linjc16/ctgov huggingface dataset:
The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases

Study Overview
=================
Brief Summary
-----------------
Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases

Official Title
-----------------
The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases

Conditions
-----------------
Chronic Venous Diseases

Intervention / Treatment
-----------------
* Drug: Combined Oral Contraceptive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The investigators consistently include patients who have been prescribed hormonal tablets for contraception, namely 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7. Clinical class C0-1 according to CEAP; 2) Able to come for checkups every 3 months; 3) The presence of informed consent. Exclusion Criteria: Age up to 45 years; A history of surgical treatment of veins of the lower extremities; Clinical class C2 and higher according to CEAP; History of DVT or PE; Aplasia or angio-dysplasia of deep veins; Restriction of mobility; Arterial insufficiency; Oncological diseases.

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

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tableted hormonal drugs for contraception<br>Tableted hormonal drugs for contraception, 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7. | Drug: Combined Oral Contraceptive<br>* The investigators consistently include patients who have been prescribed hormonal tablets for contraception, namely 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development and progression of chronic venous diseases |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep venous thrombosis |  | 1 year |
Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-trial access (PTA) program is to provide guselkumab to participants with Familial Adenomatous Polyposis (FAP) who are experiencing clinical benefit after completing 48 weeks of treatment in Study CNTO1959COR1001.

Official Title
-----------------
Post-Trial Access for Guselkumab in Patients With Familial Adenomatous Polyposis Who Are Experiencing Clinical Benefit After Completing 48 Weeks of Treatment in CNTO1959COR1001

Conditions
-----------------
Adenomatous Polyposis Coli

Intervention / Treatment
-----------------
* Drug: Guselkumab


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Guselkumab|Guselkumab 100 milligrams (mg) will be administered subcutaneously once every 8 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Outcomes After Chiropractic Spinal Manipulative Therapy With Lumbar Disc Herniation and Radiculopathy

Study Overview
=================
Brief Summary
-----------------
In a study that was approved nine years ago (EK-22/2009) we could show (i) that spinal manipulative therapy (SMT) is a very effective and safe treatment for acute and chronic lumbar disc herniation (LDH); (ii) that SMT is as effective and less expensive than lumbar nerve root injections and (iii) that the recurrence rate up to one year was very low in acute and in chronic LDH patients. However, the long-term outcome of this conservatively treated LDH patients is unknown. Thus, the objective of this amendment is to investigate the proportion of long-term recurrences in these patients who were treated with SMT for their LDH and to compare these results with already existing data from other treatments, e.g. surgery. This is important information to know whether this conservative method is a sustainable approach for treating LDH.

Detailed Description
-----------------
All 148 patients with magnetic resonance imaging-confirmed disc herniation who were recruited for the study EK 22-2009 will be re-contacted to assess the course of their back problem during the past approx. nine years using a questionnaire.

Official Title
-----------------
Outcomes After Chiropractic Spinal Manipulative Therapy for Patients With Lumbar Disc Herniation and Radiculopathy

Conditions
-----------------
Lumbar Disc Herniation

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -The same patients who were recruited for the study EK-22/2009 Exclusion Criteria: The same as for study EK-22/2009: Patients with specific pathologies of the lumbar spine that are contraindications to chiropractic manipulative treatment, such as tumors, infections, inflammatory spondylarthropathies, acute fractures, Paget's disease and severe osteoporosis, will be excluded. Also excluded will be patients with previous spinal surgery, signs of cauda equina syndrome (CES), sequestration of disc material, body mass index >30, spondylolisthesis, neurogenic claudication and pregnancy.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LDH patients<br>Patients with lumbar disc herniation which was treated with manual therapy | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of low back pain | intensity of low back pain in the last month (numeric rating scale) | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long-term outcome
Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects

Study Overview
=================
Brief Summary
-----------------
Various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. However few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological markers are compared before and after each treatment.

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Dietary Supplement: probiotic
* Dietary Supplement: probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-40 years old history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter > 3mm) and a positive response to a NPT with grass pollen (combined nasal reaction threshold <= 10000 standardized quality units/ml at the screening phase Exclusion Criteria: any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis) uncontrolled asthma (peak expiratory flow <20% of volunteer's best personal value) treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L. paracasei<br>L. paracasei | Dietary Supplement: probiotic<br> <br> |
| Experimental: L. acidophilus + B. lactis<br>L. acidophilus + B. lactis | Dietary Supplement: probiotic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal reaction threshold when provocation test with allergens |  | 4 weeks |
Registration and Treatment of Pain During Eye Examination of Prematurity

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to see if paracetamol has a pain-relieving effect during eye examination in premature infants.

Detailed Description
-----------------
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented. This is a double blinded, controlled and randomized study where the infants are examined and assessed either with or without the use of paracetamol.

