cyrilzakka/clinical-trials huggingface dataset:
The Effect Of Square Stepping Exercise Training On Cognitive Functions And Quality Of Life In Geriatric Individuals

This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group.

In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period.

The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 65-75 years old,
* Able to walk independently,
* Hodkinson Mental Test score ≥ 8,
* Without any neurological or lower extremity-affecting diseases,
* Healthy geriatric individuals who agreed to participate in the study were included.

Exclusion Criteria:

* Using 3 or more medications,
* Hodkinson Mental Test score \<8,
* Currently participating in any exercise/rehabilitation program,
* Geriatric individuals with a history of lower extremity surgery
Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score At 2-year Follow-up

"Healthy ageing" is not limited to the absence of disease, but implies the "development and maintenance of the functional skills that enable the elderly to enjoy a state of well-being": (for example : the ability to walk, go out, engage in leisure activities, memorize...) It is interesting to study whether the implementation of a Personal Health Plan (PHP) in a Multiprofessional Health Home improves the quality of life of frail elderly people.

"Healthy ageing" is not limited to the absence of disease, but implies the "development and maintenance of the functional skills that enable the elderly to enjoy a state of well-being": (for example : the ability to walk, go out, engage in leisure activities, memorize...) Between "good health" and "dependence", there is a precarious, reversible state of transition known as frailty. There are several simple tools for identifying frailty, such as the GFST (Gerontopole Frailty Screening Tool).

The Gerontopole Frailty Screening Tool and the Fatigue, Resistance, Ambulation, Illness, Loss of Weight questionnaire have proved more sensitive. The gold standard for diagnosing and assessing frailty is a comprehensive geriatric assessment based on the multidimensional model of the Standardized Geriatric Assessment (SGA). Its aim is to identify all the medical, functional, psychological and social problems that may affect a frail elderly patient, in order to set up a long-term follow-up project, taking into account the patient's needs.

It is interesting to study whether the implementation of a Personal Health Plan in a Multiprofessional Health Home improves the quality of life of frail elderly people.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 70 years
* Autonomous patient (ADL ≥ 5)
* Patient identified as frail according to the Gérontopôle de Toulouse GFST grid
* Patient whose primary care physician is in the MSPs of Charleval or Romilly sur Andelle for the intervention group, and in the MSPs of Gaillon and Pont de l'Arche for the control group.
* Patient living at home or in an RPA
* Understanding of the French language
* Patient having read and understood the information letter and signed the consent form
* Affiliation with a social security scheme

Exclusion Criteria:

* Hospital geriatric follow-up
* Geriatric assessment already carried out
* Person deprived of liberty by an administrative or judicial decision, or placed under court protection / sub-guardianship or curatorship
* History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.
SprmPik AI Sperm Selection Study SiD, an Assistant for Sperm Selection During Intracytoplasmic Sperm Injection in Medically Assisted Reproduction: Effect on Fertilization, Blastocyst Formation, Early Pregnancy Loss, and Consistent Practice. A Prospective Pilot Study.

SprmPik AI Assisted Sperm Selection Study SiD, an assistant for sperm selection during intracytoplasmic sperm injection in medically assisted reproduction: effect on fertilization, blastocyst formation, early pregnancy loss, and consistent practice. A prospective pilot study.

The purpose of this research is to evaluate the impact of sperm selection for ICSI using the investigational SiD software, on performance outcomes such as the rate of fertilization, blastocyst development, clinical pregnancy success, and other intermediate results, in a pilot study.

SiD is a software designed to identify, evaluate, and assist in the sperm selection process within a semen sample, according to motility (for instance velocity, linearity, straightness) patterns and the shape of the sperm. SID uses a mathematical model. Its purpose is to assist clinical embryologists in selecting sperm to inject during ICSI. Currently, embryologists identify and select sperm based on the sperm motility and shape; not using any mathematical interphase assistant.

