cyrilzakka/clinical-trials huggingface dataset:
Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction

This study will evaluate the potential effects of a changing metabolic environment on GnRH hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The participation of other gastro-intestinal tract hormones to these regulations will be systematically evaluated.


Eligibility Criteria:
Inclusion Criteria:

* male
* age between 18 and 25 years old
* no known pathology
* normal physical exam
* BMI between 20 and 25 kg/m2

Exclusion Criteria:

* history of endocrine disease
* no known infertility (no conception after 12 months of regular unprotected intercourse)
* abnormal results on the initial blood tests (CBC, fasting glucose and insulin, HbA1C, TSH, free T4, LH, FSH, inhibin B and total testosterone)
Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone on Pain After TKA

This study evaluate the efficacy of adding popliteal sciatic nerve block with low concentration bupivacaine and dexamethasone to abductor canal block for total knee arthroplasty in patient with NSAIDs prescribing precaution. Half of participants will receive popliteal sciatic nerve block, abductor canal block and periarticular injection, while the other half will receive a sham block, abductor canal block and periarticular injection.

After informed and consent, all patients will be devided into two groups, Sciatic group (group S) and Controlled group (group C). All patients will receive adductor canal block, then patients in group S will receive Sciatic nerve block with low concentration bupivacaine and dexamethasone while partients in group C will receive sham block. All patient will receive spinal anesthesia and intraoperative periarticular injection.

Postoperative pain score, muscle strength, total morphine consumption and adverse events will be record in case record form.

Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for single total knee arthroplasty
* patient with NSAIDs prescribing precautions such as history of NSAIDs allergy, Chronic kidney disease (GFR\< 50 ml/min), history of ischemic heart disease or cerebrovascular disease

Exclusion Criteria:

* patient refusal
* body weight less than 45 kg
* history of allergy to bupivacaine or dexamethasone
* uncontrolled diabetes mellitus
* contraindicated for spinal block, adductor canal block or sciatic nerve block
* inability to assess pain score (cognitive or psychiatric history)
* patient scheduled for revision TKA
* preexisting neuropathy or neurological deficit in lower extremity
* preexisting chronic pain (prolonged use of oral morphine 20 mg/day or equivalent)
Genotropin Study Assessing Use of Injection Pen

Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-18 years
* Using genotropin pen for at least 3 months prior to study enrollment
* Compliance with genotropin treatment

Exclusion Criteria:

* Medical conditions that can affect participation in study
* Insufficient command of English language to understand questionnaire
* Using other growth hormone device and not Genotropin pen
A Study of Vintafolide (MK-8109) in Participants With Advanced Solid Tumor (MK-8109-011)

This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration (6 weeks for nitrosoureas or mitomycin C) or not recovered from adverse events due to agents administered more than 4 weeks earlier
* Primary central nervous system (CNS) tumor
* Active CNS metastases and/or carcinomatous meningitis
* Known hypersensitivity to the components of the study therapy or its analogs
* Recent history of abdominal surgery or peritonitis
* Bowel occlusion or sub occlusion
* Prior abdominal or pelvis radiation therapy or radiation therapy to \> 10% of the bone marrow at any time in the past or prior radiation therapy within the last three years to the breast / sternum, head, or neck
* Requires anti-folate therapy
* Symptomatic ascites or pleural effusion
* Prior stem cell or bone marrow transplant
Efficacy Study of Free Flap Monitoring Using Capillary Lactate and Glucose Measurements

Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments diagnosis in free tissue transfers is realized.

These measures are done after surgical reconstructions with free tissue flap, simultaneously with clinical examination. These biological data aren't available to make clinical diagnosis of complication; only clinical examination is allowed in this way.

A posteriori, clinical and biological parameters will be compared in order to determine if capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps monitoring.

Free tissue flap reconstruction has become a reliable technique. Nevertheless, pedicle thrombosis is dreaded, and the earlier the diagnosis of such complications is made, the higher the surgical salvage rate is.

Clinical monitoring remains the most useful and used monitoring method, but makes late and unreliable diagnosis. Numerous studies are searching for ideal monitoring technics with regard to free flaps. Nowadays, the most efficient ones often deal with expensive and invasive technics. In this study, capillary lactataemia and glycaemia measurements are evaluated for pedicle impairments diagnosis.

Measurements of these 2 biological parameters seem to be a powerful screening test of pedicle impairments in microdialysis. But these parameters are measured in this case in interstitial tissues. Capillary measurements will probably provide different results, and needs to be evaluated.

For that purpose, surgical reconstructions with free tissue flap will be clinically monitored during five days, every hours for the first 24 hours, and every 4 hours for the next 4 days. Simultaneously, blind measurements of capillary lactataemia and glycaemia will be performed. Biological and clinical data will be systematically written in the corresponding table of the individual register together with the time the examination is done.

