cyrilzakka/clinical-trials huggingface dataset:
Validation of the PNQ for CIPN Patients.

The Patient Neurotoxicity Questionnaire (PNQ) represents a diagnostic tool concerning patients with Chemotherapy Induced Peripheral Neuropathy (CIPN). Application of such a tool in the Greek clinical praxis requires validation.

Validation consists of three stages: translation, reverse translation, and patient application. 100 oncologic patients were assessed by comparing the PNQ to the NCI-CTCAE at the chemotherapy onset and 2nd, 4th, and 6th sessions. Specific requirements of the diagnostic tool (compliance, validity, concordance, sensitivity, specificity, reliability) were statistically evaluated.

Differences between translated texts and between the reverse translation and the original were considered negligible. At the 2nd, 4th and 6th session compliance was 98%, 95% and 93% while Cronbach's α was 0,57 0,69 and 0,81 respectively. Cohen's weighted κ was 0,67 and 0,58, Spearman's ρ was 0,7 and 0,98 while AUC of the ROC was 1 and 0,9 for the sensory and the motor part respectively. The variance's linear regression analysis confirmed CIPN worsening over time (p-value\<0,0001).

The Greek version remains close to the original. Compliance rates reflect easy PNQ application. Cohen's κ values highlight the physicians' tension to underestimate the patients' condition. Spearman's ρ, Cronbach's α and AUC values reflect good validity, reliability and specificity of the PNQ respectively. Finally, the linear analysis confirmed the PNQ sensitivity over time.

The PNQ validation in Greek adds a crucial tool in the physicians' armory. It can now draw the necessary information to modify the chemotherapy and analgesic treatment schemes at both preventive and acute levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 and under 80 years of age
* Patients that undergo chemotherapy for the first time
* Patients regardless of cancer type
* Patients regardless of social and education underground
* Patients able to communicate with personnel

Exclusion Criteria:

* Pediatric patients
* Preexisting neurological condition
* Patients already under chemotherapy treatment
* Patients unable to communicate with personnel
To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)

The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.

Membranous nephropathy with heavy proteinuria have high risks of progressing to CRF.

Tripterygium (TW) is a Chinese traditional patent drugs, it can reduce proteinuria of chronic glomerular nephritis,such as IgA nephropathy. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus Valsartan in the treatment of heavy proteinuria of MN.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven idiopathic membranous nephropathy
* Nephrotic syndrome with proteinuria (\> 4 g/day) and serum albumin \< 30 g/dl
* Age over 18 with informed consent

Exclusion Criteria:

* Patient with abnormal liver function tests
* Prior therapy with sirolimus, CSA, MMF, tacrolimus or azathioprin, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days,
* Active/serious infection,
* Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
Hepatitis C Prevalence in Men Who Have Sex With Men

This is an observational study aimed at determining the prevalence of hepatitis C in a specific population: men who have sex with men.


Eligibility Criteria:
Inclusion Criteria:

* Having sex with men

Exclusion Criteria:

* Refusal to participate in the trial
ZETA : Prospective Observational Study

Primary objective

- Evaluate the efficacy in terms of progression-free survival (PFS) of aflibercept in combination with FOLFIRI in patients treated routinely for metastatic colorectal cancer (mCRC) after failure of treatment with oxaliplatin + EGFR.

Secondary objective

* Evaluate the efficacy of aflibercept in combination with FOLFIRI on the 2-year overall survival rate and the objective response rate.
* Evaluate the tolerance profile of aflibercept in combination with FOLFIRI.

  * Observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.•

Inclusion criteria

* All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) .
* Age ≥18 years
* Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin

Exclusion criteria :

* Concurrent participation in a clinical trial
* Patients who have previously received anti-VEGF agents and / or aflibercept in one trial.
* Patients who received FOLFIRI in the first metastatic line.

Eligibility Criteria:
Inclusion criteria

* All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) .
* Age ≥18 years
* Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin

Exclusion criteria :

* Concurrent participation in a clinical trial
* Patients who have previously received anti-VEGF agents and / or aflibercept in one trial.
* Patients who received FOLFIRI in the first metastatic line
The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.

