cyrilzakka/clinical-trials huggingface dataset:
Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers

The purpose of this study is to assess the effect of palliative pelvic radiation on symptoms and quality of life among patients with incurable prostate and rectal cancer.

With the aging population, the prevalence of cancer is on the rise, leading to an increased demand for effective palliative treatment. There is little scientific information describing the effects of palliative radiotherapy among patients treated for soft-tissue tumors of the pelvis. This is a treatment that is used relatively frequently, but delivered heterogeneously since the optimum fractionation schedule has yet to be established. This study aims to define the effects of one such fractionation schedule (3Gy x 10-13) and thus, establish a foundation for future fractionation studies.

Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* Histologically or cytologically proven adenocarcinoma of the prostate or rectosigmoid colon.
* Incurable disease (hormone-resistant in cases of prostate cancer)
* Life expectancy \> 3 months
* Symptomatic soft-tissue pelvic tumor mass (primary, recurrence or metastases)
* Planned fractionated radiotherapy (3Gy x 10-13)
* Written informed consent

Exclusion criteria:

* Unable to fill out questionnaires (due to language or cognitive barriers)
* New systemic tumor-targeted treatment (hormone manipulation, chemotherapy, monoclonal antibodies, etc.) started within four weeks of baseline or during the 6 weeks immediately following pelvic radiotherapy.
* Previous pelvic radiotherapy
* The presence of a second primary pelvic cancer or other cancer requiring treatment
* Currently receiving treatment with an investigational drug
The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma

The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the reasons result in these situations is the patent visits hospital for treatment in late stage of oral cancer. Recently, the government makes effort in oral cancer screening to find oral potentially malignant disorders (OPMD) early. However, there is no conscience in treatment strategies of OPMD up to now. In this study, we will set a OPMD data bank, and use the cases to find out the potential biomarker, which is able to predict the oral cancer malignant transformation. Sixty OPMD with oral cancer transformation will be recruited, and 60 OPMD with no oral cancer malignant transformation will also be enrolled as the disease control group. Besides, 20 normal cases and 60 oral cancer cases resulting from previous OPMD will be collected. All those groups will detect the expression of p62/SQSTM1 to investigate the possibility that p62/SQSTM1 as a biomarker to predict the malignant transformation of OPMM, and a guideline to treat or not to treat OPMD.


Eligibility Criteria:
Inclusion Criteria:

Study group was oral precancerous lesions in patients with malignant transformation; control group was generally no precancerous disease and orthodontic surgery volunteer

Exclusion Criteria:

Oral mucosa of subjects is too thin
Comparison of Infiltration Analgesia With Femoral Nerve Block After Hamstrings Anterior Cruciate Ligament Reconstruction

Pain treatment after anterior cruciate ligament reconstruction - Comparison of infiltration analgesia with femoral nerve block after.

Inclusion Criteria:

* Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
* Age \> 18 year

Exclusion Criteria:

* Revision ACL reconstruction
* Patients with cartilige lision
* Patients with arthritis
* Pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary anetrior cruciate ligament reconstruction with semiTendinos/gracillis graft
* Age \> 18 year

Exclusion Criteria:

* Revision ACL reconstruction
* Patients with cartilige lision
* Patients with arthritis
* Pregnant women.
A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.

A total of 30 patients receive the triple drug regimen saquinavir plus zidovudine plus lamivudine until the completion of the analysis after at least 4 weeks of therapy.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV antibody positive.
* CD4 count \>= 150 and \<= 500 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior antiretroviral therapy.
* Prior protease inhibitor therapy.
Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.

The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Women who have evidence of Female Sexual Arousal Disorder.
* Women who experience personal distress due to Female Sexual Dysfunction.
* Post menopausal women aged between 45 and 65 years.

