cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly participants (greater than equal to \[\>=\] 75 years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).

This is a single-center, 2-cohort, single-dose, open-label study. The duration of study will be approximately 42 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1) and open-label Treatment (Day 1) and Follow-up (up to Day 13). Esketamine will be administered by intranasal route (delivery of medications through the nasal mucosa) on Day 1. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* For Cohort 1, be a man or woman, \>= 75 years of age who are either healthy or who present with stable, well-controlled, chronic conditions which frequently occur in the elderly, such as: hyperlipidemia; controlled hypertension; impaired fasting glucose, impaired glucose tolerance or type 2 diabetes mellitus controlled with diet, and/or metformin monotherapy, dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy or a combination of metformin and DPP-4 inhibitor, who have glycated hemoglobin (HbA1c) levels less than 8 percent; degenerative joint disorders and osteoporosis; kidney function decline appropriate for age. Inclusion of participants with other chronic, well-controlled and stable conditions to Cohort 1 should be reviewed and agreed between the Investigator and the Sponsor
* For Cohort 2, be a man or woman, 18 to 55 years of age, inclusive
* For women of childbearing potential in Cohort 2, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1
* If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
* Body mass index (BMI) (weight \[kg\]/height\^2 \[m\]\^2) between 18 and 32 kg/m\^2 (inclusive), and body weight not less than 50 kg

Exclusion Criteria:

* Diagnosed with a current or previous psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
* Clinically significant medical illness
* Severe renal impairment
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center (Day -1) as deemed appropriate by the investigator
* History of drug or alcohol abuse disorder within the past 1 year, or a reason to believe a participant has such a history
Measured vs Navigated Techniques in Total Hip Arthroplasty

Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome. In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy. In order to achieve reconstruction within acceptable parameters as per pre-operative plan, some surgeons propose the use of intra-operative devices that measure component orientation and joint reconstruction ("Measured-THA"), whilst others propose the use of navigation tools ("Navigation-THA). Both techniques have shown superiority compared to the most commonly used "freehand" technique, but no prior study has assessed for superiority between these 2 techniques. Furthermore, to-date assessment of post-operative reconstruction has not been tested in detail as post-THA assessments are based on radiographs which provide incomplete, 2-dimensional, assessments and are lacking the important axial plane reconstruction parameters. The aims of this prospective, randomized, trial are to 1. appraise the ability to achieve the pre-operative 3-D plan (as per FormusLab) through a comparison of pre-op plan to post-operative reconstruction; 2. compare ability to accurately reconstruct hip following THA between "navigated-" (IntelliJoint®) and "measured-" techniques; and in doing so it will also 3. assess the accuracy of the intra-operative assessments of reconstruction through a comparison of objective (i.e. measured) intra-operative assessments with the post-operative reconstructions achieved.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are signed for a THA for primary or secondary osteoarthritis without overt deformity that would require revision type implants and with good enough bone quality to be listed for uncemented component implantation.

Exclusion Criteria:

* Secondary OA due to Dysplasia (Hartofilakidis \>1)
* Avascular necrosis of the hip with destruction of joint structure
* Sequelae of Pediatric deformity with abnormal anatomy
* Cemented fixation of femur or acetabulum
* Previous arthroplasty-type procedure
* Previous septic arthritis of the hip
MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients

Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia: No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax (56 days), and B-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab. After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative (by flow cytometry by aberrant immunophenotype in a centralized lab) status was achieved.