Our study is planned to investigate the effects of neck and trunk stabilization exercises, which are structured from Neurodevelopmental therapy method-Bobath concept (NDT-B) principles, on feeding and swallowing activity in children with Cerebral Palsy (CP) who take feeding and oral motor intervention strategies. The cases were divided into two groups, which is the group receiving feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises (n=20) (Study Group) and those receiving feeding and oral motor intervention strategies (n=20) (Control Group).

Feeding and oral motor interventions address different aspects of feeding difficulties, reflecting the range in specific problems associated with feeding and nutrition in CP.

The trunk plays an important role in the organization of postural control and balance reactions because it holds the centre of all body mass and holds therefore, the centre of gravity. The trunk also provides stable attachment points to those muscles that control the head and neck regions. "Neck and trunk stabilization exercises" were the basis of static and dynamic balance abilities, and that increased neck and trunk stability might have had a positive effect thereon.

To achieve the alignment of the head with the trunk, the pelvis must be stabilized. This has important consequences for the entire process of swallowing. If the head is not stable, then the fine movements of the jaw and tongue needed for feeding will be impaired. With feeding and oral motor interventions and structured neck and trunk stabilization exercises, these parameters are positively affected.

Eligibility Criteria:
Inclusion Criteria:

* Cases with Cerebral Palsy who had difficulties in feeding/swallowing skills.
* Cases who were cooperative without communication barriers and volunteering to participate in the study were included.

Exclusion Criteria:

* In the Videoendoscopic Swallowing Study, he/she was not included in the study if he/she had an aspiration or aspiration risk, had advanced vision and hearing loss, used any pharmacological agent to inhibit spasticity, or had undergone orthopaedic surgery or Botulinum Toxin-A injection in the past six months.
Study of Human Botulism Immunoglobulin in Infants With Botulism

OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis).

II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence of complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.

PROTOCOL OUTLINE: This is an open label, multicenter study. Patients should begin therapy within 72 hours of hospital admission, but may receive human botulism immunoglobulin (BIG) in certain circumstances after 72 hours. Patients receive (BIG) IV. Patients are monitored for side effects, disease severity, complications, and length of hospital stay.

Patients are followed at 2 weeks after treatment, then every 4 weeks for 6 months.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinical diagnosis of infant botulism in previously healthy infant
* Bulbar palsies
* Constipated Lethargy
* Diminished head control
* Poor feeding
* Generalized weakness and hypotonia
* Weak cry
* Afebrile (unless secondary infection present)
* Subacute to acute onset
* Normal electrolytes
* Any patient eligible provided no treatment available for life-threatening condition
Impact of ART Adherence on HIV Persistence and Inflammation

The purpose of this study is to evaluate the relationship between anti-retroviral therapy (ART) adherence with levels of human immunodeficiency virus (HIV) reservoir and residual viremia in suppressed, HIV-infected individuals on chronic ART.

Understanding whether the size and dynamics of the HIV reservoir are associated with adherence, measured by an objective biomarker, could have significant clinical and therapeutic implications for ART and HIV cure.

1. First, this aim will quantify levels of CA-RNA, CA-DNA, and plasma residual viremia in suppressed, HIV infected individuals and correlate them with levels of TFV-DP in DBS as a measure of cumulate drug exposure (adherence).
2. Second, this study will evaluate the changes in the HIV reservoir in relation to changes in ART adherence over time.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected males and females,
2. Ages 18 years and older,
3. Taking any TFV-based regimen,
4. HIV suppression \<20 copies/ml for at least 12 months;
5. Not co-infected with HCV;
6. Able and willing to give informed consent.

Exclusion Criteria:

1. Pregnancy.
2. Refusal to participate.
An Assessment of SAFE (Swift Accountable Fair Enforcement) in Cochise County

This is a Cochise County experiment with innovative probation supervision practices. Subjects are assigned to one of three supervision conditions.