Exclusion Criteria:

* Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
* Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
* Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.
Small Airway Obstruction in Asthma, COPD, ACOS

This study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and ACOS patients with small airway obstruction, and COPD

The data including spirometry, lung volume, impulse oscillometry, sputum data, demographic characters within 6 months are collected for later analysis. Sputum supernatants and cytospins are used to determine inflammatory and anti-inflammatory responses in those patients.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma, ACO, and COPD
* Their spirometric, IOS, lung volume, demographic data and sputum samples are available

Exclusion Criteria:

* Concomitant diseases requiring immunosuppressive therapy
* Being on treatments with NSAIDs, macrolides, statins
Biobank of Samples From Patients With Infectious Diseases

The aim of the INFECTIOTEK biobank will be to prospectively build a biobank of multiple biological samples from patients with infectious diseases in order to identify diagnostic and prognostic biomarkers, genetic susceptibility factors and immune response mechanisms in such diseases.

The population of the study will consist of patients treated in the Infectious Diseases Departments of Saint-Louis and Lariboisière Hospitals, with a diagnosis of infectious disease, and who have biological samples in the context of their routine medical care.

The diseases studied in this research project are bacterial infections (urinary tract infections, neurologic infections, sexually transmitted infections, pulmonary infections), viral infections (HIV, hepatitis, respiratory viruses, viruses affecting immunocompromised patients) and fungal infections (Aspergillus, Mucorales, Cryptococcus). These diseases are the domains of expertise and research of the clinical and biological teams at the Saint-Louis and Lariboisière hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Diagnosed with one of the following infectious diseases :

  * Infection with HIV-1 or HIV-2, or person at risk of infection with HIV
  * Viral hepatitis (HAV, HBV, HCV, HDV, HEV)
  * Pulmonary infections: bacterial (notably Nocardia), viral (Influenza, RSV, SARS-CoV-2, Adenovirus), fungal (Aspergillus, Mucorales)
  * Urinary tract infections
  * Sexually transmitted infections (Neisseria gonorrheae, Chlamydia trachomatis, Mycoplasma genitalium, Treponema pallidum)
  * Neuromeningeal infections: (Neisseria meningitidis, Streptococcus pneumoniae), viral (HSV, VZV), fungal (Cryptococcus).
  * Infections affecting immunocompromised patients: herpes viruses (HSV, VZV, CMV, EBV), polyomavirus BK
  * Emerging pathogen X (in the event of an epidemic)
  * Signature of research consent form
  * Health coverage with social security system or state medical aid

Exclusion Criteria:

* Refusal to participate
* Inability to give consent (cognitive impairment etc...)
Goal Setting in SCS Patients: a Qualitative Review

This is a prospective study in which the investigators will describe individual goals of patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
* FBSS patients suitable for SCS
* Age \> 18 years
* Native Dutch or French speeking patients

Exclusion Criteria:

* Expected inability of patients to receive or properly operate the spinal cord stimulation system
* History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
* Active malignancy
* Addiction to any of the following drugs, alcohol (5E/day) and/or medication
* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
* Immune deficiency (HIV positive, immunosuppressiva, etc.)
* Life expectancy \< 1 year
* Local infection or other skin disorder at site of incision
* Pregnancy
* Other implanted active medical device
Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration

The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).

Eligibility Criteria:
Inclusion Criteria:

* Male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated;
* At least 18 years of age;
* Life expectancy of at least 1 year;
* Capable of completing the study questionnaires without assistance.

Exclusion Criteria:

* Patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated;
* Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing hormone releasing hormone (LHRH) agonists, or GnRH or LHRH;
* Clinically significant systemic disease or condition that would, in the investigator's opinion, lead to undue risk following administration of either triptorelin or leuprolide;
* History of alcohol/drug abuse within the past year;
* History of significant medical problems that may confound the outcome of this study;
* Requires concomitant medications that may affect study assessments (e.g., topical medications used for pretreatment of injection site pain);
* Participated in another investigational drug study within 30 days
* Judged by the investigator to be unsuitable for enrollment in this study for any reason
Strategies to Maximise Patient Comfort During ESWL

Extracorporeal shockwave lithotripsy is an outpatient treatment for patients with intrarenal calculi. Standard of care involves offering oral analgesia prior to commencing the treatment. Most patients do not take the offered analgesia after the initial treatment. It has been suggested that distraction techniques may be equivalent to oral analgesia in improving tolerability of extracorporeal shockwave lithotripsy treatment. The use of distraction techniques also removes the potential side effects of mediation administration.

