cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Treadmill Training in Individuals with Traumatic Brain Injury

This pilot study aims to determine the feasibility of a virtual reality treadmill training intervention in individuals with Traumatic Brain Injury (TBI). Participants will be stratified based on age into adults' group or older adults' group and then randomized into the virtual reality treadmill training (intervention) group with feedback or the treadmill training (control) group. This pilot study will also provide preliminary evidence on the impact of the virtual reality treadmill training on mobility, balance, fear of falls, fall risk, attention and physical activity in the community in individuals with TBI. The data collected in this pilot study will also help to estimate sample size for subsequent large clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 90 years old
2. diagnosed with a non-penetrating TBI
3. at least 12 months post most recent injury
4. self-reported balance deficits and fear of falls or at least 2 falls in the last one year
5. Able to understand and speak English language to respond, understand and comply with study procedures throughout the 10-week study period and fill out the study questionnaires in English
6. Able to walk with minimal assistance or less (with bracing and assistive devices as needed)

Exclusion Criteria:

1. history of severe cardiac disease
2. neuromuscular or neurological pathologies other than TBI that limit study participation
3. uncontrolled seizure disorder
4. weight greater than 135 kg or less than 25 kg
5. height greater than 6' 2''
6. severe cognitive, visual or hearing impairment where the patient is not able to follow the study instructions
7. open skin lesion or bandage in the area of C-Mill harness contact
Newborns of Obese Mothers

This was a prospective bi-centric study, exposed-unexposed. In an effort to better understand the potential independent effect of maternal obesity on fetal growth, investigators designed a prospective study, comparing fetal growth between normal weight (18.5 ≤ BMI \< 25 kg/m2) or obese pregnant women (BMI ≥ 30 kg/m2), while maternal diabetes and hyperglycaemia was screened and treated throughout pregnancy.

The study population concerned obese pregnant women (BMI ≥ 30 kg / m² before pregnancy) and their newborn and normal weight pregnant women (18.5 ≤IMC \<25 kg/m²) and their newborn as control. Inclusion criteria were body mass index (BMI) ≥ 30 kg/m2 or 18.5 ≤ BMI \< 25 kg/m2, 18 ≤ age ≤ 40 years, singleton pregnancy. Exclusion criteria were: 25 ≤ BMI \<30 kg/m2, age \< 18 or \> 40 years, multiple pregnancy, first consultation after 18 WG, pregestational diabetes, obesity due to genetic disorder or secondary to intracranial tumor or radiotherapy, bariatric surgery, chronic diseases other than the obesity, inability to converse in French language. The matching criteria for controls were: age ± 5 years, primigravida or multigravida, duration of gestation ± 4 weeks.

The main objective of this project was to assess the independent effect of maternal obesity:

* on the weight and adipose tissue of newborn
* on the function of adipose tissue (production of leptin and adiponectin)
* on fetal growth factors (C-peptide, IGF-1)
* on carbohydrate metabolism of the newborn. Two maternities were involved in the study: Pitié Salpêtrière and Armand Trousseau, in Paris, France. This research was conducted over a 3 years period. The duration of participation of each woman corresponded to the duration of pregnancy care and duration of care for the newborn immediately after birth, usually the length of stay in the maternity.

The only differences compared to the usual care included:

* Additional oral glucose tolerance test at 32 weeks of gestation;
* Determination of fasting blood glucose during late pregnancy
* Maternal blood samples on arrival at the delivery room
* Drawing blood from the umbilical cord after section;
* Skinfold measurement of the newborn within 72 hours of life.

Eligibility Criteria:
Inclusion Criteria:

1. - BMI ≥30 kg / m² or between 18.50 and 24.99 kg / m².
2. - Pregnant woman coming to the centre before 18 weeks of gestation.
3. - Age ≥ 18 and ≤ 40 years
4. - Single Pregnancy
5. - No constitutional or progressive disease other than obesity: inflammatory disease, epilepsy, pathology psychiatric, tumor...
6. - Informed written consent.