Historically, rates of failure on routine probation have been high. The result is that large numbers of probationers are ultimately revoked from probation and sentenced to long underlying jail or prison terms. Arizona is experimenting with alternatives to routine probation with the goal of reducing the overall burden of incarceration. Cochise County in Arizona is experimenting with innovative probation supervision practices. Subjects are assigned to one of three supervision conditions: Probation-as-usual (routine supervision with no deferred jail); discretionary deferred jail in response to probation violations; and Arizona's Swift, Accountable, Fair, Enforcement, or SAFE (SAFE involves non-discretionary deferred jail in response to probation violations).

Eligibility Criteria:
Inclusion Criteria:

* Supervised on probation in Cochise County
* Residing in Cochise County

Exclusion Criteria:

* First-time marijuana possession cases
High Dose Rate Brachytherapy for Treatment of Keloids

This prospective study evaluates the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are recurrence rate, scar quality and physical complaints.

This prospective evaluation describes the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids in a large mixed Fitzpatrick skin type patient population. After intralesional excision, a unique low dose radiation scheme of 2x6Gray (Gy) was administered in 2 fractions: the first within 4 hours, the second within 24 hours. Keloids were evaluated pre- and postoperative (1 week, 3, 6, 12 months, 5years). Scars were measured and recurrence was judged. An evaluation of the outcome of the scars was obtained using the Patient and Observer Scar Assessment Scale. Statistical analyses were conducted using SPSS version 20.0 (SPSS, Inc, Chicago, III)

Eligibility Criteria:
Inclusion Criteria:

* Keloid defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (\>1yr)
* the keloid had been proven insensitive to at least one other treatment
* patients had to be older than 10 years of age.

Exclusion Criteria:

* keloids not suitable for excision with primary closure due to its size or anatomical location
* pregnancy or diabetes
Intervention With a GABA Supplement in Prediabetics

In this double-blind parallel placebo controlled intervention study the effects of 3 times daily 500 mg gamma-aminobutyric acid (GABA) supplementation on glucose tolerance and cardiovascular health will be assessed in prediabetics.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 70
* BMI higher or equal to 27 kg/m2
* Impaired fasting glucose (fasting glucose ≥ 6.1 and ≤ 6.9 mmol/L) or/and
* Impaired glucose tolerance (glucose levels ≥ 7.8 and ≤ 11.1 mmol/L, 2-hours after an OGTT or/and glucose levels ≥8.6 mmol/L, 1-hour after an OGTT)

Exclusion Criteria:

* Has been diagnosed with diabetes
* Having other conditions, like liver, pancreatic, cardiovascular, gastro-intestinal or endocrine diseases, that could influence the study results
* Use of medications or supplements that could influence the study results
* Sensitive to medical skin adhesives
* More than 5kg weight change in the past 12 weeks
* Excessive alcohol consumption (\>21 glasses/week for men and \>14 glasses/week for women on average)
* Being an employee of Wageningen University, division Human Nutrition and Health
* Currently a research subject in other research
PRCT of FICB vs LAI for Hip Arthroscopy

A prospective randomised controlled trial involving patients undergoing hip arthroscopy. Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic. Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery. Secondary outcome measures were the frequency and the dose of morphine and other medications consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain or medications used for pain relief in both the groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years
* Primary elective hip arthroscopy on a native hip for combined soft tissue injuries and FAI pathology
* Able to read, write and communicate in English

Exclusion Criteria:

* Patients who did not want to be involved in the Trial
* Unable to give informed consent
* Previous hip surgery
* Patients younger than 18 years of age
* Chronic opioids users
* Patients known to have an allergy or intolerance to local anaesthetic agents or none steroidal anti-inflammatory medications
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy

A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)


Eligibility Criteria:
Inclusion criteria includes, but is not limited to:

\* Subject has a diagnosis of definite Acute Unilateral Vestibulopathy

Exclusion criteria includes, but is not limited to:

* Acute continuous vertigo lasting more than 72 hours prior to randomization
* History of acute or chronic vestibular diseases
* History of prior acute central vestibular lesion
* Acute or chronic disease of middle ear
German Cardiac Arrest Registry

In Germany, 70.000 to 100.000 patients suffer from out-of-hospital cardiac arrest (OHCA) every year. More than half of these are due to cardiac causes. Despite the medical progress over the last decades, rates of survival with good neurological outcome remain low. For many below-mentioned issues, no adequate evidence from randomized trials is available. Therefore, a systematic and standardized recording of the pre-clinical, clinical and post-clinical treatment course and of the clinical outcomes of OHCA patients is essential to improve patient care. Aim of the German Cardiac Arrest Registry (G-CAR) is to achieve a better understanding of the disease entity, leading to an optimized treatment of OHCA patients. The recorded data include information on demographic and psychosocial aspects, course of the disease, clinical, laboratory and other examinations as well as treatment modalities in patients with OHCA due to a cardiac cause.


