cyrilzakka/clinical-trials huggingface dataset:
The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients

Analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision (CRS-R).

Previous studies suggested that olfactory stimulus have some effect on some patients with disorders of consciousness. Then, the aim of the present study is to know the prognostic value of olfactory stimulation and the diagnosis for DOC patients. DOC patients were recruited (standard diagnosis procedure is 5 times CRS-R testing within 10 days). The different stimuli were as follows: 1) 1-octene-3-ol, odor. 2) pyridine, odor. 3) water. We presented these stimuli randomly, and we recorded the patient's CRS-R scale behavioral response and response to olfactory stimulation. Analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision (CRS-R).

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old;
* non-acute phase;
* after coma;
* no nerve stimulation drugs within 48 hours before the implementation of the study;
* no neuromuscular blockers within 24 hours before implementation

Exclusion Criteria:

* history of forehead injury;
* nasal fractures;
* tracheotomy;
* developmental mental or neurological diseases leading to recorded dysfunction;
* severe fractures of the extremities.
Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.

Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy +/-Chemotherapy.

Patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study.

The study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: TomoTherapy +/-Chemotherapy (radiation therapy alone or preceded by chemotherapy).

The nature of the chemotherapy treatment will be decided according to the standards of each center.

The patients will be followed for the study up to 36 months after the surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patient with a non-inflammatory and non-metastatic invasive mammary carcinoma.
3. Indication of mastectomy and immediate prosthetic breast reconstruction.
4. Patient wishing to have an immediate mammary reconstruction with prosthesis.
5. Formal or presumptive pre-operative indication for adjuvant radiotherapy (+/- chemotherapy).
6. OMS ≤ 2.
7. Patient affiliated to a Social Health Insurance in France.
8. Patient must provide written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Metastatic breast cancer.
2. Bilateral breast cancer.
3. Inflammatory breast cancer (T4d).
4. History of breast cancer within 5 years.
5. Not applicable according to the protocol version N°6 : Previous neoadjuvant treatment for the ongoing disease.
6. Pregnant or breastfeeding women.
7. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
8. Patient protected by law.
Quantitative Evaluation of the Effect of Dehydration and Rehydration Levels on Tooth Color

This study aims to evaluate the dehydration and rehydration changes in teeth over time and the quantitative effect of these changes on natural tooth color in the clinic. In addition, it is aimed to evaluate the effectiveness of different color measuring devices used in color detection in the clinic, the use of cross-polarization filters, and white balance calibration in color evaluation. Clinicians will evaluate the results of the time intervals in which dehydration is effective in detectable levels of color change. Considering the quantitative changes in dehydrated and rehydrated teeth, it will be possible to prevent negative results in restorations.

According to the criteria determined in our study, 30 individuals were repeated with their mouths open for 15 seconds, 1 minute, 2 minutes, 3 minutes, and 5 minutes with a camera, MDP device, and the use of these devices with a cross-polarization filter to determine how dehydration will affect the tooth color. For white balance calibration, all the shots will be taken the same way with the gray reference card, and the color measurements of the teeth will be taken with two different spectrophotometers in the determined parameters. After these measurements, patients will be kept with their mouths closed and tooth color measurements will be taken after 30 minutes and 60 minutes of remineralization. The patients will be called again 24 hours after these procedures the final color measurement will be made and the basic color parameters will be recorded. Spectrophotometric images will be analyzed according to the manufacturer's instructions. The spectrophotometer shall be calibrated and used according to the manufacturer's instructions before each measurement set. In restorative dentistry clinical applications, color selection errors, which are irreversible errors caused by the color changes of the teeth due to dehydration, will be determined in detail in a short time due to dehydration in the teeth, as a result of this clinical study, and with the result of rehydration, the color change levels will be determined in detail. return will be determined. In this way, it is aimed to create a clearer template for physicians based on time in terms of color selection in the clinic. It is aimed to avoid the need for renewal and avoid unnecessary sessions, as color harmony can be achieved in restorations made by considering the color changes of the tooth during dehydration and rehydration periods. Different photographic techniques and colorimeters will also help measure color variations. In addition, the sensitivity of the color detection methods used in our study will be evaluated comparatively, ensuring which method gives more accurate and reproducible results in clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* healthy periodontal tissue
* tooth color in A1, A2, or A3

Exclusion Criteria:

* any systemic diseases
* smoking
* restoration or caries in anterior teeth
* vital and devital bleaching application
ICU Acquired Neuromyopathy and Diaphragm Function

Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation.