* 7 days prednisolone prephase
* 8 weeks induction with de-escalation of induction chemotherapy: 3 instead of 4 dauno/vncr pulses,

  1. instead of 2 Cph injections during induction,
  2. instead of 4 ARA-C blocks, distribution of of L-asp injections through all phases
* After CR achievement T-cell ALL and B-ALL patients are being study MRD (by FCM) MRD-positive patients with T-ALL will receive 1-3 consolidation with venetoclax (400 mg/d), and B-ALL patients will receive1 additional consolidation by blinatumomab
* Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement. Rotation of consolidation is permitted
* 2 years maintenance for all patients
* 21 TIT through the whole treatment with higher intensity during induction\|consolidation
* Centralized MRD monitoring at +70 d, + 133 d, + 190 days; before and after allo-HSCT
* Allo-HSCT is planned only for very high risk patients (11q23 ALL, MRD positivity after target therapy, ETP T-ALL)

Eligibility Criteria:
Inclusion Criteria:

• age 18-55 years old of patient,

- Clinical diagnosis of non-treated Ph-negative ALL

Exclusion Criteria:

• age more than 55 years old,

* Clinical diagnosis of Ph-positive ALL
* Clinical diagnosis of relapsed/refractory ALL,
NM404 as an Imaging Agent in Patients With NSCLC

This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution, and optimal imaging times (part 1 - complete).

In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3 - ongoing).


Eligibility Criteria:
Inclusion Criteria: Part 3

* Histologically or cytologically documented NSCLC with measurable of disease
* Disease is evaluable by CT scan
* At least 18 years old. Women cannot be pregnant or breastfeeding
* Karnofsky score \>/= to 60
* Adequate renal/hepatic function
* Adequate blood cell count levels

Exclusion Criteria:

* Concomitant infection
* Other active cancers
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder

This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults, 18 through 70 years of age, inclusive
* Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
* A history of at least two previous episodes of Major Depression plus the current episode
* Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline

Exclusion Criteria:

* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
* Any current Axis I disorder other than major depressive disorder which is the focus of treatment
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
* Use of any psychoactive medication after the screening visit
* Patients who have been previously treated with agomelatine
* Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply
The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis

The objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia (PCA) to oral pain medications.

To assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission.

Post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.

Eligibility Criteria:
Inclusion Criteria:

* All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.

Exclusion Criteria:

* Non-perforated appendicitis
* Normal appendix at the time of operation or other associated conditions causing abdominal pain
* Patients with history of chronic pain
* Known underlying liver disorders
* Known allergy to pain medication in protocol
* Non-English speaking
An Open Label Study to Evaluate the Safety and Efficacy of Mechlorethamine(MCH) 0.04% Formulation in Mycosis Fungoides

To evaluate the efficacy and safety of topical application of MCH 0.04% in a propylene glycol ointment (PG)in patients with stage I or IIA MF previously treated with MCH 0.02% in a PG or AP ointment who did not achieve a complete response.

This is a multi-center, open-label study of patients with previously treated stage I (IA and IB) or IIA MF who have not received a complete response after completing 12 months of treatment in clinical trial (2005NMMF-201-US)to either 0.02% MCH PG or 0.02% MCH in Aquaphor (AP) ointment formulations.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed the treatment phase of the Yaupon Therapeutics-sponsored Phase II Pivotal study of MCH 0.02% in either the PG or AP formulation and have not achieved a complete response.

Exclusion Criteria:

* Pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception
Curcumin in Rheumatoid Arthritis

Curcuma longa or turmeric is a tropical plant native to south and southeast tropical Asia. Perhaps the most active component in turmeric is curcumin which may make up 2-5% of the total spice in turmeric. The study drug being tested in this study is curcumin.

This study is called a cross-over study because all subjects will receive the study drug for a certain amount of time and then switch to placebo (an inactive substance) for a certain time or vice versa. The subject's participation may last up to 8 months.

The subject will be randomized (by chance; like flipping a coin) to receive either the study drug, curcumin, or placebo for 4 months. After 4 months, if the subject was taking curcumin they will stop taking it and begin to take placebo and if the subject was taking placebo they will stop taking it and begin taking curcumin for the remaining 4 months. By completion of the study, all 40 subjects will have taken curcumin and placebo for 4 months each.