In this register, all complications and evolutions of the flaps will be recorded.

A posteriori, parallel between clinical and biological events will be studied. This multicenter prospective study will show first if capillary measurements of glucose and lactate permit to screen pedicle complications of free flaps. In case of efficacy of this technique, thresholds of glucose and lactate permitting such diagnoses will be calculated in order to define a sensitive screening test. Moreover, temporal differences between clinical and biological diagnoses of pedicle impairments will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Informed patient
* Signed informed consent
* Free tissue flap reconstruction
* Accessible flap for measurements

Exclusion Criteria:

* Pregnancy
* Patient under 18
* Unaccessible flap
Infectious Complications After Cystectomy: A Prospective Observational Study

Patients undergoing cystectomy for either oncological or non-oncological indications are prospectively enrolled following informed consent. This study design incorporates a comprehensive medical history, detailed prospective documentation of clinicopathological parameters, and serial measurements of infectious markers pre- and post-operatively. In-hospital complications are meticulously recorded, and long-term outcomes assessed through structured follow-up interviews at 3, 6, and 12 months. These follow-ups utilize standardized questionnaires to evaluate post-discharge infectious complications and gather patients' perspectives on their in-hospital experiences, providing a robust understanding of both clinical outcomes and patient-reported experiences.

Aims of the study:

1. Prospective evaluation of the association between preoperative interleukin-6 levels and local tumor stage in patients undergoing radical cystectomy
2. Prospective assessment of interleukin-6, procalcitonin and wound drainage culture as early indicators for perioperative infectious complications after cystectomy
3. Prospective evaluation of physician-assessed vs. patient-reported grading of complications after cystectomy
4. Prospective comparison of infectious complications within the first 12 months after cystectomy: ileal neobladder vs. ileal conduit
5. Prospective evaluation of the association between in-hospital complications after cystectomy and quality of life after three months

Eligibility Criteria:
Inclusion Criteria:

* Disease which requires removal of the urinary bladder

Exclusion Criteria:

* Patient does not want to participate
Central Venous Pressure Monitoring and Prognosis of High-risk Operating Patients

While central venous pressure measurement is used to guide fluid management in high risk surgical patients during perioperative period, the relationship between the value of central venous pressure and organ dysfunction and prognosis of high-risk operating patients is unknow. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.

Although less than 15% of high-risk patients (elderly or with limited cardiopulmonary reserves) undergo surgery, these patients account for 80% of hospital deaths. The requirements for hemodynamic monitoring to critical patients during perioperative period reach are of maximal importance, for two major reasons: (i) absolute or relative volume deficiency often occurs in postoperative patients due to preoperative fasting, intraoperative bleeding and non-dominant fluid loss caused by vasodilation and fluid redistribution caused by anesthesia; (ii) insufficient fluid replacement may lead to increased postoperative organ complications and poor wound healing. Adequate and goal-oriented hemodynamic monitoring combined with early and appropriate treatment can improve the prognosis of high-risk surgical patients.

Central venous pressure is a localized parameter of the superior vena cava or the right atrium and is closely related to the right ventricular end-diastolic pressure. With volume overload, CVP levels may be abnormally elevated. Maintaining central venous pressure as low as possible is conducive to the recovery of internal organs during haemodynamic treatment, especially for the kidney, intestine, and brain, etc. However, elevated central venous pressure (CVP) occurs frequently in critical care settings, including postoperative critical patients. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.⑵ All patients undergoing surgery and admitted to our intensive care unit (ICU) directly after surgery were enrolled into the respective study.⑶ They stayed in the ICU more than 48 hours with central venous pressure monitored for more than 48 hours.

Exclusion Criteria:

* Patients who were in pregnancy. ⑵Older than 80 years. ⑶Underwent cardiac surgery or had chronic kidney disease.
Safety, Tolerability and Pharmacokinetics of KBP-7072

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single ascending dose administration and with an open label food effect panel.

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single ascending dose administration and with an open label food effect panel.

Part 1: A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (eight subjects in each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo). 5 dose levels will be evaluated. Extensive PK samplings will be collected after dosing (pre-dose (within 30 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).

Part 2: A separate panel of 6 subjects will receive a single dose of KBP-7072 under fed conditions. The dose tested in Part 2 will be determined based on the safety, tolerability and PK data available from Part 1. Extensive PK samplings will be collected after dosing (pre-dose (within 45 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).

Safety assessments will include monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.

