linjc16/ctgov huggingface dataset:
CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.

Official Title
-----------------
A Multicentre Open-label Dose Escalation Tiral of Zanolimumab in Combination With CHOP Chemotherapy in Patients With CD4 Positive Non-cutaneous Peripheral T-cell Lymphoma With Nodal Involvement.

Conditions
-----------------
T-cell Lymphoma

Intervention / Treatment
-----------------
* Biological: CHOP + CD4
* Drug: CHOP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: study is closed to enrollment Exclusion Criteria: study is closed to enrollment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CHOP chemo therapy + CD4 therapy | Biological: CHOP + CD4<br> <br> |
| Active Comparator: 2<br>CHOP chemotherapy | Drug: CHOP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Unavailable | All efforts to obtain data have been exhausted, therefore we have no data available to report. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non cutaneous peripheral t-cell lymphoma with nodal involvement
Adapting the HOPE Social Media Intervention to Reduce Prescription Drug Abuse

Study Overview
=================
Brief Summary
-----------------
The Harnessing Online Peer Education (HOPE) intervention combines social media with a psychology-based interventions to change behavior. This intervention is being applied to reduce prescription drug abuse among patients with chronic pain.

Conditions
-----------------
Non-Cancer Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Harnessing Online Peer Education (HOPE) Social Media Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (a) UCLA health system patient, (b) ≥ 18 years of age, (c) on chronic opioid therapy (> 3 and < 12 months) for chronic non-cancer pain as reported by their physician who referred them. Exclusion Criteria: ° Does not satisfy inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>behavioral intervention | Behavioral: Harnessing Online Peer Education (HOPE) Social Media Intervention<br> <br> |
| No Intervention: control<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Current Opioid Misuse Measure (COMM) Score |  | 3 months |
Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

Official Title
-----------------
Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy

Conditions
-----------------
Milk Hypersensitivity, Food Sensitivity, Protein Allergy

Intervention / Treatment
-----------------
* Dietary Supplement: extensively hydrolyzed rice protein formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants between 2 weeks and 6 months old In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month Exclusion Criteria: Exclusively breast fed infants Preterm infants Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms. Infants fed an amino acid based formula Infants who had an anaphylactic reaction in the past

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study formula<br> | Dietary Supplement: extensively hydrolyzed rice protein formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score |  | at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score |  | at 3 months | 
| Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score |  | at 6 months | 
| Growth (weight, height, head circumference) |  | 1 month | 
| Growth (weight, height, head circumference) |  | 3 months | 
| Growth (weight, height, head circumference) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cow's Milk protein Allergy
Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus

Study Overview
=================
Brief Summary
-----------------
Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011

Official Title
-----------------
Recurrence, Complications, Work-off Date, Healing Time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus Versus Excision With Healing by Secondary Intention (EHSI)Technique

Conditions
-----------------
Pilonidal Sinus, Pilonidal Cyst

Intervention / Treatment
-----------------
* Procedure: karydakis flap
* Procedure: laying open


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all types of pilonidal sinus or cyst Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 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: 1<br>Excision of the cyst and Karydakis flap | Procedure: karydakis flap<br>* Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft<br>* Other names: primary repair;|
| Experimental: 2<br>Excision of the cyst and laying open | Procedure: karydakis flap<br>* Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft<br>* Other names: primary repair;Procedure: laying open<br>* laying open the site of excision of sinus or cyst without any flap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence |  | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work off date, Healing Time |  | up to 1 Year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pilonidal sinus, karydakis, laying open
Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type

