linjc16/ctgov huggingface dataset:
Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

Study Overview
=================
Brief Summary
-----------------
This protocol is an single patient IND to provide clofazamine to treat one patient who has MAI and is resistant to or can not tolerate standard of care. The drug is not otherwise available.

Official Title
-----------------
IND for One Patient to Receive Clofazamine for Treatment of MAI

Conditions
-----------------
Infection, Mycobacterium Avium-Intracellulare

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment of one patient with MAI Exclusion Criteria: No other patients will be treated
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Only one patient is being treated under a single patient IND. | |

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
-----------------
Mycobacterium avium-intracellulare
Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?

Study Overview
=================
Brief Summary
-----------------
The study of sarcopenia is a subject that is the subject of numerous research and publications, particularly because of its link with a poor prognosis for many cancers. In an article published by the digestive surgery team, the role of feeding jejunostomy has been demonstrated: it allowed more patients to reach the 2nd stage of surgery and a better tolerance of chemotherapy. Investigators wanted to study retrospectively the impact of feeding jejunostomy on radiological sarcopenia. Is the positive effect of jejunostomy in gastric cancers associated with a decrease in sarcopenia?

Official Title
-----------------
Could a Preoperative Feeding Jejunostomy Decrease Sarcopenia for Patients With Oesogastric Adenocarcinoma ?

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Criteria for inclusion: Age 18-80 years Sex: H or F Subject giving their consent for their participation Gastric cancers stage> IB whether or not a feeding jejunostomy CT scan performed at the HUS, after the end of the courses of chemotherapy and / or before the surgery. Exclusion criteria: antecedent level L3 surgery, psoas hematoma No CT performed at HUS at the end of chemotherapy and / or before surgery Impossibility of giving the subject informed information Subject under the protection of justice Subject under guardianship or curatorship

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate muscle status by CT evaluation of sarcopenia in patients | Evaluate the impact of feeding jejunostomy in patients with gastric cancer | 24 hour after the realization of the MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcopenia, jejunostomy, oesogastric adenocarcinoma, scanography
Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation

Study Overview
=================
Brief Summary
-----------------
This study compares the short-term effects of a new humidification system (Hygrovent Gold) and two other humidification devices (heated and moisture exchanger and heated humidifier) on respiratory pattern and work of breathing, during invasive ventilation.

Detailed Description
-----------------
Three humidifying devices are commonly and indifferently used during mechanical ventilation, but their impact on respiratory mechanics and, eventually, mechanical ventilation efficacy, particularly in patients highly dependent from mechanical ventilation, are not superimposable. It has already been described that heated and moisture exchangers (HME), increasing dead space, can negatively affect ventilatory function and gas exchange, in comparison to heated humidifiers (HH). The Hygrovent Gold, mainly because of its position between the tracheostomy and the Y-piece of the ventilatory circuit and its structure, may lead to analogous or even worse effects, determining and increase in inspiratory resistances and dead space and consequently an increase in the work of breathing.

Official Title
-----------------
Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation

Conditions
-----------------
Chronic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Hygrovent Gold
* Device: Heated and moisture exchanger (HME)
* Device: Heated humidifier (HH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hypercapnic respiratory failure (PaCO2 of 45 mmHg or more) Long-term mechanical ventilation via tracheostomy Clinical stability Exclusion Criteria: Non collaborative subjects Acute respiratory failure Haemodynamic instability Encephalopathy

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Every patient receives 20 minutes of invasive mechanical ventilation with each of the three humidification systems in random sequence: Heated and moisture exchanger (HME) Heated humidifier (HH) Hygrovent Gold | Device: Hygrovent Gold<br> <br> Device: Heated and moisture exchanger (HME)<br> <br> Device: Heated humidifier (HH)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle pressure-time product (PTPoes) |  | Baseline and 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Invasive mechanical ventilation, Humidifying devices, Respiratory mechanics
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.

Official Title
-----------------
A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib

Conditions
-----------------
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: Dasatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 18 or older CP or AD CML or Ph+ ALL Intolerant of resistant to imatinib ECOG PS 0-2 (CP CML) ECOG PS 0-3 (AD CML and Ph+ ALL) Adequate hepatic and renal function Exclusion Criteria: Pregnant or breastfeeding females History of significant cardiac disease History of significant bleeding disorder (not CML)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- |
|Drug: Dasatinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of drug-related adverse events. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Phase CML: Cytogenetic and Hematologic Response |  |  | 
| Advanced Phase CML and Philadelphia positive ALL: Hematologic Response |  |  | 
| Time to and duration of Cytogenetic and Hematologic Response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic and Advanced Phase CML and, Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
Evaluation of Anti-mullerian Hormone Levels as Predictive of IVF Outcomes in Women Over 38 Years Old

Study Overview
=================
Brief Summary
-----------------
The present study is designed to evaluate the basal serum levels of anti-mullerian hormone (AMH) and inhibin B as early predictors of ovarian response, implantation rate, and pregnancy rate in women 38 years old or older that are undergoing an IVF cycle.

Detailed Description
-----------------
Specifics aims are: a) to describe AMH and inhibin levels on day 3 previous to ART cycle; b) to analyze the association between these hormone levels and the retrieved metaphase II oocytes quantity; c) to analyze the association between these hormone levels and quality embryo score d) to analyze the association between these hormone levels and the number of gestational sacs per transferred-embryo (implantation rate); e) to analyze the association between these hormone levels and the pregnancy rate; f) to make a prediction model for pregnancy rate by using a multivariable regression analysis. Patient participation includes signing the consent and having additional tubes of blood drawn at a regularly scheduled blood draw. This blood is used to run the study tests (AMH and inhibin levels).

