cyrilzakka/clinical-trials huggingface dataset:
Chronobiology of Meal Timing: Effects on Vascular and Renal Function

The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

Despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in 3 Americans and accounts for more than $50 billion of health care spending. Importantly, hypertension is the leading cause of cardiovascular (CVD) and kidney diseases (CKD). As a result, the AHA/ACC lowered the diagnostic criteria for hypertension to encourage earlier preventative lifestyle intervention. There is a critical need to identify and implement novel lifestyle interventions in individuals with early-stage hypertension to prevent the subsequent development of CVD and CKD. Chronotherapy that aligns behavioral cues (such as time of eating) with the body's internal biological clocks, has gained much attention as a potential strategy to prevent and manage hypertension, however, the underlying mechanisms are not yet fully understood. The purpose of this study is to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women aged 18-45 years
* Elevated (SBP 120-129; DBP \<80 mmHg) or stage 1 hypertension (SBP 130-139; DBP 80-89 mmHg)

Exclusion Criteria:

* History of chronic disease (CV, lung, cancer, renal, sleep apnea, diabetes, autoimmune)
* Anti-hypertensive medication use
* Currently pregnant or lactating
* Current shift worker
* Travel \>3 time zones four weeks before the start of the study or during the study
* Insomnia
* Practiced intermittent fasting in past six months
* Current nicotine use
* Current hormone replacement therapy
* Current melatonin use
* Current use of antioxidants and unwilling to stop taking them for the duration of the study
* Unable to provide informed consent
Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease

To date key drugs in the treatment of MAIS, M.malmoense and M.xenopi (Opportunist Mycobacteria have been rifampicin and ethambutol. Clarithromycin and Ciprofloxacin are active in vitro against these species of mycobacteria. The primary aim of this study was to compare these to agents as supplements to rifampicin and ethambutol. A secondary aim was to assess the vale of immunotherapy with M.vaccae.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary disease due to M.avium intracellulare, M.malmoense or M.xenopi. Aged 16 or over. With clinical and/or radiological evidence of active infection and producing sputum positive on culture on at least 2 occasions.

Exclusion Criteria:

* Pregnant women and women of childbearing age not taking adequate contraceptive precautions.

Patients who have sputum currently positive on culture for M.tuberculosis or M.bovis.

Patients who have AIDS or who are known to be HIV positive
IV Pulsed-Nicotine As a Model of Smoking: the Effects of Dose and Delivery Rate

This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.

Seventy smokers will be randomized to nicotine doses of either 0.2 or 1 mg per 70 kg body weight. Across 5 test sessions, within each dose group, participants will be randomly assigned to a sequence of 5 treatment conditions: placebo (saline) and 4 different delivery rates of nicotine. In each session, participants will receive either nicotine- or saline-pulsed infusions that will be delivered every 30 seconds for a total of 10 pulsed infusions. While receiving the pulsed infusions, participants will inhale a tobacco-flavored EC without nicotine, which will allow for a closer matching of the sensory aspects of inhaled tobacco use. There are four pulse duration conditions for the nicotine sessions: 2-, 4-, 6- and 8-second pulses. For those assigned to 1.0 mg/70kg nicotine dose, the pulse duration conditions correspond to nicotine delivery rates of 50, 25, 16.6, and 12.5 mcg nicotine/second. For those assigned to 0.2 mg/70 kg dose, the corresponding delivery rates will be 10, 5, 3.3 and 2.5 mcg nicotine/second. Participants in both nicotine dose groups will each have one placebo test session wherein they will receive 10 pulsed-saline infusions.

Eligibility Criteria:
Inclusion Criteria:

* Female and male, aged 21 to 55 years;
* past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests
* women, -using acceptable birth control methods.

Exclusion Criteria:

* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study
* risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including history of lung diseases (e.g., asthma or COPD), vaping THC or CBD
* regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
* current alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine
* for women, pregnant as determined by pregnancy screening, or breast feeding
* seeking (or undergoing) treatment for tobacco dependence or smoking; reported aversion to e-cigarettes, or tobacco flavored e-liquid.
RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.


Eligibility Criteria:
Key Inclusion Criteria

* Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction
* Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki
* Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique

Exclusion Criteria:

* Unprotected left main disease
* Subjects with planned PCI of three vessel disease
* Planned two stent technique (main branch and side branch) of a bifurcation
* Subjects with more than one bifurcation lesion
Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate

Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with nonobstructive azoospermia
* underwent microdissection testicular sperm extraction

Exclusion Criteria:

* without intact clinical information
* low data quality
Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative recovery of RBC mass by retrospectively analyzing and comparing the changes of postoperative hematocrit values after the surgery in patients underwent elective uni-limb total knee arthroplasty surgery with or without IV-iron supplementation during surgery