Eligibility Criteria:
Inclusion Criteria:

* patients with out-of-hospital cardiac arrest with assumed cardiovascular cause

Exclusion Criteria:

* rejection of register participation by patient or legal representative
PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei

The main objective of this study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through PCR.

The main objective of this proposed study is to identify unique DNA sequences within the genome of human scabies that can be utilized to identify the parasite through polymerase chain reaction or PCR. The goal of the project is to design an assay that can distinguish samples from skin scrapings containing scabies mites, eggs, or fecal material confirmed by clinic based microscopic evaluation (gold standard) from negative controls (i.e. scrapings for tinea and/or demodex folliculitis) that do not contain Sarcoptes scabiei. We hypothesize that specifically amplifying the unique regions of the Scabies genome using PCR can serve as a means to diagnosis infestations in humans. To address this question, we will optimize PCR amplification of known scabies samples then apply our procedure to DNA extracted from patient samples.

Eligibility Criteria:
Inclusion Criteria:

* 1. Male/Female of all ages whose standard clinical treatment produces one or more of the following:

  * Slides from skin scrapings containing scabies mites, eggs, and/or fecal material
  * Slides from skin scrapings of suspected tinea
  * Slides from skin scrapings of demodex mites

Exclusion Criteria:

* 1. Patients who are clinically concerning for having both scabies and tinea/demodex folliculitis to avoid contamination of positive and negative controls in the same sample. Subjects or guardians who cannot understand and read English and so are unable to consent to participation.
A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors

A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
* measurable lesion by CT or other techniques according to RECIST

Exclusion Criteria:

* Inadequate bone marrow reserve
* history of poorly controlled hypertension
Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.

This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Age ≥ 18 years
* Histologically-confirmed adenocarcinoma of the prostate
* Hormone-refractory prostate cancer
* Failed 1st-line docetaxel-containing regimen
* No prior immunotherapy including:

  * Vaccines
  * GM-CSF
* Minimum prostate-specific antigen (PSA) \> 5 mg/dL and rising according to the PSA Consensus Criteria
* Karnofsky Performance Status (KPS) \> 60%
* Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3
* Life expectancy \> 6 months

Exclusion Criteria:

* Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist
* Use of herbal products known to decrease PSA levels
* Use of supplements or complementary medicines, except for:

  * Conventional multivitamin supplements
  * Selenium
  * Lycopene
  * Soy supplements
  * Vitamin E
* Initiation of bisphosphonates within one month prior to enrollment or throughout the study
* Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment
* Major surgery or radiation therapy completed \< 4 weeks prior to enrollment
* Any concomitant second malignancy other than non-melanoma skin cancer
* Any concomitant serious infection
* Any nonmalignant medical illness
* Absolute neutrophil count (ANC) \< 1,500/µL
* Platelet count \< 100,000 µL
* Hemoglobin \< 8 mg/dL
* Total bilirubin greater than 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN if no demonstrable liver metastases, or greater than 5.0 x ULN in presence of liver metastases
* Ejection fraction \< 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
* Noncompliance with study procedures
Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation Vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery

The purpose of this study is to To determine the effect of warm and humidified (WH) carbon dioxide (CO2) on post-operative pain/analgesia requirement in patients undergoing laparoscopic bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.

Exclusion Criteria:

* emergency surgery, reoperation within 30 days
* patients who are taking pain medications (narcotics) daily preoperatively for whatever reason
* history of narcotics addiction
* paraplegic and quadriplegic patients
* dementia or altered mental status
* patients on steroids
* pregnant women
* psychiatric patients
* minors
* unable to give informed consent