Curcumin/placebo will be provided in capsule form and the subject will take it by mouth. The dose dose will be increased every week for up to a total of 4 grams per day.

Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years; read and understand English
2. Stable dose of non-steroidal anti-inflammatory agents (NSAID) for ≥ 2 weeks.
3. Oral prednisone or equivalent ≤ 10 mg daily and stable dose for ≥ 2 weeks(and must be kept stable throughout the duration of the protocol).

   * ESR \> 20 mm/hr, or CRP \> 0.8 mg/dl
4. May be using any of the following DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or leflunomide. If using any of these DMARDs must be using them for ≥ 12 weeks and stable dose for ≥ 4 weeks. If using other DMARD, or DMARD combinations, these additional or other DMARDs must be stopped for ≥ 4 weeks before baseline visit. May also participate if patient not on DMARD,
5. Subjects must be diagnosed with rheumatoid arthritis based on the revised American College of Rheumatology criteria:Presence of \> swollen and \> 6 tender joint count (28 joint count), and either ESR \> 20 mm/hr or CRP \> 0.8 mg/dl

Exclusion Criteria:

1. Acute medical conditions deemed as inappropriate by the investigators (acute heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
2. AST/ALT \> 1.5 upper limit of normal (ULN)
3. Serum creatinine \> 1.6 mg/dl
4. Hemoglobin/Hematocrit \< 10.0 gram/dl/ 30.0
5. Platelet count \< 100,000
6. Current use of warfarin (as there is a drug interaction between curcumin and warfarin).
7. Currently on biologic therapy (must have stopped etanercept for ≥ 4 weeks or adalimumab or infliximab for ≥ 8 weeks at time of Time 1 visit),
8. Women who are pregnant,
9. Subjects who are taking digoxin, warfarin and/or heparin,
10. Subjects with a history of antiphospholipid syndrome and other thrombophilic states,
11. Subjects who have an INR \>= 1.5 at baseline,
12. Subjects with acute episode(s) of cholecystitis within the last 6 months,
13. Subjects with active peptic ulcer disease within the last 6 weeks
The Effect of Phytosterol Esters of Omega-3 (Vayarol) Versus Omega-3 Acids Ethyl Esters in Reducing Triglyceride Levels

The primary objective is to determine the efficacy of phytosterol esters of omega-3 (Vayarol) versus Omega-3 acids ethyl esters in reducing triglyceride levels in hypertriglyceridemia patients with fasting triglyceride levels ≥ 200 and \< 500 mg/dL.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age \> 18 years
2. Triglycerides ≥ 200 mg/dL and \< 500 mg/dL
3. Ability to give written informed consent

Exclusion Criteria:

1. Female patient who are pregnant or breastfeeding or planning to become pregnant
2. Fasting plasma glucose (FPG) levels \> 110 mg/dL
3. Type 2 diabetes mellitus that is poorly controlled (glycosylated hemoglobin \[HbAlc \] \>8.0%
4. Patients who are under use of lipid altering drugs excluding use of Simvastatin, Atorvastatin, and Rosovastatin for 6 weeks or more
5. Patients who are under use of products containing omega-3 fatty acids or other dietary supplements with potential lipid altering effects
6. History of bariatric surgery or currently on weight loss drugs.
7. Uncontrolled hypertension (BP\>140/90)
8. Subjects with secondary causes of hypertriglyceridemia: alcoholism, dysglobulinemia, thyroid disease that is poorly controlled (TSH\<0.35 or TSH\>5.5)
9. Subjects with an abnormal level of liver enzymes (twice the normal level)
10. Suffered from ischemic event such as myocardial infarction, cerebrovascular accident and angina pectoris in the last 6 months
11. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins such as cushing syndrome
12. Gastrointestinal disease that may influence lipid metabolism such as celiac, crohn, colitis or other malabsorption problem
13. Subjects who have had any malignancy. Subjects who have had basal cell carcinoma that have been disease free for at least 3 years are eligible for the study.
14. Consumption of one fish serving (200 grams) or sea food x2 a week or more.
15. HIV infection by history
16. History of hypersensitivity or allergy to fish, fish oil or soy
17. BMI≥35
18. Weight change \> 3 kg during the run-in period
19. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient
Effect of Foot Massage Performed to the Mother After Bırth on Breastfeedıng Success, Sleep Qualıty and Newborn Stress