The investigators are aiming to assess if distraction techniques help improve patient comfort while undergoing extracorporeal shockwave lithotripsy treatment for renal calculi. Improved tolerability of treatment would result in longer duration of time on the lithotripsy machine and may lead to better stone fragmentation. Outcomes will be completion of treatment and scores on the short form McGill pain questionnaire.

Patients will be randomised into three groups. The randomisation will not be blinded as this is not possible within the design of the study. The first group will be given stress balls to squeeze during treatment and will also receive standard care (the offer of oral analgesia). The second group will be given headphones to listen to music during treatment and will also receive standard care. The third group will receive standard care.

Prior to commencing extracorporeal shockwave lithotripsy, patients will be given the shortened Health Anxiety Inventory score to complete. Following lithotripsy treatment, patients will be given the short form McGill pain questionnaire to complete.

The initial pilot study will aim to recruit sixty patients and further recruitment will take place on the basis of the outcomes of the pilot study.

Inclusion criteria All patients over eighteen years old undergoing extracorporeal shockwave lithotripsy for the first time

Exclusion criteria Patients not capable of giving informed consent Patients in whom extracorporeal shockwave lithotripsy is contraindicated

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* First ESWL treatment

Exclusion Criteria:

* Patients not capable of giving informed consent
* Patients unsuitable for ESWL
Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD

Study purpose is to evaluate if subjects with chronic obstructive pulmonary disease (COPD) are more likely to be responsive to additional inhaled corticosteroids if they have a positive response to hyperosmolar challenge with mannitol than if their response is negative.

In patients with chronic obstructive pulmonary disease (COPD), the treatment with inhaled corticosteroids (ICS) is controversial. Preliminary results of our recent pilot study in 30 COPD patients showed for the first time, that ICS response mey be predicted by a bronchoprovocation challenge test with mannitol. However, this finding needs to be proven in a placebo-controlled trial. For this cohort study, 100 corticosteroid-naive, non reversible (FEV1) patients with COPD will be recruited. Spirometry before and after bronchodilation will be measured at study entry and at four weeks run-in (only tiotropium) and at three month of treatment with tiotropium and ICS or placebo. Quality of life (St. George Respiratory Quality of Life Questionnaire) and exacerbation rate of COPD will be assessed. Measurement of exhaled nitric oxide and mannitol challenge will be performed at study entry and at 1 and 4 month. Primary endpoint will be improvement in FEV1 in each group (positive and negative mannitol challenge) after 3 months follow up. Secondary endpoints will be the difference in dose-response-curve in the mannitol challenge, exacerbation rate and change in quality of life after three month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC \< 70%
* FEV1 % predicted \> 60%

Exclusion Criteria:

* Other major disease
* Asthma
* Currently taking inhaled corticosteroids
* oral corticosteroids in the last 3 month
* significant cardiovascular disease
* pregnancy/breast feeding
* current use of salmeterol or other long acting bronchodilator
Multicenter, Safety Study Of Maraviroc

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
* Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.
* Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.

Exclusion Criteria:

* Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
* Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and Pfizer.
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Frail elderly individuals
* Able to understand and perform the study procedures

Exclusion Criteria:

* Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)
* No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)
* Use of anti-coagulation medication (except of Acetyl Salicyl acid)
* Renal insufficiency (eGFR \<60 mL/min/1.73 m2)
* Allergic or sensitive for milk proteins
Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy

Several studies demonstrated a significant reduction of contrast-induced nephropathy (CIN; definition: increase in serum creatinine of \>=0.5mg/dl and/or \>=25% increase within 48h after contrast-medium) by acetylcysteine (A) or theophylline (T). However, the results are contradictory. Therefore, it was the aim of our double-blind study to compare the effects of A, T, a combination of A and T (A+T), and placebo (P).

