cyrilzakka/clinical-trials huggingface dataset:
A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women

The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women, right-handed, aged from 18 to 60 years
* Subject of normal body weight or with overweight i.e. not obese (body mass index between 18 and 30 kg/m2).
* For fertile women, complying with one of the other medically approved methods of contraception

Exclusion Criteria:

* Subject with any current psychiatric or eating or suicidal attempt disorder, or history of such disorder.
* Subject with any history of chronic GI disorder or disease.
* Subject with any significant active or prior metabolic disorder or disease.
* Subject with any use of probiotic supplements or antibiotics in the previous month.
* Subject with current use of any medications with potential central nervous system effects (antidepressants, anxiolytics, opiate pain medications...).
* Subject with allergy or hypersensitivity to milk proteins or lactose intolerance or immunodeficiency
* Subjects with claustrophobia or other condition (such as metallic implants) that would preclude MRI scanning
Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial

A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with at least moderate glabellar lines at maximum frown as determined by severity score of at least 2-point (moderate) on the Facial Wrinkle Scale (4-point FWS) as assessed by investigator.

Exclusion Criteria:

1. Any medical condition that can affect the neuromuscular function
2. History of facial nerve paralysis or ptosis
3. Significant facial asymmetry
4. Subjects whose glabellar lines cannot be sufficiently improved by physical method
5. Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves
6. Subjects with skin abnormalities at potential injection sites
Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer

The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach.

This is a multi-center, retrospective chart review study of all consecutive lobectomies performed for clinical stage IA, IB, IIA, IIB and IIIA lung cancer, performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of lobectomy performed for clinical stages, IA, IB, IIA, IIB and IIIA lung cancer via robotic-assisted, VATS (video assisted thoracic surgery) and open approach that meet the study inclusion and exclusion criteria will be considered for inclusion in the study. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution and going back to 2013 (i.e most current data in 2017 and chronologically going back through 2013). The retrospective chart review and data collection is anticipated to occur in two phases:

Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes data will be obtained from hospital records. Each participating institution will contribute approximately 100-800 cases from one or more surgeons. Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment and no patient consenting is required

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Subject who has undergone elective robotic-assisted, VATS or open lobectomy for clinically diagnosed primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy

Exclusion Criteria:

* Subject with stage IIIB lung cancer
* Subject who received lobectomy as an emergent procedure
* Subjects who received lobectomy for metastatic cancer
Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated.

The investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases .

The patients that will be enrolled are:

* 50 patients ≤ 75 year old with acute myocardial infarction;
* 30 patients ≤ 75 year old with Tako-Tsubo syndrome;
* 50 women ≤ 75 year old, recently operated on breast cancer:
* 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy.

At the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory (STAXI 2).

In two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered.

The same evaluation will be done for the healthy subjects.

After the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy.

At first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered.

The following data will be evaluated:

Psychological characteristics at follow-up. Incidence of new relevant medical events Quality of life Relationship between psychological characteristics and health status, and quality of life

At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients within one week from an Acute myocardial infarction treated with primary or urgent PCI
* Patients within one week from the onset of Tako Tsubo cardiomyopathy.
* Patients with a diagnosis of breast cancer in the preceding six months
* Age and sex matched control subjects without relevant medical pathologies in the preceding 10 years

Exclusion Criteria:

* Cognitive impairment
* Refusing the enrolment
The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia

This study is a prospective multicenter randomized controlled Interventional study, to assess the clinical efficacy and safety of corticosteroids compared to corticosteroids in combination with Ruxolitinib in the treatment of severe checkpoint inhibitor pneumonitis.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old≤ Aged ≤80 years old.
2. Diagnosis of malignancy.
3. Malignant tumors initially treated with immune checkpoint inhibitors (antibodies targeting PD-1, PD-L1, CTLA-4, or new immune checkpoint inhibitors) in combination with or without chemotherapy.
4. Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4.
5. Patients who and whose family members understand the study protocol, are willing to participate in the study and could provide written informed consent.

Exclusion Criteria:

1. Predicted life expectancy\<12 weeks.
2. Any evidence of active or uncontrolled viral infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), or any clinical signs of bacterial, other viral, parasitic or fungal infection requiring treatment.
3. malignancy progression.
4. Patients with other serious complications that may affect safety or adherence judged by the investigator.
5. Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation.
6. Patients can't fully understand the study protocol, arrangement and other study-related elements.
7. Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment.
8. Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion.
9. Patients who cannot comply with study treatment and follow-up according to the trial protocol.
Antibiotic-induced Disruption of the Microbiota

The use of antibiotics causes profound changes in the microbiota. However, the magnitude of the effect of intrapartum and early-life antibiotics on the breast milk and the infant oral and intestinal microbiota, and whether effects are only short-term or persist long-term remain uncertain and will be determined in this study.

