linjc16/ctgov huggingface dataset:
Opiate Sleep Disordered Breathing Study

Study Overview
=================
Brief Summary
-----------------
Lay title: A study of breathing pauses during sleep in patients on long term opiates. Sleep apnoea is a term which refers to frequent breathing pauses during sleep. Breathing can stop at night due to the upper airway collapsing (Obstructive sleep apnoea)or reduced signals from the brain driving breathing (central sleep apnoea). Clinical observation has noticed that patients on opiates have an increase in sleep apnoea. Hypothesis: This study looks at the relationship of opiates (when used for patients chronic pain) and the occurrence of sleep apnoea. It is expected that there will be an increase in sleep apnoea (particularly of the central variant) particularly in patients on long term opiates.

Detailed Description
-----------------
The purpose for this study is to test the hypothesis that sleep disordered breathing is more prevalent amongst a group of patients on high dose opiates for chronic pain. Aims To define the prevalence of sleep disordered breathing in a group of patients on oral morphine for chronic pain. To determine the prevalence of respiratory failure in this cohort of patients. Patients on long term opiates (>6 months) from an outpatient pain clinic population on long acting morphine formulations > 40 mg/day, Oxycontin 30 mg/day, and Methadone > 20 mg/day were prospectively recruited. Home polysomnograms were done on them. During their clinical review they have spirometry, arterial blood gases, psychomotor vigilance tests done on them.

Official Title
-----------------
Sleep Disordered Breathing in Patients With Chronic Pain and Long Term Opiate Therapy

Conditions
-----------------
Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on long acting Morphine >40mg/day, Oxycontin >30mg/day, and Methadone >20mg/day were contacted. Stable opiate dose for 2 weeks Lives within 80KM of FMC Exclusion Criteria: Significant CCF/CVA Severe COPD Major Psychiatric illness History of substance abuse in the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Prevalence of sleep disordered breathing in patients on long term opiates. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ventilatory failure in this cohort |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opiates, sleep apnea, ventilatory failure
GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose

Study Overview
=================
Brief Summary
-----------------
Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin hormones not only stimulate insulin release but also inhibits gastric emptying. This effect can be utilized for further drug development.

Detailed Description
-----------------
Effects of GIP and GLP-1 on gastric emptying, appetite control and insulin release in relation to glucose levels in the bloodstream. Infusions of GIP and GLP-1 are given under simultaneous gastric emptying study and appetite questionnaires and blood sampling for analysis of insulin, glucose, and other gut hormones such as glucagon, ghrelin, and PYY, as well as those administered, GIP and GLP-1.

Official Title
-----------------
Effects of GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose Homeostasis

Conditions
-----------------
Physiology, Gastroenterology, Endocrinology

Intervention / Treatment
-----------------
* Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18-50 years old; otherwise healthy and HIV and HCB, HCV negative Exclusion Criteria: Age >50, all types of diseases and drug users.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIP two doses and GLP-1 one dose<br>Intervention with infusion of GIP or GLP-1 intravenously | Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1<br>* GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min<br>* Other names: Saline;|
| Placebo Comparator: Saline infusion<br>Control | Other: Glucose-insulinotropic peptide, Glucagon-like peptide-1<br>* GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min<br>* Other names: Saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying rate |  | 2005-2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose, insulin release, appetite |  | 2005-2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incretin hormones, Glucose-insulinotropic peptide, Glucagon-like peptide-1, Gastric emptying, Appetite, Glucose disposal, Gut hormones
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL).

