linjc16/ctgov huggingface dataset:
Spinal Manipulative Therapy for Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Context: Acute low back pain (LBP) is a common reason for consultations in primary care. Reducing the pain in the first hours and days and restoring the functional capacity of the lumbar spine may result in a decrease in medical costs and earlier return to work. Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute low back pain.

Detailed Description
-----------------
Design: Randomised controlled parallel-group trial comparing standard care plus spinal manipulative therapy with standard care alone. Intention-to-treat analysis. Patients: Outpatients with acute low back pain. Setting: Emergency Department of Bern University Hospital and a primary care practice network.

Official Title
-----------------
Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Procedure: manipulative therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 20 and 55 years Duration of acute low back pain less than 4 weeks Informed consent Exclusion criteria: Pregnancy Radicular origin of back pain (with irradiation) Cauda equine syndrome Neurologic deficit Epidural glucocorticoid injections in the preceding three months Previous low back surgery Severe osteoporosis Blood-coagulation disorder Allergy to planned rescue medications Suspicion of a specific cause of low back pain (fracture, tumor, infection, inflammatory disease of the spine, HIV-infection) in the patient's history or by physical examination History or signs of severe dysfunction of the liver or kidney

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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 |
| --- |
|Procedure: manipulative therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back pain overall measured by a numeric rating scale(range 0 to 10) |  |  | 
| Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Score |  |  | 
| Serious adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain, Spinal manipulative therapy, Randomised controlled trial
ALY688-SR in Generally Healthy Overweight or Obese Adults

Study Overview
=================
Brief Summary
-----------------
First in human study of ALY688-SR administered as a subcutaneous injection

Detailed Description
-----------------
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.

Official Title
-----------------
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Drug: ALY688-SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg, Exclusion Criteria: Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Single dose escalation study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ALY688-SR<br>single dose subcutaneous injection | Drug: ALY688-SR<br>* single dose subcutaneous injection<br>|
| Placebo Comparator: Matching placebo for ALY688-SR<br>single dose subcutaneous injection | Drug: ALY688-SR<br>* single dose subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between pre- and post-intervention safety and tolerability assessments | Incidence of Treatment-Emergent Adverse Events as assessed by lab evaluations, ECG, vital signs and physical examinations | baseline, pre-intervention through study completion at 16 days |
Immediate Bonding and Caesarean Section

Study Overview
=================
Brief Summary
-----------------
The randomised study analyzes the effects of immediate bonding (skin-to-skin contact) on different psychobiological and somatic outcomes of mother and child. The investigators compare 3 bonding conditions. Cortisol and Oxytocin are also measured during the bonding process.

Official Title
-----------------
Effects of Immediate Bonding (Skin-to-skin Contact) During Caesarean Section- Psychobiological and Somatic Outcomes of Mother and Child

Conditions
-----------------
C-Section

Intervention / Treatment
-----------------
* Other: Skin-to-skin contact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers with elective Caesarean Section and their partners Exclusion Criteria: premature birth severe diseases drug abuse

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate mother-skin-to-skin contact(SSC)<br>The immediate mother-SSC begins directly after birth (still during the C-section) | Other: Skin-to-skin contact<br> <br> |
| Active Comparator: immediate father-SSC<br>The immediate father-SSC begins directly after birth (still during C-section) | Other: Skin-to-skin contact<br> <br> |
| Other: Routine care;mother-SSC after 30 minutes<br>After birth (still during C-section) the newborn gets routine care of a midwife close to the mother. SSC with mother after 30 minutes | Other: Skin-to-skin contact<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cortisol Level | Cortisol is assessed as a stress parameter by Saliva. It will be tested in the mother and child to measure the effect of immediate bonding with the mother compared to the other 2 conditions on the stress level | 30 and 60 minutes after bonding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | assessed by EPDS | 1-3 days and 6 weeks after childbirth | 
| Mother-child-bonding | assessed by PBQ | 1-3 days and 6 weeks after childbirth | 
| Child's heart ratio |  | 30 and 60 minutes after birth | 
| Child's oxygen saturation |  | 30 and 60 minutes after birth | 
| Child's temperature |  | 30 and 60 minutes after birth | 
| Oxytocin | Saliva measurement | 30 and 60 minutes after birth |
Study on the Effect of Surgical Intestinal Manipulation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes.

