cyrilzakka/clinical-trials huggingface dataset:
Thoracic Mobility Exercises Impact in Tibio Femoral Arthritis Patients

The aim of this randomized clinical trial is to find the effect of thoracic mobility exercises on thoracic hyper kyphosis and hamstring flexibility with tibiofemoral arthritis patients on reducing hyper kyphotic posture, knee pain and improving flexibility of hamstring muscles.

Tibio Femoral Arthritis is a painful heterogeneous musculoskeletal condition that comprises of articular cartilage degradation, distortion of joint tissues, depletion in synovial fluid and progression over time. Decline in joint ROM usually began in fourth decade, more common in women in the age of menopause mostly the age of 45 years or elder. In Pakistan prevalence of Tibio femoral arthritis is 28.0% in urban population and 25.0% in the rural population, estimated o outstretch 35% by 2030. Hamstring muscle are part of superficial posterior anatomical chain in body that form meridians or myofascial chains connected to thoracolumbar fascia via sacro tuberous ligament.

Knee joint movements are primarily facilitated by the quadriceps and hamstrings, which play a crucial role in ensuring smooth and accurate ambulation. Tightness in hamstring put stress on Tibio-femoral joint which further reduce its range of motion especially knee extension, joint loading problems, induce compensatory movements, gait limitations, disturbs overall spinal postural alignment, increase thoracic kyphosis, decrease lumbar lordosis, and inducing posterior pelvic tilt. Until now most existing studies focus on the impact of thoracic mobility on thoracic spine issues or general posture, with limited research on its secondary effects on lower limb flexibility in 45 to 65 years old Tibio femoral arthritic patients. There is still research gap present to identify comprehensive effects of thoracic mobility exercises, on hyper kyphotic postures with tightened hamstrings, complementing Tibio femoral arthritis with aging.

Eligibility Criteria:
Inclusion Criteria:

* Thoracic Kyphotic angle \> 40
* Asymptomatic (no pain symptoms in) thoracic spine
* Able to stand independently
* Less than 70 degree Hip Flexion Angle on active SLR, with limited knee extension range more than 20 degree restriction on AKE test
* Bilateral Hamstring tightness
* Visual Analogue Scale in targeted Joint Tibiofemoral arthritis \&gt;3 cm
* Having Osteoarthritis in Tibio femoral Joint, according to KL (Grade 2 and 3)
* X-rays showing evidence of reduced knee spaced/osteoarthritis symptoms B/L( \>2 year)

Exclusion Criteria:

* Muscle/tendon injuries of hamstring
* Spinal Injuries, scoliosis, tumors and malignancies
* Any surgery, infection, skin sensitivity, trauma, fracture and fall
* Involvement in regular flexibility yoga program
* Patient with intra articular steroidal therapy with in last 6 months
* Patient unwilling to comply follow up schedule
* Patient involvement in another interventional study
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo


Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 18 and 65 years of age
* Subjects that meet DSM IV diagnostic criteria for Insomnia
* Subjects that report a time in bed NLT 6.5 and NMT 9 hours
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep \>1.0 hour
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
* On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
* On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
* On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights

Exclusion Criteria:

* Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
* Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
* Subject with a history (past year) of alcohol or substance abuse
* Subject that needs to smoke during the sleep period time
* Subject that reports habitual napping (more than 3 times per week)
Medication Review in Chronic Complex or Polymedicated Patients After Hospital Discharge.

The goal of this prospective multicentre clustered randomized controlled trial is to evaluate the effect on new hospitalization episodes of a multidisciplinary medication review in primary care patients with polypharmacy or chronic complex conditions after hospital discharge.

The multidisciplinary team will be integrated by a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). Patient will be adults aged 65 years and older. Polypharmacy refers to the use of 10 or more drugs based on information in electronic prescription software.

