linjc16/ctgov huggingface dataset:
Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile

Study Overview
=================
Brief Summary
-----------------
Recent progress in immunotherapy (IT) has shifted treatment paradigms for multiple malignancies including breast cancer. It has been shown that levels of certain cytokines were correlated with increased response to immunotherapy in patients with metastatic breast cancer. In this study investigators will perform cytokine profiling among patients diagnosed with metastatic triple-negative breast cancer at different time points during the treatment.

Detailed Description
-----------------
This is a prospective study that has two groups of patients as determined by their prescribed treatment plan. Group A (control group) are patients with metastatic triple-negative breast cancer (TNBC) who receive chemotherapy only (current standard of care). Group B (experimental group) are patients with mTNBC who receive a combination of chemotherapy and IT immunotherapy (Atezolizumab) which is a standard of care for patients whose tumor express >1% of PD-L1 molecules. T-cell cytokines will be measures prior to treatment and at multiple time points during the treatment.

Official Title
-----------------
Predicting Response of Metastatic Triple Negative Breast Cancer to Immunotherapy Based on Patients Cytokine Profile

Conditions
-----------------
Metastatic Triple-Negative Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of metastatic triple negative breast cancer 18 years of age or older Exclusion Criteria: Younger than 18 Unwilling to participate or unable to give informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Patients with mTNBC who receive chemotherapy only | |
| Experimental Group<br>patients with mTNBC who receive a combination of chemotherapy and Immunotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokine, breast cancer
Effects of Low FODMAP Diet on Leaky Gut

Study Overview
=================
Brief Summary
-----------------
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.

Official Title
-----------------
Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: FODMAP diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-65 years at the time of screening normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms IBS-SSS score of ≥175 at the end of 7-day screening period Exclusion criteria: individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months individuals with any known food allergy or insulin-dependent diabetes known history of celiac disease, inflammatory bowel disease or microscopic colitis prior small bowel or colonic surgery or cholecystectomy pregnant patients antibiotics in the past 3 months those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FODMAP diet<br> | Other: FODMAP diet<br>* low FODMAP diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonic permeability | Lactulose:Mannitol ratio pre and post treatment | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonic immune cells | expression of tight junction proteins pre and post treatment using RT-PCR | 4 weeks | 
| colonic microbiome | relative stool microbial abundance pre and post treatment measured using 16s RNA | 4 weeks |
Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life

Study Overview
=================
Brief Summary
-----------------
Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC) and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL.

Detailed Description
-----------------
Pulmonary hypertension (PH) impairs physical condition (PC), body composition (BC) and health-related quality of life (HRQOL). Specific pharmacological treatment and - in selected patients, refractory to agents - lung or combined heart and lung transplantation can improve physical functioning and long term survival. Initial trials with limited numbers of patients were encouraging. Investigation of larger cohorts is essential to assess the efficacy of rehabilitation programmes in PH. We hypothesize that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL in patients with PH in functional classes (FC) II and III. Critical ill patients with a functional class IV are excluded. All patients with PH undergo a 3-week inpatient rehabilitation program (interval bicycle and strength training, physiotherapy, psychological support, education). Exercise testing (peak work load (PWL) 6-min-walk distance), body composition (bioimpedance analysis BIA: lean body mass (LBM), body cell mass (BCM), BCM/LBM ratio, phase angle (PA)) and HRQOL (SF 36 questionnaire) are assessed at baseline and completion of PR.

