temporomandibular disroders, shamanism, chronic pain
Effects of Denosumab Therapy for Japanese

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition. The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

Detailed Description
-----------------
Registry criteria: Patients treated in the investigators hospital using denosumab. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%). Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Official Title
-----------------
Effects of Denosumab Therapy for Japanese Osteoporotic Patients

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Denosumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporotic patients Exclusion Criteria: cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Denosumab|every 6 month injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD increase by denosumab in Japanese | The investigators evaluate BMD increase by denosmab in Japanese patients. | Up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The determinants related to BMD increase and fracture prevention for denosumab treatment | The investigators evaluated lumbar and femoral neck BMD. The investigators evaluated baseline patients characteristics. The investigators will evaluate the relationship between BMD increase or fracture and patients characteristics using univariate and multivariate analysis. | Up to 48 months | 
| Effects of previous therapy to denosumab | The investigators evaluate effects of previous osteoporosis treatment to denosumab in BMD increase and bone turnover marker response using univariate and multivariate analysis. | Up to 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMD, Osteoporosis, denosumab, previous therapy
Cyanocobalamin as Photosensitizing Agent

Study Overview
=================
Brief Summary
-----------------
is cyanocobalamin active as Photosensitizing Agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea

Official Title
-----------------
Cyanocobalamin as Photosensitizing Agent Using to Make Cross-linking to Cornea Collagen in Treatment of Progressive Keratoconus

Conditions
-----------------
Keratoconus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing; Exclusion Criteria: Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRESERVATION of presence of red flare by using slit lamb | Cyanocobalamin react with cornea collagen and format red flare | Base line |
Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if ipamorelin is safe and effective in the management of post-operative ileus.

Detailed Description
-----------------
The safety and efficacy of ipamorelin in the management of post-operative ileus

Official Title
-----------------
A Phase II, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of Ipamorelin Compared to Placebo for the Management of Post-Operative Ileus in Patients

Conditions
-----------------
Ileus

Intervention / Treatment
-----------------
* Drug: Ipamorelin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willing to comply with protocol undergoing bowel resection surgery ASA Class I-III Females must not be pregnant Body weight 40-150 kg Exclusion Criteria: mentally incompetent or unable to provide informed consent clinically unstable significant liver disease clinically significant lab or EKG abnormalities alcohol or illicit drug abuse history of or current surgery that would prevent proper evaluation of safety or efficacy of drug

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Ipamorelin<br> | Drug: Ipamorelin<br>* IV<br>* Other names: ST;|
| Placebo Comparator: 2 Placebo<br> | Drug: placebo<br>* IV<br>* Other names: ST;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of GI function |  | Until hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative Ileus
Outcomes in the Palm of Your Hand: Improving the Quality and Continuity of Patient Care

Study Overview
=================
Brief Summary
-----------------
This study evaluates the usability of personal digital assistants (PDAs) by nurses for collecting, utilizing and communicating patient health information, and the feasibility of using PDAs to increase nurses' access to and utilization of best-practice guidelines.

Official Title
-----------------
Outcomes in the Palm of Your Hand: Improving the Quality and Continuity of Patient Care

Conditions
-----------------
Computers, Handheld, Outcomes Assessment, Patient

Intervention / Treatment
-----------------
* Device: handheld Personal Digital Assistant (PDA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurses are eligible to participate if they work on a participating unit, 20 or more hours/week Patients are eligible if they are being cared for on a participating unit, are able to provide informed consent in English, and are able to answer questions about their daily activities and symptoms (pain, nausea, dyspnea, fatigue.) Exclusion Criteria: none

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: handheld Personal Digital Assistant (PDA)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nursing communication and coordination |  |  | 
| patient functional status |  |  | 
| patient symptoms (pain, nausea, dyspnea, fatigue) |  |  | 
| patient therapeutic self care |  |  |
Prediction of Weaning Outcomes by Using Rate of Change of Rapid Shallow Breathing Index

Study Overview
=================
Brief Summary
-----------------
This trial examines weaning outcomes using the rapid shallow breathing index rate.

Detailed Description
-----------------
We hypothesize that the trend of the Rapid Shallow Breathing Index or RSBI rate, is a better predictor of weaning outcome than the RSBI as a single value during the weaning trial. patients are recruited during a weaning trial on t-piece and the RSBI during what the RSBI is measured periodically. The outcome is ventilatory status at 24 hours after the weaning trial.