Eligibility Criteria:
Inclusion criteria for Male Partner (sperm source)

* Informed consent signed by the patient before treatment.
* IVF treatments with medical or embryology indication to perform ICSI.
* Fresh or frozen ejaculated motile sperm.
* Selection of sperm using a 7% or 10% PVP solution.
* Presence of motile sperm at the time of sperm selection for ICSI.
* Partner sperm

Exclusion criteria for Male Partner (sperm source)

* Sperm extracted by testicular biopsy.
* That the recommendations for use of SiD have not been fully followed.
* Inability to reliably trace sperm-oocyte-embryo throughout the process.
* Patients with immotile sperm

Inclusion criteria for Female Partner (egg source)

* Informed consent signed by the patient before treatment.
* IVF treatments with medical or embryology indication to perform ICSI.
* Cycles with at least 4 mature oocytes (Metaphase II).
* Fresh or frozen oocytes.

Exclusion criteria for Female Partner (egg source)

* Inability to reliably trace sperm-oocyte-embryo throughout the process.
* Oocytes that are not in Metaphase II.
Esomeprazole to Reduce Organ Failure in Sepsis

Sepsis is a severe disease with a high mortality rate and lack of efficacious therapies. Proton pump inhibitors (PPI) are drugs widely used to inhibit acid secretion by gastric cells and with a high safety profile. Carta and Rubartelli (IRCCS San Martino - Genova) have recently reported that PPI, such as esomeprazole, inhibit TNF-alfa and IL-1ß secretion. Moreover, they showed that a single administration of PPI protects mice from endotoxic shock with no adverse effects. PPI-SEPSIS is a randomized, double blind, controlled against placebo clinical trial to test if high-doses esomeprazole in septic patients reduces the severity of organs failure.

In parallel, the investigators will evaluate ex vivo in monocytes from septic patients: redox state and response to inflammatory stimuli; ATP release; metabolic changes and pH; cytokine production; the effects of PPI on these parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Admitted to intensive care unit or emergency department
* Sepsis or septic shock
* Able to express informed consent. For unconscious patients, current laws will be applied as requested by Ethical Committee.

Exclusion Criteria

* Able to express informed consent and deny it
* Known allergy or intolerance to study drug
* Little chance of survival, as defined by a SAPS II score more than 65 point
* Concomitant acquired immunodeficiency syndrome
* On immunosuppressant or long-term corticosteroid therapy
* Receiving lifesaving drugs known to have a strong interference with esomeprazole
* Sepsis or septic shock since over 36 hours
* Severe hepatic dysfunction
* Pregnant or breastfeeding
T-cell Based Immunotherapy for of Melanoma

The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.

Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.

After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.

Exclusion Criteria:

* Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
PsyDoMa : Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders

Recruitment is carried out directly at the geriatric unit of the CIMIEZ University Hospital Center by geriatric doctors during day consultation or in short stay unit. The doctor wil select carer -patient couples more likely to take part in the study. The investigator will give them an informative leaflet and they will have to sign the consent form.

A diagnosis is made by the investigator. The patient will first have to undergo a neurocognitive assessment carried out at the Cimiez Hospital (test for the evaluation of a cognitive deficit) by a psychologist.

The non-drug approaches presented will be carried out directly at the participant's home with the help of the carer for therapeutic purposes.

The therapeutic objectives and the choice of approaches are specified within the Personalised Accompaniment Project (PAP).

The carer, if he or she wishes, participates in the sessions in order to reproduce the behaviours implemented by the psychologist.

Different workshops will be offered : Cooking, Art Therapy, Games, Multi-sensory, Soft Gymnastic, Relaxation, Music and Reminisence.

Patients will received three visits per week during six months. The carer will receive one visit per week for six months.


Eligibility Criteria:
Inclusion Criteria:

For Patients

* Men or women over 65 years old showing signs of cognitive decline
* Living at home with specific needs ( meals, etc.) and the regular presence of a carer,
* Living in Nice
* Diagnosed with Alzheimer or dementia
* Presence of at least one behavioural disorder
* Person who agreed and signed the informed consent or his/her guardian For Carers
* Carer of the patient who meets the inclusion criteria: spouse, children, siblings or other family members at home or a professional carer.
* Person involved during the motivational interviewing session regarding the psychoeducational program.
* Person who agreed and signed the informed consent.

