cyrilzakka/clinical-trials huggingface dataset:
Very Small Embryonic-like Stem Cells for Ovary

The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.

Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, \> 40 IU/L)、luteinizing hormon (LH, \> 40 IU/L)、estradiol (E2, \> 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed as premature ovarian failure by professional doctor.
* Those have clear abnormal sex hormone levels

Exclusion Criteria:

* Unmarried woman
* Suffering from other serious gynecological diseases or gynecological tumors
* Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Effectiveness of a Virtual Reality-Based Sensory Stimulation Intervention in Preventing Delirium in Intensive Care Units

The goal of this clinical trial is to evaluate the effectiveness of a VR-based sensory stimulation system in preventing ICU delirium in patients. The main questions it aims to answer are:

Is the VR-based sensory stimulation system more effective in preventing ICU delirium compared to usual care? Does VR sensory stimulation improve patient psychological well-being and clinical outcomes in the ICU?

Participants will:

Experimental Group:

Engage in VR-based sensory stimulation sessions involving visual or/and auditory stimulation.

Control Group:

Receive usual care without additional VR-based interventions.

Comparison:

Researchers will compare the outcomes between the experimental group (receiving VR-based sensory stimulation) and the control group (receiving usual care) to determine the effects of VR sensory stimulation on ICU delirium prevention, as well as its impact on patient psychological well-being and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All ICU patients admitted to the study setting will be recruited if they are have: (1) ≥ 18 years, (2) the first time admitted to ICU and (3) a Richmond Agitation-Sedation Scale (RASS) score ≥-3

Exclusion Criteria:

* Patients will be excluded if they have: (1) been diagnosed with dementia, delirium or acute psychiatric illness at admission, (2) been diagnosed with end-stage cancer, (3) severe hearing impairment and cannot be corrected by hearing aids and (4) been admitted to ICU with radioactive material.
Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride

Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in average (with high variability) in the fourth decade. The disease progression is classically characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining depression and irritability) and metabolic disorder (cachexia). The disease is fatal within 15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also beneficial and adverse effects on other disease characteristics (motor, psychiatric, cognitive or metabolic). Their profile between beneficial and adverse effects could be different according the neuroleptics and their classification. The aim of this study is to compare beneficial and adverse effects of 3 different neuroleptics in HD.

We proposed a randomized controlled trial, including 180 patients, in 3 groups: Olanzapine, Tetrabenazine and Tiapride, followed during 12 months. These treatments have been selected according their profile and their frequency of use.

The principal criteria is the Independence scale, one of the functional scales of the Unified Huntington's Disease Rating Scale, the only validated scale in HD.

Secondary criteria will assess motor,functional, psychiatric and cognitive functions, metabolic parameters, tolerance and cost.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic disease with motor, behavioural and/or psychiatric disorder required medical treatment.
2. HD diagnosed with abnormal number of CAG repeats: 38 ≤ nucleotide expansion (CAG) (amendment n°5 suppressed the limit ≤ 48)
3. Neuroleptic Prescription required.
4. Age ≥ 18 (amendment n°5 suppressed the limit ≤ 65 years old)
5. Patient gave its written consent
6. Realization of medical examination and a Electroencephalogram

Exclusion Criteria:

1. Severe cognitive impairment or neuropsychiatric troubles.
2. Existing diabetes.
3. Neuroleptic prescription forbidden according to the neurologist decision.
4. Current participation to another clinical trial.
5. No drug compliance to previous treatment.
6. No national health insurance affiliation
Cerebral Oximetry and NIRS in Cardiac Arrest Patients

This is an observational study to define the role and future applications of cerebral oximetry in cardiac arrest patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Non-traumatic cardiac arrest or post non-traumatic cardiac arrest
* No purposeful response to verbal or noxious stimuli

Exclusion Criteria:

* Age \< 18 years
* Open head injury/trauma
Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein

To evaluate the values of portosystemic shunt and other interventional radiology approaches for treatment of symptomatic portal hypertension in patients with cavernous transformation of portal vein.


Eligibility Criteria:
Inclusion Criteria:

* All patients with portal hypertention who have enough image information to confirm cavernous transformation of portal vein.

Exclusion Criteria:

* Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs.
Phase II Study of Growth Hormone in Children With Cystic Fibrosis

OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis.

