cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.

The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.

In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.

The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.

Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.

To evaluate efficacy of extend treatment during 24 weeks more in co-infected HIV-HCV patients with genotype 1 and/or 4 who at 44 week of treatment with peginterferón alfa-2a in combination with ribavirin have RNA-HCV undetectable.

Eligibility Criteria:
Inclusion Criteria:

* Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week
* RNA-HCV positive at 48 week before study and genotype 1 or 4.
* HIV-1 positive: ELISA y Western-blot.
* Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).
* Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
* Willingness to give written informed consent and willingness to participate to and comply with the study.

Exclusion Criteria:

* Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).
* Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.
* More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.
Neurocognitive Effects of FMT in MDD Patients With and Without IBS

This study is a phase 2/3 open-label controlled trial (CT) in which adults with Major Depressive Disorder (MDD) and adults who have MDD plus comorbid Inflammatory Bowel Syndrome (IBS) will be assigned to either receive oral Fecal Microbiota Transplantation (FMT) or to continue with the treatment they are currently receiving in a Treatment As Usual (TAU) arm. An IBS alone group receiving TAU will be recruited as a clinical control group.

The primary goals of this study are to determine effectiveness, safety and tolerability of oral FMT in adults with MDD and in MDD who have comorbid IBS. Additional goals are to characterize patterns and progressions of cognitive and neural correlates associated with MDD and with MDD + IBS and to determine if they improve with FMT. It is known that both, individuals with MDD and those with MDD and IBS show cognitive alterations as well as changes in neural structures, but this study is designed to see if those are changed with treatment response to FMT."


Eligibility Criteria:
Inclusion Criteria:

1. Between 18-60 years of age:

   Participants should be at least 18 years old and not older than 60 years at the day of screening
2. Have a primary diagnosis of MDD as assessed/confirmed by the M.I.N.I. International Neuropsychiatric Interview (MINI)
3. Have had a well-documented inadequate response to at least 2 approved antidepressants
4. A MADRS score of ≥ 19 at screening and visit 2a
5. Have a comorbid diagnosis of IBS. IBS patients can include any of the following: diarrhea predominant IBS (IBS-D), constipation predominant IBS (IBS-C), IBS with mixed bowel habits (IBS-M), or unclassified with IBS (IBS-U) as confirmed by the referring doctor using ROME III criteria
6. Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS)

Exclusion Criteria:

1. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5)\[1\] Criteria for the following conditions according to the M.I.N.I:

   1. Substance Use Disorder within the last 3 months. \*(Criteria should include Alcohol and non-alcohol substances except Cannabis)
   2. Moderate or severe substance use disorder for Cannabis use the last 3 months
   3. Active Anorexia Nervosa or Bulimia nervosa
   4. Schizophrenia, schizoaffective or bipolar disorder
   5. Active suicidality
2. Regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the three (3) months prior to study entry
3. Use of prebiotics or probiotics for medical purposes for more than two (2) weeks within the last three (3) months
4. Conditions causing immunosuppression
5. Women who are breastfeeding, pregnant or seeking to get pregnant during the course of this study. Not using an acceptable method of birth control (implants, injectable, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)
Mushroom Ingestion Study

The investigators propose to determine the effect of consuming 0, 1 or 2 servings of white button (Agaricus bisporus; most popular, lower ergothioneine) or yellow oyster (Pleurotus citrinopileatus; higher ergothioneine) mushrooms on postprandial changes in plasma levels and urinary excretions of mushroom-specific compounds.

The investigators hypothesize that consuming different mushroom varieties will elicit distinct postprandial nutrimetabolomic profiles in the plasma and urine and that the amount of metabolites present will increase with the servings of mushrooms. Measuring ergothioneine in the plasma will provide a quantitative outcome to document the postprandial responses to consuming the test meals. The nutrimetabolomic related outcomes are exploratory and have not been documented in human research.

Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* age 30-69 y;
* BMI: 25.0-34.9 kg/m2;
* Not severely or extremely depressed (Beck's Depression Inventory score ≤30)
* Total cholesterol \<240 mg/dL, low-density lipoprotein cholesterol \<160 mg/dL, triglycerides \<400 mg/dL, fasting glucose \<110 mg/dL;
* Systolic/diastolic blood pressure \<140/90 mm Hg;
* Body weight stable for 3 months prior (± 3 kg);
* Stable physical activity regimen 3 months prior;
* Medication use stable for 6 months prior;
* Non-smoking;
* Non-diabetic;
* Not acutely ill;
* Females not pregnant or lactating;
* Participants must be willing and able to consume the prescribed diets and travel to testing facilities.