Study Overview
=================
Brief Summary
-----------------
The progressive myoclonus epilepsy of the Unverricht-Lundborg disease (ULD) type is an autosomal recessive disease characterized by progressive stimulus-sensitive and action-related myoclonic jerks. The mainstay of the current treatment in myoclonic epilepsies including ULD are valproic acid and clonazepam among several other antiepileptic drugs. Unfortunately the disease may often be resistant to antiepileptic drugs leading to major reductions in daily activities and disability to walk without assistance. Therefore new treatment modalities are needed. Experimental treatments of ULD patients with dopamine agonists have relieved myoclonic symptoms. Further, in accordance with this, a recent study indicates decreased dopaminergic neurotransmission in the basal ganglia of ULD patients, determined by PET. The purpose of this study is to investigate the effect of dopaminergic medication (ropinirole hydrochloride, Requip ®) on relieving the symptoms of ULD patients. Patients will undergo sixteen weeks intervention period. The main efficacy determinants are changes in unified myoclonus rating scale (UMRS), nerve conduction, multi-modality evoked potentials including visual evoked potential (VEP), somatosensory evoked potential (SSEP) and brainstem auditory evoked potential (BAEP), blink reflex habituation and electroencephalography (EEG). Tolerability and the safety of the medication are determined. The study setting is placebo controlled, crossover, two-group and double blind study.

Official Title
-----------------
Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type

Conditions
-----------------
Unverricht-Lundborg Syndrome

Intervention / Treatment
-----------------
* Drug: Ropinirole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unverricht-Lundborg Syndrome Exclusion Criteria: Pregnancy Intolerability to ropinirole hydrochloride Mental illness

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ropinirole|8 + 8 weeks cross-over placebo controlled|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified myoclonus rating scale |  | 3 |
Validation of a Psychological Fragility Questionnary in the Elderly in Isolation

Study Overview
=================
Brief Summary
-----------------
Social isolation and loneliness of the elderly have become major public health problems, because of the deleterious consequences if not lethal they can generate. Because of frequent resignation to these phenomena, support must be given to all means of prevention to prevent or at least mitigate their impacts. It appears from the literature that are isolated or living as they have adjustment difficulties which are linked to fragility. If geriatric frailty have been defined to date in somatic and cognitive criteria, psychological fragility criteria have been little discussed outside of psychiatric disorders (depression, anxiety disorders in particular). This study aims to test in the elderly in isolation psychological fragility questionnaire and to study the statistical qualities and relations with socio-demographic variables, environmental and other known vulnerabilities.

Conditions
-----------------
Loneliness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People over 65 Living alone at home (rural and urban ) or institution ( nursing home , no family member or spouse in the same institution). No not refusing to participate in the survey Exclusion Criteria: Overt or decompensated psychiatric pathology: major depressive disorder , bipolar disorder, psychotic disorder, severe personality disorder , primary addiction ( ICD-10 criteria) Alzheimer's disease or related illness probable or confirmed (ICD criteria 10) Sequel to severe neurological disease , unstabilized somatic pathology and / or may disrupt data collection Patients do not have the capacity to understand the objectives of the survey

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Psychological scales used to evaluate the elements of fragility in the elderly in isolation |  | 2 years |
Lactic Acid in the Rectum and Life-Threatening Infection

Study Overview
=================
Brief Summary
-----------------
Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of lactic acid. The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ failure or death.

Official Title
-----------------
Does the Concentration of L-Lactate in the Rectum Correlate With Mortality and Morbidity in Patients With Septic Shock?

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Procedure: Measurement of rectal lactic acid.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluid resuscitated septic shock < 24 h. Exclusion Criteria: Septic shock > 24 h. Pathology in the rectum. Bleeding per rectum. Limitation of therapy. Where informed consent from relatives cannot be obtained.

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

| Intervention/Treatment |
| --- |
|Procedure: Measurement of rectal lactic acid.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Correlation Salivary Cortisol and Free Serum Cortisol to Total Serum Cortisol in MICU Septic Shock

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is: to correlate salivary cortisol to free serum cortisol (as salivary cortisol is considered to be almost complete free cortisol) and, to correlate free serum cortisol to total serum cortisol levels Both in patients with septic shock (severe sepsis requiring vasopressors). We believe that: total serum cortisol does not correlate with free serum cortisol in patient with septic shock and, that salivary cortisol correlates with free serum cortisol and can be used to determine the level of free serum cortisol.

