cyrilzakka/clinical-trials huggingface dataset:
Short-term Efficacy of Antidepressant in Patients Underwent TKA

By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.

In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs.

The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
2. Primary TKA surgery,Varus is smaller than 20°
3. Always there is no history of mental illness, no history of relevant medicine
4. Be able to read and understand Chinese, with good communication skills
5. Voluntary participation in this clinical study

Exclusion Criteria:

1. Previous history of mental and psychological illness
2. With severe diseases in respiratory system, circulatory system or digestive system
3. Allergic to duloxetine and celecoxib
Safety Study of HPP593 in Subjects During and After Limb Immobilization

This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking.
* Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results.
* Not restricted to a wheel-chair or confined to a bed.
* Weight ≥ 50.0 kg.
* BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.

Exclusion Criteria:

* Any of the following abnormalities at Screening Visit and Baseline:

  * Fasting glucose \> 110 mg/dL (Screening visit only).
  * Serum creatinine \> 1.5 mg/dL. If serum creatinine is \>1.5 mg/dL and creatinine clearance is \>60 mL/min, the subject need not be excluded
  * Troponin I level above the upper limit of normal (ULN)
  * Liver function tests (LFTs) \> 1.5x ULN
* Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)
* Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.
* Has received HPP593 in a previous clinical trial.
* Smoking within 6 month prior to Day -1.
* Michigan Alcohol Screening Test score greater than 2.
A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)

This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Renal anemia treated with Mircera for at least 6 months before entering study

Exclusion Criteria:

* Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH)

This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH who have completed two years of treatment in the 111-202 study.


Eligibility Criteria:
Inclusion Criteria:

* Have completed 24 months of BMN 111 treatment in Study 111-202.
* Parent(s) or guardian(s) are willing and able to provide written, signed informed consent. Subjects under the age of majority are willing and able to provide written assent (if required). Subjects who reach the age of majority in their country will be asked to provide their own written consent upon reaching the legal age of majority.
* If sexually active, willing to use a highly effective method of contraception while participating in the study.
* Females \>= 10 years old or who have started menses must have a negative pregnancy test at baseline and be willing to have additional pregnancy tests during the study
* Willing and able to perform all study procedures as physically possible
* Parents/caregivers willing to administer daily injections to the subjects and complete the required training.

Exclusion Criteria:

* Requires any investigational agent prior to completion of study period.
* Have a condition or circumstance that, in the view of the Investigator, places the subject at high risk for poor treatment compliance or for not completing the study.
* Concurrent disease or condition that, in the view of the Investigator, would interfere with study participation or safety evaluations for any reason.
* Permanently discontinued BMN 111 during the 111-202 study.
* Subject is pregnant at Baseline visit or planning to become pregnant (self or partner) at any time during the study.
* Current chronic therapy with restricted medications.
A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients

The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.

Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 cell count of at least 100 cells/mm3.
* Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

* Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
* Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening.
* Inability to tolerate oral medication.
* Any other clinical condition that would preclude compliance with dosing requirements.

Patients with the following prior conditions are excluded:

* History of acute or chronic pancreatitis.
* Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry.
* Proven or suspected acute hepatitis within 30 days prior to study entry.

  1. Potent neurotoxic drugs, such as vincristine and thalidomide.
* Other anti-HIV therapy.

  1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP.
* Immunizations recommended by ACIP for routine practice.
* Erythropoietin and G-CSF are allowed if myelosuppression emerges on study.

  1. Any antiretroviral therapy.
* Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.

  1. Any prior antiretroviral therapy.
* Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.

Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.
Effects of Targeted Follow-up of New Fitness Center Members

Objective: To investigate the long-term effects of targeted follow-up of new fitness center members compared to usual practice, on frequency of visits and membership terminations after four years.

Design and setting: A participant and provider blinded parallel group randomized controlled trial conducted at eight Fitness Centers in Trondheim, Central Norway.

Participants: The inclusion criteria were new members \>16 years who between September 1st to 9th 2014 signed up for an ordinary contract with a minimum duration of 12 months.

Intervention: The intervention consisted of two phone calls and one e-mail delivered over 6-8 weeks after enrollment, aiming to motivate members to get started using the fitness center and its services. Usual practice at the fitness center is self-directed use.


Eligibility Criteria:
Inclusion Criteria:

* The study included new members (16 years in 2014 or older) on ordinary contracts with a minimum duration of 12 months and monthly automatic membership renewal that enrolled independent of the study at one of eight 3T-Fitness Centers in Trondheim between September 1st and September 9th, 2014.

Exclusion Criteria:

* Exclusion criteria were members with free contracts, employee contracts, cash membership, shorter membership contracts (duration \<12 months) and loyalty contracts (indicates that the member is improving his old contract and is not a new member).
Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer

This pilot research trial studies continuous activity monitoring during fractionated radiotherapy in patients with head and neck, lung, or gastrointestinal cancer. This study explores the use of fitness trackers to study the activity levels of patients before, during, and after radiation therapy and the use of weekly assessments to measure the patients' quality of life during radiation therapy. This may allow doctors to see if there is any relationship between activity levels, quality of life, treatment interruptions, hospitalizations, and clinical outcomes.

