cyrilzakka/clinical-trials huggingface dataset:
Effect of CAFfeine on Cognition in Alzheimer's Disease

Sporadic Alzheimer's disease is a multifactorial illness arising a major medico-economic stakes for our aging societies. There is currently no curative treatment available.

Coffee is a complex beverage with psychostimulant properties whose main effective element, caffeine, has a pleiotropic effect on the central nervous system. Caffeine pharmacological properties enable its use like an Alzheimer's disease symptomatic treatment. Its supposed benefits mustn't obscure anxiety and insomnia caffeine effect at large dose, which Alzheimer's patients might be more vulnerable.

The main study objective is to evaluate placebo-controlled caffeine efficacy (30 treatments weeks) on cognitive decline in Alzheimer's disease dementia at beginning to moderate stage (MMSE 16-24).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 at screening
* Probable Alzheimer dementia according to the criteria of the National Institute on Aging-Alzheimer's Association; diagnosis must be supported by brain imaging (CT or MRI) and blood test (including ionogram, kidney and liver function, calcemia, CRP, TSH, B12 vitamins and folates) performed in routine care
* MMSE score ≥16
* Presence of an informant and caregiver, living with the patient
* IAChE and/or Memantine treatment non-compulsory ; If implemented it must be effective and stable for 2 months before the selection visit and must remain stable for the duration of the study

Exclusion Criteria:

* Patients who refuse to adopt a low caffeine diet (eviction of tea, caffeinated sodas, chocolate in large quantities)
* Current major depressive episode according to DSM-5 criteria
* Another chronic pathology of the central nervous system
* Major anxiety according to the clinician (consistent with the corresponding nPI-R items that must indicate a severity \>2 and an impact \>3)
* Sleep disorders defined by severity and an impact on NPI-R; a patient fitted for OSA may be included if the device has been in use for 3 months and well tolerated (stable)
* Decompensated heart disease or severe rhythm disorder (excluding slow, treated and stable chronic atrial fibrillation)
* Active smoking
* For childbearing women : pregnancy in progress or planned (A pregnancy test will be performed)
* Patients who take forbidden treatment :

  * Psychotropic treatments introduced or modified \< 2 months before inclusion
  * Chronic use of CYP1A2 inducing or inhibiting drugs
  * All caffeine-containing specialties
  * Drugs that influence caffeine metabolism
  * Drugs that may interact with caffeine
Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting

This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:

* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.

the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) requiring procedural sedation and analgesia for painful procedures in ED . The following procedures are indications for PSA:
* Cardioversion
* Reduction of fracture or joint dislocation
* Procedures as central venous catheter (CVC) and chest tube insertion or wound management

Exclusion Criteria:

* Patients with anticipated difficult airway.
* Post cardiac arrest patients.
* Contraindication to study drugs.
* Pregnant women.
* Patients \> 65 years.
The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube

Single-center prospective randomized trial to evaluate the effect of thermal damage of Ligasure® to destroy cornual portion of fallopian tube tisse.

Right of Left side of fallpian tube is randomized and coagulated one more time than other side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at both cornual portion of cut off specimen.

When investigators perform salpingectomy, both side of cornual portion of the uterus are coagulated by Ligasure®. The randomized, the same word selected side of the fallopian tube is coagulated one more time at the cornual portion than unselected other side of fallopian tube. Hypothesis is that the side selected and coagulated twice would have less fallopian tube tisse left at fianl pathology than the side only once coagulated by Ligasure®.