Official Title
-----------------
CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation

Conditions
-----------------
Intestinal Manipulation

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are brain death patients who undergo an elective abdominal aortic aneurysm repair Exclusion Criteria: < 18 years of age

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: brain death organ donors<br>cases - blood sampling | Other: blood sampling<br>* cases - blood sampling controles - blood sampling<br>|
| Other: abdominal aortic aneurysm repair<br>controls - blood sampling | Other: blood sampling<br>* cases - blood sampling controles - blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subtypes of monocytes | evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection | 1 day | 
| evaluate effect of intestinal manipulation | evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain-death organ donors, intestinal manipulation, monocytes
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ABT-384 in elderly subjects.

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

Intervention / Treatment
-----------------
* Drug: ABT-384
* Drug: Matching placebo to ABT-384


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age is 65 years or greater Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: Use of protocol-prohibited medications within 2 weeks prior to study drug administration. Positive urine drug screen for non-prescribed drugs of abuse including alcohol. Receipt of any drug depot by injection within 30 days prior to study drug administration. Receipt of any investigational product within 6 weeks prior to study drug administration. History of significant sensitivity or allergy to any drug. History of drug or alcohol abuse within 2 years. Positive test result for HBV, HCV or HIV. Estimated creatinine clearance < 30 mL/min. Donation or loss of 5 mL/kg or more blood volume or receipt of any blood product within 8 weeks prior to study drug administration. Current enrollment in another clinical study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose ABT-384<br> | Drug: ABT-384<br>* 3 escalating doses will be administered daily for 21 days<br>|
| Experimental: Mid dose ABT-384<br> | Drug: ABT-384<br>* 3 escalating doses will be administered daily for 21 days<br>|
| Experimental: High dose ABT-384<br> | Drug: ABT-384<br>* 3 escalating doses will be administered daily for 21 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Matching placebo to ABT-384<br>* Doses will be administered daily for 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) |  | Days -2 through 84 | 
| Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect) |  | Days -1 through 27 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacology, Drug Safety, Phase 1 Clinical Trials, Pharmacokinetics
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM). The second purpose is according to the international clinical guideline and the specialty of TCM to build a standard clinical trial regulation for traditional Chinese medicine.

Official Title
-----------------
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis

Conditions
-----------------
Posthepatitic Cirrhosis

Intervention / Treatment
-----------------
* Drug: Fuzheng Huayu Tablets
* Drug: sham Fuzheng Huayu Tablets (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of B Post hepatitic cirrhosis. Male or female patients between 18 65 years old. Written informed consent. Exclusion Criteria: Child-Pugh C above 12, or ALT > 2×ULN, TBiL > 2×ULN, or combined with hepatic encephacopathy, Obstinate ascites, bleeding tendency, hepato-renal syndrome, or primary liver cancer. Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease. Deformed man by the law. Pregnancy or breast feeding women, or unwilling to have contraception. Irritability body constitution, or irritability of the Fuzheng Huayu Capsules. Enter other trials lately one month. Other cause of cirrhosis.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fuzheng Huayu Tablets | Drug: Fuzheng Huayu Tablets<br>* Tablet,three times a day,four tablets one time<br>|
| Sham Comparator: 2<br>sham Fuzheng Huayu Tablets | Drug: sham Fuzheng Huayu Tablets (placebo)<br>* Tablet, three times a day, four tablets one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the value of Child-Pugh and symptoms scale for Posthepatitic Cirrhosis |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hepatic function; blood test; blood ammonia and blood sugar determination |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fuzheng Huayu Tablets, Multicenter clinical study
Functional Recovery After Partial Hip Arthroplasty: Anterior or Posterolateral Approach?

