linjc16/ctgov huggingface dataset:
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic

Study Overview
=================
Brief Summary
-----------------
This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.

Official Title
-----------------
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic

Conditions
-----------------
Infant Conditions, Colic, Infantile, Gastro-Intestinal Disorder

Intervention / Treatment
-----------------
* Other: Manual treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: infants diagnosed with colic, with 0-90 days of age, who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study. Exclusion criteria: infants diagnosed with any sort of pathological illness, allergies or food intolerance who have suffered any intracranial hemorrhages or skull fractures.

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 90 Days

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Craniosacral therapy<br>Craniosacral therapy and parent information on how to manage colic. | Other: Manual treatment<br>* Craniosacral therapy protocol.<br>|
| No Intervention: Parent information<br>Parent information on how to manage colic. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crying | Total amount of time the infant cries within a day. Crying is recorded by the parents in a diary. The higher the score is, the more hours of crying per day. | Change from baseline crying at 24 days, also evaluated at days 7 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | Total amount of time the infant sleeps within a day. Sleep is recorded by the parents in a diary. The higher the score is, the more hours of sleep per day. | Change from baseline sleep at 24 days, also evaluated at days 7 and 14 | 
| Severity-ICSQ | Severity of colic is measured according to a validated Infant Colic Severity Questionnaire. Minimum score is 24 and maximum 100. A score higher than 50 points suggests that the patient suffers from infantile colic. | Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infantile Colic, Skull, Osteopathic Manipulation, Clinical Trial, Massage, Infant, Osteopathic Medicine
A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Interferon-gamma 1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Male or Female, 20-79 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon-gamma 1b|200 mcg, SQ, 3x per week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival time |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IPF, lung
Smart Textile Technology for Scoliosis

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a garment-integrated sensing system will be able to detect with clinical accuracy the position of the spine. The investigator will evaluate this using healthy adult volunteers, who will don sensing garments and assume a series of spinal postures. Concurrent with garment sensing, the participant's spine position will be measured using a motion-capture system that uses reflective markers to detect positions of markers in 3D space. The motion-capture system provides a gold-standard reference measure to which the sensing garments will be compared. Because the investigators are evaluating the accuracy of the sensing garment, it is only necessary that the investigator test the garments on participants with subtly different body shapes. Healthy adult volunteers provide an adequate input to the sensing signal.

Official Title
-----------------
Smart Textile Technology for Scoliosis: Aim 1

Conditions
-----------------
Spinal Deformities, Scoliosis, Kyphosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults Exclusion Criteria: Under age 18 or over age 65 Any medical condition that impairs movement or makes movement painful or difficult.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body movement | The movement and position of participants' spine will be recorded using a motion capture device and using a prototype sensing garment during the 1-2 hour lab test. (This is the only point at which investigators will interact with participants) | Participants will be assessed during a 1-2 hour visit. Visits will be scheduled over a period of approximately one year. |
Effect of Whole Body Vibration on Bone and Fall Related Parameters

Study Overview
=================
Brief Summary
-----------------
The effect of whole body vibration (WBV) on bone strength and fall frequency in older adults is still vague. Although there is some evidence that WBV may impact Bone Mineral Density in very frail elderly, there is a lack of data concerning the effect of WBV in community-living elderly woman. We hypothesize that WBV significantly affects bone parameters as assessed by DXA, QCT, US and bone markers with parallel positive changes of fall related risk factors (power, strength, balance, and reaction time). We further hypothesize that the effects of WBV were superior to conventional resistance exercise.

Official Title
-----------------
Effect of Whole Body Vibration on Bone and Fall Related Parameters - the Erlangen Longitudinal Vibration Study (ELVIS)

Conditions
-----------------
Atrophy

Intervention / Treatment
-----------------
* Behavioral: whole body vibration
* Behavioral: resistance exercise
* Behavioral: wellness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: community living elderly females >/=65 years live expectation > 2 years Exclusion Criteria: secondary osteoporosis CVD-events including stroke participation in other studies medication and illness affecting bone metabolism within the last 2 years medication with impact on falls low physical performance (<50 Watt during ergometry) excessive alcohol-intake

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: whole body vibration|nan|
|Behavioral: resistance exercise|nan|
|Behavioral: wellness|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD after 6, 12 and 18 months |  |  | 
| strength |  |  | 
| power |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| balance |  |  | 
| bone markers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
whole body vibration, exercise, elderly woman, Bone Mineral Density, falls, higher age
Efficacy Study of IL-21 to Treat Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.