Official Title
-----------------
Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Pulmonary Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life - an Observational Study

Conditions
-----------------
Pulmonary Hypertension: Efficacy of Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of pulmonary hypertension Functional class II-III Exclusion Criteria: Functional class I and IV Right heart decompensation

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | Exercise capacity (peak work load and 6-minute walk distance at completion of an 3-week inpatient pulmonary rehabilitation) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Body composition (bioimpedance analysis) | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary hypertension, Rehabilitation, Exercise capacity, Body composition, Health related Quality of Life
Drug Interaction Study of Warfarin and MT-3995

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin

Detailed Description
-----------------
The purpose of this study is to evaluate the potential effects of multiple once daily doses of MT-3995 on the PK of (S)-warfarin and (R)-warfarin after single-dose administration of racemic warfarin

Official Title
-----------------
A Phase I, Open-label, Single-Centre, Drug-Drug Interaction Study to Evaluate the Influence of MT-3995 on Pharmacokinetics(PK) and Pharmacodynamics of Warfarin in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Warfarin
* Drug: MT-3995


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide written informed consent to participate in this study Healthy, free from clinically significant illness or disease White Caucasian male or female, aged 18 to 55 years Body weight ranging from 50 (females) and 60 (males) to110 kg (inclusive) Must have coagulation test results (including international normalised ratio [INR] and activated partial thromboplastin time [aPTT]) within the laboratory reference range at Screening. Exclusion Criteria: Presence or history of serious adverse reaction or allergy to any medicinal product Known contraindication or adverse reaction to warfarin. Presence of Cytochrome P450 2C9 (CYP2C9) and Vitamin K epoxide reductase complex subunit 1 (VKORC1) genetic polymorphisms that are known to increase warfarin sensitivity at Screening. Known contraindications to heparin administration. Known contraindication to parenteral vitamin K administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warfarin and MT-3995<br>Subjects will be administered a single dose of warfarin on day1. Subjects will be administered MT-3995 Days 8 to 20. Subjects will be administered MT-3995 and warfarin on Day21. Subjects will be administered MT-3995 from Day 22 to 27. | Drug: Warfarin<br> <br> Drug: MT-3995<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of warfarin with MT-3995 versus warfarin alone |  | 8 days | 
| AUC of warfarin with MT-3995 versus warfarin alone |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone |  | 8 days | 
| INR AUC of warfarin with MT-3995 versus warfarin alone |  | 8 days |
Perioperative Thoracotomy Analgesia; Different Analgesic Modalities

Study Overview
=================
Brief Summary
-----------------
the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries

Detailed Description
-----------------
comparing the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries regarding pain control and possible side effects

Official Title
-----------------
Perioperative Thoracotomy Analgesia; Different Analgesic Modalities

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: serratus anterior block
* Procedure: thoracic epidural
* Procedure: erector spinae block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for thoracotomy age 18-65 Exclusion Criteria: patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: thoracic epidural<br>thoracic epidural will be done before induction of general anesthesia | Procedure: thoracic epidural<br>* thoracic epidural<br>|
| Experimental: serratus anterior block<br>ultrasound guided serratus anterior block will be done after induction of general anesthesia | Procedure: serratus anterior block<br>* ultrasound guided block<br>|
| Experimental: erector spinae block<br>ultrasound guided erector spinae block will be done after induction of general anesthesia | Procedure: erector spinae block<br>* ultrasound guided block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue score | minimum value 0 and maximum value 10 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure | measurement of mean arterial blood pressure | 24 hours |
Facilitation and Barriers to Breastfeeding in the NICU

Study Overview
=================
Brief Summary
-----------------
To date, there is a paucity of research focusing on maternal breastfeeding goals, how these goals may change after an unexpected event such as a preterm birth, and how mothers of ill and preterm infants define breastfeeding success. No studies were identified that focused exclusively on the breastfeeding goals of mothers of hospitalized preterm infants The purpose of this study is to answer the following research questions: 1) What are the breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers' perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?

Detailed Description
-----------------
As the objective of this study is to describe the breastfeeding goals of mothers and their perceptions of breastfeeding support in the NICU, this study will follow a descriptive, qualitative design. Mothers of preterm newborns in the Royal Victoria Hospital will participate in a semi-structured interview about their breastfeeding goals and what they perceived to be facilitators and barriers to achieving their intended goals. During the interviews, the mothers will be asked a set of socio-demographic questions, open-ended questions about their breastfeeding goals, and open-ended questions about their perceptions of barriers and facilitators to meeting these goals in the NICU Participants may also receive one follow-up phone call to clarify their responses to the questions or to validate the information obtained from the interview.