Study Overview
=================
Brief Summary
-----------------
Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation. The investigators hypothesis was Hueter anterior approach allows quicker functional recovery after partial hip replacement.

Official Title
-----------------
Approach Your Neck Fracture

Conditions
-----------------
Hip Arthroplasty, Femoral Neck Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Femoral Neck Fracture Partial Hip Arthroplasty Exclusion Criteria: Total Hip Arthroplasty Osteosynthesis Pathologic fracture

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 |
| --- | --- |
| Hueter Anterior Approach<br> | |
| posterolateral approach<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of mobility | Efficacity issue | Timed Get Up and Go Test at six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of mobility |  | Using 2 cruches or walker at 6 weeks after surgery | 
| Dislocation rate |  | At 6 weeks postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial Hip Arthroplasty
Effects of Forskolin on Intraocular Pressure in Glaucomatous Patients Under Treatment With Either Beta-blockers or Prostaglandins Eye Drops

Study Overview
=================
Brief Summary
-----------------
Elevated intraocular pressure is still the main risk factor for development and progression of glaucoma. Several drugs exist on the market that may decrease IOP in glaucomatous patients. However, some patients cannot reach the target pressure despite a multitherapy with a combination of drugs, and are therefore addressed to surgical treatments. Forskolin is a natural compound that is a receptor-independent adenyl-cyclase activator, that increases intracellular cAMP. It has been shown to be able to decrease IOP after topical application, by a mechanism that is not used by the other drugs. Aim of the present study is to see whether oral administration of a food supplement containing forskolin (KRONEK) has any effect on the IOP of POAG patients with stable IOP obtained by treatment with either beta-blockers or prostaglandins.

Official Title
-----------------
Effects of the Oral Administration of an Association of Forskolin With Rutin and Vitamins B on Intraocular Pressure in Patients Affected by Primary Open Angle Glaucoma and Treated With Either Beta-blockers or Prostaglandin Eye Drops

Conditions
-----------------
Primary Open Angle Glaucoma, Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Open Angle Glaucoma associated with ocular hypertension Target pressure achieved by single-agent therapy (beta-blockers or prostaglandins) Visual acuity > 6/10 Exclusion Criteria: Miopy or Hypermetropy > 5D Concomitant ocular pathologies Previous ocular surgery Known hypersensitivity to any of the components in the KRONEK tablets Concomitant participation in other trials Changes of topic glaucoma therapy during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| 2<br>POAG patients with IOP under control by prostaglandins eye drops treatment and assuming two tablets per day of the food supplement KRONEK | |
| 1<br>POAG patients compensated by the treatment of betablockers eye drops and taking two tablets per day of KRONEK | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | Enrollment, 1, 2, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure fluctuations during the day |  | Enrollment, 1, 2, 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POAG, IOP, Forskolin, beta-blockers, prostaglandins
Surgeon-Patient Communication: A Randomized Controlled Trial Evaluating the Impact of an Orthopaedic Related Smoking Cessation Discussion After Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.

Conditions
-----------------
Orthopaedic Decision Making

Intervention / Treatment
-----------------
* Behavioral: Intervention
* Behavioral: Verbal Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 year old or older, daily smoker inpatient post fracture operation, patient that have never received an orthopaedic related smoking cessation discussion Exclusion Criteria: Younger than 18, patients unable to provide consent patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (Intervention Group)<br>The discussion about how smoking cigarettes impacts patient orthopaedic management plus aid | Behavioral: Intervention<br>* Discussion<br>|
| Active Comparator: (Control Group)<br>The discussion about how smoking cigarettes impacts patient orthopaedic management. | Behavioral: Verbal Group<br>* Detailed Discussion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comprehension | Knowledge-Based Question | 20 minutes |