linjc16/ctgov huggingface dataset:
Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

Study Overview
=================
Brief Summary
-----------------
The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.

Detailed Description
-----------------
vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.

Official Title
-----------------
Pilot Study of Intradermal Vaccination of Melanoma Patients With a Fixed Combination of mRNAs Compared to an Individualized Selection After Analysis of Antigen Expression in Tumor Tissue

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: mRNA coding for melanoma associated antigens
* Drug: GM-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: malignant melanoma stage III/IV fresh frozen tumor tissue available informed consent given Karnofsky >= 70% Exclusion Criteria: brain metastasis parallel chemotherapy systemic treatment with glucocorticoids other malignancies

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mRNA Vacc<br> | Biological: mRNA coding for melanoma associated antigens<br>* mRNA vaccine s.c. applied weekly<br>Drug: GM-CSF<br>* Given s.c. as adjuvant drug one day after vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated. | every 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccination, mRNA
Family Workshops for Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
This pilot study is looking at the effects of a brief psychoeducational workshop. These one day workshops are designed to increase family members knowledge about bipolar disorder and to help with processing emotions that go along with having a relative with bipolar disorder.

Official Title
-----------------
An Acceptance Based Psychoeducation Intervention to Reduce Expressed Emotion in Family Members of Bipolar Patients

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: integrative behavior couples therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-identified adult relatives of people diagnosed with bipolar disorder between ages 18 and 64; up to two persons per family can participate in the multifamily group Exclusion Criteria: relative with bipolar disorder will not be involved in the workshop

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: integrative behavior couples therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge |  |  | 
| Anger |  |  | 
| Attributions |  |  | 
| Expressed Emotion |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relatives, Bipolar Disorder, Psychoeducation
Revision Meniscal Transplants; Lateral and Medial

Study Overview
=================
Brief Summary
-----------------
During the period 1989-1999, a number of patients underwent a meniscal transplantation. A few transplants were not successful. These patients form the population of this study. They all underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after the failure of the transplants The goal of this study is to evaluate their current medical condition, to perform a survival analysis, and to determine the clinical outcome. The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36)and clinical examination.

Official Title
-----------------
Revision Meniscal Transplants; Lateral and Medial

Conditions
-----------------
Revision of Meniscal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: failed Meniscal transplantation between 1989 and 1999

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 |
| --- | --- |
| failed meniscal transplantation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perform a survival analysis of meniscal transplants. Failure of transplant was defined as replacement of the allograft by a knee prothesis. | The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36) and clinical examination. | 20 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of the knee after TKP/UKP following a failed meniscal transplant. |  | 20 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meniscal transplant
Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis

Official Title
-----------------
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Biological: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen years or older Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control Females - negative pregnancy test at screening Confirmed diagnosis of active RA >= 6 swollen joints and >= 9 tender joints Met ACR criteria for diagnosis of RA for at least 3 months Active RA defined by a DAS >= 3.2 at study entry Exclusion Criteria: Subject had prior treatment with cyclophosphamide or chlorambucil Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin

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 |
| --- |
|Biological: adalimumab|40 mg adalimumab every other week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Registry of Pancreatic Disease

Study Overview
=================
Brief Summary
-----------------
This clinical data registry records information about the health status and healthcare performances received by participants affected by every type of pancreatic disease or disorder. All data (demographic, clinical, biochemical, radiological, pharmacological, genetic...) and audio and/or video recording from operative room are collected in order to be used for prospective or retrospective studies.

Official Title
-----------------
Registry of Subjects Affected by Pancreatic Disease and Evaluated at the Pancreas Institute of Verona

Conditions
-----------------
Pancreatic Diseases, Pancreatic Neoplasms, Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any type of pancreatic disease: inflammatory and neoplastic (including solid and cystic lesions) Exclusion Criteria: physically or mentally inability to provide consent

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 |
| --- | --- |
| Patient with pancreatic disease<br>Patients diagnosed with pancreatic disease evaluated at this institution. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Survival from Diagnosis to time of death | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | Occurrence of Pancreatic Fistula, Biliary fistula, Enteric fistula, Delayed Gastric Emptying, Hemorrhage or Sepsis. | 90 days |
Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.

Detailed Description
-----------------
Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. Many studies have shown that the drug contributes to the expansion of regulatory T cells and preserves the highly suppressive function of autoreactive T cells. Patients with RITP often display a decreased proportion of regulatory T cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP patients.

