cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Role of Low Dose Magnesium Sulfate in Anesthesia for Toxic Goiter Resection

Anesthesia for toxic goiter removal is a challenging because of of hemodynamic instability especially during induction, intubation, manipulations of the gland, after removal of the gland and during emergence. So, hemodynamic stability is required all through the operation and even in the first 12 hours of the postoperative period to protect against complications e.g., hypertension, tachycardia, myocardial ischemia, bleeding and thyrotoxic crisis.Mg sulphate used in blunting pressor response during laryngoscopy and intubation. Also it was used in controlled hypotension technique. Also it was reported in decreasing postoperative nausea, vomiting, shivering and postoperative complications compared to controlled group.

Patients and Methods:

After obtaining the approval of the Ethical Committee number (R68) of Al Fayoum University Hospitals and written informed consent from the patients, sixty (60) patients ASA ǀ \&ǁ patients of both sex aging 20-70 years (with primary or secondary thyrotoxic goiter and will be presented for thyroidectomy) will be allocated into one of two groups: Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume. The surgeon , anesthesiologist and the person who will collect the data will be blinded for the prepared solution. The solution will be prepared by an expert anesthesia nurse.

Eligibility Criteria:
Inclusion Criteria:

1. patients ASA ǀ \&ǁ
2. patients of both sex
3. Aging from 20-70years
4. Pstients with primary or secondary thyrotoxic goiter

Exclusion Criteria:

1. Major hepatic disease
2. renal disease.
3. Cardiac dysfunction e.g. (heart Failure).
4. Uncontrolled hypertension
5. Advanced Ischemic heart diseases.
6. Known allergy to Mg So4.
7. Morbid obesity \& pregnancy.
8. History of neuromuscular diseases.
9. cerebrovascular diseases.
10. Diabetic neuropathy.
11. patients receiving magnesium. supplementations.
12. Mental retardation
13. Patients on antiepileptic treatment
14. patients antipsychotics.
15. Hug goiter with retrosternal extension.
Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia

Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.

Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior to these sessions patients undergo a training of physical activity. Half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.

Eligibility Criteria:
Inclusion Criteria:

* Subject familiarized with experimental procedure and had given written informed consent
* Diagnosis of panic disorder with agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
* Score \>= 18 in Hamilton Rating Scale for Anxiety
* Score \>= 4 in Clinical Global Index
* Reachability of patient for treatment and follow-up

Exclusion Criteria:

* DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II borderline personality disorder
* Change in pharmacological treatment in the last 4 weeks
* Acute suicidality
* Medical contraindications for mild to moderate exercise training or exposure
Ondansetron Augmentation in Treatment-resistant OCD

The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of OCD established by clinical interview with a licensed psychiatrist;
* a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale
* a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose

Exclusion Criteria:

* diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder
* undergoing concomitant behavior therapy
* or having significant cardiovascular, hepatic, renal or pulmonary diseases
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack

The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects
* 18-65 years of age
* Primary diagnosis of migraine attack with aura or migraine attack without aura
* Migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year
* Female subjects must use an effective form of birth control
* Listing of additional inclusion criteria are available through the Sponsor

Exclusion Criteria:

* Excluding subjects with a history of other serious events causing secondary headaches
* Excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication
* Excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug
* Listing of additional exclusion criteria are available through the Sponsor
A New Deep-learning Based Artificial Intelligence Iterative Reconstruction (AIIR) Algorithm in Low-dose Liver CT

CT-enhanced scans are routine imaging modality for the diagnosis and follow-up of liver disease. However, this means that patients will receive more radiation dose. Therefore, it is necessary to reduce the radiation dose received by patients as much as possible. Deep learning-based reconstruction algorithms have been introduced to improve image quality recently. For many years, researchers attempt to maintain image quality using an advanced method while reducing radiation dose. Recently, a new deep-learning based iterative reconstruction algorithm, namely artificial intelligence iterative reconstruction (AIIR, United Imaging Healthcare, Shanghai, China) has been introduced. In this study, we evaluate the image and diagnostic qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT.

In our hospital, patients with abdominal pelvic cancer undergo follow-up low-dose CT for the evaluation of treatment plan after clinical treatment or disease progress. The raw-data of low-dose CT were collected retrospectively and reconstructed using KARL and AIIR algorithm. In this study, we evaluate the image and diagnostic qualities of AIIR for low-dose portal vein and delayed phase liver CT with those of a KARL method normally used in standard-dose CT.