Exclusion Criteria:

For patients :

* Elderly person presenting no NINCDS- ADRDA criteria,
* Presence of sensory deficit (hearing or vision)
* Person unable to communicate,
* No regular presence of a home carer, waiting for a place in a nursing home
* Aging psychiatric pathologies,
* Elderly person attending a day-care centre

For carers :

* carer absent or not present enough,
* Elderly person with undiagnosed behavioural disorders
* Drug treatment that can interfere with assessments (psychotropic drugs, neuroleptics, etc.).
Functional Exercises With Water Intake in Primary Dysmenorrhea

Dysmenorrhea and its associated symptoms are very common in women. In Pakistan, almost 78% of women report Primary Dysmenorrhea. This will be a randomized controlled trial with two parallel groups. one group will be receiving functional exercises along with water intake and the other will be receiving no interventions.

Mostly in the reproductive years of age women suffers from the Pain of Menstruation which is known as Dysmenorrhea. In Pakistan every other girl is silently suffers from this disease leading to the inefficiency and one of the main cause of school and work absenteeism. This novel study is designed to target the menstrual symptoms of women with functional exercises combine with optimal intake of water. The objective of this study is to determine the effects of functional exercises with water intake on menstrual symptoms and pain in Primary Dysmenorrhea.

This is a Randomized controlled study. Before the study, all the participants will go through baseline evaluation, and then allocated to the groups. The exercise protocol consisting of the combination of exercises with regular intake of water (in bouts) will be informed to them. Females fulfilling the criteria and willing to participate in exercise trial will be recruited in the study. Outcome will be assessed at baseline and post treatment after 8th week.

Eligibility Criteria:
Inclusion Criteria:

* Age group 15-35
* Patients with pain at a severity level of 5 on NPRS during menstruation.
* Primary Dysmenorrhea diagnosis made on WALIDD score
* Patients having regular menstrual cycle

Exclusion Criteria:

* Patients having some previous surgical history
* Patients diagnosed with Secondary Dysmenorrhea
* Abnormal Cognition
* Involved in any regular physical activity for last 6 months
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis

The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Completion of NGM 13-0103
* Males or females, between 18 and 75 years of age, inclusive
* PBC Diagnosis consistent with AASLD and EASL guidelines
* Stable dose of UDCA

Exclusion Criteria:

* Chronic liver disease of a non-PBC etiology
* Evidence of clinically significant hepatic decompensation
Chronicity Dependence of a Balance Training in Adults Post-stroke

The level of stroke chronicity has been proposed as an influential variable related to functional balance. However, little is known about the effect of this variable on the effectiveness and maintenance of gains of physical therapy interventions on balance. The objective of this study is to determine the influence of time since injury on the rehabilitation of balance after stroke. Participants will be assigned to a least (6-12 months), a moderate (12-24 months), or a most chronic (\> 24 months) group. All the participants will train for 20 one-hour sessions, administered three to five times a week, combining conventional physical therapy exercises and customized exercises interfaced on a balance board that promotes the training of the ankle and hip strategies. Participants will be assessed before, after the intervention, and one month later with a posturography test (sway speed and limits of stability) and clinical scales (Berg Balance Scale, Functional Reaches Test, 30-Second Sit-to-Stand Test, Timed Up and Down Stairs Test, Stepping Test, Timed Up-and-Go Test, and the 10-meter Walking Test).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 and ≤ 65 years old
* Chronicity \> six months
* Fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23
* Ability to walk 10 meters indoors with or without technical orthopaedic aids.

Exclusion Criteria:

* Impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45
* Unilateral spatial neglect
* Ataxia or any other cerebellar symptom
* Severe auditory or visual impairments
* Motional or behavioural circumstances that impede adequate collaboration.
Infection After Implant-based Breast Reconstruction

Infections following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with infection following two-stage implant-based reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received implant-based breast reconstruction following mastectomy between 2015 and 2020 in Seoul National University Hospital

Exclusion Criteria:

* Patients who received flap surgery simultaneously with implant insertion
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)

This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.