In this prospective cohort study, the investigators will determine the effect of (i) intrapartum antibiotics on the composition of the breast milk, and the infant oral and intestinal microbiota and antibiotic exposure in the first year of life on the composition of the infant intestinal microbiota (including the development and persistence of antibiotic resistance) and (ii) the association of this disruption with adverse health outcomes. (iii) The investigators will also determine the association between the maternal intestinal microbiota, the breast milk microbiota and the infant oral and intestinal microbiota.

Eligibility Criteria:
Inclusion Criteria:

* healthy infants
* term infants (\> 37 weeks of gestation)

Exclusion Criteria:

* maternal HIV infection
* maternal hepatitis B or C infection
* antibiotics in the third trimester of pregnancy
* intake of probiotics during pregnancy
* infants with the low birth weight \<2500 g
* infants with congenital abnormality
Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle

The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.

Patients will be asked to complete a questionnaire during follow-up consultations.


Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 years
* having undergone septic nailing in the operating theatre
* with social security coverage

Exclusion Criteria:

* Patient with 6-month follow-up not possible (medical wandering, transient patient),
* Patient who has benefited from another means of osteosynthesis
* Patients whose long-term return to weight-bearing will not be possible for reasons other than ankle arthrodesis surgery.
* Persons able to give consent but unable to read or write French
* Opposes participation in the study
* Patients whose cognitive capacity does not allow them to answer questionnaires
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery

This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.

Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.

Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).

Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.


Eligibility Criteria:
Inclusion Criteria:

* Elective valvular or coronary surgery
* Under cardiopulmonary bypass
* Patient requiring Swan Ganz catheter monitoring
* Patient in sinus rhythm
* Patient requiring post-operative volemic expansion
* Echographic criteria of hypovolemia, without hypervolemia

Exclusion Criteria:

* Pulmonary hypertension (SPAP \> 60mmHg)
* No pre-operative sinus rhythm
* Emergency surgery
* Age \< 18 years
* Chronic renal failure treated with dialysis
* Severe hypernatremia
KF2019#1-trial: Effects of a Thrombocyte Inhibitor on a Cholesterol-lowering Drug

The cholesterol-lowering drug rosuvastatin is a substrate of the breast cancer resistance protein (BCRP). BCRP is an efflux transporter expressed e.g. in the small intestine. It limits the oral bioavailability of rosuvastatin by transporting rosuvastatin from enterocytes back to the gut lumen. Inhibition of BCRP can increase rosuvastatin bioavailability and systemic concentrations. Ticagrelor is a platelet aggregation inhibitor used in treatment and prevention of atherothrombotic events. Ticagrelor may inhibit BCRP in humans. This study is aimed to investigate the possible interaction of rosuvastatin with ticagrelor. Ten healthy male or female non-smoking volunteers aged 18-40 years are taken into the study. Primary endpoint is area under the plasma concentration-time curve of rosuvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-40
* Healthy
* Systolic blood pressure ≥100 mmHg
* Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
* Fully vaccinated against COVID-19.

Exclusion Criteria:

* Significant disease
* Abnormal result from the Helsinki University Hospital bleeding questionnaire
* Smoking
* Using oral contraception pills or other regular medication
* Pregnancy (current or planned) or nursing
* Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
* Donation of blood within three months prior to the entry into this study
* Significant overweight / small or hard-to-find veins
* Weight \< 45 kg
* BMI \< 18.5 kg/m2
* Insufficient Finnish language skills
A Study to Test V930/V932 in Patients With Cancers Expressing Human Epidermal Growth Factor Receptor 2 (HER-2) and/or Carcinoembryonic Antigen (CEA)(V930-003)(COMPLETED)

Treatment of patients with cancer types known to express the HER-2 and/or CEA tumor antigens.

The optional followup period for this study is 1 year after the last vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed surgical treatment for his/her primary disease at least 1 month prior to enrollment
* Patient must not be pregnant 3 days prior to enrollment

Exclusion Criteria:

* Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent
* Patient has had their spleen removed or has a history of autoimmune disorders
* Patient is a regular user of any illicit drugs or has used within the past year of drug or alcohol abuse
* Patient is pregnant or breastfeeding or is expecting to conceive anytime following the study
* Patient is known to be Human Immunodeficiency Virus (HIV)-seropositive
* Patient has a known history of Hepatitis B or C
* Patient has received a vaccine for any disease or condition within one month of enrollment
* Patient has a primary central nervous system tumor.
Understanding the Burden of ACC Through the Eyes of Patients

This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.

Primary Objectives:

* To identify the specific burdens faced by patients with ACC
* To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)

This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.