Eligibility Criteria:
Inclusion criteria

* Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery
* Patients provided a written informed consent.
* Patients with s-ferritin \< 300 mg/dl (male) or 200 mg/dl (female)
* Patients with preoperative serum hemoglobin concentration \>10 g/dL

Exclusion criteria

* Patients with history of anaphylaxis, iron overload, active infection.
* Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.
Safety and Tolerability of MK0773 in Healthy Older Men (0773-004)

This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good general health
* Subject agrees to avoid excess alcohol and strenuous physical activity during the study
* Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study

Exclusion Criteria:

* Subject has significant drug allergies
* Subject has donated blood within the last 8 weeks or has taken an investigational drug in another clinical trial within the last 4 weeks
* Subject is a regular user or past abuser of any illicit drug (including alcohol)
* Subject drinks excessive amounts of caffeinated beverages
* Subject has a history of cancer
* Subject has a history of prostate or testicular surgery
Comparative Effectiveness and Cost-Benefit Analysis of Vancomycin Powder in High Risk Spine Surgery Patients

Despite the use of prophylactic systemic antibiotics and improved surgical technique, surgical site infections remain a serious concern. The incidence of deep infection after spine surgery has been lowered with systemic antibiotics, yet after instrumented fusion for traumatic injuries infection rates remain as high as 10%. The impact on patients and cost of treating such infections is profound. With diminishing healthcare dollars and policy that refuses to reimburse for postoperative infections, it is critical that physicians and hospital systems seek out cost effective ways of decreasing postoperative infections. Local delivery of antibiotics into the surgical site have been found to significantly decrease infection rates in those undergoing posterior spine fusion for traumatic injuries as studied in a retrospective manner by the investigators of this grant. In this proposal the investigators will prospectively randomize patients undergoing posterior spinal stabilization for traumatic injuries into either receiving vancomycin powder into the surgical site (treatment) versus not receiving vancomycin powder (control) and subsequently follow infection rate, complications, and cost of care. The investigator's hypothesis is that i) vancomycin powder will decrease infection rates ii) have no systemic toxicity iii) and be a cost saving advancement in the safety of delivering spine surgical care.


Eligibility Criteria:
Inclusion Criteria

* All English-speaking patients ≥ 18 years undergoing posterior spine fusions at Vanderbilt University Medical Center for the treatment of traumatic injuries will be considered for inclusion

Exclusion Criteria

* have a known allergy to vancomycin
* do not agree to participate
* had previous spine surgery at the injury level within 6 months
* are pregnant
* have a history of Steven's Johnson Syndrome
* have a history of infections at the surgical site
* have a history of cancer or radiation treatment at the injured level
* have open spine fractures
* have traumatic injuries to non-spine organ systems that limit their functional capacity
Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.

To explore the benefits of using closed loop spinal cord stimulation (SCS) in the treatment of patients experiencing painful chemotherapy induced peripheral neuropathy (CIPN) by assessing changes in pain, quality of life, pain medication use, sensory improvement through quantitative sensory testing, and improvement of gait through quantitative gait testing.

Primary Objective:

To explore the impact of using closed loop spinal cord stimulation (SCS) on pain control, quality of life, and pain medication use in patients suffering from chemotherapy induced peripheral neuropathy (CIPN).

Secondary Objective:

To assess the relationship between pain control from closed loop spinal cord stimulation and any associated changes in quantitative sensory testing (QST) and quantitative gait testing (QGT).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis history of CIPN of lower extremities
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of SCS
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients undergoing active chemotherapy or immunotherapy
* Patients undergoing medical litigation.
* Patients with active infection, being treated with antibiotics
* Patients that are pregnant or planning to conceive
* Patients who are receiving any investigational agents.
* Patients with brain metastases.
* Patients with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with history of alternative forms of sensorimotor neuropathies prior to CIPN presentation
Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children

Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. The investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. K-wire fixation.

Methods: Between May 2007 and September 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III. Closed reduction failed in all participants. Therefore, open reduction was performed under general anesthesia. One absorbable screw was used for fixation in the experimental group, while two 1.8-mm K-wires were used in the control group. At 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started.

Eligibility Criteria:
Inclusion Criteria:

All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III

Exclusion Criteria:

participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
Early Removal of the Urethral Catheter Following Trans-urethral Resection of Prostate

Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement. However, catheter removal day is variable. The objective of this study is to compare early and delayed catheter removal groups in terms of, urinary retention after catheter removal, length of hospital stay, weight of resected prostate, duration of resection, peri-operative blood transfusion, and postoperative complications.

This randomized controlled trial will carried out in Urology clinic at Jordan university hospital. Patients with benign prostate hyperplasia will be selected by simple random sampling technique after taking informed consent and will divided into two groups: Group A- early catheter removal group( catheter removed after 24 hours) and Group B-delayed catheter removal group ( catheter removed after 48 hours). in this study we will exclude patients with large post-void urine volume, simultaneous internal urethrotomy and transurethral resection of prostate, co-morbidity( diabetes mellitus, CVA) spinal cord injury, urethral stricture, prostate cancer proved by biopsy and intra-operative complications. Patients will discharged after removal of catheter if they voided successfully.

