cyrilzakka/clinical-trials huggingface dataset:
Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression

The purpose of this study is to assess the effects of simultaneous administration of oral aspirin and oral ketamine as a therapeutic for those with Treatment Resistant Depression.

The objective of the study is to evaluate the effect of simultaneous administration of oral aspirin and oral ketamine, formulated for partial release in the oral cavity and partially swallowed, as an adjunct to the oral antidepressant on depressive symptoms in patients suffering from Treatment Resistant Depression (TRD) in outpatient Psychiatric Clinic. Investigators will evaluate the effects of simultaneous administration of oral aspirin and oral ketamine, on depressive symptoms.

This is a prospective open-label, proof of concept clinical trial of simultaneous administration of proprietary formulations of oral aspirin and ketamine in medically stable adult patients with a diagnosis of Treatment Resistant Depression. All eligible participants will commit to three visits. The first two visits are in-person at the clinic for administration of oral ketamine and oral aspirin. Participants will be under observation for at least two hours. Study participant's vital signs will be monitored, periodically. The last visit will be conducted remotely.

Adult patients 18 years of age and older, with a diagnosis of TRD presenting to the psychiatric clinic will be screened for enrollment by study team.

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Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Treatment Resistant Depression with Montgomery-Asberg Depression Rating Scale score \>22 upon presentation to the clinic
* Treatment Resistant Depression is defined as Major Depressive Disorder that does not cease after at least 6 week trial of another class of antidepressants
* Unipolar Depression

Exclusion Criteria:

* Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to act
* History of Bipolar Disorder, Obsessive Compulsive Disorder, antisocial personality disorder, borderline personality disorder, and congestive cardiac failure
* Uncontrolled hypertension (BP \>140 mm Hg systolic and/or \>90 mm Hg diastolic on two separate readings at the time of screening) or on 2 medications for hypertension
* Patients with unstable vital signs (systolic blood pressure \<90 or\>160 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min),
* History of Gastrointestinal hemorrhage, renal and hepatic insufficiency
* Allergy to Ketamine or Aspirin
* Active Substance Abuse Disorder
* Active psychosis
* Active Peptic Ulcer Disease
* Lithium Therapy
* Swallowing difficulty
* Consumption of Aspirin or NSAID's within 6 hours of arrival to the site
* Previous participation in this study; a patient may not re-enroll in another study while in this study
* Pregnant or breastfeeding
Slipped Capital Femoral Epiphysis Treatment

Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children. The primary source for the blood supply of the head of the femur is the deep branch of the medial femoral circumflex artery. Loder described a classification for Slipped capital femoral epiphysis based on ability of the child to walk or not(walking=stable, non-walking=unstable).

In slipped capital femoral epiphyses (SCFE), the severity of slippage correlates with poor long-term clinical outcome scores and radiographic evidence of osteoarthritis . In situ fixation of higher-grade SCFE has a low surgical risk and has been advocated by authors who believe the deformed hip has the potential to remodel with some restoration of the disturbed anatomic axes ; however, the remodeling potential remains controversial . Despite remodeling, the head-neck offset will remain abnormal . This is the cause of potential impingement of the femoral neck with the acetabular cartilage . Impingement in SCFE has been associated with damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after SCFE .

Ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip osteotomy and anterior capsulotomy preserving the blood supply to femoral head. The technique is based on extensive study of blood supply to the proximal femur. This technique allows us to completely dislocate the joint which allows complete access to intra articular pathology and allow reduction of the slipped capital femoral epiphysis .

Eligibility Criteria:
Inclusion Criteria:

* 1- Patients with moderate Slipped capital femoral epiphysis 2- Patients with severe Slipped capital femoral epiphysis

Exclusion Criteria:

* Patients with mild Slipped capital femoral epiphysis
Comparison of 50% Tilt and Tuned Waveforms in Single-Coil Active Can Configuration

The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.

There has been one prospective study that found some benefit of using tuned waveforms over 50/50% tilt waveforms.11 Other studies have failed to show much change in defibrillation efficacy with different duration biphasic waveforms. A vast majority of patients in these studies were tested with dual coil leads. Although dual coil leads can lower defibrillation thresholds, it is known that dual coil leads can make the lead extraction difficult, lead to venous obstruction and are more prone to failure. Results from a recent study showed that that a single coil configuration is adequate in a vast majority of patients when DFT testing was performed with tuned waveforms. This makes the use of single-coil leads during ICD/ CRT-D implants an attractive option.