Contrast-induced nephropathy (CIN) is the third leading cause of hospital-acquired acute renal failure (ARF). Accounting for 12% of ARF cases, CIN is defined as an increase of serum creatinine of at least 0.5 mg/d ("Barrett´s definition") and/or 25% within 48 hours of contrast-medium application. CIN is associated with prolonged hospitalisation and increased mortality. CIN frequency depends on several risk-factors including pre-existing renal dysfunction, high amounts of contrast-medium, diabetes, and concurrent use of nephrotoxic drugs. CIN incidence is low in the absence of risk-factors; however, in high-risk patients, CIN occurs in more than 50% of patients.

A variety of prophylactic approaches have been investigated. Despite nephro-protective effects of hydration with saline or with sodium bicarbonate, other trials reported CIN-incidences between 20 and 50% despite hydration. Several studies and two recent meta-analyses demonstrated a significant reduction of renal impairment after contrast-medium using medical prophylaxis with the adenosine antagonist theophylline. However, a recent trial failed to prove prophylactic effects of theophylline.

The antioxidant acetylcysteine (ACC) was effective in patients with impaired renal function in at least six studies, but it was not preventive in at least 21 trials and two recent meta-analyses. A recent study comparing the prophylactic efficacy of theophylline and acetylcysteine demonstrated superior prophylactic effects of theophylline. Nevertheless, this study did not include a placebo group, was not restricted to patients with impaired renal function and exclusively enrolled ICU-patients.

Therefore, we performed a double-blinded study to compare the effects of acetylcysteine, theophylline, a combination of both, and placebo in patients with impaired renal function (serum creatinine \>=1.3mg/dl) parenterally receiving \>=100ml of contrast-medium.

Eligibility Criteria:
Inclusion Criteria:

* Impaired renal function (serum creatinine \>=1.3mg/dl)
* \>=100ml of contrast-medium
* Age \>= 18years
* Informed consent

Exclusion Criteria:

* Previous dialysis and/or haemofiltration
* Pre-treatment with acetylcysteine and/or theophylline within the last 2 days,
* Pregnancy
* Contraindications to theophylline (untreated high grade arrhythmia or a history of seizures) or acetylcysteine (known allergy).
Video Recording in the Delivery Room in Very Preterm Infants (Video Apgar Trial)

A video of the delivery room management will be taken using standardized conditions. The video will be evaluated either locally by those directly involved in the delivery room care of this specific infant or anonymously at the main study center. Using a standardized evaluation form a set of predefined interventions is rated regarding at what time they took place and at what time they should have taken place. The difference in time for all interventions is summed up to a score. This score should allow to assess the delivery room management in comparison to the desired standard as well as between hospitals. The evaluation forms of all centers will be analyzed at the main study center to define correlations between certain delivery room interventions and short term outcome.

Aim of the study is to

* gather data on how delivery room care is currently done,
* come closer to an agreement between different NICUs towards what should be done in the delivery room under what circumstances in which way,
* find those interventions with potential influence on short term outcome. Those aspects of management that are different between centers and show correlation with short term outcome will be the focus of future prospective intervention trials in order to find the best way how to take care of preterm infants in the delivery room.

Hypothesis:

In preterm infants \<32;0 weeks of gestational age a correlation exists between specific delivery room interventions and short term outcome.

Delivery room interventions measured are: Stimulation, Ventilation, Oxygen, Cardiac massage, Suctioning, ven / art access, fluid and drugs given

Short term outcome measurements are: IVH, PVL, Pneumothorax, BPD, DOL when first time 120mL/kg oral feeds, NEC, ROP, death, Head circumference at discharge

Eligibility Criteria:
Inclusion Criteria:

* preterm infants \<32;0 weeks of gestational age

Exclusion Criteria:

* Infants in whom no life support is being planned - e.g. those with lethal malformations
Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* admitted to participating detox facility with a positive BAL at the time of admittance
* signed a written informed consent

Exclusion Criteria:

* serum acetaminophen level greater than 20 mcg/ml
* serum AST or ALT levels greater than 200 IU/L
* INR greater than 1.5
* if female, positive for beta-subunit of chorionic gonadotropin (beta-HCG)
* clinically intoxicated, psychiatrically impaired or unable to give informed consent
* known hypersensitivity to acetaminophen
* history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
* currently enrolled in another trial or had been enrolled in another trial in the preceding three months.