Official Title
-----------------
Prediction of Weaning Outcomes by Using Rate of Change of Rapid Shallow Breathing Index

Conditions
-----------------
Rapid Shallow Breathing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requires need of mechanical ventilation for > 48 hours with a tube size no smaller than 7.5 Exclusion Criteria: Healthy volunteers
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rapid Shallow Breathing Index, Mechanical Ventilation
Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension. To obtain information on the dosage used in practice and the tolerance at the start of treatment (12 weeks)

Official Title
-----------------
Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension, Under Normal Conditions Compared With an Open Clinical Trial

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Motens® (lacidipine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-hospitalised patients of both sexes aged 18 years or more with essential hypertension requiring treatment according to the recommendations of the German League for Hypertension Exclusion Criteria: Patients who had the contraindications listed in the product information (the case report file contained a copy of the product information)

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 |
| --- | --- |
| Motens<br> | Drug: Motens® (lacidipine)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by the investigator on a 4-point verbal rating scale based on changes in blood pressure |  | Up to 12 weeks after start of drug administration | 
| Assessment of tolerability by investigator on a 4-point verbal rating scale |  | Up to 12 weeks after start of drug administration | 
| Number of patients with adverse events |  | Up to 12 weeks after start of drug administration |
The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies

Study Overview
=================
Brief Summary
-----------------
Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. More rapid, accurate and sensitive diagnostic tools are needed. Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for multiplex PCR at admission and 3x/week thereafter until discharge or recovery from neutropenia

Official Title
-----------------
Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study

Conditions
-----------------
Neutropenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged ≥18 years autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed Exclusion Criteria: No blood samples were taken
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bone marrow transplant unit patients<br>hospitalized patients in the bone marrow transplant unit for an autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy | |

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
-----------------
neutropenia, multiplex PCR, infection
CT Versus CEUS Findings of Complex Cystic Renal Lesions

Study Overview
=================
Brief Summary
-----------------
Retrospective comparison of complex cystic renal lesions which are found with computed tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS).

Detailed Description
-----------------
All subjects receive an contrast enhanced CT due to different clinical indications. When a complex cystic renal lesion is found an evaluation with CEUS is performed. The CEUS protocol included a native baseline examination of both kidneys. After a bolus injection of 1.5 ml SonoVue (Bracco, Milano, Italy) an examination of the affected kidneys is performed over a time period of at least three minutes. An optional dose will be given when the initial examination is not conclusive, e. g. when the arterial phase is partly missed. When both examinations are done the lesions were classified using the Bosniak classification system and a comparison of both methods will be done.

Official Title
-----------------
Complex Cystic Renal Lesions: Evaluation of Computed Tomography Findings With Contrast Enhanced Ultrasound in Terms of the Bosniak Classification System.

Conditions
-----------------
Kidney Neoplasms, Computed Tomography, Ultrasonography, Contrast Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Finding of a complex cystic renal lesion Exclusion Criteria: age < 18 y, gravity

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 |
| --- | --- | --- |
Ethnicity and Analgesic Practice in a Pediatric Emergency Department

Study Overview
=================
Brief Summary
-----------------
Early and appropriate pain management in the emergency department (ED) is an important aspect of child care. Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED. The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture.

Detailed Description
-----------------
Early and appropriate pain management in the emergency department (ED) is an important aspect of child care. Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED. The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture .

Official Title
-----------------
Ethnicity and Analgesic Practice in a Pediatric Emergency Department

Conditions
-----------------
Limb Fracture

Intervention / Treatment
-----------------
* Drug: Arab children


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Any patient with a limb fracture Exclusion Criteria: Multi trauma patients Patients with unidentified ethnicity

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Arab children (case subjects)<br>Arab patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014, who were treated with Oxycodone | Drug: Arab children<br>* Treatment with Oxycodone<br>* Other names: Arabs;|
| Jewish children (controls)<br>Jewish patients who were admitted to the pediatric ED due to a limb fracture between 01 January 2011 and 31 October 2014, who were treated with Oxycodone | Drug: Arab children<br>* Treatment with Oxycodone<br>* Other names: Arabs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of oxycodone treatment by the nursing staff |  | At triage up to 1 hour after admission at the recpetion desk | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients who were admitted to the pediatric ED
Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer.

Detailed Description
-----------------
RAndomized pilot study of supplemental Iscar in combination with Gemcitabine vs. Gemcitabine alone as second line treatment for advanced non-small cell lung cancer.

Official Title
-----------------
Randomized Pilot Study of Supplemental Iscar in Combination With Gemcitabine vs. Gemcitabine Alone as Second Line Treatment for Advanced Non-Small Cell Lung Cancer.

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Iscar Quercus
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed IIIB and IV NSCLC who have failed one prior line of chemo Karnofsky score 60% or greater patients who will be treated with Gemcitabine

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

| Intervention/Treatment |
| --- |
|Drug: Iscar Quercus|nan|
|Drug: Gemcitabine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if Iscar improves immune function and quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced stage, Lung cancer