Eligibility Criteria:
Inclusion Criteria:

* males and surgically sterile or postmenopausal females
* aged between 18-45 years
* body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2,
* no significant medical history
* normal renal function
* good general health

Exclusion Criteria:

* Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
Depression Prevention in Older Spousally-bereaved Adults

Using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 12 months after spousal death who are at high risk for major depression disorder because of subthreshold symptoms of depression. A confirmatory efficacy trial will be conducted in which participants will be randomly assigned to (a) self-monitor sleep, meals, and physical activity for 12 weeks using digital monitoring plus motivational health coaching (WELL; n=75); or (b) enhanced usual care (EUC, usual care plus study assessments, n=75). Objective actigraphic measures of the 24-hour pattern of day and nighttime activity - known as the rest-activity rhythm - will be measured to evaluate circadian rhythms as a mediator of treatment outcomes. Participants will be assessed at baseline, months 1 \& 2, post-intervention, and 3, 6,12, 18-months post-intervention. In addition, the investigators will include a subset of participants bereaved by COVID-19 (or suspected as bereaved by COVID-19). Participants in this subset will undergo the same research procedures as the main cohort. Participants in both the main cohort and subset determined to be fully eligible will be randomized into two groups with a total of: usual care (EUC;n=125) and WELL (WELL; n=125).

The primary aim of this R01 application is to test the efficacy of a new behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity to stabilize circadian rhythms, for reducing symptoms of depression during the spousal bereavement period.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 years and older;
* spousally (or partner) bereaved up to 12 months (includes bereaved as a result of COVID-19);
* at-risk for major depressive disorder (MDD), based on high-risk markers defined as subthreshold symptoms of depression (Hamilton Depression Rating Scale score of \> or = 9), together with absence of current MDD, post-traumatic stress disorder, or persistent complex bereavement disorder

Exclusion Criteria:

* current Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) criteria for syndromal mood, psychosis within the last 12 months;
* dementia/cognitive impairment; Telephone Interview Cognitive Screening (TICS) \<19;
* acute suicide risk; based on Herbeck et al. protocol for suicide risk management;
* patients taking new psychotropic medications after spousal death to stabilize depression including antidepressants and benzodiazepines \>4 days/week for more than two months. Individuals who have been on a stable dose for at least 1 month and agree not to change during participation, unless it is medically necessary, will be included.
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II

KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 2 to 11 years of age.
2. Confirmed diagnosis of HAE Type I or II.
3. For patients ≥20 kg at screening, patient has had at least 1 documented HAE attack in the last year prior to screening.
4. Caregiver, as assessed by the Investigator, must be able to appropriately store and administer IMP and be able to read, understand, and complete the diary.
5. Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
6. Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable).

Exclusion Criteria:

1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH, idiopathic angioedema, or angioedema associated with urticaria.
2. A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
3. Patient weighs \<9.5 kg.
4. Use of angiotensin-converting enzyme inhibitors after the Screening Visit.
5. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
6. Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers.
7. Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial.
8. Known hypersensitivity to sebetralstat or to any of the excipients.
9. Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to the Screening Visit.
Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies

The STHLM3-MRI trial is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context.

The study includes individualised repeat invitations for re-screening to participants not diagnosed with prostate cancer.

The overarching strategy of the STHLM3-MR/Fusion projects are to study an improved diagnostic pipeline including an improved blood-based test for identification of men with increased risk of prostate cancer and use of MRI to select men for diagnostic workup with targeted prostate biopsies. The aim is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers.

The primary endpoints are the number of performed biopsies, the number of performed MRI and the number of detected high-risk prostate cancers. Secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. Additional aims include to assess the health economic consequences and development of automated image-analysis.

The STHLM3-MR project is performed in two separate phases, analyzed separately. STHLM3-MR Phase 1 closed inclusion 2017-06-01. All participants underwent target and systematic biopsies together with STHLM3 test analysis. The study is constitutes a current practice cohort and levels of the STHLM3 test were not used for selecting participants.

STHLM3-MR Phase 2 is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context. STHLM3-MR Phase 2 reported outcomes from the first screening round 2023. Repeated screening with individualised screening intervals will be offered to participants without prostate cancer detected.

Eligibility Criteria:
Inclusion Criteria:

* Permanent postal address in Stockholm

Exclusion Criteria:

* • Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia

  * Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.

Because seizures are one of the leading neurologic complications in brain tumor patients, neurosurgeons prescribe antiepileptic drugs (AEDs) to help prevent them. Although the American Academy of Neurology (AAN) guidelines recommend that AEDs be stopped after the first post-operative week in patients without seizures, there is no standard length of treatment and some patients may stay on AEDs indefinitely.

In an attempt to develop clinical guidelines for AED use in post-operative brain tumor patients, we will try to determine if taking levetiracetam for 1 week results in less neurotoxicity than taking it for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years of age and older) patients who have or will have undergone surgical resection or biopsy of a supratentorial brain tumor and are able to consent for themselves.
* Able to be randomized prior to or up to 48 hours after surgery.

Exclusion Criteria:

* No known history of seizure activity.
* Pregnant or breastfeeding.
* Renal dysfunction (CrCl \< 30ml/min).
* Beck's Depression Inventory (BDI) ≥14
* Allergy to levetiracetam.