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility of continuous, accelerometer-based evaluation of patient activity levels before, during, and after treatment with fractionated external beam radiotherapy.

SECONDARY OBJECTIVES:

I. To demonstrate the feasibility of performing weekly quality of life assessments during fractionated external beam radiotherapy.

II. To explore how accelerometer-based metrics change throughout patients' treatment courses and if these changes are associated with quality of life assessments, treatment interruptions, hospitalizations, and clinical outcomes.

OUTLINE:

Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the head and neck region, lung, or gastrointestinal tract
* Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
* Women of childbearing potential must:

  * Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
  * Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
  * Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry
Duration of Antibiotic Therapy in Critically Ill Patients: C-reactive Protein-guided Therapy Versus Best Practice

The judicious use of antibiotics is one of the main measures to limit the emergence of multidrug-resistant pathogen related to excessive antimicrobial use. A recent study demonstrated that C-reactive protein (CRP) was as useful as procalcitonin (PCT) in reducing the time of antibiotic therapy in adult septic patients treated in the ICU setting. Therefore, the present study proposes to compare the time of use of antimicrobials, costs of hospitalization and clinical outcomes of interest among a group of antibiotic therapy guided by serum levels of CRP and a group of therapy based on the best practices of antibiotic therapy (Best Practice).

All adult patients (aged\> 17 years), hospitalized at the ICU (total of 50 beds) of the Hospital das Clínicas - UFMG, with an assumed or proven infection, will be considered for inclusion. Patients who meet the inclusion and exclusion criteria will be allocated randomly into one of the following groups: 1) PCR group: antibiotic therapy will be discontinued according to serum CRP levels; 2) "Best Practice" group, length of antibiotic therapy based on the most recent guidelines in the medical literature, according to the focus and / or causative micro-organism. PCR assays shall be performed daily on serum obtained from blood collected for routine intensive care examinations up to 2 days after antibiotic withdrawal. In the PCR group, antibiotic suspension will be encouraged when levels of this marker are \<35mg / L (if peak PCR below 100mg / L); or reduce 50% of the highest value (if PCR peak \> 100mg / L), with a limit of seven days, if there is clinical improvement. Primary outcomes will be duration of antibiotic therapy and antibiotic-free live days corrected for 1000 days of hospitalization. Secondary outcomes will be costs, clinical cure rate, therapeutic failure, 28-day mortality, 90-day mortality, in-hospital mortality, length of hospital stay, nosocomial infection rate, recurrence of infection, and isolation of multidrug-resistant bacteria

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed informed consent
* Assumed or proven infection
* Patient admitted to the unit participating in the study

Exclusion Criteria:

* Patients with severe immunosuppression, such as severe neutropenia (\<500 neut/mm3), transplantation of solid organs or cells hematopoietic, HIV infection with CD4+ \< 200/mm3
* Patients with multiple trauma, burns or surgery grid size in the last 5 days (Except surgery for focus control)
* Use of antibiotics supposedly or proven to be effective against the infectious process in for more than 48 hours.
* Patients undergoing palliative care.
* Patients with death expectancy for the next 24 hours.
* Patients with bacteremia caused by Staphylococcus aureus or Candida spp
* Patients with infections that are known to require prolonged antibiotic therapy
Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 1

The acute and subacute sensations that occur on the scalp with injection of different concentrations of bupivacaine for grater occipital nerve blockade will be compared. Each Veteran participant will be randomized to receive three different concentrations, which will be injected one week apart each.

Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted.

Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden.

The acute burning that occurs during injection and then the numbing over the scalp that occurs shortly after anesthetic GON blockade make controlled investigations against placebo difficult to interpret. In sub-study 1 of this project, different concentrations of bupivacaine (0.0%, 0.01%, 0.05%, 0.1%) will be examined in order to identify a suitable control dose to later compare to the full dose of 0.5%. Acute and subacute sensations from bupivacaine GON blockade will be measured and the lowest concentration that resembles the sensations elicited by full dose (0.5%) will be used in a subsequent efficacy trial (sub-study 2).