Eligibility Criteria:
Inclusion Criteria:

* those scheduled for contrast-enhanced liver CT

Exclusion Criteria:

* images affected by artifacts (motion or implants)
Peripheral Nerve Block Compared to Intra-articular Injection for TAA Post-operative Pain

Ankle arthritis is associated with debilitating pain and chronic disability. For the treatment of severe ankle arthritis, total ankle arthroplasty (TAA) is one treatment option. Postoperative pain management in joint arthroplasty is an ongoing and relevant issue. The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using an intra-articular injection in the operating room compared with a peripheral nerve block in patients undergoing TAA.

This is a two-arm, prospective, randomized, controlled clinical study. Use of intra-articular injections in TAA are not widely reported in literature; however, they are commonly used during total knee arthroplasty's (TKAs). The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using the intra-articular injection compared with a peripheral nerve block in patients undergoing TAA. Results will contribute to the literature for the best surgical practice for pain management following a TAA for ankle arthritis.

Patients will be randomized to receive one of the following interventions for pain control in the operating room:

1. Intra-articular Injection
2. Preoperative Peripheral Nerve Block:

The study aims are:

* Aim 1: Determine if intra-articular injection as source of pain control for TAA lowers postoperative pain as measured by self-reported narcotic use and pain vs. the peripheral nerve block.
* Aim 2: Evaluate differences in functional outcomes and health related quality of life between intra-articular injections and peripheral nerve block as reported by pre- and post-operative patient questionnaires

Patients who consent to participate will complete study activities pre-operatively, and at 2 weeks, 6 weeks, and 3 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 40 - 80 years old
* Patient is having a primary, unilateral TAA
* Patient has signed the current, Institutional Review Board approved informed consent document

Exclusion Criteria:

* Patient has untreated endocrine disease
* Patient has uncontrolled diabetes; lab result of hemoglobin A1c level \> 8.0 mg/dL
* Patient has significant heart, liver, kidney or respiratory disease
* Patient has peripheral vascular disease
* Patient has active cancer
* Patient has current history of narcotic use beyond that of oral medications
* Patient discharge status is known to be to care facility
Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes

The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.

The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.

This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention.

During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.

All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes of any duration
* Hb A1c ≥ 7% (no upper limit)
* BMI ≥ 30 kg/m2
* Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
* Access to a smartphone device

Exclusion Criteria:

* Any insulin use in the past 3 months
* Planned use of insulin in the next 6 months
* Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
* Current use of a weight loss medication
* Unable or uncomfortable with wearing a CGM device
Pre-Exercise for Allogeneic Stem Cell Transplant Patients

The PRESENT-P study is a one-arm exercise intervention study for hematological cancer patients prior allogeneic stem cell transplantation (allo-HCT). This pilot study will investigate in a prehabilitation approach the safety and feasibility of high-intensity exercise program directly prior transplantation.

The major objective of PRESENT-P is to investigate the feasibility and safety of a high intensity endurance exercise training (HIIT) and progressive resistance exercise prior allo-HCT. This multicenter pilot study will include n=30 patients. Patients perform two supervised exercise sessions per week. Recruitment take place 6-12 weeks prior allogeneic stem cell transplantation. Further aims of this pilot study are: to estimate the number of eligible patients, evaluate the recruitment procedure, and to explore the effect of HIIT prior allo-HCT on maximal oxygen uptake (VO2peak),submaximal endurance capacity, muscle strength, patient-reported-outcomes including QoL and physical functioning.

Eligibility Criteria:
Inclusion Criteria:

* Hematological cancer, e.g. AML, CLL, MM
* Scheduled for allo-HCT at the University Clinic Heidelberg or other cooperation sites within the next 4-12 weeks
* Patients ≥ 18 years of age
* Sufficient German language skills
* Willing/ able to train at the provided exercise facilities twice per week and to take part in the scheduled testing
* Signed informed consent

Exclusion Criteria:

* Heart insufficiency \> NYHA III or uncertain arrhythmia
* Uncontrolled hypertension
* Severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl)
* Reduced standing or walking ability
* Insufficient hematological capacity (either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL)
* Any other comorbidities that preclude participation in the exercise programs
* Engaging in systematic intense exercise training (at least 1h twice per week)
Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes

The experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects without diabetes. Both participants with type 2 diabetes and participants without diabetes will be studied after consuming either a low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.

Physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-75
* BMI 20-35kg/m\^2
* Participants with type 2 diabetes:

  * HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU)

Exclusion Criteria:

* Pregnancy or breast feeding
* Morbidities precluding participation
* Participants with type 2 diabetes:

  * Therapy with insulin
  * SGLT2 inhibitors
  * GLP-1 based approaches
  * TZDs
  * Unstable diabetic retinopathy
  * Microalbuminuria
  * Macrovascular disease
  * Medications affecting GI motility (eg., erythromycin, pramlintide)
  * Upper GI disorder/surgery
* Participants without diabetes:

  * Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance
  * History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes
A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods

This study will assess the continuation rates among women using oral contraceptive pills, Depo-Provera and Ortho Evra following a first trimester abortion.

Unintended pregnancy rates among women in the United States continue to surpass that of the rest of the developed world at great cost to society. Contraceptive failure has been attributed to poor compliance with contraceptive methods and results in unintended pregnancies. This study will evaluate the 3-month continuation rates among women using the oral contraceptive pill and Depo-Provera. It will also assess the continuation rates of Ortho Evra®, which has not previously been studied in the adolescent population. This study will provide information with regard to pregnancy rates and 3-month patterns of use of contraception among women seeking first-trimester abortion. It will also assess other factors contributing to successful contraception such as the use of emergency contraception and concomitant condom use. The results of this study will be used to inform the practice of providers who provide reproductive health care to women and add to the sparse body of literature available comparing the success of different contraceptive methods used by women.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-45 women presenting at the ambulatory surgery at Grady Memorial Hospital who want to use either oral contraceptive pills, ortho evra or depo provera?

Exclusion Criteria:

* Leaving the Atlanta area within 6 months?
* Desires pregnancy within the next 6 months?
* Unable to provide contact information?
* Contraindications to hormonal contraceptive?
Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to assess the effects of administration of daratumumab when combined with VELCADE (bortezomib) and dexamethasone compared with bortezomib and dexamethasone alone, for participants with relapsed or refractory multiple myeloma.

This is an open-label (physicians and participants know the identity of the assigned treatment), randomized (the study medication is assigned by chance), multicenter, active-controlled study comparing daratumumab, VELCADE, and dexamethasone (DVd) with VELCADE and dexamethasone (Vd) in participants with relapsed or refractory multiple myeloma. Approximately 480 participants will be randomly assigned in a 1:1 ratio to receive either DVd or Vd. Randomization will be stratified by International Staging System (ISS), number of prior treatment programs (1 vs. 2 or 3 vs. \>3), and prior VELCADE treatment ("no" vs. "yes"). Within each stratum, participants will be randomized to one of the treatment groups.The study will consist of a Screening Phase, a Treatment Phase, and a Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study.

Eligibility Criteria:
Inclusion Criteria:

* Must have had documented multiple myeloma
* Must have received at least 1 prior line of therapy for multiple myeloma
* Must have had documented evidence of progressive disease as defined based on Investigator's determination of response of International Myeloma Working Group (IMWG) criteria on or after their last regimen
* Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
* Must have achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen in the past

Exclusion Criteria:

* Has received daratumumab or other anti-CD38 therapies previously
* Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy or another PI therapy, like ixazomib and carfilzomib
* Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
* Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day \[mg/day\] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM).
* Has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization
* Has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures
Cricopharyngeal Dysfunction and Esophageal Diverticulum

Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

A prospective, multi-institutional study comparing the effectiveness of the above procedures will provide a large cohort using standardized diagnostic studies, diverticulum size measurements, treatment approaches, pre-operative and post-operative assessment of symptoms in order to both compare the effectiveness of the procedures and to stratify the patients in order to determine whether demographics such as age, pre-operative size, and/or peri-operative co-morbidities influence outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cervical esophageal diverticulum, with Zenker's as most common, or CP bar (with diagnosis of early Zenker) as indicated on an esophagram who the participating institutions enroll regardless of surgical management and future treatments. Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

Exclusion Criteria:

* Patients who undergo division of the common wall between the diverticulum and esophagus using flexible endoscopy will not be included in the study.