This is a Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220. The study will consist of two parts: Part 1 will enroll up to 10 patients and is open label. Part 2 is randomized, sham controlled and will enroll approximately 40 patients. The study follow-up duration is 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis.
* Has had a prior bilateral total ethmoidectomy.
* Has computed tomography (CT) ethmoid cavity opacification.
* Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit.
* Minimum cardinal symptom score.
* Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site or regulatory authority if applicable by national law.
* Agrees to comply with all study requirements.

Exclusion Criteria:

* Pregnant or breast feeding.
* Known history of hypersensitivity or intolerance to corticosteroids.
* History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
* Known history of hypothalamic pituitary adrenal axial dysfunction.
* Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
* Past or present functional vision in only one eye.
* Past, present, or planned organ transplant or chemotherapy with immunosuppression.
* With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
* Ethmoidectomy that was unilateral or partial.
* Currently participating in an investigational drug or device study.
Investigation of the Safety of Intranasal Glulisine in Down Syndrome

This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo in patients with DS. Subjects will be randomized into this cross-over study and within subject comparisons conducted between single treatment of intranasal insulin glulisine and single treatment of intranasal placebo. All subjects will also receive a single treatment of placebo prior to randomization to ensure adherence to study procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 35-80 years with a Down syndrome diagnosis that is confirmed by karyotype.
* Vital signs must be within normal limits for their age. (Medically treated hypertension will be allowed).
* Must have an electrocardiogram free of clinically significant findings.
* Must have an authorized representative to provide written informed consent.
* Level of speech and comprehension of verbal commands are sufficient to understand and to answer simple requests.
* Must have a reliable caregiver or family member who agrees to accompany the subject to all visits, provide information about the subject as required by this protocol.
* Must be independent for activities of daily living.
* Must tolerate the initial IN treatment of placebo and adhere to study procedures.

Exclusion Criteria:

* Any current psychiatric or neurologic diagnosis other than Down syndrome or Down syndrome with dementia that is judged to impact cognition.
* Subjects who currently meet or have within the past five years met DSM-IV (Diagnostic and Statistical Manual) criteria for drug or alcohol abuse or dependence.
* Subjects residing in a skilled nursing facility or subjects who are anticipated to enter a nursing home within the next 6 months. (Subjects may reside in group homes, assisted living, or other residential settings where they do not require 24 hour skilled nursing.)
* Subjects receiving any experimental drug for Down syndrome within the past 30 days of screening visit.
* Subjects with significant allergies to or other significant intolerance insulin.
* Presence of active seizure disorder.
* Presence of significant aggression or agitation that may impact participation with testing and IN administration. All subjects must have NPI-C aggression and agitation subscore ≤ 4 (severity ≤ 2; frequency ≤ 2).
* Significant cerebrovascular disease with Modified Hachinski Score\>4.
* Subjects who may not be able to comply with the protocol or perform the outcomes measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.
* Subject has been diagnosed with any form of diabetes mellitus, actively takes insulin, or has HbA1c \> 6.1% at screening.
Chronic Schizophrenia With Obsessive-Compulsive Symptoms: Comorbidity or a Subtype?

Evaluating the prevalence and characteristics of obsessive-compulsive (OC) symptoms in patients with chronic schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenic patients
* Schizophrenic patients with OCD

Exclusion Criteria:

* Organic problems
Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency

Vitamin D supplementation in patients with uterine fibroids who present hypovitaminosis D to re-establish their normal serum values could stabilize the size of the uterine fibroids and thus prevent their growth or reduce their size thanks to the anti-proliferative action of Vitamin D on the myoma cells.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with at least one fibroid \> 3 cm
* With hypovitaminosis D (25(OH)D \< 30 ng/ml)
* BMI \< 30
* No hormonal treatment in the 3 months prior to the ultrasound study

Exclusion Criteria:

* Black race
* Symptomatic fibroids subsidiary to hormonal or surgical treatment
* Desire of gestation in the next 6 months
* Presence of degenerating adenomyosis or fibroids
* Treatment with sexual hormones: mifepristone, aGnRH or any other medication that may interfere with fibroids.
* History of neoplasia of gynecological origin and/or existence of uterine malformations.
* Hypercalcemia or abnormal liver or kidney function is present