Exclusion Criteria:

1. - Pregnant woman coming to the center after 18 weeks of gestation, BMI \<18.5 kg / m² or between 25 and 29.99 Kg / m².
2. - Age \<18 or\> 40 years
3. - Multiple pregnancy
4. - Presence of a constitutional disease or progressive disease other than obesity.
5. - Patients who underwent obesity surgery type "bypass" or gastroplasty
6. - Obesity secondary to genetic disorder, intracranial lesions or pituitary radiotherapy
7. - not stabilized endocrine pathology.
8. - pregestational diabetes
9. - No affiliation to a social security scheme
Mentalizing Education in a Psychiatric Out-patient Clinic

Mentalization-based Mental Health Education in a naturalistic patient population from a psychiatric out-patient clinic in North Norway: A randomized controlled study

Half of an unselecected waiting list group of patients (randomized) from a psychiatric out-patient clinic are offered a 6 hour mental health education course abour mentalizing. 1 year follow up period. Primary outcome variable is use of hospital services. Secondary outcome variables are questionnaire scores.

Eligibility Criteria:
Inclusion Criteria:

* all norwegian speaking patients referred to the outpatient clinic

Exclusion Criteria:

* none
Treatment of Patients With Diabetic Kidney Disease

Due to irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns. So, this study aimed to compare the effectiveness of SGlT2i versus ACEi in the progression of diabetic kidney disease including progression of albuminuria. Doubling of serum creatinine and need for renal replacement therapy

Diabetic kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide and continues to be the major contributor to kidney replacement therapy (KRT).

Despite the significant decline in diabetes-related complications in recent decades, the same trend cannot be observed in chronic kidney disease (CKD) patients due to DKD that requires KRT. Hence, there exists a significant requirement for novel treatment approaches that can enhance glycemic control while minimizing the risk of hypoglycemia, as well as reducing cardiovascular and renal risks within this population. Irrespective of the limitations associated with estimated glomerular filtration rate (eGFR), it is crucial to develop new treatments that can effectively address these concerns.

ACE inhibitors may delay the progression of nephropathy and reduce the risks of cardiovascular events in hypertensive patients with diabetes mellitus type I and type II.

SGLT2i have become the new standard of care for slowing CKD progression in patients with type 2 diabetes mellitus (T2DM, due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects.

Research questions:

Q1. Is there a significant effect of ACEi in treatment of patients with diabetic kidney disease.

Q2: Is there is a significant effect of SGLT2i in treatment of patients with diabetic kidney disease.

Q3: Which is more significantly efficient in treatment of patients with diabetic kidney disease (ACEi versus SGLT2i)

Eligibility Criteria:
Inclusion Criteria:

* Patients that suffer from Diabetic kidney disease (DKD)

Exclusion Criteria:

* Genital mycotic infections
* Urosepsis and Pyelonephritis
* Lower limb amputation
* diabetic Ketoacidosis
* Euglycemic DKA
* Acute Kidney Injury
* Hypoglycemia
* Fournier Gangrene
* Hypersensitivity Reactions
* Bone fracture
* Bladder cancer
* Hyperkalemia
* Dyslipidemia
The Assessment of Knee Joints Function in People After Stroke

The study aims to assess the function of knee joints in patients after stroke compared to healthy people and evaluate the impact of rehabilitation on the function of knee joints in people after stroke.

Stroke patients were examined twice at the beginning of rehabilitation and after approximately 15 days of exercise. The control group (healthy participants) was assessed once. Wireless motion sensors connected to a mobile application were used to assess the kinematics of the knee joints. They were used to assess the range of motion in the knee joints (passive, active, active at maximum speed), proprioception (joint position sense tests), step-up test, step-down test, getting up and sitting on a chair, step and squat. Functional tests such as The Five Times Sit-to-Stand Test, Timed Up\&Go, The Step Test, the 5m walking test, and the 30-s Chair Stand Test were carried out. The strength of the knee extensors and flexors was also assessed using the Leg Force Feedback device. Balance was assessed on a posturography platform by performing tests such as standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface. The symmetry of lower limb loads in a standing position was also assessed.

Eligibility Criteria:
Inclusion criteria to the stroke group were as follows :

* the time from stroke: less than a year,
* age: between 35 and 65 years old,
* ability to stand independently for at least 5 minutes without an assistive device,
* ability to walk 5 m independently,
* ability to communicate and understand the tasks required in the study,
* a modified Ashworth scale spasticity score of 1+ or less in the affected knee (0: no resistance, 5: affected parts stiff in flexion or extension),
* muscle strength on the Manual Muscle Test of 3/4 or more in the affected knee,
* Barthel Index score 80 or more.