The main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a MRC score \< 48).

The second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the Medical Research Council - MRC score).

Diaphragm function will be assessed through phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion (expressed in cmH2O). It will be assessed during a spontaneous breathing trial for each patient with a known critical illness neuromyopathy. The diaphragm (thickness and course) will be studied by ultrasound assessment as well. Peripheral limbs force will be evaluated by the MRC score. A total of 40 analysable patients will be included.

All these measurements will be made at the time of the spontaneous breathing trial (SBT) during the weaning phase. No modification of the clinical practices of the care should be modified by the study. The twitch airway pressure during airway occlusion will be assessed at the begining of the SBT. The other measurements will be performed 30 mn after the SBT if this one will be well tolerated.

Participants will be followed for the duration of ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* MRC score \<48
* ready for weaning from mechanical ventilation

Exclusion Criteria:

* previous history of neuromyopathy
* impossibility to perform a magnetic stimulation
* cervical spine injury
* bihemispheric or brain stem lesion
Association Between ABO Polymorphism and Gastric/Colorectal Cancers

To assess ABO gene polymorphism (rs8176746) in the patients histopathologically confirmed gastric and/or colorectal cancers relative to healthy controls by real time PCR.

The ABO blood group system was discovered by the Austrian pathologist Karl Landsteiner in 1901, who classified the blood groups based on the presence of A and B antigens on the surface of red blood cells after noting patterns of agglutination during blood transfusion. Since the discovery of the ABO blood group system , several studies investigating the relationship between the ABO blood group system and various diseases have been conducted , cancer included .

First association between ABO blood group and cancer risk was reported in 1953 in The English patients with gastric cancer.

Gastric cancer is one of the most common malignant tumors of the digestive system , worldwide, gastric cancer is still the fourth most common cancer and the second most common cause of cancer death . The development of gastric cancer is caused by the interaction of genetic and environmental factors , ABO blood grouping is one of the most stable genetic factors.

This association is also observed with other gastrointestinal malignancies, including colorectal cancer which considered the third common cancer in both women and men and responsible for approximately 10% of all cancers, and the third most common cause of cancer related mortality for men and fourth for women .

The ABO is also the first blood group system defined at the gene level . SNP is a single nucleotide polymorphism, is a germ line substitution of a single nucleotide at a specific position in the genome that is present in a sufficiently large fraction of considered population , SNP may act as biological markers, as they can relate to the genes that are associated with various complex diseases as heart diseases, diabetes, cancer ... etc.

In previous studies , significant association between ABO gene SNP (rs8176746) , H. Pylori infection, gastric and pancreatic cancer were found , as they observed that this gene SNP was associated with decreased risk of these disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patients that histopathologically confirmed gastric and/or colorectal cancer.
* males and females.

Exclusion Criteria:

* Presence of other haematological , autoimmune disorders or other malignancies.
Progesterone & Postpartum Relapse to Smoking

The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive 4 weeks of active or placebo exogenous progesterone starting on the 4th day postpartum. Participants will be in contact with study staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels and receive behavioral counseling.

Eligibility Criteria:
Inclusion Criteria:

* Woman
* 18-35 years old
* Zero CPD for past 4 weeks
* 5 or more CPD for at least 6 out of past 12 months
* Motivated to remain abstinent (7 or higher out of 10)
* Stable physical/mental health
* Established prenatal care
* Stable physical/mental health
* Willing to take Progesterone
* Willing to use double-barrier protection if sexually active
* English fluency
* Able to provide informed consent

Exclusion Criteria:

* Psychotropic medications
* Illicit drugs
* Other types of tobacco, NRT, smoking cessation medications
* Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of \>2 miscarriages)
* Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors
* History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone
Treatment of Multiple Attacks of Acute Migraine (0462-025)

A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patient had at least a 6-month history of migraine, with or without aura
* Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
* Patient was judged to be in good health, apart from migraine

Exclusion Criteria:

* Patient was pregnant or a nursing mother.
* Patient had abused drugs or alcohol within 12 months prior to entering the study
* Patient had a history of cardiovascular disease
* Patient had clinically significant ECG abnormality
* Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
* Patient received treatment with an investigational device or compound within 30 days of the study start
* Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
* Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
* Patient had prior exposure to rizatriptan
Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis

Appendicitis is the most common cause of abdominal pain requiring emergent surgical intervention in children and approximately one third of patients present with perforation. Perforated appendicitis has been demonstrated to have a significant impact on patients and families due to the prolonged hospitalization, high complication rates, and tremendous economic burden from treatment. The most significant complication following operative treatment of perforated appendicitis is intra-abdominal abscess, which develops in approximately 20% of children following appendectomy in recent literature. Due to this frequent and morbid complication, continued research has been driven at determining the most efficacious and cost-effective postoperative antibiotic treatment regimen to reduce post-operative abscess. As postoperative abscess rates following appendectomy for perforated appendicitis remain high, the primary aim of this study was to evaluate a new postoperative antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with randomization into ten day completion course of home antibiotics with IV ertapenem versus oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer reduced rates of postoperative abscess, with no major difference between completion courses of home IV versus oral antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.

Exclusion Criteria:

* Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.
Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis

The objective of the study is to evaluate the clinical utility and the feasibility, in an outpatient setting, of sputum induction using hypertonic saline. This study will also study pilot techniques on a sub using a sub-sample to assess the lower airway inflammatory cells and markers in relation to new emerging organisms in cystic fibrosis (CF) and antibiotic therapy in CF.

Chronic airway infection, mainly by Staphylococcus aureus (SA) and Pseudomonas aeruginosa (PA), is a major cause of morbidity and mortality in patients with cystic fibrosis (CF). Isolation of organisms from the respiratory tract is important to optimize treatment. The current recommended methods for bacterial evaluation are bronchoalveolar lavage (BAL) and expectorated sputum (ES) analysis. However, a significant proportion of young CF patients cannot produce sputum spontaneously. The method used most frequently therefore is to isolate respiratory organisms is to perform throat swabs (TS) which have poor sensitivity and specificity in the evaluation of respiratory pathogens in CF patients.

Induced sputum (IS) using hypertonic saline has been used in a limited number of studies to evaluate respiratory organisms in CF patients. These studies have reported that IS may be a useful non-invasive diagnostic test to increase the yield of detection of respiratory pathogens.

Beside its use as a diagnostic test to identify bacterial pathogens induced sputum has been used to assess lower airway inflammation in CF. While numerous studies have clarified the role of S. aureus and P. aeruginosa in CF lung disease, the role of other emerging bacteria such as Stenotrophomonas maltophilia (SM) and Achromobacter xylosoxidans (AX) species remains largely unclear. IS offers the potential to possibly differentiate between colonisation and infection for the emerging pathogens and to help clarify their role in CF lung disease.

Eligibility Criteria:
Inclusion Criteria:

1. Children diagnosed with CF (by sweat chloride ≥60 and/or genetic testing)
2. Children ages between 6-18 years
3. Ability to perform pulmonary function tests
4. FEV1 ≥ 30% predicted18.

Additional inclusion criteria for sub-sample undergoing antibiotic therapy:

1. Above criteria
2. Admitted to hospital for i.v. antibiotic therapy

Exclusion Criteria:

1. Acute respiratory distress or hypoxia (oxygen saturation \<92% at room air)
2. New onset of wheezing
3. Previous history of intolerance of inhalation of HS
A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.

The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening

Ongoing symptoms for at least 2 months prior to screening, including:

* Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
* At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
* Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
* Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
* Active/chronic helminthic infection
* History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
* Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Comparison of Effects of Vestibular Visual Cues and Proprioception To Improve Postural Control in Elderly

Background/Objective: The aim of this study was to compare the effects of vestibular visual cues and propriception to improve postural control in elderly.

RCT study was conducted. Fourty four healthy elderly volunteers aged from 65 years to 75 years were assigned to a group 1 (n=22) engaging in vestibular visual cues exercises and group 2 (n=22) engaging in proprioception exercises. Training sessions (\~30 minutes each) occurred twice a week for consecutive six weeks. The following parameters were analyzed before and after training for both groups: Berg balance scale (BBS) and Clinical test of sensory organization and balance (CTSIB).

Eligibility Criteria:
Inclusion Criteria:

* Ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance.
* Able to follow simple directions, for example, left, right, up, or down.
* Either using visual aids.
* Fakuda test for screening.
* VOR reflex for screening

Exclusion Criteria:

* • Presence of orthopedic problems.

  * Neurological disorders.
  * Psychological problems.
  * Cognitive issues.
  * People with severe visual issues
  * Participants with other medical complications.