Eligibility Criteria:
Inclusion Criteria:

* female 35-50
* premenopausal
* plan to perform hysterectomy

Exclusion Criteria:

* disease in fallopian tube before surgery
* has history of pelvic inflammatory disease
Glycemic Control in Diabetic Hospitalized Patients

With the advanced management of diabetes and new innovative anti-hyperglycemic therapy hyperglycemia remains a culprit factor affecting the outcome of patients admitted to the hospital in general wards. Efforts from health care providers to assess and control blood sugar by a simplified method such as certified point of care hand-sized glucometers is the fruitful protocol if the results near the target that is endorsed by well-known diabetes societies. In non-critically patients the premeal blood sugar ≤140 mg /dl and ≤ 180 mg /dl after a meal. The unstable economy and political crises with the pandemic of Covid-19 making us use a glucometer to monitor and control the fluctuation of blood sugar in order to decrease the burden on the patients and health care providers in the form of a stay in the hospital and minimize wasting laboratory resources.


Eligibility Criteria:
Inclusion Criteria:

* admitted to the hospital

Exclusion Criteria:

* none
Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma

The aim of our study is to confirm the relevance of PET using \[68Ga\]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga -PentixaFor/FDG discordances explored.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Symptomatic MM patients according to IMWG criteria (12) requiring first-line treatment
* Written and signed informed consent (obtained on the screening day at the latest and before any investigation)
* ECOG (Eastern Cooperative Oncology Group) \< 2
* Patient affiliated to or beneficiary of the National Health Service

Exclusion Criteria:

* HIV positive, active Hepatitis B or C
* Childbearing or child breast feeding women
* Women or men without effective contraceptive barrier if needed
* eGFR \< 50 ml/min by MDRD or CKDEPI
* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Known active infection
* Patient with uncontrolled insulin-dependent or non-insulin-dependent diabetes mellitus
* Patient under guardianship or trusteeship
* Patient under judicial protection
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation

Eligibility Criteria:
Inclusion Criteria:

* leukemia patients with allogeneic HSCT
* KFS score \>90
* after transplantation, the patient was implanted (peripheral blood neutrophil absolute value \>500/ul for 3 consecutive days)
* no uncontrolled infection after transplantation
* activity II above aGVHD
* patients agreed to participate in the study

Exclusion Criteria:

* patients refused to participate in the study
* patients have poor compliance
* has received hormone therapy
* patients had serious heart, lung, liver, kidney and other vital organs damage
* researchers believe that patients who are not suitable for observation study
Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan


Eligibility Criteria:
Inclusion Criteria:

1. Must be 20 years of age or older
2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
3. BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
4. Able and willing to give signed informed consent and following study instructions

Exclusion Criteria:

1. Clinically significant ocular diseases
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
3. Previous glaucoma intraocular surgery
4. Refractive surgery in either eye
5. Ocular trauma
6. Ocular infection or inflammation
7. Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
8. Cannot demonstrate proper delivery of the eye drop
9. Clinically significant abnormalities in screen lab tests
10. Clinically significant systemic disease
11. Participation in any investigational study within 30 days of screening
12. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>/= 18 years
* Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening

Exclusion Criteria:

* Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
* Recreational drug use within past 30 days
CFTR Modulators and Gastrointestinal Complications

To elucidate the similarities and distinctions in non-pulmonary manifestations of cystic fibrosis (CF) including distal intestinal obstruction syndrome (DIOS) incidence and pancreatic enzyme replacement therapy (PERT) use between US and UK CF populations in a parallel study using data from the UK and US CF registries. To assess how CFTR modulators impacted upon recorded PERT use and incidence of DIOS.

Cystic fibrosis (CF) is a autosomal recessive multi-system disorder caused by mutations to the cystic fibrosis transmembrane conductance regulator (CFTR) gene. As well as the documented respiratory complications of CF, gastrointestinal manifestations are of clinical importance. CFTR mutations in the gastrointestinal tract are responsible for pancreatic exocrine insufficiency in around 85% of people with CF (pwCF). In addition a severe gastrointestinal complication in CF is distal intestinal obstructive syndrome (DIOS), affecting 5.7% pwCF in the UK (2.5% in \<16 years and 7.7% in adults) and 2.1% in the US (\<18 years 1.7%, adult 2.4%) in 2019.