Research questions are:

In elderly patients with polypharmacy, which is the effect of an interdisciplinary medication review after hospital discharge in comparison with standard care, in terms of:

* new hospitalization episodes?
* number of drugs prescribed?
* prescribed drugs adequacy?

Centres will be randomized to medication review intervention or usual care group. Eligible patients will be ask for informed consent. For patients in the intervention group, PCP will collect information about prescribed medication and diseases from the electronic health record and e-prescribing application. The medication review in primary care will be focus to reconcile the medications the patient was taking prior to admission and those initiated in hospital, with the medications they should be taking post-discharge to ensure all changes are intentional and that discrepancies are resolved as soon as possible. The review process will include detection of potential drugs interactions, wrong doses, lack of adherence (based on dispensing recorded data) and adequacy to explicit criteria for potentially inappropriate prescriptions included in different tools: a) STOPP-STAR, STOPP-Pal, LESS-CHRON lists; b) Guideline for Medication Review in Primary Care, a local publication and c) Medication review in patients with polypharmacy. A list of drugs frequently associate with potentially inappropriate prescriptions. Andalusian health Service). PCP will write a report to communicate the results of medication review to primary care physician and nurse. The multidisciplinary team will define a personalized therapeutic plan to be implemented for every patient.

Patients in the control group will receive usual care.

Eligibility Criteria:
Inclusion Criteria:

- Hospital discharge in the last 48 h and one of the following conditions:

* Polypharmacy: ten o more drugs prescribed in a chronic schedule OR
* Complez Chronic Condition

Exclusion Criteria:

* Patients in last days of life
* Major mental health disorder
* Patient on dialysis
* Organ transplant patients
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone


Eligibility Criteria:
Inclusion Criteria:

* ≥18- and ≤77-years-old
* Type 2 diabetes
* Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
* Glycosylated hemoglobin (A1C) ≥7% and ≤10%
* Body mass index (BMI) ≤40 kg/m2

Exclusion Criteria:

* Women of childbearing potential unable or unwilling to use acceptable birth control
* Women who are pregnant or breastfeeding
* Significant cardiovascular history
* Active liver disease
* Renal impairment
Reasons for Recourse and Diagnoses Associated With Early Recourse to an Emergency Structure After Initial Treatment

To date, studies have been carried out on emergency department revisits but most are studies carried out in Anglo-Saxon territories. The studies carried out in France, for their part, concern the elderly geriatric population, or populations with specific pathologies such as child psychiatrists or patients with acute heart failure, but not the general adult population. Nevertheless, these studies have shown that knowledge of the risk factors for early readmission of a patient makes it possible to carry out targeted prevention actions in order to reduce this early recourse rate.

However, in a context of increasing emergency flow and increasing tension in the field with limited healthcare resources, returning home and outpatient care are increasingly favored. However, these strategies only make sense if outpatient follow-up is organized when early reconsultation is possible for certain indications that remain to be determined. In this context, it would be interesting to have information on the reasons for which patients return to the emergency room early after initial treatment. This would indeed make it possible to consider carrying out preventive actions in the long term in order to reduce this revisit rate on the one hand and on the other hand to identify the signs of seriousness which should bring the patient back to the emergency room as soon as possible.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject treated in the emergency room of the NHC or Hautepierre and having consulted the emergency room of one of the two sites 7 days after their first visit for an identical reason for recourse between January 1, 2017 to January 31, 2023.
* Patient who has not expressed his opposition to the reuse of his data for scientific research purposes.

Exclusion Criteria:

* Patient having expressed his opposition to the retrospective reuse of his data
Training of Orthopedic Residents in OP Treatment

Objective: To assess whether residents (R1, R2 or R3 according to the year of residency) of an orthopedic tertiary service, investigate, treat and / or refer the patient with an osteoporotic fracture to treat osteoporosis (OP) and whether this learning is improved over the years of residence.

Methods: Residents answered diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture (OF) in 4 scenarios, which were the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months. Answers were compared between years of residence.