Official Title
-----------------
Registration and Treatment of Pain During Eye Examination of Prematurity

Conditions
-----------------
Infant, Premature, Retinopathy

Intervention / Treatment
-----------------
* Drug: paracetamol
* Drug: sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants < 32 weeks of gestational age (< 31+6 weeks) Exclusion Criteria: Infants with ongoing analgesic treatment

Ages Eligible for Study
-----------------
Minimum Age: 31 Weeks
Maximum Age: 37 Weeks

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paracetamol<br>Paracetamol mixture 20 mg/kg + pacifier and sucrose | Drug: paracetamol<br>* Paracetamol mixture 20 mg/kg + pacifier and glucose<br>|
| Placebo Comparator: placebo<br>pacifier and sucrose only | Drug: sucrose<br>* pacifier and sucrose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Premature Infant Pain Profile (PIPP): score range 0-21. Used independently by 2 experienced observers | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prematurity, retinopathy, pain, acetaminophen
A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

Study Overview
=================
Brief Summary
-----------------
This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

Official Title
-----------------
A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

Conditions
-----------------
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: SGN-35
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed CD30-positive hematologic malignancy. Patients with HL must have failed systemic chemotherapy. Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy. Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique. Exclusion Criteria: Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible). History of allogeneic stem cell transplant. Patients who have had previous treatment with any anti-CD30 antibody.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SGN-35 alone or in combination with gemcitabine | Drug: SGN-35<br>* IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles<br>* Other names: brentuximab vedotin;Drug: gemcitabine<br>* IV; 1000 mg/m2 weekly 3 out of 4 weeks<br>* Other names: Gemzar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and laboratory abnormalities |  | 1 month after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile |  | 2 months after last dose | 
| Immunogenicity (anti-SGN-35 antibodies) |  | 1 month after last dose | 
| Anti-tumor activity |  | 1 month after last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, monomethyl auristatin E, Combined Modality Therapy, Drug Therapy, Immunotherapy, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma
Next Generation Sequencing of Tumor Cells in Locally Advanced Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
All patients referring to the U.O .of Digestive Endoscopy of the Humanitas Hospital to undergo EUS with biopsy in the pre-treatment evaluation of locally advanced pancreatic adenocarcinoma, satisfying all the inclusion criteria and without any of the exclusion criteria, will be enrolled. Patients will then undergo endoscopic procedures (EUS with biopsy) provided by good clinical practice in consideration of the suspected diagnosis for which they come to Investigator's attention. Biopsy will be performed using a histology needle (22 G, Acquire, Boston Scientific, MA, United States). The obtained material will be processed in the Pathological Anatomy. A small part of this will be sent to the NGS analysis. At the time of preparation for the examination, the patients will be asked for blood collection (10 ml of blood) in order to evaluate any circulating tumor cells that will be identified by SmartBioSurface technique (Tethis S.p.A) and analyzed by appropriate molecular markers and NGS. The clinical evaluation of the patient will take place at 6 months from the date of the procedure, through telephone contact and / or outpatient visit.

Official Title
-----------------
Next Generation Sequencing di Cellule Tumorali Nell'Adenocarcinoma Pancreatico Localmente Avanzato

Conditions
-----------------
Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Biopsy EUS guided


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years, Signature of informed consent, Naïve patients with pancreatic adenocarcinoma (confirmed cito/ histologically), not subjected to previous treatments, Need to perform EUS with biopsy, Life expectancy over 6 months. Exclusion Criteria: Patients with non-primary pancreatic tumors, pancreatic neuroendocrine tumors or benign pancreatic masses Patients who have already undergone cancer treatment of any kind

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Biopsy EUS guided|NGS Sequencing on Biopsy samples|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isomatic genetic mutations will be evaluated in locally advanced naïve pancreatic adenocarcinoma in order to better understand the best way to treat patient. |  | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of samples obtained by biopsy - EUS guided with needles Acquire from 22G in providing the diagnosis, |  | 18 Months |
A Trial of Group Versus Individual Family Planning Counseling in Ghana

Study Overview
=================
Brief Summary
-----------------
This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana.

Official Title
-----------------
A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Behavioral: group family planning counseling
* Behavioral: Individual family planning counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older fertile desires to delay pregnancy for at least 12 months Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Counseling<br>Group family planning counseling | Behavioral: group family planning counseling<br>* group family planning counseling for gynecological patients with unmet need<br>|
| Active Comparator: Individual Counseling<br>Individual family planning counseling with gynecological patients who have unmet need | Behavioral: Individual family planning counseling<br>* Individual family planning counseling with gynecological patients - the current standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive Intention |  | Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modern contraceptive method knowledge |  | baseline and follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contraception, noninferiority, intention, family planning counseling, post abortion care, Family planning intention among women with unmet need
Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: PHX1149T
* Drug: PHX1149T
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy BMI 25 to 48 kg/m2, inclusive HbA1c 7.0% - 10.0%, inclusive Age 18 to 75 years, inclusive Exclusion Criteria: Currently on 3 or more oral antidiabetic drugs or insulin. Type 1 diabetes mellitus

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br>PHX1149T 200 mg | Drug: PHX1149T<br>* 200 mg<br>* Other names: dutogliptin;|
| Experimental: 3<br>PHX1149T 400 mg | Drug: PHX1149T<br>* 400 mg<br>* Other names: dutogliptin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate changes in HbA1c |  | Day 28 to Day 196 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dutogliptin, PHX1149, DPP4 inhibitor