Official Title
-----------------
Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia

Conditions
-----------------
Immune Thrombocytopenic Purpura

Intervention / Treatment
-----------------
* Drug: rapamycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnoses of idiopathic thrombocytopenic purpura Hormone and immune suppression, splenectomy is invalid Exclusion Criteria: patients had a bad tolerance to rapamycin platelet counts < 10*10E9/L during the treatment of rapamycin
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rapamycin|4mg oral administration on the first day, 2 mg/d oral administration for 3 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory Immune Thrombocytopenic Purpura, rapamycin, regulatory T cells
The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements

Study Overview
=================
Brief Summary
-----------------
The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.

Conditions
-----------------
Chronic Vegetative State

Intervention / Treatment
-----------------
* Dietary Supplement: RPh201
* Dietary Supplement: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic vegetative patients Exclusion Criteria: Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RPh201 group<br>Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months | Dietary Supplement: RPh201<br>* Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months<br>|
| Placebo Comparator: placebo group<br>Patients will receive 400 microliter s.c., of saline twice a week for 3 months | Dietary Supplement: saline<br>* Patients will receive 400 microliter s.c., of saline twice a week for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the awareness status of the patients. | Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation. | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the awareness status of the patients. | clinical and fMRI assessment will be performed 1 month following treatment cessation | 1 month following the end of the trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic vegetative state, RPh201, functional MRI
Pharmacist's Influence on Breast Cancer Patient Quality of Life

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the impact of pharmacist behavioral intervention's influence on breast cancer patients' quality of life. Croatian randomized controlled trial. Targeted population: general population of breast cancer patients under the first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23 questionnaire result from the baseline to after 3 week cycle.

Official Title
-----------------
Influence of a Clinical Pharmacist's Intervention on Quality of Life of a Breast Cancer Patient Under Adjuvant Chemotherapy

Conditions
-----------------
Breast Cancer, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Pharmacist's behavioral intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early breast cancer First adjuvant chemotherapy Chemotherapy protocol: anthracycline x 4 Exclusion Criteria: Cardiovascular comorbidities Regular nausea or vomiting during six months before enrollment Unable to answer the quality of life questionnaire on their own
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Under pharmacist's behavioral intervention | Behavioral: Pharmacist's behavioral intervention<br>* Pharmacist's 30 min counselling on antiemetic therapy, causes of nausea or vomiting and ways to prevent them during chemotherapy.<br>|
| No Intervention: Control<br>No pharmacist's behavioral intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in quality of life of a breast cancer patient under chemotherapy, after a clinical pharmacist's behavioral intervention, measured by EORTC B23 questionnaire |  | up to two months |
Plethysmographic Waveform for Monitoring the Quality of Cardiopulmonary Resuscitation

Study Overview
=================
Brief Summary
-----------------
Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early identification ROSC is very important. Now there is no an easy, non-invasive and real-time method to monitor the quality of CPR. In this study the investigators hypothesis the pulse oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR to the physicians.

Official Title
-----------------
The Application Research of Plethysmographic Waveform in Quality Control Feedback System During Cardiopulmonary Resuscitation

Conditions
-----------------
Cardiopulmonary Arrest, Cardiopulmonary Resuscitation, Return of Spontaneous Circulation, Pulse Oximeter Plethysmographic Waveform

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiopulmonary arrest, without do-not-resuscitation(DNR) patients After cardiac arrest, there is no more than 10 minutes until basic life support. must be carried out advanced life support (tracheal intubation and end-tidal carbon dioxide monitoring) comply with ethical requirements and signed informed consent Exclusion Criteria: DNR patients rib fractures hemorrhagic shock caused cardiac arrest severe anemia, hemoglobin less than 7g/dl tension pneumothorax without closed drainage pulmonary embolism or pericardial tamponade caused cardiac arrest onychomycosis people who paint fingernails clearly influential peripheral oximetry underlying diseases (such as Raynaud's phenomenon, vasculitis) The study physicians believe there is any case is not suitable for inclusion.

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 |
| --- | --- | --- |
| survival rate |  | 4 weeks |
Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Detailed Description
-----------------
Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.

Official Title
-----------------
Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

Conditions
-----------------
Premature Birth of Newborn

Intervention / Treatment
-----------------
* Other: Post discharge formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed). Gestational week 30-34. Exclusion Criteria: Congenital major malformation (e.g. congenital heart disease). Chromosomal abnormality (e.g. Down's syndrome) Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC Milk allergy Chronic disease (e.g. oxygen treatment)

Ages Eligible for Study
-----------------
Minimum Age: 30 Weeks
Maximum Age: 34 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post Discharge Formula<br>Babies will be given formula for first three months post discharge | Other: Post discharge formula<br>* Babies will be given either materna sensitive or similac neosure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth | weight (kg), length (cm), head circumference (cm). | 3 months post discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature neonate, Post-discharge, Formula