Conditions
-----------------
Breastfeeding, Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have one (or more) infant(s) currently admitted in the NICU at the RVH; intended to provide breast milk to their infant(s); are able to speak English; and are willing to be audiotaped during the interview. Exclusion Criteria: Include mothers who: never intended to breastfeed; have high risk social situations (for example, known maternal mental illness; involvement of youth protection; known alcohol and drug abuse; adoption; identified congenital anomalies); gave birth at term; and have infants with significant birth defects or serious medical conditions in addition to prematurity.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Breastfeeding premature infants
Treatment Result of KTP Laser Nasopharyngectomy in Recurrent NPC Patients

Study Overview
=================
Brief Summary
-----------------
Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients

Detailed Description
-----------------
Nasopharyngeal carcinomas (NPCs) are highly radiosensitive tumors, and the primary treatment of NPCs is radiotherapy.1 Because most patients who have NPC are at advanced stages when initially seen, local failures in terms of persistence or recurrence are not infrequent after primary radiotherapy.2,3 Local regional relapse without the presence of distant failure can still be salvaged and should be aggressively treated. Tumors relapsing in the nasopharynx can be salvaged using either re-irradiation or surgical techniques.1 Although re-irradiation to the recurrent tumor can extent the 5-year actuarial survival rate, it is associated with high morbidity. 4-6 Traditional nasopharyngectomy has been associated with local control rates on the order of 40% 50%, but it has also been associated with complications such as palatal defects, trismus, facial scarring, osteomyelitis, etc.7-10 That is the reason why surgeons continue searching for new methods for performing nasopharyngectomies with lower morbidities. Nasopharyngectomies are difficult to perform because of the inaccessibility of the nasopharynx. More difficulties are encountered in performing a nasopharyngectomy through the nose due to the restricted surgical field. With advances in techniques of endoscopy and application of the potassium-titanyl-phosphate (KTP) laser in surgery, pathologic lesions located either at the choanal margin or in the nasopharynx can easily be managed with instruments inserted via the nasal cavities. The surgical technique had been accepted by the authority journal. This time, we will review the therapeutic result of KTP-laser nasopharyngectomy in patients with recurrent NPC.

Conditions
-----------------
Recurrent, Nasopharyngeal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent NPC patients Exclusion Criteria: patients with distant metastasis

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPC, Nasopharyngectomy, KTP laser, recurrence
Digestive Tolerance of Maltitol and FOS

Study Overview
=================
Brief Summary
-----------------
Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.

Official Title
-----------------
Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults

Conditions
-----------------
Digestive Tolerance in Healthy Adults

Intervention / Treatment
-----------------
* Other: maltitol 85% / FOS15%
* Other: maltitol alone
* Other: maltitol 68% / FOS 32%
* Other: maltitol 50% / FOS 50%
* Other: FOS alone
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18.5 and 30 normal and regular stool frequency: at least 3 stools per week and no more than 3 per days subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption subjects not sufferinf from IBS according to Rome III criteria subjects not using mdeiction which could affect nutrients absoprtion Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sugary dessert cream<br> | Other: Placebo<br> <br> |
| Experimental: maltitol alone<br> | Other: maltitol alone<br> <br> |
| Experimental: maltitol 85% / FOS 15%<br> | Other: maltitol 85% / FOS15%<br> <br> |
| Experimental: maltitol 68% / FOS 32%<br> | Other: maltitol 68% / FOS 32%<br> <br> |
| Experimental: maltitol 50% / FOS 50%<br> | Other: maltitol 50% / FOS 50%<br> <br> |
| Experimental: FOS alone<br> | Other: FOS alone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score of gastrointestinal symptoms in the 24h following the consumption of products |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences |  | 24 and 48 hours | 
| Stool frequcency and consistency |  | 24 & 48 hours | 
| Glycaemic response |  | 2 hours |