Detailed Description
-----------------
Free serum cortisol is considered the active hormone. In patients with septic shock only the total serum cortisol level is available, however, the free cortisol level can be normal despite a low total cortisol level due to changes in the serum protein. The hormone can be replaced improperly in these patients and contribute to poor outcome in septic shock. We are studying adult MICU patients with septic shock who are not receiving corticosteroid replacement. This study does not include any intervention. In-hospital or 28-day mortality are registered in all the patients.

Official Title
-----------------
Correlation Between Salivary Cortisol and Free Serum Cortisol Compared to Total Serum Cortisol in MICU Patients With Septic Shock

Conditions
-----------------
Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with septic shock Exclusion Criteria: Corticosteroid replacement Blood in mouth

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 |
| --- | --- | --- |
| Salivary cortisol | salivary cortisol in mg/dL | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cortisol
Pain Control in Bariatric Patients: EXPAREL(R) vs. the On-Q(R) Pain Ball

Study Overview
=================
Brief Summary
-----------------
This study was conducted to compare the effectiveness of two local pain control methods in bariatric patients by assessing the amount of postoperative pain and amount of postoperative pain medications needed. This information was used to determine which local anesthetic provided the best pain control.

Detailed Description
-----------------
The investigators have previously utilized the On-Q® pain ball to obtain local control by continuous delivery of bupivacaine to pain fibers at the incision site. On-Q makes use of an implanted catheter and a continuous infusion pump that the patient carries with them typically for 48-72 hours after surgery. EXPAREL is a long-acting liposomal delivery vehicle that extends the life of bupivacaine in the surgical site for up to 72 hours. It can be injected in all trocar sites and offers another potential solution to patient pain control without the need for a catheter and the hardware needed to deliver the local anesthetic. Patient NRS (numerical rating scale) scores for postoperative pain and total medication consumed were used to assess the differences between the two treatment groups.

Official Title
-----------------
Pain Control in Bariatric Patients: A Prospective Trial Comparing the Effectiveness of EXPAREL(R) Versus the On-Q(R) Pain Ball

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: EXPAREL
* Drug: On-Q Pain Ball


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80, male or female Exclusion Criteria: Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EXPAREL<br>EXPAREL (bupivacaine liposome injectable suspension) | Drug: EXPAREL<br> <br> * Other names: bupivacaine liposome injectable suspension;|
| Active Comparator: On-Q Pain Ball<br>Device for delivering bupivacaine. | Drug: On-Q Pain Ball<br>* bupivacaine HCl 0.25%<br>* Other names: bupivacaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS) pain intensity scores | The NRS was from 0 = no pain and 10 = worst pain. | 4-6 hours postoperatively and in the mornings of postoperative Day 1 and Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, postoperative pain
A Study of Single Dose RO6811135 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers. Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135 or placebo subcutaneously.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Healthy Subjects.

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO6811135
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female volunteers, 18 to 45 years of age inclusive Body mass index (BMI) 22-32 kg/m2 inclusive Females of child-bearing potential and males with female partners of child-bearing potential must agree to use adequate contraception as defined by protocol Exclusion Criteria: History or presence of any clinically relevant disease or disorder History of drug hypersensitivity or food allergies Significant infection or known inflammatory process at screening or Day -1 Any history of alcohol and/or drug of abuse addiction Alcohol consumption of more than 14 units (1 unit = 10 mL of pure alcohol) per week Smoking more than 5 cigarettes a day or equivalent amount of tobacco Positive for hepatitis B, hepatitis C or HIV infection Participation in an investigational drug or device study within 3 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* single doses sc<br>|
| Experimental: RO6811135<br> | Drug: RO6811135<br>* single ascending doses sc<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve |  | Pre-dose and up to 96 hours post-dose | 
| Pharmacodynamics (blood analysis) of RO6811135 |  | 96 hours |