Aim: To Reveal The Effect Of Foot Massage Performed To The Mother After Bırth On Breastfeedıng Success, Sleep Qualıty And Newborn Stress Material and Method: This randomized controlled trial was conducted with 70 people (35 experimental, 35 control) in a public hospital in Kahramanmaraş.

: Aim: To Reveal The Effect Of Foot Massage Performed To The Mother After Bırth On Breastfeedıng Success, Sleep Qualıty And Newborn Stress Material and Method: This randomized controlled trial was conducted with 70 people (35 experimental, 35 control) in a public hospital in Kahramanmaraş.

In the first stage, the researcher participants were informed about the purpose of the researcher and the questionnaire, and their consent was obtained for participation in the study.

In the second stage, Before starting the foot massage, the client will be informed about the number of sessions, their duration, and when they will be held. The average interview time for the patients in the experimental group will be 15-20 minutes. The first interview with the women in the experimental group will be held at any time after birth when the woman feels well. Before the application, the researcher washes and dries her hands, and massages them with baby oil to warm them up properly and facilitate the process. First, a three-minute general massage is given to prepare the feet, and then the correct points are massaged for 10 minutes for each foot. The "Introductory Information Form", "LATCH Breastfeeding Diagnostic Measurement Tool", "Neonatal Stress Scale", and "Pittsburgh Sleep Quality Index (PSQI)" forms related to the study will be filled out. The woman's address and telephone information will be obtained in order to meet again.

Eligibility Criteria:
Inclusion Criteria:

* Literate,

  * Communicative,
  * Poor sleep status (with a global score of ≧5 on the PSQI,
  * Patients who volunteer to participate in the study,
  * Minimum and maximum gestational age of 37 and 42 weeks,
  * No psychological disorder,
  * Low-risk singleton pregnancy,
  * Good foot health (cuts, burns, fungus, warts, etc.)
  * No sensitivity to touch or massage.

Exclusion Criteria:

* Those who wish to withdraw from the study, • Patients with deficiencies or errors in any of the forms used to collect data will be removed from the study.
Impact of NMES and HPRO on Recovery After SAH- Pilot Study

The study purpose is to investigate the hypothesis that in adults with SAH, early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls receiving standard of care interventions for nutrition and mobilization. The investigators will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH. This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as compared to age and severity-matched SAH patients undergoing standard of care interventions for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health recovery outcomes.


Eligibility Criteria:
Inclusion criteria:

1. . Being diagnosed with aneurysmal SAH
2. . Aneurysmal repair within 48 hours of ictus.
3. . Age between 25 and 80 years old. (\>=25 years old and \<=80 years old)
4. . Expected stay in the NCCU \> 72 hours.
5. . Admission Hunt Hess Grade \>=2.
6. modified Fisher score \>1.

Exclusion criteria:

1. . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
2. . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
3. . Unlikely to remain in the ICU for more than 7 days;
4. . Body mass index \< 15 or \>40 kg/m2;
5. . Allergy to whey protein;
6. . Evidence of lower extremity paresis or spasticity within 48 hours of injury
7. . Pre-morbid modified Rankin Score \>1.
8. . Known pregnancy
9. . Presence of active malignancy
10. . Diagnosis of an inflammatory disorder
11. . Presence of a neuromuscular disorder
12. . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR \< 30 mL/min/1.73m2)
13. . Hepatic insufficiency defined as AST/ALT levels \>2.5 above normal upper limits.
14. . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment
15. . Prisoner.