Exclusion Criteria:

* BMI \<25 or \>35;
* Severely depressed (Beck's Depression Inventory score \>30);
* Total cholesterol \>240 mg/dL, low-density lipoprotein cholesterol \>160 mg/dL, triglycerides \>400 mg/dL, fasting glucose \>110 mg/dL;
* Body weight changes in previous 3 months (±3 kg);
* Changes in physical activity regimen in the previous 3 months;
* Medication changes in the previous 6 months;
* Smoking;
* Diabetic;
* Acute illness;
* Pregnant or lactating;
* Allergic to mushrooms
Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors

This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Primary Objectives:

I. To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.

II. To determine the safety and toxicity of this regimen in these patients. III. To determine the pharmacokinetics of this regimen in these patients.

Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant solid tumor
* Advanced disease, meeting both of the following criteria: Metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective.
* No known active brain metastases
* Life expectancy \> 3 months
* ECOG performance status 0-2
* Bilirubin normal
* No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit study compliance.
* Negative pregnancy test
* Fertile patients must use effective contraception
* Recovered from prior therapy
* No prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C).
* No prior targeted therapy within the past 4 weeks
* No prior immunotherapy within the past 4 weeks
* No prior radiotherapy within the past 4 weeks.
* No more than 2 prior chemotherapy regimens for advanced solid tumors.
* No other concurrent investigational agents. Bisphosphonate therapy (e.g., pamidronate or zolendronate) is not considered investigational therapy.
* No concurrent antiretroviral therapy for HIV-positive patients.
* No other concurrent anticancer agents or therapies.
* Tumor has spread to other parts of the body or cannot be removed by surgery.
* More than 4 weeks since chemotherapy, biological therapy, or radiation therapy.
* No more than two previous chemotherapy regimens for advanced solid tumor.
* WBC \>= 3,000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Creatinine clearance \>= 60 mL/min
* Absolute neutrophil count \>= 1,500/mm³
* AST and ALT =\< 2.5 times upper limit of normal
* No prior cumulative cisplatin dose \> 300 mg/m\^2
* No preexisting neuropathy \<= grade 2
* Not pregnant or nursing
A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes

The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.

Breast cancers that are hormone sensitive require estrogen suppression as a part of multimodal treatment. Estrogen suppression also reduces the likelihood of a breast cancer recurrence. Therefore, breast cancer survivors with estrogen sensitive tumors are placed on hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen or aromatase inhibitors like anastrazole. This therapy typically is administered for five years after a cancer diagnosis. Regardless of age or pre-existing menopausal status, the hormone suppression reduces estrogen levels and can either exacerbate existing menopausal symptoms or induce medical menopause in otherwise premenopausal women. This study will evaluate the patient's perspective of vaginal therapy using the Viveve® device in breast cancer patients.

Eligibility Criteria:
Key Inclusion Criteria:

* 18 years or older
* Breast cancer survivors defined as women with a history of hormone sensitive breast cancer on tamoxifen
* Self-reported vaginal laxity
* Meet diagnosis of sexual dysfunction
* Patients must be able to understand and willing to sign a written informed consent document and be willing to complete the patient reported outcome tools at the scheduled time points

Exclusion Criteria:

* Cognitive impairment
* Women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention
* Women with active breast cancer disease
* Women currently on hormone therapy or who are pregnant
* Women who have had vaginal or pelvic surgery involving the genitalia
Nitrous Oxide - Sevoflurane-Remifentanil Interaction

patients are allocated to one of the two study groups.

In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.

During the study, at predefined times, we will assess different levels of sedation (OAA/S score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded continuously and non invasive bloodpressure will be recorded using a 1 minute interval time. Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical cerebral drug effect.

The null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the results of this study will be compared with a former interaction study of the same study group that did not involve nitrous oxide, in order to depict the shift in the response surface evoked by nitrous oxide.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia class I and II patients
* aged 18-60 years
* scheduled for surgery under general anesthesia.

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* neurological disorder
* diseases involving the cardiovascular system, pulmonary disease, gastric diseases, endocrinological diseases
* recent use of psycho-active medication, including alcohol
Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder

This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.


Eligibility Criteria:
Inclusion criteria

* Men and women age 18-65 years
* Patients with DSM-IV defined schizophrenia or schizoaffective disorder
* Treated with any atypical antipsychotic for at least 2 months
* Patients with documented weight gain \> 7% with current antipsychotic medication
* Able to provide written consent

Exclusion criteria

* Women who are pregnant or nursing. Female participants must have a negative urine pregnancy test at screening.
* DSM-IV defined substance or alcohol dependence within the 2 months preceding the start of the trial
* Treatment with a monoamine oxidase inhibitor (e.g., tranylcypromine, phenelzine, isocarboxazid) within 2 weeks of starting the trial
* Patients considered at high risk for suicide or violence
* Patients with history of or symptoms on systems review consistent with clinically significant and currently relevant hematologic, renal, hepatic, gastrointestinal, endocrine, pulmonary, dermatologic, oncologic or neurologic (including seizures or epilepsy) disease
* Patients with a history of or symptoms on systems review consistent with significant cardiovascular disease, bypass surgery, or concurrent cardiovascular disease, including uncontrolled hypertension, hypotension, congestive heart failure, angina pectoris, or recent (within last 6 months) myocardial infarction
* Use of any investigational drug within 4 weeks before screening
* History of hypersensitivity or other intolerable adverse effects to modafinil
* Patients who experience severe sleep disturbances from modafinil
Precision of Complete-arch Digital Implant Impressions With Intraoral Scanning Versus Photogrammetry

The goal of this cross-over clinical trial is to investigate the precision of digital implant impressions using an intraoral scanner and photogrammetry in obtaining complete-arch implant-supported scans.

