cyrilzakka/clinical-trials huggingface dataset:
Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)

This study addresses a "lifespan approach to healthy development and aging" with direct relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot study to: i) better estimate power for a larger trial, ii) establish the safety and potential beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the effects of acarbose on the microbiome likely play a role in its enhancement of longevity and/or healthy aging. These are essential initial steps for translating acarbose into an anti-aging human therapy.

Treatment with acarbose, an α-glucosidase inhibitor, extends median lifespan by 22% in male mice. Acarbose is FDA-approved for use in humans and has been extensively employed for the management of diabetics; there have been few associated side effects reported. Acarbose is considered a very safe treatment. Thus, the investigators hypothesize that acarbose treatment could be used in elderly humans to elicit improvement in systems known to be negatively affected by aging. Since the outcomes of acarbose treatment may be differentially affected by age, it is imperative to test the drug directly in older subjects for its safety and efficacy. Towards this end, the investigators propose to perform a small pilot study assessing the effects of acarbose in ten elderly subjects, aged 75-95 years old. Briefly, a cohort of non-diabetics will be recruited; subjects will be in generally good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. Trial participants will be studied before drug initiation (pre-treatment), during 3 months of acarbose (blood draws at 1 month and 3 months of treatment), and following termination of the drug (1 and 3 months post treatment) such that each subject will serve as his own control. Gut microbiome composition will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* age 70-95
* participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
* participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

Exclusion Criteria:

* unstable ischemic heart disease
* clinically significant pulmonary disease
* history of immunodeficiency or receiving immunosuppressive therapy
* history of a coagulopathy or receiving a medical condition requiring anticoagulation
* an estimated glomerular filtration rate of \<30ml/min
* uncontrolled hypercholesteremia \>350mg/dl;
* uncontrolled hypertriglyceridemia \>500mg/dl
* diabetes
* history of skin ulcers or poor wound healing
* smoking
* liver disease treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)
The Effect of Vitamin D3 Therapy on Vitamin D Status in Pregnant Women With Vitamin D Deficient and Insufficient

This study is a randomized controlled trial which compares the effect of vitamin D3 therapy 5,000 IU daily and 50,000 IU on 25(OH)D and 1,25(OH)2D, VDBP, and 24,25(OH)2D maternal serum levels in pregnant women with vitamin D deficient and insufficient.

This is a randomized controlled trial of vitamin D therapy of 5,000 IU daily or 50,000 IU weekly during pregnancy. The study is conducted at Cipto Mangunkusumo National Center General Hospital and Koja Distict Hospital in Jakarta, Indonesia from April 2021 - December 2023. All the pregnant women are screened for eligibility when they presented to the clinic for antenatal care visits and are offered enrolment if they meet the following inclusion criteria: gestational age of ≤ 14 weeks, vitamin D deficient or insufficient (25(OH)D \<30 ng/ml\], and positive fetal heart rate from ultrasound examination.

Participants are randomly assigned to one of two parallel intervention groups, with allocation concealment: vitamin D3 (cholecalciferol) 5,000 IU/week or 50,000 IU/week. All participants are given a standard prenatal multivitamin. A medical history, physical, and ultrasound examination are performed. Participants complete a questionnaire about sunlight exposure. Interventions in both groups are given for four weeks. Baseline blood tests, including serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D are performed at recruitment. After four weeks of interventions, the maternal venous blood is collected to assess serum 25(OH)D, 1,25(OH)2D, VDBP, and 24,25(OH)2D.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with gestational age of ≤ 14 weeks
* vitamin D deficient or insufficient (25(OH)D \<30 ng/ml\]
* positive fetal heart rate from ultrasound examination.

Exclusion Criteria:

* multiple pregnancy
* pregnancy with congenital anomaly
* hyperemesis gravidarum, diarrhea
* complicated medical history (hypertension, diabetes mellitus, heart, kidney, or liver disease)
* use of any dietary supplement containing vitamin D prior to enrolment
Does Cervical Mobilization Have an Effect on Hand Function in Patients With Double Crush Syndrome?

All Double Crush Syndrome patients were assessed via VAS, BCTQ \& Nerve conduction study before and after the treatment program.

The patients were classified randomly into two groups, the control group received a standard physical therapy program of nerve glide, hand strengthening exercise and mobilization and the study group they received a cervical mobilization in addition to the standard physical therapy program for 12 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Thirty female patients diagnosed as Double Crush Syndrome based on the clinical diagnostic criteria of the American Academy of Neurology, (American Academy of Neurology 2019).
* Patient ages ranged from 25 to 35 years old. Patient who reported pain, hyperesthesia, and/or paresthesia at the course of median nerve distribution and upper limb.
* A Nerve Conduction Study (NCS) evidence of peripheral entrapment of median nerve at level of carpal bone "Carpal tunnel Syndrome" with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less and with sensory peak latency \> 3.6 ms and recordable and with motor distal latency \>4.4 ms and less than 6.5ms.