Detailed Description
-----------------
This is an open label, randomized phase II study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous T-cell lymphoma (CTCL) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Official Title
-----------------
A Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell Lymphoma

Conditions
-----------------
Cutaneous T-cell Lymphoma (CTCL)

Intervention / Treatment
-----------------
* Drug: Sapacitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with advanced CTCL Have had at least 2 systemic therapies Must have evaluable disease Eastern Cooperative Oncology Group performance status 0-2 Adequate bone marrow, hepatic and renal function At least 3 weeks from prior therapies Not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks Able to swallow capsules At least 3 weeks from major surgery Agree to practice effective contraception Able to understand and willing to sign the informed consent form Exclusion Criteria: Receiving systemic steroids Receiving topical or systemic retinoids or vitamin A Receiving radiotherapy, biological therapy,or any other investigational agents Uncontrolled intercurrent illness Pregnant or lactating women Known to be HIV-positive Active hepatitis B and/or hepatitis C infection

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: Arm A: High dose<br>High-dose (Arm A): 200 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest | Drug: Sapacitabine<br>* Sapacitabine<br>* Other names: CYC682;|
| Experimental: Arm B: High dose<br>Low-dose (Arm B): 100 mg b.i.d. x 3 consecutive days per week for 2 weeks followed by 1-week rest | Drug: Sapacitabine<br>* Sapacitabine<br>* Other names: CYC682;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate in overall skin disease | Decrease of lesion from baseline | over the course of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CTCL
Ancillary Study to Protocol 20060104

Study Overview
=================
Brief Summary
-----------------
Ancillary study to the Etanercept protocol 20060104. Subjects have been asked to provide additional blood samples for further assessment.

Official Title
-----------------
Protein Phosphorylation Ancillary Study to Amgen Protocol 20060104: Open Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed Consent Meet all inclusion critieria outlined in Amgen Protocol 20060104 Exclusion Criteria: Meet exclusion criteria outlined in Amgen Protocol 20060104

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 |
| --- | --- |
| blood draw<br>One time blood draw | Procedure: Blood draw<br>* blood draw at baseline, week 12 and week 24<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the correlation between pheripheral blood cell protein phosphorylation assessemnts and rheumatoid arthritis disease activity. |  | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the correlations to etanercept clinical response (ACR and DAS scores) may also be explored. |  | week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enbrel, Amgen, Rheumatoid Arthritis, etanercept
Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction

Study Overview
=================
Brief Summary
-----------------
This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.

Official Title
-----------------
Phase IV, Multicenter, Open Label, Randomized Trial to Compare the Effectiveness and Safety of the Dinoprostone Vaginal Pessary vs. Oxytocin for Women Requiring Cervical Ripening Prior to Induction of Labor

Conditions
-----------------
Vaginal Delivery, Cesarean Section

Intervention / Treatment
-----------------
* Drug: Dinoprostone
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Gestational age ≥ 38 weeks Fetal cephalic presentation Bishop score < 6 Exclusion Criteria: No uterine scar (no previous delivery by caesarean section) No more than 3 previous vaginal births No condition that disallows use of prostaglandins for induction of labor Premature rupture of the membranes Oligohydramnios

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

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

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: A<br> | Drug: Dinoprostone<br> <br> |
| Active Comparator: B<br> | Drug: Oxytocin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal birth delivery within 24 hours and C-section rate |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure rate |  | 24 hours | 
| Uterine hyperstimulation and/or fetal distress |  | 24 hours | 
| Use of additional oxytocin |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaginal Birth delivery within 24 hours and C-section rate
Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the levels of serum proteins and other biomarkers in cervical cancer patients. We believe that some of these markers may be useful in selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.

Detailed Description
-----------------
SPECIFIC STUDY AIMS Specific Aim 1: To use gene expression analysis of primary cervical cancers to identify a gene expression signature that predicts for lymph node metastases in this disease. Specific Aim 2: To predict lymph node metastases by performing multiplex measurements of cancer-associated proteins and cytokines using proximity ligation assay (PLA) on plasma samples. Specific Aim 3: To measure circulating human papilloma virus (HPV) DNA in the plasma samples of cervical cancer patients using real-time quantitative polymerase chain reaction (qPCR) and determine its ability to predict for nodal metastases. Specific Aim 4: To use deep sequencing to evaluate gene and sequence differences between cervical cancer patients with and without lymph node metastasis.

