cyrilzakka/clinical-trials huggingface dataset:
Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have advanced head and neck cancer.

OBJECTIVES: I. Determine the response rate of patients with advanced squamous cell carcinoma of the head and neck when treated with oxaliplatin. II. Characterize the toxicities and pharmacokinetics of this drug in this patient population. III. Determine the duration of response, time to progression, and survival of these patients receiving this drug.

OUTLINE: Patients are stratified according to prior treatment with neoadjuvant chemotherapy (yes vs no). Patients receive oxaliplatin IV over 2 hours weekly for 4 weeks followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed until toxicity resolves or for no less than 30 days.

PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 17 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck Recurrent or metastatic OR Locally advanced and judged incurable by surgery or radiotherapy Bidimensionally measurable disease New and unirradiated lesion within prior radiation field acceptable as measurable disease if at least 3 months since prior radiotherapy No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of neuropathy No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol therapy No other concurrent uncontrolled illness (e.g., ongoing or active infection) Not HIV positive AND receiving antiretroviral therapy (HAART)

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for head and neck cancer No concurrent colony stimulating factors during first course of therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease At least 3 months since prior chemotherapy as initial treatment Endocrine therapy: No prior hormonal therapy for head and neck cancer Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy as initial treatment Surgery: See Disease Characteristics Prior surgery allowed Other: No other concurrent investigational or commercial agents or therapies
The Detection of Circulating Tumor Cells (CTCs) in Patients With Prostatic Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment

Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in prostatic cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of prostatic cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.

1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with prostatic cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>60
3. Diagnosis of prostatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery and/or DC-CIK treatment
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except prostatic cancer
2. History of coagulation disorders or anemia
Effect of Music Intervention on Intravitreal Injection

The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. The study used a randomized controlled experimental design. The study was conducted with a total of three groups: two experimental (Before-IVTI (Group1) and During-IVTI music intervention group (Group 2)) and one control group. Each of the experimental and control groups consisted of 75 patients. The patients' anxiety was evaluated using the VAS anxiety scale, pain using the VAS pain scale; surgeon-patient cooperation using the Numeric Rating Scale; and patient satisfaction with a 5-point likert-type satisfaction scale.


Eligibility Criteria:
Inclusion Criteria:

* The participants were patients aged 18 or above,
* Who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective IVTI was carried out, or who had undergone IVTI previously.

Exclusion Criteria:

* The participants were patients aged under 18 years
* Who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone IVTI previously.
GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers.

Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.

Eligibility Criteria:
Inclusion Criteria:

* Must be within 20% of ideal body weight and must weigh at least 45 kg.
* Must understand the study procedures and provide written informed consent.
* Must meet DSM-4 criteria for abuse or dependence on cocaine.
* Must be non-treatment seeking at the time of the study.

Exclusion Criteria:

* Please contact the study site for more information.
A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma

This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically confirmed evidence of T-cell lymphoma
* Measurable disease.
* Adequate organ function.
* At least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy.

Exclusion Criteria:

* Treatment with systemic immunosuppressive medication.
* History of allogeneic hematopoietic stem cell transplantation.
* History of primary immunodeficiency, solid organ transplantation.
* History of opportunistic infection within 180 days of starting study drug.
* Females who are pregnant, lactating, or intend to become pregnant
* History of invasive prior malignancy that required systemic therapy within last 3 years.
* Concomitant use of strong inhibitors or inducers of CYP3A.
Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool

This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

PRIMARY OBJECTIVES:

I. Conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. A subset of participants from control and intervention groups will also have their clinic conversations with providers recorded II. Conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of Aim 1 participants.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients review decision aid.

GROUP II: Patients receive standard of care.

After completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1: Suspected lung cancer
* AIM 1: English fluency
* AIM 1: \> 6-month life expectancy
* AIM 1: Score of ≥ 3 on the cognitive impairment screener
* AIM 2 PARTICIPANTS: Participation in Aim 1
* AIM 2 CLINICIANS: Discussing lung cancer treatment decisions with Aim 1 participants
Inverted T-shape Free Gingival Graft for Treatment of RT2 / RT3 Gingival Recession Defects

The aim of this study is to compare the use of T-inverted shape Free Gingival Graft with Free Gingival Graft for improving the clinical attachment, gain partial root coverage, and improve Keratinized tissue width in recession type 2 /recession type 3 gingival recession defects .

Research question : In patients with RT2 / RT3 mandibular defects will the use of inverted T-shape free gingival graft differ from free gingival graft in Recession depth?


Eligibility Criteria:
Inclusion Criteria:

* Patients with RT2/RT3 gingival recession.
* Indication for FGG treatment at mandibular incisor area (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession.
* KT width (KTW) \&amp;amp;lt; 2 mm.
* Ages 18-40 years old.
* Patients with healthy systemic condition (Brightman. 1994).
* Gingival and plaque index \&amp;amp;lt;10.
* Good oral hygiene (Wiesner et al. 2010).
* Accepts 6 months follow-up period (cooperative patients)

Exclusion Criteria:

* Smokers.
* Poor oral hygiene.
* Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
* Intake of any medications known to affect gingival homeostasis or to interfere with wound healing.
* Pregnant or lactating women.
* RT1 gingival recession.
* Caries or non-carious cervical lesions at recipient sites.
* Severely malpositioned teeth.
* Teeth with residual probing depth ≥ 4 mm.
* Mobility ≥ 1 mm.
* Pervious periodontal surgery within the last 6 months before the start of the trial.
* Patients with active periodontal disease. -
A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer

The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.
* Participants must be "light ex-smokers" or "never-smokers".