Eligibility Criteria:
Inclusion Criteria:

* Physicians enrolled in the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.

Exclusion Criteria:

* Abandonment of the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
* Withdrawal from the medical residency program in orthopedics and traumatology at the IOT-HC-FMUSP for a period of more than 120 days.
* Expulsion from the medical residency program in orthopedics and traumatology at IOT-HC-FMUSP.
* Transfer of the medical residency program in orthopedics and traumatology from IOT-HC-FMUSP to another institution.
Comparison of the Escape Room and Storytelling Methods in Learning the Stress Response

The goal of this randomised controlled study is to evaluate the effects of storytelling and escape room methods on the level of learning about stress response of nursing students and students' opinions about these methods.

The main questions it aims to answer are:

* Is there a difference between the pretest-posttest scores of the students who received training on stress response with the escape room method?
* Is there a difference between the pretest-posttest scores of the students who were trained on the stress response with the storytelling method?
* Is the difference between the knowledge levels of the students who received stress response training with the escape room and storytelling methods statistically significant? The students, who received training on stressors, stress response and the long-term effects of stress through lecture, were divided into two groups four weeks after this training and were retrained on the same subject with escape room and storytelling methods. Before and after the Escape room and storytelling practices, the students' knowledge of the stress response was evaluated. After both applications, focus group discussions were held with the students and their opinions and feedbacks on the applications were evaluated.


Eligibility Criteria:
Inclusion Criteria:

Nursing students taking internal medicine course

Exclusion Criteria:

N/A
Effect of Probiotics (Vivomixx®) on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn

The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight body composition of their infants.

Accumulating evidence indicates that the gut microbiota plays a significant role in obesity and because the "ideal" composition of the gut microbiota remains poorly understood, modulation of the gut microbiota composition represents a potentially attractive treatment option against excessive gestational weight gain and adverse outcomes for obese pregnant women and their newborn. Dietary supplements in the form of probiotics could be an efficient treatment for controlling weight gain in pregnancy by inducing changes in the gut microbiota and could have influence on infant's microbiota, which could have important implications for infant development and health.

A pilot study including 50 obese pregnant nulliparous with BMI between 30-35 kg/m2 will, after accepting participation, be randomized to receive daily placebo or probiotics (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery. The infants will be followed until 9 months of age. Shortly after birth, tissue composition will be measured in the infants by DEXA-scanning. The women will be monitored by weight, blood-, fecal- and urine samples, diet questionnaires and hospital record review. Vivomixx® is a probiotic mixture of 8 probiotic strains, (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus).

This is the first pilot study in which the probiotic Vivomixx® are added in a randomized fashion to the standard of care in obese pregnant women. 50 pregnant women are planned to be included. The aim of this group size is to clarify the feasibility, compliance and to estimate parameters such as the standard deviation which will be used in a sample size calculation for a full-scale trial.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 and ≤35 kg/m2- calculated from pre-pregnancy weight
* Primiparous singleton pregnancy
* Able to read and speak Danish
* Normal ultrasound scan of the fetus at gestational age 12-14
* Oral glucose tolerance test at gestational age 14-20

Exclusion Criteria:

* Pregnancy at \> 20 weeks gestation at recruitment
* Pre-gestational diabetes or other serious diseases
* Multiple pregnancy
* Previous bariatric surgery
* Ingestion of probiotics \< 1 month before the inclusion or ingestion of other kinds of probiotics than the study probiotics
Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. This risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. At the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. Recently, a medication containing the blocking agent naltrexone was approved in the US; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. This study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in Norway. The main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. After the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Opioid dependence (DSM-IV TR)
* Age 18 or above
* Applied \& Approved for Norway's national OMT program
* Discharge within 30 days of inclusion from a controlled environment; e.g. inpatient treatment or correctional (prison) facility
* Voluntarily seeking treatment for opioid dependence

Exclusion Criteria:

* Pregnant or breast-feeding
* Acute or recurring severe psychiatric disorder, e.g. psychosis, suicidality
* Serious debilitation of liver or renal function (e.g. Child-Pugh level C)
* Use of excluded medication
* Known intolerance to study drugs or their ingredients
* Employment in firm manufacturing one of the study drugs or close relation to such person
Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

This randomized study evaluates the effectiveness of the a probiotic formula, compared with the antibiotic rifaximin, in the treatment of Small Intestinal Bacterial Overgrowth (SIBO) in Irritable Bowel Syndrome (IBS) patients.

Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention.

IBS pathophysiology is multifactorial and may include alterations of the gut microbiota, food intolerances and Small Intestinal Bacterial Overgrowth (SIBO). However, SIBO is a distinct entity than IBS, as patients can present SIBO without IBS. SIBO is diagnosed based on objective tests (breath test or microbial culture of duodenal aspirate) while IBS is a functional syndrome, diagnosed on symptoms (Rome-IV criteria).

A probiotic formula composed of strains Pediococcus acidilactici CECT 7483 and Lactobacillus plantarum CECT 7484 and CECT 7485 was previously shown to improve quality of life in patients with IBS.

Rifaximin is a a non-absorbable antibiotic commonly used for the treatment of SIBO.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with IBS according to Rome IV criteria (Lacy et al. Gastroenterology 2016) and with SIBO according to North American Consensus (Rezaie et al., Am J Gastroenterol. 2017), providing Informed Consent.

Patients taking set doses of Proton Pump Inhibitors (PPIs) or antispasmodics can be included.

Exclusion Criteria:

* Use of antibiotics in the 4 weeks before study initiation.
* Use of probiotics in the 2 weeks before study initiation.
* Use of loperamide or other prokinetics in the week before study initiation.
* Use of Plantago ovata, lactulose or other laxans in the week before study initiation.
* Use of antidepressants.
* Suspicion or confirmed diagnose of coeliac disease, inflammatory bowel disease (IBD), symptomatic diverticulosis/diverticulitis, or endometriosis.
* Previous intestinal surgery, except appendectomy and herniorrhaphy.
* Short bowel syndrome or pancreatitis.
* Concomitant treatment with immunosuppressors, oncologic disease, severe cardiovascular disease, positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Other conditions that can interfere with the effect of probiotic.
* Pregnant or lactating women.
The 5R Shared Leadership Program in Older Adult Walking Groups

To test the efficacy of the 5R Shared Leadership program in older adults on participants' identification with their walking group, group cohesion, walking activity, and well-being, compared to a regular group walking program, the investigators conducted a cluster randomised trial.

All walking groups participated in a 12-week structured group walking program. Half of these walking groups were randomly assigned to the intervention condition and received additionally the 5R Shared Leadership Program

Eligibility Criteria:
Inclusion Criteria:

* Being part of a community-based OKRA SPORT+ meeting point that engages in the 12-week walking program

Exclusion Criteria:

* n/a
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes

This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement)
2. Relapsed or refractory disease after first line treatment
3. Availability of archival or freshly collected tumor tissue before study enrollment
4. Evaluable lesion by PET-CT or CT scan
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
6. Life expectancy greater than or equal to (\>/=) 3 months
7. Informed consent

Exclusion Criteria:

1. Patients with central nervous system (CNS) lymphoma
2. History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
3. Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
4. Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

   Neutrophils\<1.0×10\^9/L Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.

   Creatinine is 1.5 times higher than the ULN.
5. HIV-infected patients
6. Active hepatitis infection
7. Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
8. Pregnant or lactation
9. Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease
Needlescopic-assisted Uniportal vs Uniportal VATS

The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.


Eligibility Criteria:
Inclusion Criteria:

Lung or mediastinal disease requiring thoracoscopic surgery

Exclusion Criteria:

Thoracoscopic esophagectomy Decortication for empyema