Eligibility Criteria:
Inclusion Criteria:

* United States Military Veterans within VA Connecticut Healthcare System
* Chronic post-traumatic headache per ICHD-3 criteria (i.e., headaches are continuing to occur three months after the head injury)
* At least two headache days per week
* MRI brain scan completed within the past 3 months if chronic PTH for less than one year, within the past year if chronic PTH for less than 5 years, and within 5 years if chronic PTH for more than 10 years
* Review of MRI and the medical record does not reveal another source for headache

Exclusion Criteria:

* Skull defect
* Other contraindication to bupivacaine

  1. Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine
  2. Instruction from clinician to avoid amide anesthetics, such as lidocaine
* Pregnant or lack of adequate birth control
Comparison of Absorption of Vaginal Diazepam Using Different Delivery Systems

The purpose of this study is to determine which of three delivery systems of vaginal diazepam have the best systemic absorption, measured by serum diazepam levels. The three delivery systems are: moistened tablet, suppository or cream. Additionally the study will compare the side effects and absorption of vaginal diazepam with oral diazepam. Vaginal diazepam is used off-label vaginally to relax pelvic floor muscles and reduce pelvic pain caused from pelvic floor dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Premenopausal women \> age 18
* Able to provide urine and serum samples during the time period

Exclusion Criteria:

* Current use of benzodiazepines in any form. If history of benzodiazepine use, must not have taken for one week prior to study screening and enrollment
* Pregnancy
* Concomitant use of any narcotic drug, ethanol, or any illicit drug use during the study period that could be deemed unsafe in combination with benzodiazepine medication use as judged by the investigators.
* Any evidence of vaginitis on wet mount slide
* Postmenopausal
* Subject with any other vaginal epithelial disorder that could affect absorption of medication as deemed by the investigators.
* Any indication/condition/medication that the investigators identify as contraindicated in conjunction with diazepam.
Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate

The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.

This is a modified case control study to investigate the association of genotype with phenotype in subjects who experienced alanine aminotransferase and bilirubin derangements following exposure to lapaquistat acetate.

The DNA profile of subjects who experienced significant biochemical hepatic derangement following exposure to lapaquistat acetate (cases) will be compared with a population of pre-genotyped untreated individuals (controls) from a public database. The DNA from subjects who had hepatic derangement during lapaquistat acetate studies, in the absence of exposure to lapaquistat acetate, will be stored. If data from the subjects exposed to lapaquistat acetate indicates that there is a genetic marker of interest, the stored DNA from non-exposed subjects will be assayed to further investigate the signal. One 10 mL sample of whole blood will be collected in plastic K2EDTA tube, after informed consent has been obtained.

Each subject will sign the informed consent document prior to undergoing the study-related procedure. One 10 mL sample of whole blood will be collected from each subject. Extracted DNA will be analyzed using a whole genome scan approach as well as a candidate gene approach.

Eligibility Criteria:
Inclusion Criteria:

* Has experienced an alanine aminotransferase level greater than or equal to 5 times the upper limit of normal, or concurrent elevation of alanine aminotransferase greater than or equal to 3 times the upper limit of normal and bilirubin greater than or equal to 2 times the upper limit of normal while participating in lapaquistat acetate clinical studies.

Exclusion Criteria:

* None
Mindfulness-Based Therapy for Serious Mental Illness

Serious mental illness (SMI), encompassing schizophrenia-spectrum and major mood disorders, has been estimated to affect approximately 5.4% of the U.S. adult population each year. Research shows low rates of evidence-based treatment being provided to patients with SMI. This is unfortunate, because evidence-based psychological therapies have been shown to be effective for improving outcomes in SMI. One such efficacious psychological intervention is mindfulness-based therapy (MBT), which integrates mindfulness practice with cognitive-behavioral strategies to improve illness management. Previous trials conducted in the United Kingdom have shown that MBT improves symptoms and functioning in community-based outpatients with SMI, including in routine practice settings. In the U.S., most patients with SMI receive treatment at local community mental health centers (CMHCs). However, patients in CMHCs often cannot access evidence-based therapies like MBT due to the lack of trained staff able to provide these interventions. Further, previous studies of MBT have been conducted exclusively outside the U.S. It is essential to confirm that MBT is effective when delivered for patients with SMI in the U.S., and how it can be sustainably implemented in CMHCs where this clinical population is commonly treated. Thus, the investigators propose to test the effectiveness of MBT for SMI and study its implementation in a typical CMHC setting. The investigators will randomize 160 patients with SMI (psychotic-spectrum and major mood disorders) to receive treatment as usual (TAU) vs TAU plus MBT delivered by frontline clinicians in a large, diverse CMHC. The investigators will conduct blinded assessments at baseline and at 6- (mid), 12- (post), and 24-weeks (follow-up). Consistent with an experimental therapeutics approach, the investigators will examine potential mechanisms of action (e.g., mindfulness skills), as well as collect implementation-focused quantitative and qualitative data from our community partners (patients, administrators, clinicians). If found to be effective and aided by a certified training program and the implementation data collected, MBT could be adopted as a future evidence-based practice and integrated into the routine community care of patients with SMI, thereby reducing health disparities.


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving treatment in a community mental health center
* Diagnosed with schizophrenia-spectrum disorder or major mood disorder based on clinical interview
* Age 18 years or older
* Ability to speak and read English

Exclusion Criteria:

* Not clinically stable enough to participate in treatment.
* Established weekly mindfulness practice