  * "Light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
  * "Never-smokers" are defined as having smoked \<100 cigarettes or equivalent during his/her lifetime.
* Participants must be of East Asian ethnicity.
* No prior systemic therapy for lung cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
* Any evidence of clinically active interstitial lung disease. Asymptomatic participants with chronic, stable, radiographic changes are eligible.
* Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Participants in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.
N-acetyl Cysteine and Clomiphene Citrate or Metformin and Clomiphene Citrate for Women With CC Resistant Polycystic Ovary Syndrome (PCOS).

The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

In combined NAC-CC group group,patients received NAC (200 mg per sachet, SEDICO, Egypt) for 5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g orally in three divided doses, 3 sachets per dose). All patients in other group received metformin HCl (Cidophage®; Chemical Industries Development, Egypt), 500 mg thrice daily for 5-6 weeks from the 1st day of spontaneous or induced menstruation. Then after the end of this period, patients in either group received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation, it was increased by 50 mg for the next cycle. Patients continued treatment for three successive cycles using the same protocol. NAC and metformin were stopped only when pregnancy was documented.

Eligibility Criteria:
Inclusion Criteria:

* CC resistant PCOS

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors
Use of Biperiden for the Prevention of Post-traumatic Epilepsy

There is no AED or medication that has been demonstrated to affect the development of post-traumatic epilepsy. Biperiden is a cholinergic antagonist, acting in the muscarinic receptor, that is widely used as an anti Parkinson drug. The investigators data with animal models of epilepsy indicate that anti-muscarinic agents might affect the natural course of the disease in the case of post-traumatic epilepsy.

Treatment with biperiden should be initiated in the first 12 hours after trauma as means to avoid the epileptogenic process. The treatment will be repeated every 6 hours for 10 consecutive days. The efficacy of biperiden as an antiepileptogenic drug will be established by analyzing the development of PTE between the biperiden and placebo groups. Several patients' aspects (clinical, electroencephalography, brain imaging, genetic and behavioral data) will be monitored for two year follow-up to unravel the mechanisms by which biperiden exerts its actions on epileptogenesis. The investigators are already at the early stages of patient's recruitment using the available resources.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 75 year of age
* patients with a diagnosis of acute TBI admitted to an emergency unit within 12 hours of the accident, regardless of the accident
* brain CT scan with signs of acute intraparenchymatous contusion
* signed informed consent (possibly by a relative)

Exclusion Criteria:

* malignant neoplasia and other severe comorbidities
* neurodegenerative disorders
* previous cerebrovascular accident
* record of convulsive seizures or use of anti-epileptic medication
* pregnancy
* concomitant use of the other anticholinergic medications
* presence of any factor that may contraindicate the use of biperiden
* participation in other clinical trial
* alcohol intoxication will not lead to exclusion of the subject.
Comparison of Different Ratio of Ketofol (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Eligibility Criteria:
Inclusion Criteria:

* Having ERCP procedures using sedatives
* ASA (American Society of Anesthesiologist) physical status Class I to III
* Body mass index (BMI) of 18-30 kg/m2
* Willing to participate in the study

Exclusion Criteria:

* Patients with a history of allergic reaction to medications used in the study
* Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction
* Patients with unstable hemodynamic
* Patients with psychiatric medications
* Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women
RESCEU: Defining the Burden of RSV Disease

This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 6 years until November 2026. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation.

Mortality (RSV associated and all-cause) through all RSV seasons and the health care costs, resource use and Health Related Quality of Life will also be determined. The study also aims to determine important risk factors for RSV infection (by severity and healthcare utilisation.

Infants will be recruited into one of two cohorts:

Passive (around 1800 participants) - Demographic data will be collected at inclusion and a parental questionnaire at one year of age. Infants admitted to a hospital with an acute respiratory tract illness will be followed up to the age of 3 years or 6 years with additional consent.

Active (around 200 participants) - Demographic data, parental questionnaire and the following samples will be collected at inclusion; blood, nasopharyngeal swabs, urine and stool. During the infants first RSV season (Oct - May) weekly phone contact will monitor respiratory symptoms. Infants with respiratory symptoms associated with RSV (confirmed by point of care testing) will have further samples of blood, nasopharyngeal swabs, urine and stool collected at the time of infection and 7 weeks later. Infants in the active cohort will be followed up for up to 3 years or 6 years with additional consent.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children, gestation age at least 37+0 weeks, born at participating centres.
* Written informed consent obtained from the mother.
* Parents able and willing to adhere to protocol-specified procedures (active cohort).

Exclusion Criteria:

* Major congenital defects or serious chronic illness (i.e. severe congenital heart and/or lung disease, genetic, immunologic and/or metabolic disorder).
* Gestational age of less than 37+0 weeks.
* Acute severe medical condition at moment of sampling (e.g. sepsis, severe asphyxia, for which the child is admitted to the hospital).
* Child in care.
* Parents not able to understand and communicate in the local language.
* Living outside catchment area of study sites.
* Mother vaccinated against RSV during pregnancy (by parental report).
Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.

PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

OBJECTIVES:

* Correlate optical coherence tomography images of the airway with airway histology.
* Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.

OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing pneumonectomy or lobectomy for malignant or benign lung processes

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose En Plaques (SEP) Sévère

The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis criteria of multiple sclerosis (MS) fulfilling revised McDonald criteria (2010)
* EDSS score from 6.5
* no relapse during the 3 last months
* Informed consent prior to any study procedure

Exclusion Criteria:

* Any severe Chronic Obstructive Pulmonary Disease (III or IV)
* Pregnancy or woman with childbearing potential
* contraindication to MRI