Official Title
-----------------
An Open-label, Dose Escalation Safety and Tolerability Study of Recombinant Human Interleukin-21 (Phase 1) Followed by an Open-label Treatment Study (Phase 2a) in Patients With Stage IV Malignant Melanoma

Conditions
-----------------
Cancer, Malignant Melanoma

Intervention / Treatment
-----------------
* Drug: recombinant interleukin-21


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed surgically incurable metastatic melanoma Patients must have measurable disease ECOG performance status of 0 or 1 Expected life expectancy at least 4 months Exclusion Criteria: History of and signs/symptoms of uncontrolled brain metastases or edema. Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.) Radiotherapy: Radiation therapy within 4 weeks prior to entering the study. Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: recombinant interleukin-21|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor size assessed according to international criteria |  | After 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of antibodies against recombinant human IL-21. |  |  | 
| Markers of immunomodulation in blood. |  |  | 
| Safety evaluation. |  |  | 
| Time to progression. |  |  |
Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

Study Overview
=================
Brief Summary
-----------------
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients

Detailed Description
-----------------
in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients. patients will be divided into 2 group: group1, will be operated by the bariatric surgery and cholecystectomy in the same session. group 2 will be operated by cholecystectomy at least 6 months after bariatric surgery or whenever develop complications

Official Title
-----------------
Concomitant Cholecystectomy With Bariatric Surgery Versus Delayed Post Bariatric Cholecystectomy for Obesity With Gallstone

Conditions
-----------------
Morbid Obesity, Gallstone

Intervention / Treatment
-----------------
* Procedure: concomitant cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 35 presence of gallstone fit for laparoscopic surgery Exclusion Criteria: BMI < 35 unfit for surgery refuse to share in the study

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: concomitant cholecystectomy<br>concomitant cholecystectomy with bariatric procedure | Procedure: concomitant cholecystectomy<br>* delayed cholecystectomy<br>* Other names: delayed cholecystectomy;|
| Active Comparator: delayed cholecystectomy<br>delayed cholecystectomy | Procedure: concomitant cholecystectomy<br>* delayed cholecystectomy<br>* Other names: delayed cholecystectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of complications | the incidence of complications of cholecystectomy or of left of gallstone | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time of cholecystectomy | operative time of cholecystectomy | 30-90 minutes | 
| %EWL | percentage of excess weight loss | one year |
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.

Official Title
-----------------
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Intervention / Treatment
-----------------
* Drug: eptacog alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery Exclusion Criteria: Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eptacog alpha users<br> | Drug: eptacog alfa (activated)<br>* Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed |  | Year 1 | 
| Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed |  | Year 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AEs), including serious adverse events (SAEs) |  | Year 1, Year 10 |
Sarcopenia Studies for the Elderly Population in Taiwan

Study Overview
=================
Brief Summary
-----------------
Health promotion in the elderly has been a major recent public health concern. Sarcopenia is a term utilized to define the loss of muscle mass and strength that occurs with aging. It has been demonstrated to be associated with decreased functional capacity among the elderly. The magnitude of the public health problem posed by sarcopenia is not yet established. The purposes of this study are to investigate sarcopenia and its relationship with functional status in elderly Taiwanese community-dwellers, and to develop the preventive strategy for sarcopenia in the elderly. Firstly, the investigators will recruit 100 volunteers (aged 18-90 years old) to participate in this study. All of the participants will receive bioelectric impedance analysis (BIA), muscle strength and endurance assessment, physical activity level assessment by a seven-day recall questionnaire, protein intake assessment, cognition evaluation (Mini-Mental State Examination) and functional status assessment by the Functional Independence Measurement (FIM) questionnaire. A multiple regression model will be used for statistical analyses. Then, this project will be used to evaluate the efficacy of a 12-week supervised resistance strengthening exercise program for sarcopenia in the elderly. Participants who are defined as having sarcopenia from the previous examination will be randomized into either the exercise or control groups. Subjects in the exercise group will receive resistance strengthening exercises 3 times per week for 12 weeks. All measurements will be performed as described above. The investigators expect that resistance exercises are effective in offsetting age-related decline of muscle mass and strength in the elderly.

Official Title
-----------------
Sarcopenia Studies for the Elderly Population in Taiwan

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-90 year old healthy adults Exclusion Criteria: No systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
-----------------
Sarcopenia, exercise
Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be evaluated via a number of demographic lenses in order to find trends that could benefit future Congestive Heart Failure sufferers.

Official Title
-----------------
An In Depth Study Investigating Patterns of Patients In Congestive Heart Failure Clinical Trials

Conditions
-----------------
Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lives in the United States Is 18+ years old Participant has a diagnosis of congestive heart failure Participant has enrolled in an interventional clinical for congestive heart failure (self-reported) Exclusion Criteria: Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form No diagnosis of congestive heart failure confirmed

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 |
| --- | --- | --- |
| Number of patient decides to enroll in a congestive heart failure clinical trial |  | 3 months | 
| Rate of patients who remain in a congestive heart failure clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
congestive heart failure, heart failure