This is a parallel data registry study using data from the UK and US CF registries, with data provided for the time period 2007-2018. As such no individual participants will be recruited to the study. The CFTR modulators to be studies are Ivacaftor and lumacaftor/ivacaftor.

Study aims;

* Describe DIOS events and PERT usage in UK and US registries
* Determine the effect of CFTR modulators on the incidence of DIOS and use of PERT: population time series
* Determine the effect of CFTR modulators on the incidence of DIOS and use of PERT: patient-level time series

The outcomes of the above aims will be used to generate hypotheses regarding the effect of the newer CFTR modulators such as Symdeko/Symkevi and Tricaftor/Kaftrio on PERT usage and DIOS incidence in CF registry data post 2018. This will form the basis of future studies.

Eligibility Criteria:
Inclusion Criteria:

* All patients with CF of any genotype on the UK and US cystic fibrosis registries from the period 2007 - 2018.

Exclusion Criteria:

- Patients whose CFTR modulator status is unknown or only have one year of CFTR data recorded on the registry will be excluded from the analysis of the effects of CFTR modulators. This is to account for the fact that DIOS data is annualised on the registries, therefore there is no certainty at what time of year DIOS was diagnosed in relation to commencing CFTR modulator therapy.
6-year Follow-up of Dysphagia in Patients With Parkinson's Disease

We recruited 116 patients with idiopathic PD who were from the Neurology clinic of the Second Affiliated Hospital of Zhejiang University, School of Medicine from January 2014 to November 2014. Perform videofluroscopic swallowing study and psychiatric and neurological evaluations and followed up after 6 years.

In baseline, 116 patients with idiopathic PD were recruited from the Neurology Clinic of the Second Affiliated Hospital of Zhejiang University School of Medicine according to the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria. They were admitted from January 2014 to November 2014, and were followed up after 6 years.

Perform psychiatric and neurological evaluations. And use Videofluoroscopic swallowing study (VFSS) to assess the swallowing function of PD patients. Added 200mg of barium sulfate to 286ml water to achieve a concentration of 60%. Add a thickener (Ourdiet Swallow, Ourdiet Biotech Co. Ltd, Guangzhou, China) to prepare juice and pudding viscosities, No thickener was added to the liquid viscosity. The patients were advised to have boluses of 3, 5 and 10 ml of the liquid, juice, pudding viscosities in sequence according to the clinician's instructions under X-ray fluoroscopy. The patients ware sitting or standing, The lateral view of the patients' swallow was recorded by a camera (30 frames per second). The radiologist, the clinician, and the rehabilitation therapist completed this examination. Two person analyzed the video in slow motion and frame - by - frame, and record abnormal results. The VFSS inspection parameters are Penetration/aspiration score and Residue score. In order to reduce the influence of drugs on dysphagia, all patients were in the off - period. The patients stopped taking anti-Parkinson's disease drugs from 9 o'clock the night before the examination, and were tested in the morning (free of medicine for more than 12 hours).

The patients had completed the above tests in 2014 and were asked to perform the above assessments again.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic PD according to the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria.

Exclusion Criteria:

* (1) Parkinsonian syndromes;(2) with severe lung disease, severe liver insufficiency and cardiac insufficiency; (3) Kubota water drinking test grade ≥3; (4) have had or combined other diseases that affect swallowing function; (5) Nasal feeding, gastric reflux or gastrostomy; (6) Mental disorders Or patients with low intelligence and cognitive function, unable to understand and cooperate with the examination.
Measurement of Cardiac Index Using an Implanted Central Venous Access Port in Patients Scheduled for Oncologic High-risk Surgery

Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. We currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Germany). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique.

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. We conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.

Eligibility Criteria:
Inclusion Criteria:

* presence of port
* scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol
* oral consent of the patient after oral and written information

Exclusion Criteria:

* age inferior to 18
* Contraindication or failure to the insertion of the CVC
* Contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow
Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry

This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with miltefosine (Impavido) in the US and who weigh \> 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.