Theoretical analysis has shown that difference between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished). Accordingly, this study has been designed to prospectively compare the DFT estimates with tuned and 50% tilt waveforms in left-sided, active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets standard indication for an ICD/ CRT-D and will be implanted with an FDA approved SJM ICD/ CRT-D and compatible defibrillation lead system in the left pectoral region.
* Patient is able to tolerate DFT testing.

Exclusion Criteria:

* Patient has the pulse generator on the right side.
* Patient is pregnant.
* Patient is less than 18 years old.
* SVC coil was turned ON during DFT testing
The Effect of Spinal Anesthesia on Hemodynamics

In this study, it was planned to provide more stable hemodynamics in geriatric patients with low-dose spinal anesthesia. We will compare 7.5mg hyperbaric bupivacaine with 5mg hyperbaric bupivacaine.

The researchers hypothesized that low-dose bupivacaine would provide adequate anesthesia, less hypotension, and faster recovery.

Hypothesis It is hypothesized that low-dose bupivacaine can provide adequate anesthesia, less hypotension, and faster recovery.

patient population Patients over 65 years of age who will undergo spinal anesthesia due to hip fracture.

Hemodynamic data(Blood pressure-mmHg, heart rate-beats per minute) of patients, bromage scores, perfusion index (PI) values, discharge time, pain with NRS (numerical rating scale), patient satisfaction will be evaluated ( Numeric output from 1-10).

Hemodynamic variables will be recorded every 2 minutes in the first 20 minutes after spinal anesthesia. hemodynamic variables will be recorded 30 minutes after spinal anesthesia and at the end of the operation.

The perfusion index is the ratio of the blood volume to the pulsatile to non-pulsatile fraction. An increase in the pulsatile fraction that occurs during vasodilation corresponds to a higher PI. Therefore, patients with a higher PI have a higher risk of post-spinal hypotension.

Eligibility Criteria:
Inclusion Criteria:

* ASA(American Society of Anesthesiologists) I-II-III patients
* BMI( body mass index) in the range of 18-40
* over 65 years old hip fracture

Exclusion Criteria:

* Refusal to participate in the study
* Left ventricular ejection fraction below 40%
* cardiac arrhythmia
* Patients with peripheral vascular disease
* Failure of spinal anesthesia
Post-COVID-19 Monitoring in Routine Health Insurance Data With Focus on Autoimmune Diseases (POINTED-AD)

The SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) infection was in 2020 responsible for new disease related chronic conditions which have been referred to as Post-COVID. To date it is still unknown how common this condition is and how it might effect the working of the Immune system. The aim of the study is therefore to monitor the onset of autoimmune diseases in a large observational study consisting of German health insurance data.

SARS-CoV-2 is a virus of the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus causes acute symptoms associated with the infection and can cause chronic conditions known as Post-COVID. To understand how the virus might effect the working of the Immune system a large observational study of health insurance data from Germany was set up. The exposed patients were identified by a diagnosis indicating a confirmed laboratory test for COVID-19.

The basic question concerns the burden of the Post-COVID condition. The study investigate which autoimmune diseases or groups of autoimmune diseases are more common in humans after the exposure to the virus compared to a matched unexposed cohort. Further will this be investigated in subgroups of the population.

Eligibility Criteria:
Inclusion Criteria:

* At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the year 2020
* Continuously insured with the respective health insurance between 2019-01-01/birth and 2021-06-30/death

Exclusion Criteria:

* Only an outpatient or inpatient diagnosis of COVID-19 without laboratory detection of the virus( ICD-10:U07.2!) till 30th of June 2021
* At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!) in the first half of the year 2021
Guanidinoacetic Acid With Creatine Compared With Creatine Alone for Tissue Bioenergetics, Hyperhomocysteinemia and Exercise Performance

Co-administration of creatine and guanidinoacetic acid (GAA) has been recently put forward as an advanced dietary strategy to optimize tissue bioenergetics. The investigators hypothesized that creatine-GAA mixture would result in more powerful rise in brain and skeletal muscle creatine, as compared to creatine supplementation alone.