II. Determine the effect of growth hormone on pulmonary function in these patients.

III. Determine the impact of this drug on the quality of life in these patients.

IV. Determine if the clinical response from this drug is sustained in these patients.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only.

Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.

Quality of life is assessed at baseline and then every 6 months for 2 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of prepubertal cystic fibrosis
* No colonization by Burkholderia cepacia

--Prior/Concurrent Therapy--

* No prior or concurrent insulin requirement

--Patient Characteristics--

* Hematopoietic: No hematologic disease
* Hepatic: No liver disease
* Renal: No kidney disease
* Pulmonary: Must be able to perform pulmonary function testing
* Other: No history of diabetes Must be less than 25% of normal height and/or weight for age and sex
Impact of Bed Availability and Cognitive Load on Intensive Care Unit Bed Allocation: a Vignette-based Clinical Trial

Decisions about ICU beds allocations are made everyday, specially in countries with scarcity of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that external factors may influence the decision making process. The investigators intend to evaluate the impact of bed availability and cognitive load on the ICU bed allocation process by submitting groups of individuals to a vignette based randomized controlled trial simulating conditions with or without increased cognitive load and conditions with or without scarcity of ICU beds.

Vignettes will be constructed based on consecutive patients for whom ICU bed was solicited. Vignettes will be validated through the evaluation of 8 experts in situations with or without bed scarcity. Vignettes with more than 80% concordance on ICU disposition (admission or refusion) will be used in the trial.

Intensive care doctors in Brazil will be asked to answer an online questionnaire with demographic characteristics and randomized to one of two groups. The experimental group will be submitted to increased cognitive load conditions, meaning that they will be encouraged to give their first impression on the vignettes, will have a time limit to answer the questions and will have popups with sound and videos, with the purpose to distract the respondents. The control group will be encouraged to think thoroughly and will have no time limit or distractions.

Vignettes will be presented, randomly, in conditions with or without scarcity of ICU beds to both groups. So, respondents with and without increased cognitive load will evaluate vignettes in conditions with and without scarcity of ICU beds.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care unit doctors participating in specialty email lists

Exclusion Criteria:

* Consent not provided
Proof of Principle for a Diagnostic Blood Test of Recurrent Seizures

The primary goal of this observational study is to establish the accuracy of CNS-specific Assay for Recurrent Paroxysmal Events (CARPE) as a diagnostic blood test for epilepsy. The target population is patients who have been newly referred to the Penn Epilepsy Center or patients who are admitted to HUP for continuous video EEG monitoring. (Subjects without an epilepsy diagnosis will be included.) Subjects will be asked to provide consent, agree to allow the study team to collect information from their medical record, and to provide at least one blood sample.


Eligibility Criteria:
Inclusion Criteria:

* Male/female patients aged 12 and older
* Evaluation in at least one of the following settings:
* Newly referred to the University of Pennsylvania Penn Epilepsy Center. These patients may not have completed any diagnostic evaluation at Penn, other than an initial physician consultation, prior to enrollment and must agree to allow the study team to collect records regarding their diagnostic evaluations (including EEG). Diagnostic evaluations may take place at Penn or outside sites
* All patients who are admitted to the University of Pennsylvania for continuous video EEG (cVEEG) monitoring

Exclusion Criteria:

* Patients who, in the opinion of the investigator or the patients neurologist, are unable to give Informed Consent due to mental impairment or any other reason AND do not have a LAR who can give Informed Consent on their behalf. Patients aged 12-17 (inclusive) must provide assent if they are mentally capable of doing so, and must also have a caregiver who provides Informed Consent on their behalf
* Patients who, in the opinion of their neurologist at the University of Pennsylvania, are not good candidates for donating blood for any reason
The Effects of Glucagon on Hepatic Metabolism

Whether impaired postprandial glucagon suppression in prediabetes and T2DM is an attempt to overcome resistance to glucagon's actions on hepatic AA catabolism, a defect in α-cell function, or a combination of both are important, unanswered questions. NAFLD is associated with T2DM risk and impaired insulin action. Unfortunately, it is unclear if glucagon resistance is caused by obesity, hepatic steatosis or both. The experiments outlined will determine if glucagon's actions on hepatic amino acid catabolism and EGP interact with hepatic lipid metabolism in lean and obese subjects with and without T2DM (and with varying degrees of hepatic steatosis).