Official Title
-----------------
Evaluation of Serum Anti-Mullerian Hormone (AMH) and Inhibin B Levels as Early Predictors of a Successful IVF Cycle in Women Over 38 Years Old.

Conditions
-----------------
AMH Levels, Inhibin B Levels, IVF Patients Over 38 Years Old

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Women 38 years old or older at the time of initiating treatment Exclusion Criteria: Uterine disease: malformation, septum, submucosal myomas, endometrial polyps Advanced endometriosis with endometrioma (s) No uterus Single ovary

Ages Eligible for Study
-----------------
Minimum Age: 38 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 |
| --- | --- | --- |
| AMH levels as predictive of oocyte quality | Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and the oocyte quality as observed during the IVF cycle | within 3 months | 
| AMH levels as predictive of embryo quality | Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and the embryo quality as observed during the IVF cycle | within 3 months | 
| AMH levels as predictive of implantation and pregnancy outcomes | Evaluate the relationship between a patients AMH and inhibin level prior to beginning IVF treatment and rates of implantation and delivery during that IVF cycle | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMH, inhibin B, infertility
Comparison of Serological Test s for the Virus Chicken Pox Virus (VZV) and Correlation With the Patient's Memory of the Infection or Vaccination

Study Overview
=================
Brief Summary
-----------------
Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women. Secondary goals : Correlation memory / Immunity; Prevalence of VZV immunity in pregnant women; Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory; Evaluation of acceptability of vaccination in the post partum period in non immune patients. Methods Not randomized prospective study, Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients

Official Title
-----------------
Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Biological: Serological Test s for the Virus Chicken Pox Virus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women aged over 18 Affiliated to a social protection scheme or women benefiting from such a regime Women who gived a writing consent Exclusion Criteria: Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not. HIV-positive women Garfted women whatever organ

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br>Pregnant women | Biological: Serological Test s for the Virus Chicken Pox Virus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity |  | 35 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of immunity detecting depending on whether the patient remember having varicella, have been in contact with next of kin with varicella or been vaccinated against varicella or not |  | up to 35 weeks | 
| Percentage of women accepting the vaccination in case of negative history |  | day during the first visit |
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Official Title
-----------------
A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions
-----------------
Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
-----------------
* Drug: Comparator: sitagliptin phosphate
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has type 2 diabetes mellitus Males Females who are highly unlikely to become pregnant Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications Exclusion Criteria: Participant has a history of type 1 diabetes mellitus or history of ketoacidosis Participant required insulin therapy within the prior 8 weeks Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sitagliptin<br>Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks. | Drug: Comparator: sitagliptin phosphate<br>* Sitagliptin tablet 100 mg, administered once daily before the morning meal.<br>|
| Placebo Comparator: Placebo<br>Participants randomized to this arm will be administered matching placebo, daily for six weeks. | Drug: Comparator: placebo (unspecified)<br>* Matching placebo tablet, administered once daily before the morning meal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 | Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement. | Baseline and Week 6 |
The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants

Detailed Description
-----------------
The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.

Official Title
-----------------
The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants

Conditions
-----------------
Prematurity of Fetus

Intervention / Treatment
-----------------
* Device: near infrared spectroscopy: invos 5100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 32 gestational age and/or < 1500gr. ≥ 28th day preterm infants Instilled mydriatic eye drops for ROP examination Exclusion Criteria: Sepsis Shock Severe intracranial hemorrhage NEC Abdominal and cranial surgery

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 90 Days

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: near infrared spectroscopy: invos 5100|NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, the investigators applied NIRS probes to the forehead and abdomen for cerebral (rSO2C) and abdominal (rSO2P) regional oxygen saturation measurements.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation | By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mydriatic, NIRS, preterm, eye drops, cerebral, mesenteric oxygenation
Effectiveness of Kinesio Tape in Morning Stiffness and Functional Capacity in Patients With Rheumatoid Arthritis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how the applications of Kinesio Tape affect the morning stiffness in patients with rheumatoid arthritis.

Conditions
-----------------
Wrist Morning Stiffness

Intervention / Treatment
-----------------
* Procedure: Kenzo Kase Method
* Device: Kinesio Taping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Rheumatoid Arthritis according to the criteria of the American Rheumatism Association with a minimum of 6 months evolution from diagnosis. These subjects must have morning stiffness daily in the wrist joint of a member or bilateral at least a month. Exclusion Criteria: Subjects in postoperative affecting the mobility of joints to study phase. Subjects with sensory deficits or other inflammatory arthropathies. Subjects who are or come in a state of emergence of the hand or wrist joints during the investigation. Subjects who change their usual treatment (medication or other therapies) two months before the study or during the study. We exclude subjects who present some kind of allergy to Kinesio-Tape in which case it will be removed immediately.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Kinesio taping<br>Epicondilar and epitroclear muscle Kinesio Taping with a Space Correction on the wrist according Kenzo Kase Method | Procedure: Kenzo Kase Method<br> <br> Device: Kinesio Taping<br> <br> |
| No Intervention: No intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Wrist Morning Stiffness |  | participants will be followed for the duration in minutes of the morning stiffness, an expected average of 45 minutes] |