Targeting energy-demanding tissues in health and disease continues to be a challenging task in human nutrition and biomedicine. Impaired bioenergetics accompanies many different conditions, including cardiometabolic diseases, neurodegenerative disorders or high-intensity exercise, with various dietary interventions developed to restore cellular energy. Creatine is recognized as a beneficial and safe energy-boosting agent in both athletic and clinical environments. However, its effectiveness in specific conditions seems to be fairly restrained due to its limits in transportability and performance. Guanidinoacetic acid (GAA), a metabolic precursor of creatine, appears as a novel energy-enhancing supplement, with GAA being superior to creatine in facilitating creatine concentrations in the human brain and skeletal muscle. This perhaps happens due to GAA interaction with cellular transporters previously dismissed as untargetable carriers by other similar therapeutics. On the other hand, GAA loading remains under scrutiny due to its hyperhomocysteinemia-inducing potential, and possible neurotoxic effects. Co-administration of creatine and GAA has been recently proposed as a better strategy comparing to administration of each compound per se. Besides providing a competitive advantage for enhanced levels of tissue creatine, GAA-creatine mixture might also diminish side effects related to isolated GAA administration. However, no human studies so far evaluated the effects of this mixture. In the present study, the investigators compared the impact of 4-week co-administration of GAA and creatine vs. creatine administration alone on serum biomarkers, exercise performance and tissue bioenergetics in healthy young men.

Eligibility Criteria:
Inclusion Criteria:

* men age 18-45 years
* BMI 18.5-24.9 kg/m2
* physically active (\> 150 min per week)
* free of known disease
* must be able to give written informed consent

Exclusion Criteria:

* serum homocysteine \> 15 µmol/L
* use of dietary supplement (\> 1 month)
Uterine Balloon Treatment for Heavy Period Bleeding.

The purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding.

This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.

Eligibility Criteria:
Inclusion Criteria:

* Female at least 30 years of age who is premenopausal and for whom childbearing is complete.
* Excessive menstrual bleeding documented by a diary score of at least 150.
* Have documented 3 months failed medical therapy or either a) contraindicated for or b) refused medical therapy.
* Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than 12cm.
* Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the procedure.
* Agree not to switch from hormonal to non-hormonal contraception or vice versa during or just prior to the study.
* Agree to use reliable contraception throughout the study.
* Freely agree to participate in the study, including all study related procedures and evaluations, and document this agreement by signing informed consent documentation.

Exclusion Criteria:

* Active pelvic inflammatory disease (PID) or recurrent chronic PID.
* Active genital or urinary tract infection at the time of the procedure.
* History of malignancy of the reproductive system within 5 years of the procedure or have ever had malignancy of the endometrium.
* Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of procedure.
* Cavity distorting submucous myoma(s) determined by preoperative hysterogram, hysteroscopy, or transvaginal sonography within 6 months of the procedure.
* Previous endometrial ablation procedure.
* Previous uterine surgeries (such as full thickness myomectomy, subserosal myomectomy, uterine reconstruction, or any surgery in which thinning of the uterine musculature could occur) except for low transverse caesarean section.
* Pregnant or desirous of future pregnancy.
* Taken endometrial suppression medication, except for oral contraceptives, within 3 months of the procedure.
* Concurrent open or laparoscopic surgery.
Rocky Mountain Alzheimer's Disease Center Longitudinal Biomarker and Clinical Phenotyping Study

This study plans to establish a large bank of blood, cerebral spinal fluid (CSF), imaging, and clinical data. These data and samples will be used for future research into the causes of Alzheimer's disease (AD), Down Syndrome (DS) and other diseases that cause thinking and memory problems. This future research will also study how treatments for these diseases work. This research may help develop new treatments for some diseases of the nervous system and help understand these diseases better.


Eligibility Criteria:
Inclusion Criteria:

1. Persons with age-related MCI or AD according to clinical diagnosis, consistent with NIA-AA diagnostic criteria
2. Community-dwelling controls, Age \> 60 years
3. Ability to complete baseline assessments
4. Has an informant (study partner) available to complete functional interviews/survey measures annually

Exclusion Criteria:

* Presence of concomitant medical, neurological, or psychiatric illness or condition that in the opinion of the investigators would confound interpretation of study results. These include: Korsakoff encephalopathy; active substance abuse; hepatitis C; opportunistic brain infection; brain tumor; active neoplastic disease (skin tumors other than melanoma are not exclusionary; participants with stable prostate cancer may be included at the discretion of the project director); multiple sclerosis; history of clinically significant stroke; current evidence or history in the past 2 years of focal brain lesion, head injury with loss of consciousness, or DSM-V criteria for any major psychiatric disorder, including psychosis, major depression, bipolar disorder, alcohol or substance abuse; blindness, deafness or any other disability which may prevent the participant from participating or cooperating in the protocol.
* Presence of contraindication for MRI scan
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients (American Society of Anesthesiologists I; ASA I)
* Patients diagnosed with recession (RT1)
* Fair oral hygiene
* Patient accepting to provides an informed consent and the follow-up

Exclusion Criteria:

* Carious teeth and teeth with periapical infection.
* Patients diagnosed with periodontitis
* Smokers
* Pregnant and lactating females
Long-term Results After Bariatric Surgery in Type 1 Diabetes Patients

There is a lack of long-term data on the impact of bariatric surgery in type 1 diabetes (T1D). The aim of this study is to gain long-term outcome data on the effects of bariatric surgery in obese patients with T1D.

This study aims to evaluate long-term data on the effect of bariatric surgery in T1D regarding weight lost, insulin-requirement, and quality of life.

Inclusion criteria are patients who underwent bariatric surgery (Sleeve, One anastomosis gastric bypass, Roux en Y Gastric Bypass) and the presence of T1D prior to surgery. Labor parameters include verification of T1D antibodies, and level of C-peptide. Exclusion criteria is T2D.

In order to obtain a sufficient number of patients for the evaluation, several sites are involved in the acquisition of these specific data.

Eligibility Criteria:
Inclusion Criteria:

* T1D-specific antibodies
* C-peptide level
* status after bariatric surgery

Exclusion Criteria:

* T2D
* patients without T1D
* patients with T1d without bariatric surgery
Effects of Curcumin-containing Toothpaste on Dental Biofilm and Associated Oral Halitosis

Purpose: To investigate the short-term clinical effect of curcumin-containing toothpaste on halitosis as compared to placebo and to assess potential shifts in the composition of dental biofilm associated with the use of curcumin-containing toothpaste

Participants: This clinical study will 30 adult participants under prophylactic or periodontal maintenance protocol.

Procedures (methods): Participants will be included and throughout the protocol will not allow the use any other oral hygiene products except standard manual toothbrush and study toothpaste (either test -curcumin-containing or placebo). Additionally participants will be instructed to odiferous foods such as onions, garlic and spices. At each of the three examination sessions, Plaque Index (six sites, O'Leary) and volatile sulphur compounds (VSC) will be measured.


Eligibility Criteria:
Inclusion Criteria

* Participants must be adult males or females between the ages of 18 and 65 years (inclusive) reporting halitosis
* Participants must be able and willing to follow study procedures and instructions
* Participants must have read, understood and signed an informed consent form
* Participants must present with at least 8 teeth in the functional dentition and with at least 4 teeth in each posterior sextant, 3 of which are adjacent teeth with interproximal papilla in each posterior sextant that will have the stent
* Participants must be in good general health

Exclusion Criteria

* Patients ongoing restorative or periodontal dental treatment or any other medical treatment
* Subjects with any pathological alterations of the oral mucosa
* Any known allergy to previously used oral hygiene products or any known allergy to any of the ingredients of the study products, which are used during the study
* Pregnant women
* Subjects with untreated periodontitis or active caries lesion
* Subjects diagnosed with acute sinusitis, bronchitis or tonsillitis
* Subjects under treatment on medications which can cause malodor, e.g. amphetamines, nitrates and nitrites
* Known diabetes, liver or kidney insufficiency
* Subjects diagnosed with reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
* Subjects who underwent preventive periodontal treatment, i.e. oral prophylaxis treatment, within the last week
* Volunteers unwilling to abstain from additional oral hygiene (only tooth brushing allowed) particularly mouthrinse, chewing gums, breath strips, etc and alcohol 12 h prior the first measurement at the study site and until the completion of all measurements
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study and provide written informed consent.
* Male and female adults aged \> 18 years.
* Must have NASH and fibrosis on a liver biopsy sample
* If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening;
* Subjects may have a diagnosis of T2DM

Exclusion Criteria:

* History or presence of liver disease (other than NAFLD or NASH)
* History or presence of cirrhosis and/or history or presence of hepatic decompensation