T2DM and prediabetes are characterized by abnormal post-prandial suppression of glucagon, which contributes to postprandial hyperglycemia by increasing EGP. Although these effects are magnified by decreased and delayed insulin secretion, they are also apparent when insulin secretion is intact. In rodents, altered glucagon signaling changes α-cell function and mass - an effect mediated by changes in circulating AA concentrations. Are the elevated concentrations of branched-chain AA and other AA metabolites in T2DM a cause or an effect of global α-cell dysfunction? Could altered glucagon signaling precipitate a vicious cycle resulting in T2DM?

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Able to give consent

Exclusion Criteria:

* History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.
* Contraindications to MRI (e.g. metal implants, claustrophobia).
* Hematocrit \< 35%
* TSH \< 0.4 or \> 5.5.
* Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire
The Effects of Zn-containing Granulate on Patient Morbidity and Wound Healing After Free Gingival Graft Surgery

There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic Zn-containing granules which was prepared chairside.

There are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.The highest pain level perceived in the palatal region after the FGG operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. Although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.

Eligibility Criteria:
Inclusion Criteria:

* Periodontal and systemically healthy

  * ≥19 years old
  * Amount of attached gingival width in the maxillary or mandibular anterior region \<2 mm
  * Full mouth plaque index score, bleeding index score on full-mouth probing \<15%

Exclusion criteria;

* Previously undergone surgery for a graft harvested from the palate
* Presence of systemic disease
* Taking medication known to interfere with periodontal health
* Smoking
Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics

The purpose of this study is to determine whether Q cells separated from the glioma sample are determinants in treatment response and prognosis of glioma patients

The unique markers of Qcell were screened using the method of genomics and

proteomics, then these markers will be qualitatively and quantitatively evaluated in

glioblastoma patients by comparing their relationship with overrall

survival/progression-free survival and treatment response.

Eligibility Criteria:
Inclusion Criteria:

1. \>=18 years old
2. Primary Glioblastoma is newly diagnosed and confirmed histologically
3. Patient is expected to be treated with temozolomide and followed up routinely at the study site.
4. Willing to sign the informed consent

Exclusion Criteria:

1. Currently enrolled in any other clinical study
2. History of any other malignancies
3. Refusal to give consent
4. No available tumor tissue for IDH analysis.
Ahmed Glaucoma Valve Surgery With Mitomycin-C

This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.

Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.
* Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.
* For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.

Exclusion Criteria:

* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
* Pregnant or nursing women.
* Previous cyclodestruction or glaucoma drainage device (GDD) surgery.
* Patients with nanophthalmos.
* Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
* No light perception vision.
* VA \<20/200 in non-study eye.
* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
* Previous scleral buckling procedure or silicone oil present.
* Uveitic glaucoma.
Opioid Laws and Pediatric Use

The legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. The overarching goal of application is to assess opioid use and outcomes of pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large academic pediatric medical center before and after Ohio opioid prescription rules for acute pain were implemented on August 21, 2017. Also, to evaluate patient use of opioids at 90-days post-treatment.

This study has a prospective and retrospective component. Phase 1 involves a retrospective chart review will be performed among pediatric patients undergoing burn care or knee arthroscopy at our institution to determine a whether there was a reduction in prescribed opioid medications following the 2017 Ohio opioid prescription law. A 24-month pre-law period (August 1st, 2015, to August 31st, 2017) and 24-month post-law period (September 1st, 2017, to August 31st 2019) will be compared. This phase will include 300 patients (n=150 burn, n=150 knee arthroscopy) evenly divided between the pre-law and post-law periods.

Phase 2 involves a prospective patient telephone survey 90 days after burn care or knee arthroscopy procedure to assess the association of opioid prescribing, consumption and amount of left-over medications, and pain control status after 90 days. This phase will include 100 patients (n=50 burn, n=50 knee arthroscopy) recruited via convenience sampling.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients age 0-18 years (inclusive)
* treated at our institution for either a burn injury or knee arthroscopy procedure
* received at least one opioid prescription

Exclusion Criteria:

* patients age 19 years and above
* patients who did not receive any opioid medications
* patients undergoing knee arthroscopy with simultaneous anterior cruciate ligament (ACL) reconstruction
* families unable to to communicate in English
Combined rTMS and Relaxation in Chronic Tinnitus

Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a pilot trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bothersome, subjective chronic tinnitus
* Duration of tinnitus more than 6 months

Exclusion Criteria:

* Objective tinnitus
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Prior treatment with TMS