Official Title
-----------------
Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Other: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a known or suspected cervical cancer. Age >=18 years. Patients must have no other active cancer at the time of diagnosis. Patients must have no history of a hysterectomy. Patients must be able to give informed consent. Patients must be willing to undergo a biopsy of the cervical tumor to provide tissue for the study. Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of therapy, for assessment of lymph nodes. Exclusion Criteria: - Pregnant women

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 |
| --- | --- |
| Validation<br> | Other: Blood draw<br>* phlebotomy<br>|
| Testing<br> | Other: Blood draw<br>* phlebotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers (genes and proteins) of lymph node involvement |  | 4 years |
Covid Vaccination in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients. Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19. The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination. Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria. The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population. The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion. A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis. Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.

Official Title
-----------------
EVALUATION OF THE RESPONSE TO mRNA SARS-CoV-2 VACCINE IN A COHORT OF LIVER TRANSPLANTED OR LISTED PATIENTS

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Liver transplanted patients for > 6 months after transplantation Listed cirrhotic patients Age >18 years-old Consent for vaccination with mRNA vaccine Exclusion criteria: Vaccination with non mRNA anti-SARS-CoV-2 vaccine Expressed opposition to participation to the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective description of the serological response to the anti-SARS-CoV-2 mRNA vaccine |  | Files analysed retrospectively from January 18, 2020 to April 30, 2021 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-COV-2, Coronavirus Vaccine, COVID-19 Pandemic, COVID-19 Virus Disease, SARS-CoV-2 Infection, Solid organ transplant, mRNA vaccine, MODERNA, liver transplant, Serological testing, serological response, SARS-CoV-2 mRNA vaccine, Anti-SARS-CoV-2 IgG antibodies
Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
The current trial is intended to assess the efficacy of oral versus vaginal progesterone for luteal support in frozen IVF cycles.

Detailed Description
-----------------
Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF. Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone in frozen IVF cycles.

Official Title
-----------------
Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer: a Non-inferiority Randomized Clinical Trial

Conditions
-----------------
ART

Intervention / Treatment
-----------------
* Drug: Dydrogesterone 10 MG
* Drug: Endometrin 100Mg Vaginal Insert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-39 Modified natural cycle (induction of ovulation with HCG) Consent to participation Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral progesterone<br> | Drug: Dydrogesterone 10 MG<br>* Oral progesterone 10 mg TID<br>|
| Active Comparator: Vaginal progesterone<br> | Drug: Endometrin 100Mg Vaginal Insert<br>* Vaginal Endometrin 100 mg twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Birth of a live infant after 24 weeks gestation | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Viable pregnancy as demonstrated by ultrasound | Outcome assesed 6-7 weeks following treatment | 
| Implantation rate | Number of gestational sacs divided by number of embryos transferred (percentage) | Outcome assessed 6-7 weeks following treatment |
Outcome After Arthroscopic Surgery in Patients Treated With PAO

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate outcome after arthroscopy if the hip in patients previous treated with periacetabular osteotomy

Detailed Description
-----------------
It is well known the patients with developmental dysplasia of the hip beyond the bony malformation has intraarticular damage to labrum and chondral structures. In DK, if the patients has persistent pain in the hip joint after PAO, they have been offered a hip arthroscopy, however we do not if their hip functions and pain improved by the surgery The investigator aimed to make a short to middle-term followup study to see if the patients had benefits of the surgery.

Official Title
-----------------
Outcome After Arthroscopic Labrum Surgery in Patients Treated With Periacetabular Osteotomy

Conditions
-----------------
Developmental Dysplasia of the Hip

Intervention / Treatment
-----------------
* Procedure: hip arthroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous PAO and hip arthroscopy developmental dysplasia of the hip Exclusion Criteria: calve legg perthes disease femoral osteotomy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hip arthroscopy|Follow up after hip arthroscopy in pt with previous PAO. Follow up by questionnaires send til the cohort|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with the need of a total hip arthroplasty after PAO and hip arthroscopy | Questionnaire | 48 months after hip arthroscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the patients pain in rest and during activity on a NRS Scale | Questionnaire | 48 months after hip arthroscopy | 
| Evaluation of hip function and pain using MHHS (modified harris hip score) | Questionnaire | 48 months after hip arthroscopy | 
| Evaluation of hip function and pain using HOS (Hip outcome score) | Questionnaire | 48 months after hip arthroscopy |