Primary Objectives:

* To identify the specific burdens faced by patients with ACC
* To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)

Secondary Objectives:

* To assess QoL implication in patients living with ACC (Adenoid Cystic Carcinoma)
* To compare the burdens and QoL impacts in people living with ACC, with their tumors bearing Notch mutations or Notch Wild Type due to:

  * Rate of disease progression
  * Location of Metastases

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be a person diagnosed with ACC who is 18 years or older
2. For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor
3. Histologically-confirmed diagnosis of ACC with written proof of disease and molecular profile of tumor provided. This can be a note showing genetic diagnosis from a relevant testing laboratory, physician consult notes, a medical record of diagnosis, or any other single piece of documentation that connects your name/the patient's name with ACC.
4. Able to read, write and understand English, Hebrew, Arabic, or Russian
5. Able to grant informed consent
6. Willing to participate in a 45-to-60-minute telephone interview, including follow up questions (if necessary)

Exclusion Criteria:

1. Inability to meet any of the inclusion criteria
Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy

This project was a Randomized clinical trial conducted to find out the Comparative Effects of Gong's Mobilization with Gradually Graded Exercise Therapy for Chronic Neck Pain among the users of Electronic Gadgets so that we can have best treatment option for patients.

The study design was a Randomized Clinical Trial. For the study data was collected from sports and spine professionals. Sample size was calculated with the help of Epitool calculator. The study will be completed in 6 months duration. Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS) for pain intensity and Universal Goniometers for measuring (ROMs) and Forward head posture (FHP) were assessed before and 4 weeks after the treatment through the craniovertebral angle (CVA) measured from a digitized, lateral-view photograph of each subject. All the subjects were selected using Non Probability convenient sampling technique. The Subjects were randomly assigned to one of the following two groups: Gong's Mobilization (Group 1) or Gradually Graded Exercise Therapy (Group 2).This study was conducted in accordance with the rules of the Declaration of Helsinki. Written Informed consent were taken from all the subjects before participating in this trial. SPSS 25 was used for data entry and analysis.

Eligibility Criteria:
Inclusion Criteria:• Subjects with an age range of 15 to 65 years having Chronic neck pain for more than 3 months and subjects having a baseline NDI score of atleast 20% (10 points).

-

Exclusion Criteria:

* • Cervical stenosis

  * History of traumatic Injury
  * Previous surgery related to cervical spine
  * Hypermobility
  * Cancer
  * Inflammatory rheumatologic diseases
  * Severe psychological disorders
  * Being pregnant and
  * Intervention including exercise or physical therapy in the last 3 months.
Neuronal Integrity in Bipolar Depression

The aim of this study is to examine the neurological unity in bipolar depression and to investigate white matter abnormalities that may contribute to etiology

Bipolar disorder is a chronic mood disorder which is characterized by repetitive episodes, usually manifests through adolescence or early adulthood. It has a prevalence of approximately 2,5% with a 1:1 ratio of male and female. It is a disorder that may disrupt central nervous system functions such as cognition, thought, perception, affect, judgement, adaptation to the environment and behavioural regulation. It may manifest with various clinical onsets. Although etiology of bipolar disorder is still unknown, some biological factors such as BDNF, oxidative stress and structural changes of brain are proven to have a role in etiology.

Diffusion tensor magnetic resonance imaging (DTI) is a neuroimaging technique that elucidates abnormalities of brain white matter (WM), based on structural investigation of a tissue via measurement of diffusion rate and direction of water molecules. This method lets imaging of white matter tracts, whole anatomical extent and structural integrity of the brain tissue. So, it can provide data about anatomical connectivity of brain. There are some parameters used for indicating microstructural integrity of white mat-ter such as fractional anisotropy (FA) and apparent diffusion coefficient (ADC) in DTI. FA is a measure which reflects directional coherence of water diffusion, and it is sen¬sitive to microstructural WM differences. It is defined on a scale ranging from mostly isotro¬pic (when approaching to zero) indicating poor integrity of the axons to mostly anisotropic (when approaching to 1) indicating intact WM integrity. ADC is a scalar index of the rate of water diffusion among different dif¬fusion directions under a Gaussian distribution. A higher value of ADC indicates lesser restricted diffusion, and it implies fewer organized structures in WM which supports presence of abnormalities in the structural in¬tegrity of white matter. As it has a complicated literature, in this study, we aimed to investigate neuronal integrity and its abnormalities by DTI, which may contribute to the etiology of bipolar depression.

Eligibility Criteria:
Inclusion Criteria:

Patients;

* Aged between 18 and 65
* Having a diagnosis of bipolar type I disorder depressive episode by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
* Having no other general medical, neurological or psychiatric condition Healthy controls;
* Matched with bipolar depressive patients by age and sex
* Having no other general medical, neurological and psychiatric condition

Exclusion Criteria:

* Bipolar depressive patients and healthy control subjects with any other general medical, neurological or psychiatric condition, metal implant, severe head injury or pregnancy