Exclusion Criteria:

* Patients had Systemic disease causes double Crush Syndrome as rheumatoid arthritis (RA), thyroid disease, Diabetes mellitus (DM), Pregnant women, Patients with concomitant neurological disease as peripheral neuropathy, Patients with history of wrist surgery, fracture, or carpal tunnel injection in the last two weeks before the study, Patients who have wasting of the thenar muscles, Patients with previous surgery for CTS.
* Patients with complete conduction block on EDX or previous regular exposure to hand-held vibrating tools, Patients with Nerve Conduction Study with motor distal latency \> 6.5 ms.
Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation

There is few randomized controlled clinical to investigated the impact of anesthetic type on outcome in patients with acute ischemic stroke in posterior cerebral circulation. It is unknown whether the choice of anesthesia is impacted on the outcomes for these patients or not. The investigators will perform a randomized controlled pilot clinical trial of general anesthesia versus local anesthesia/conscious sedation to explore and find out a potential fact whether anesthetic type alters perioperative neurological function in patients with acute ischemic stroke in posterior cerebral circulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke in posterior cerebral circulation scheduled to receive emergency endovascular treatment; Age \> 18; The onset time is within 24 hours; Modified rankin score ≤2 before onset.

Exclusion Criteria:

* Radiological ambiguity concerning infarction and vessel occlusion; Additional intracerebral hemorrhage; Anterior circulation infraction; Coma on admission (Glasgow coma score less than 8); NIHSS less than 6 or more than 30; Severe agitation or seizures on admission; Obvious loss of airway protective reflexes and/or vomiting on admission; Being intubated before treatment on admission; Known allergy to anesthetic or analgesic;
A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer

A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
* Patient must have at least one unidimensionally measurable lesion.
* Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
* Performance status 0 to 2
* Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease

Exclusion Criteria:

* Treatment with any drug within the last 30 days that has not received regulatory approval.
* Serious systemic disorder (cardiac or pulmonary disease, active infection)
* Documented brain metastases not amenable to surgery or unstable after radiation
* Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
* Presence of fluid retention that can not be controlled by drainage.
Osteopathic Support Evaluation of Fibromyalgia Patients

At present, the literature does not account for much of scientific data on the assessment of osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic interventions in the treatment of FM, in order to improve the painful experiences of FM patients. This study must include 44 patients with FM according to (American College of Rheumatology) ACR criteria and followed the University Hospital of Caen.

The osteopathic care will last eight months and will be followed by a report three months after the end of osteopathic interventions. This in order to evaluate the effect in the short term and long term, of osteopathic care in patients with FM.


Eligibility Criteria:
Inclusion Criteria:

* FM patient diagnosed according to the ACR criteria.
* Patient Having realized biological balances excluding any underlying pathology that may be causing the pain.
* Patient Over 18 years followed at Caen University Hospital.
* Patient Treated with drugs to its FM.
* Patient Being informed and having signed his consent.
* Patient Affiliated to the social security system.
* French-Patient.

Exclusion Criteria:

* FM undiagnosed according to the ACR criteria.
* Patient Showing against -indications to the osteopathic surgery.
* Patient Treated by manual therapy ( physiotherapy, osteopathy, acupuncture... ) during the trial and during the three months preceding the study.
* Concomitant Maladie (type cancers, cardiovascular diseases, rheumatic diseases ) or all diseases causing bone pain and myalgia.
* Important Surgery of less than 3 months.
* Inability to submit to medical monitoring study for geographical or social reasons.
* Inclusion The subject in another biomedical research protocol for this study.
* Women Pregnant or nursing.
Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery

This study evaluates the myocardial protection against perioperative ischemia comparing two standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of the patients will receive volatile anesthesia while the other half will receive total intravenous anesthesia. Primary and secondary outcome parameters will be assessed after induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.

Volatile anaesthetics such as Sevoflurane have shown to have a protective effect regarding myocardial ischemia in the perioperative setting - the so-called "preconditioning". However the observed response of preconditioning in clinical trials is not consistent.

An increased perioperative insulin resistance especially in diabetic patients resulting in an increased postoperative morbidity and mortality may be responsible for these findings.

In an animal model, the use of propofol that is being routinely applied for general anesthesia was associated with a change of the insulin receptor substrate via phosphorylation and thus a change of insulin resistance.

Avoiding a total intravenous anesthesia and applying a volatile anesthesia may result in an increased cardioprotective effect by a reduction of the perioperative insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes
* Elective cardiac surgery

Exclusion Criteria:

* Emergency procedures
* Preop myocardial infarction
* Preop cardiac failure
* Preop renal replacement therapy
The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction

The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD.


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of SIJD
* Being between the ages of 18 and 40
* Volunteering to participate in the study

Exclusion Criteria:

* Having a history of any neurological, psychiatric and/or orthopedic disease
* Being pregnant or having a suspicion of pregnancy
* Having one or more of disc herniations, spondylosis, spondylolisthesis and/or similar lumbar pathologies that may cause low back pain
* Having a history of previous spine/hip/lower extremity surgery
* Having a history of active malignancy and/or infection
* Having a history of any injection and/or surgical procedure for the sacroiliac joint within the last 3 months
A Protected Discharge Model Using Technology in Multimorbid and Poly-treated Older Subjects

The main goal of thi clinical trial is to evaluate if a protected discharge model can reduce the length of hospital stay in older participants aged over 65 years old who have been admitted to the hospital for an acute event and have been considered stable and dischargeable. Participants of the intervention group will be asked to transfer to a small apartment, inside the hospital setting, equipped by technological devices and to be involved in cognitive and physical activities during the stay. Researchers will compare this intervention group with a control group who receive normal clinical practice where older people remain in the hospital ward.