Eligibility Criteria:
Inclusion Criteria:

- All men with benign prostate hyperplasia who planned to undergo TURP will be included in this study.

Exclusion Criteria:

* Large post void residual urine.
* Simultaneous internal urethrotomy and TURP.
* Uncontrolled Diabetes Mellitus (DM).
* Cerebrovascular accident accident (CVA).
* Spinal cord injury.
Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors.

OBJECTIVES: I. Evaluate the early efficacy and toxicity profile of high-dose cisplatin, etoposide, bleomycin, and amifostine in children with newly diagnosed, high-risk malignant, extragonadal germ cell tumors. II. Determine whether the use of amifostine can reduce the hematologic and nonhematologic toxic effects of this combination chemotherapy in these patients when compared to similar patients treated on POG-9049/CCG-8881 with the same combination chemotherapy. III. Determine the response rate of patients treated with this regimen.

OUTLINE: Patients undergo surgical biopsy or resection. Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV over 1 hour, amifostine IV over 15 minutes, and cisplatin IV over 1 hour on days 1-5. Treatment repeats every 3-4 weeks for 4 courses in the absence of unacceptable toxicity or disease progression. Patients who have no disease after 4 courses of chemotherapy receive no further treatment. Patients who have residual disease undergo second-look surgery. After surgery, patients who still have active tumor receive 2 additional courses of chemotherapy. Those patients who still have tumor after the 2 additional courses may have a third surgery. Patients are followed every month for 6 months, every 2 months for 6 months, every 6 months for 1 year, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1.39 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, high-risk, extracranial germ cell tumors including the following: Yolk sac carcinoma (endodermal sinus tumor) Embryonal carcinoma Choriocarcinoma Teratoma with mixed malignant elements (malignant teratoma) OR Malignant recurrence (stage III or IV) of previously resected stage I extracranial, extragonadal tumor High-risk disease defined as stage III or IV extragonadal tumors Measurable disease by diagnostic imaging

PATIENT CHARACTERISTICS: Age: Under 15 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 750/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine normal OR Glomerular filtration rate at least 50% of normal

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region

The present study is a human, prospective, single centre, single blind randomised controlled clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel expander (Osmed®) to gain keratinised tissue around the dentulous area. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients.

All the patients were implanted with self-inflating hydrogel expander (Osmed®) in subperiosteal positions using the pouch technique in the mandibular anterior region. The clinical parameters were recorded at baseline, two weeks post expander retrieval, three months and six months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate in the study
* Patients above 18 years of age
* Systemically healthy patients
* Patients exhibiting keratinized tissue width \< 2 mm
* Patients manifesting Miller's Class I or Class II recession
* Patients who demonstrate good plaque control ( PI \< 10% ) and showing good compliance
* Uncompromised adjacent teeth with healthy gingival conditions

Exclusion Criteria:

* Untreated periodontal disease, caries
* Insufficient oral hygiene
* Thin biotype ( \< 0.8 mm )
* Use of tobacco
* Previous radiation therapy
* Patients with known systemic diseases and conditions as uncontrolled diabetes mellitus or haemorrhagic disorders
* Pregnant and lactating women
* Non-compliant patients
Effects of Craniosacral Therapy on Chronic Neck Pain

The purpose of this randomized controlled trial is to determinate the efficacy and safety of Craniosacral Therapy in the treatment of chronic unspecific neck pain.

Craniosacral Therapy (CST) is a variation of osteopathic manipulation with an integrative approach. By soft manual palpation of the craniosacral and fascia system sensory, motor, cognitive, and emotional processes can be influenced. In the prevention and treatment of chronic pain syndromes Craniosacral Therapy is demonstrated to be effective in clinical practice and quite a few scientific trials. But yet there are no randomized controlled studies concerning to chronic neck pain. So the aim of this study is to investigate whether a total of 8 CST units of 45 minutes will be effective in patients suffering from chronic nonspecific neck pain in contrast to sham therapy of the same extent. The prospective study design includes measurement points at baseline, post treatment, and 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Chronic unspecific neck pain for at least 3 months
* Mean neck pain of moderate intensity (\>/=45mm on VAS)
* Therapy-naive subjects

Exclusion Criteria:

* Specific neck pain due to severe deformity of the spine, prolapse, rheumatic or neurological disorder, trauma, operation or cancer
* other severe somatic or psychiatric comorbidity
* pregnancy
* regular intake of opiates, corticosteroids (\>10mg prednisolon), muscle relaxants or antidepressants
* recent invasive or manipulative treatment of the spine
* participation in other clinical trials