Objective: The purpose of this observational study is to fulfill PMR 2127-4 for the miltefosine NDA (204684): implement a higher-weight-patient registry for the time period Mar 2015-Mar 2020.

Study Design: This study is a prospective observational study in which patients undergoing treatment for leishmaniasis with Impavido in the US and who weigh \> 75 kg can volunteer to provide information about their clinical response to treatment up to 6 months after the start of treatment.

Population: Leishmaniasis patients treated with Impavido who weigh more than 75 kg.

Drug Product:

Drug name: Impavido (50 mg capsules). Dosing regimen: as per the Impavido Product Label

Study Procedures: Patients who weigh more than 75 kg will become aware of the Impavido Higher-Weight Patient Registry via the Impavido website. By calling 1-866-588-5405, the patient will be connected to the Impavido Higher-Weight Patient Registry Coordinating Center. A trained staff member will acquaint the patient with the goals and procedures of the study. If the patient tentatively agrees to participate in the study over the telephone, the patient will be mailed information forms, the Consent/Assent Forms, and the Consent for the patient's physician to release medical information. Receipt of the two signed Consent and/or Assent Forms by the Coordinating Center will signify patient consent. The Coordinating Center will contact the patient's physician at the end of treatment, and at 1, 3, and 6 months after completing treatment, to collect data on efficacy and adverse effects (only during treatment).

Sample Size and Study Duration: Estimated 3-10 patients per year for 5 years.

Outcome Parameters:

Efficacy Adverse effects

Analysis: Baseline data, compliance to prescribed treatment, and outcomes will be reported for individual patients and for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Did the subject give consent to collect data from her or her physician?
2. Was the subject treated for leishmaniasis with miltefosine?
3. Does the subject weigh more than 75 kg?

Exclusion Criteria:

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STEM (Science, Technology, Engineering & Math) Familia Talk

After development of the Talk Stem Familia (TSF) smart-speaker application prototype, the study will evaluate the prototype's efficacy in a within-subjects pre-post design study. The sample will contain 50 parent-student/child dyads who will use the Alexa skill app for 6 weeks.

Participants will receive an Echo Dot device enabled with the application prototype using a research Amazon account created for each dyad. The Echo Dot devices will be preconfigured by project staff onto research Amazon accounts. Parents will come to one of several orientation sessions to obtain their device and set-up instructions; staff will provide follow-up phone support as needed. Usage data will show how much the device is used by each dyad. To ensure exposure to TSF, parents will be asked to engage at least 3 times per week; project staff will prompt parents bi-weekly (via text, email, device notification, phone) during the 6-week intervention to encourage usage and provide needed technical support.

Eligibility Criteria:
Inclusion Criteria:

* Latino parents and their children who are students in grades 3 through 6.
* Parents have Spanish as primary home language.
* Family has wi-fi in the home.
* No age limits for parents. Their child must be in grades 3 through 6.

Exclusion Criteria:

* Parents and their children who are students in grade levels below grade 3 or above grade 6.
* Parents do not have Spanish as primary home language.
* Family does not have wi-fi in the home.
* Children younger than 8 (or in grade levels below grade 3).
Use of Sentinel Cells for the Development of Molecular Tests to Control the Quality of Cryopreservation

The aim is to set up tools that will serve as quality tracers for cryopreservation procedures.

To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in the medium term, can be used as controls to guarantee the quality of preservation for biological samples.

The biological tools and an optimised follow-up strategy will make it possible to validate preservation procedures at the CRB in order to guarantee the perfect stability of samples and the validity of clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years
* All patients presenting an abdominal aorta diameter of at least 5 cm at the time of discovery and who have surgery

Exclusion Criteria:

* Patients who do not have aneurysm of the abdominal aorta
* Refusal to sign the consent form for participation
* Patients who do not wish to have their operation in Dijon or Strasbourg CHU