Participants who fit the inclusion criteria are randomized in two arms (intervention or control groups). All of them are evaluated with a comprehensive geriatric assessment (Multidimensional Prognostic Index), a depression scale (Geriatric Depression Scale), quality of Life scale (Short-Form 12 items), and physical parameters (Hand Grip, Short Physical Performance Battery, gait speed). In the intervention group the following clinical parameters will be collected through technological devices: spontaneous physical performance, sleep monitoring, gait speed, quality of movements, heart rate, SpO2, and other vital parameters.

Eligibility Criteria:
Inclusion Criteria:

1. participants aged 65 years or older;
2. admitted to the acute geriatric units for an acute event;
3. deemed stable and dischargeable from the hospital;
4. good personal autonomy in the Activities of Daily Living (ADL) (according to the Katz ADL scoring≥ 3/6);
5. normal cognition or mild cognitive impairment (Short Portable Mental Status Questionnaire (SPMSQ) ≤ 5/10);
6. signed informed consent

Exclusion Criteria:

1. participants aged less than 65 years old
2. not considerable stable and dischargeable
3. ADL \<3/6
4. SPMSQ \> 5/10
5. not signed informed consent
A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk

The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.

The main objective of the study is to explore the differences in human milk composition from mothers delivering by Caesarean-section and normal vaginal deliveries. To further associate the differences found in human milk composition to infant outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Human milk to be selected from the mothers who have delivered at full term (\>37 weeks of gestation).
2. 125 subjects will be selected who have delivered infants by Caesarean-section.
3. 125 subjects will be selected who have delivered infants by vaginal/normal deliveries.
4. Subjects will be selected based on sample availability.
5. Based on sample availability to balance by stage of lactation, geographical locations within China.
6. Subjects of Han ethnicity.
7. The collection of existing biological material and/or health-related personal data have been consented in the frame of the approved original study scope. We will propose to the participants to consent to this specific research.

Exclusion Criteria:

1) Incomplete information either for the subject or the sample collected.
Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery

The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).

About 108 people will take part in this study (54 in the study group and 54 in the control group). Subjects will have an ultrasound of the abdomen before their scheduled surgery. The ultrasound will determine how much fluid remains in the abdomen.

Researchers will also review subjects' medical records and will include: age, body mass index, history of cannabis use including how often and how consumed, reason for surgery, and length of time without eating before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years and older
* Planned surgery at one of two hospitals within the healthcare system
* Willing to state if they use or do not use cannabis
* Able to read and consent on their own behalf

Exclusion Criteria:

* Cognitively impaired
* Unable to read
* Children under the age of 18
* Pregnant women - Pregnancy status will be obtained from the routine pregnancy test performed prior to surgery
* History of gastroparesis
* Gastric surgeries
* Advanced liver or renal dysfunction
* Critically ill
* Emergent/urgent cases
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone

This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.


Eligibility Criteria:
Inclusion Criteria:

* Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
* Subjects who receive Norditropin NordiFlex® according to the SPC

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Child and/or parent unable to give consent or fill out the questionnaires
* The receipt of any investigational medicinal product within 3 months prior to this study
* Suffer from a life-threatening disease
Patient Satisfaction With Contoura Vision Topography-Guided LASIK

To evaluate patient reported outcomes associated with quality of vision before and after treatment with Contoura Vision Topography-Guided LASIK.


Eligibility Criteria:
Eligibility criteria: The study enrollment will include all willing patients with: pre-operative BCVA 20/20 for each eye individually, myopic refractive error up to -8.00 diopters, refractive astigmatism that ranges from 0 to 3 diopters, maximum spherical equivalent of -9.00 diopters, the designated age requirements, and only patients that have signed the informed consent document.

Exclusion criteria: Patients are excluded that are not willing to participate in a research trial, are unable to cooperate well enough to safely perform the procedure, fail to meet inclusion criteria, have ocular disease (including but not limited to keratoconus, macular degeneration, glaucoma, corneal dystrophy, dry eye syndrome and corneal scarring), and patients that have had previous ocular surgery. Any patients with known allergies to the post-operative medications or preservatives in the medications will also be excluded.
Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids

Cell-based immune therapy using modified macrophages is a promising therapeutic approach in breast cancer. The objective of this cohort study is to collect tumor samples to develop patients' derived organoids to test the antitumor activity of newly developed CAR-macrophages. Other biological samples will be collected such as blood to analyze the host inflammatory status.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or more
* Histologically confirmed breast cancer at any stage
* Requiring surgery or tumor biopsy as standard of care
* Any or no systemic treatment
* Signed informaed consent
* Health insurance coverage

Exclusion Criteria:

* Opposed to biospecimen collection