Exclusion criteria from the post-stroke group were as follows:

* age below 35 or over 65,
* sensorimotor aphasia,
* cognitive disorders that make it impossible to understand and obey commands,
* lack of active movement in the knee joint,
* Manual Muscle Test strength of the quadriceps muscles below 3,
* no ability to walk 5 meters,
* lack of informed consent to participate in the study,
* other neurological diseases (such as MS, Parkinson's disease, neuropathies),
* fractures in the lower limbs, which could affect the structure and function of the knee joint,
* previous operations on the lower limbs (including ACL reconstruction, knee arthroplasty or hip, osteotomy of the knee joint).
* vision disorders,
* unilateral spatial neglect syndrome.

The control group consisted of healthy volunteers with no prior history of trauma or neurological disease affecting the structure and function of the lower limb.
Role of Sweetness in Glucose Regulation

Data from several studies show that consuming a diet high in low-calorie sweeteners (LCS), mainly in diet sodas, is linked to the same metabolic disorders as consuming a diet high in added sugars, including an increased risk of developing type 2 diabetes. Sweet taste receptors, once thought to be unique to the mouth, have now been discovered in other parts of the body, including the intestine and the pancreas, where they play a role in blood sugar control. These newly identified receptors provide new avenues to explore how LCS may affect metabolism and health. This project is designed to examine the role of sweet taste signaling, both in the mouth and in the gut, on blood sugar control and how habitual consumption of LCS may affect sweet taste signaling and metabolism in people with obesity.

The overall goal of this research is to assess the role of oral and gut sweetness signaling in postprandial glucose metabolism and to determine how acute and chronic low-calorie sweetener (LCS) consumption may affect this signaling in people with obesity. The aims will determine the independent and combined contributions of pharmacological inhibition (Aim 1) or extra stimulation (Aim 2) of sweet taste signaling in the gut, mouth, or both on hormonal responses to an oral glucose tolerance test (OGTT) in two groups of subjects with obesity: habitual and non-habitual LCS consumers. Validated sensory evaluation techniques will also ascertain subjects' taste perception (Aim 3) to test the hypotheses that habitual consumption of LCS blunts perception of sweetness and, in turn, affects postprandial glucose regulation.

Eligibility Criteria:
Inclusion Criteria:

* All races/ethnicities
* Habitual (\> 5 diet sodas per week) and non-habitual (≤1 diet soda or 1 packet of LCS per week) LCS consumers
* 30 ≤ BMI \<40 kg/m2
* Not severely insulin resistant (HOMA-IR2 \< 2.6)

Exclusion Criteria:

* BMI \< 30 and 40\< BMI kg/m2
* HOMA-IR2\>2.6
* Irregular LCS consumers (\>1 diet sodas or packets of LCS per week but \<5)
* Current smokers or quit smoking nicotine cigarettes for less than 6 months ago
* Pregnant, breastfeeding, menopausal
* Presence of anemia : \<12g/dl for women and \<13g/dl for men
* Blood donation in the past 8 weeks
* Presence of malabsorption syndrome
* History of bariatric surgery
* Presence of inflammatory intestinal disease, liver or kidney disease
* Have diabetes (fasting glucose level \>126mg/dl or plasma glucose level 2h after glucose challenge \>200 mg/dl)
* Taking any medication that might affect glucose metabolism or the results of our study
The Application of Pleth Variability Index in Continuous Monitoring the Volume Status of Intraoperative Patients

To assess the value of using pleth variability index(PVI) to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor surgeries.

Objective: To assess the value of using PVI to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and pleth variability index(PVI) and their correlation in patients undergoing intestinal tumor surgeries.

Methods: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ, aged 18-65 years. After the induction of general anesthesia, cardiac index(CI), cardiac output(CO), stroke volume variability(SVV), stroke volume index(SVI) were monitored with Vigileo system, while pleth variability index(PVI) and perfusion index(PI) were monitored with Massion Radical 7 system. During the surgery, goal directed fluid therapy was conducted according to the data of CI、SVI and SVV. Heart rate(HR), mean arterial pressure(MAP), central venous pressure(CVP), CO, CI, SVI, SVV, PI, PVI were recorded while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4). And we calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective intestinal tumor surgery
* American Society of Anesthesiologists (ASA) physical status of grade I-Ⅲ
* Aged 18-65 years
* BMI 18\~30kg/㎡

Exclusion Criteria:

* Patients under 18 years or above 65 years
* patients with severe aortic regurgitation
* patients with permanent cardiac arrhythmias
* patients with intra-aortic balloon pump
* patients with severe pulmonary disease
* patients undergoing emergency surgery
Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse

A Randomized Clinical Trial on Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement VS sacral colpopexy isolated for vaginal posterior prolapse

Laparoscopic sacral colpopexy is the gold standard procedure for pelvic organ prolapse. Anyway, vaginal fascial surgery is already considered the most appropriate for posterior vaginal prolapse. This prospective randomized pilot study is aimed to verify if the combination of laparoscopic duplication of vaginal fascia with absorbable sutures could increase benefits of sacral colpopexy on the posterior vagina in terms of prolapse (evaluating 1 year POP-Q).