The main question\[s\] it aims to answer are:

* Is there a difference in precision between intraoral scans and photogrammetry in obtaining digital implant scans?
* Will arch perimeter and jaw type (maxilla vs. mandible) affect the precision results?

Procedures: At each appointment, participants existing permanent/temporary prosthesis or healing caps were unscrewed and temporarily removed for the period of the consultation appointment.

Scanbodies were screwed into their implants for the duration of the appointment.

They underwent two types of digital implant impression procedures (five times each), including intraoral scan and photogrammetry.

Intraoral and extraoral photography were taken.

At the end of each appointment, the scanbodies were removed, and existing bridge/healing caps were reinserted.

The procedures were not painful or required any form of local anesthetic

Comparison group: Researchers compared the precision of intraoral scanning vs. photogrammetry to see which device provided the best precision outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Present with a completely edentulous arch with at least four implants
* Have bone-level implants
* Intended for restoration with a screw-retained abutment-level fixed implant-supported prosthesis.

Exclusion Criteria:

* Patients unable to tolerate the digital scans impressions
* Presented with implants other than bone-level platforms
* Not intended for restorations with screw-retained abutment-level fixed implant-supported prosthesis
* Not completely edentulous.
Hip Arthroplasty with Logica Mirror Femoral Stem

Logica Mirror femoral stem is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect additional evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within three years after the surgery, and thus to assess the short-term performance and safety of this implant.


Eligibility Criteria:
All patients that underwent partial or total hip arthroplasty and implanted with LOGICA MIRROR femoral stem between Jan 2010 and Dec 2021 at Nemocnice Kyjov Hospital (CZ) in accordance with the indication for use of the product and site standard of practice.

Additional Inclusion criteria:

* Availability of patients' immediate post-operative radiograph (baseline) and of a number of follow-up x-rays that the Principal Investigator deems sufficient for an effective radiographic implant evaluation and stability assessment;
* Patient is willing and able to complete additional follow-up evaluations if needed after signing ICF.

Exclusion criteria

* Age \< 18 years;
* Female patients who are pregnant, nursing, or planning a pregnancy
The Effect of Different Support Surfaces on Balance in Healthy Individuals

This study will evaluate how age, visual sensation and different ground properties affect of postural sways and stability limits at different support surface widths. 60 individuals will be included in this study.

Balance is considered to be an important component of performance during activity as a result of a complex process in which musculoskeletal and neurological systems function. Two different balance states are defined as the static balance where the individuals maintain their inactive position or the dynamic balance when they perform a foreseen movement. The balance is maintained by keeping the center of gravity within the boundaries of the support surface and is provided by sensory impulses from the visual, vestibular and somatosensory systems organized by the central nervous system. Balance is an important factor to lead an independent life, and it is imperative that the balance be ensured in order to ensure that daily living activities are performed safely. The neural control of the bipedal posture varies depending on the width of the supporting surface, which has a significant impact on the frontal plane biomechanics. There is a linear relationship between increased support surface size and mechanical stability. In experimental studies, it has been shown that increasing muscle width levels in response to translational perturbations seen on the support surface on the horizontal plane have decreased with increasing step width. The changes in the preferred support surface vary depending on the age of the external environment, recurrent falls due to decreased sensory input, or various neurological disorders. However, there are few quantitative studies examining the relationship between different support surface widths and equilibrium, and the effect of posture width on sensory feedback control is still poorly understood. This study was planned to evaluate the effect of age, visual sensation and different soil properties on postural release and stability limits at different support surface widths.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged between 18-50
* Without any diagnosed disease
* Individuals who voluntarily agree to participate in this research

Exclusion Criteria:

* The presence of previous lower extremity surgery
* Pain during evaluation
* Foot ankle instability
* Important and irreversible visual deficits
* Body mass index (BMI) greater than\> 40 kg / m²
* Limitation of ankle, knee and hip joint in lower extremity
* Muscle strength of the lower extremity (dorsiflexors, plantar flexors, quadriceps, hamstring, gluteus maximus, gluteus medius) and the trunk (rectus abdominous, internal and external oblique abdominals, back extensor) below 5.