Secondary endpoints of this comparison are incidence of intra- or postoperative complications estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.

Statistical Analysis and Study Design This is a single Institution prospective randomized clinical trial conducted at the Pia Fondazione Panico of Tricase, Italy.

To have an imbalanced results and to reduce any bias, a randomization list has been checked.

Probability (p) values will be considered to be statistically significant at the \<0.05 level.

There will be recruited 32 patients for Groups. Group 1: Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement Vs Group 2: Laparoscopic sacral colpopexy isolated for vaginal posterior prolapse.

All patients will be adequately informed and inserted in the study only after having read and signed an informed consent. Diagnostic, clinical and surgical data of each patient will be prospectively recorded. At the end of the procedure, a schedule will be compiled with intraoperative data. All clinical and histologic data will be recorded prospectively using a database. Pain associated with the procedure will be evaluated by a subjective assessment (analysis of VAS scale values reported by patients at 8 and 24 hours after surgery). Post-operative complications will be evaluated during the first 30 days after surgery according to Dindo's classification.

Eligibility Criteria:
Age ≤ 80 years Patient's informed consent American Society of Anesthesiologists: \< class III or IV

No previous major abdominal surgical procedures POP-Q stage \> or =III for posterior compartment. No uterine cervix dysplasia or endometrial disorders. No uterine size larger than conform 10 weeks gestation
Mechanisms of Panic Disorders Treatment

Investigation of mechanisms of exposure based learning by

1. Investigating the effects of fear augmentation by interoceptive exposure during in vivo exposure
2. Disentangling the effects of interoceptive exposure exercises in panic disorder

The study aims on investigating the effect of fear augmentation during in-vivo exposure by adding interoceptive exposure (e.g., hyperventilation) in PD/AG patients. By comparing the fear augmentation group with the therapist-guided CBT exposure, and by measuring autonomic arousal during and between exposure sessions, it will be possible to study the mechanisms of exposure based learning. A second aim is to disentangle effects of specific interoceptive exposure exercises (e.g., respiratory vs. vestibular stimulation). Finally, by including patients without agoraphobic avoidance it will be possible to investigate whether interoceptive exposure alone will have any effect. This might open the door for early interventions for individuals after experiencing an initial panic attack to prevent the development of a severe panic disorder with agoraphobic avoidance.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of panic disorder, panic disorder with agoraphobia OR initial panic attacks
* CGI ≥ 4 (except persons with initial panic attacks)
* Informed Consent

Exclusion Criteria:

* Acute suicidality
* Current substance use disorder
* Lifetime diagnosis of psychotic disorders, bipolar disorders, borderline personality disorders
* Severe medical condition (chronic conditions)
* Current psychotherapeutic or psychopharmacological treatment
A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years of age
* Undergone allogeneic HSCT
* Written informed consent
* Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:

Patient with Adenovirus Infection:

1. Antiviral treatment with cidofovir for at least 7 days

   * no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or
   * cluster of differentiation 3 (CD3) + cells \< 300/µL on treatment for at least 7 days
2. Or if antiviral treatment is contraindicated

Patient with EBV:

1. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg/m2)

* No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or
* CD3+ cells \< 300/µL 7 days after receipt of treatment or
* Clinical progression

Patient with CMV:

1. Antiviral treatment with ganciclovir or foscavir for 14 days

   - No Virus load decrease (≤ 1 log) or virus load increase on day 14
2. Or if \> 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells \< 300/µL
3. Or if antiviral treatment is contraindicated -

Patient Exclusion Criteria:

* graft-versus-host disease (GVHD) \> grade 2 at the time point of planned infusion
* Known allergy to iron-dextran or murine antibodies
Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Patients in an acute psychotic episode requiring full hospitalization

Exclusion Criteria:

* Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia)
* Pregnancy
* Breastfeeding
* Previous hypersensitivity to sodium nitroprusside
* DSM-IV diagnosis of drug abuse or dependence