cyrilzakka/clinical-trials huggingface dataset:
A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

1. Goals

   The primary goal of this phase II trial is to:

   evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment

   Secondary goals are to:

   evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population
2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure


Eligibility Criteria:
Inclusion Criteria:

1. Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
2. Patients must be ≥ 18 years old of age
3. ECOG performance status ≤ 1
4. Estimated life expectancy of more than 3 months
5. Treatment with only one prior chemotherapy
6. At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
7. Adequate bone marrow function (absolute neutrophil count \[ANC\] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL \[correction by transfusion is acceptable\], and platelets ≥ 100,000/µL)
8. Adequate kidney function (serum creatinine \< 1.5 x upper limit of normal \[ULN\])
9. Adequate liver function (serum total bilirubin \< 1.5xULN; serum transaminases levels \< 2.5xUNL)
10. Provision of fully informed consent prior to any study specific procedures

Exclusion Criteria:

1. Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
2. Patients who received prior chemotherapy including paclitaxel or docetaxel
3. Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
4. Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
5. Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment \[NYHA class III or IV\], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
6. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Disorders of Sexual Development and Gonadal Tumor Risk

Disorders of Sexual Development are rare and represent a spectrum of heterogeneous pathologies. The risk of developing a malignant gonadal germ cell tumor (MGCT) exists and varies according to the etiology.

The indication for prophylactic gonadectomy must be modulated and discussed for all patients. It is essential to assess each patient's individual risk.

The aim of our study is to assess gonadal tumor risk in patients with Disorders of Sexual Development according to etiology

The primary objective is to evaluate tumor risk and the indication for gonadectomy in cases of Disorders of Sexual Development according to etiology.

The secondary objectives are to evaluate the timing of gonadectomy, to monitor changes in practice over time, and to assess the contribution of imaging and/or biological tests to tumor detection.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent gonadectomy for variation in genital development between 1990 and 2022.
* Pathological anatomy examination in Lyon
* With clinical data
* With karyotype
* 3 categories:

  * with genetic diagnosis
  * without genetic diagnosis because searched but not found
  * without genetic diagnosis because not searched

Exclusion Criteria:

* Biopsies without gonadectomy
* Fetus
* Operated outside the period 1990-2022
* Lack of clinical data
* No karyotype
A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.

The study has two parts which enroll separately from each other such that participants may choose to participate in either but not both: the main study and a study addendum.

* The main study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab.
* The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 \[2018\]), with a history of migraine headaches of at least 6 months prior to screening.

Exclusion Criteria:

* Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline.
* Known hypersensitivity to monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
* Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
* History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
* History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
* Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3

The purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.


Eligibility Criteria:
Please contact site for information.
SWC for Treatment of Superficial Partial-Thickness Burns

The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

Current management options for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

This study is a prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to routine care, Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited from the Burn Center/Clinic adult patient pool who have sustained superficial partial-thickness burn wounds that comprise ≤15% of total body surface area (TBSA).

Eligibility Criteria:
Inclusion Criteria:

* Patients who have sustained superficial, partial thickness burn wounds no less than 5% and up to 15% of total body surface area (TBSA; 5-15%). Contiguous superficial and deep partial-thickness burns are eligible for inclusion.
* Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment.

Exclusion Criteria:

* Inability to provide informed consent
* Deep partial-thickness burns except as noted in the inclusion criteria and full-thickness burns
* Radiation, chemical or electrical burn injury
* Patients with burns primarily located to the face, genitals, or span across joints
* Patients whose burn injury was ≥ 8 days prior to entry into the Burn Center/ Clinic.
* Patients with uncontrolled cerebrovascular disease, cardiovascular disease, concurrent endocrine, hepatic or renal disease, or other severe conditions for whom, in the investigators' discretion would render study participation unsafe
* Patients with documented or self-reported shellfish allergies
* Current pregnancy
* Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion
* Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient.
Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients

Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years

This is a multi-center, prospective, real-world observational study. Patients who have completed 6 months of induction therapy (YISAIPU 50mg / week ± csDMARDs) and achieved clinical remission or low disease activity will be observed for 2.5 years. During the maintenance period, through full communication between doctors and patients, YISAIPU 50 mg/wk or YISAIPU 25 mg/wk will be chosen as maintenance treatment. The clinical efficacy evaluation parameters include DAS28, HAQ-DI, modified Sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. Drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of YISAIPU due to adverse events. Exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of Interstitial Lung Disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Meet the ACR revised RA classification criteria(2010);
* Disease duration is more than or equal to 6 weeks;
* DAS28-CRP\>2.6;
* Patient is eligible for TNF inhibitors treatment according to the judgment of the attending doctor in clinical practice;
* A written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure.

Exclusion Criteria:

Exclusion criteria:

* Patient has contraindication(s) to the use of fusion-protein type of TNF inhibitor;
* Patient is participating in other ongoing drug clinical trials;
* Patient whose LTBI screening result is positive, or had not received standard anti-TB treatment for TB history, is unwilling to take prophylactic treatment for TB;
* Patient with HBV infection and positive for HBV replication (not up to active replication) is not willing to receive anti-HBV treatment;
* Anti-HCV antibody is positive and HCV-RNA is positive, and patient is unwilling to start anti-HCV treatment;
* Other reasons the researchers think the patient is not eligible for participation in the study.
Advanced Breast Cancer and Lifestyle Exercise Study

About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 78 years old,
* newly diagnosed with a metastatic breast cancer (i.e. within the last 3 months)
* treated in the CLB by chemotherapy, and/or radiotherapy and/or hormonotherapy and/or targeted therapy.
* ECOG Performance status \<2,
* being French-speaking
* able to complete questionnaires and follow instructions in French
* valid health insurance affiliation.
* medical certificate of no contraindications to exercise physical activity

Exclusion Criteria:

* untreated brain metastases
* uncontrolled cardiac disease,
* contraindications to PA,
* unable to be followed for medical, social, familial, geographical or psychological reasons over the study duration,
* deprivation of liberty by court or administrative decision
* pregnancy
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure

The primary objective of this study is to evaluate the safety and tolerability of SK\&F-105517-D in japanese patients with chronic heart failure.


Eligibility Criteria:
Inclusion criteria:

* Patients with symptomatically stable chronic heart failure (CHF) based on ischemic heart disease or dilated cardiomyopathy
* Patients who are maintained on basic heart failure therapy with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) and their dosage/administration is not changed within 2 weeks
* Patients diagnosed with New York Heart Association (NYHA) class I to III
* Patients with a left ventricular ejection fraction (LVEF) between 25% and 45%

Exclusion Criteria:

* Patients contraindicated for ß-blockers
* Patients with occurrence of acute myocardial infarction within 2 weeks
* Patients with unstable angina, coronary spastic angina, or angina at rest
* Patients who have collected blood \>400 mL within 4 months prior to screening or \>200 mL within 1 months
Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk

The purpose of this study is to determine the treatment outcome of postoperative concurrent chemoradiation for head and neck squamous cell carcinoma with multiple minor risks.

Currently, postoperative chemoradiation is recommended for head and neck squamous cell carcinoma with some poor prognostic feature, such as extracapsular spread of metastatic lymph node, or positive resection margin. Other patients may receive postoperative radiotherapy only, if they have other risk factors. In our previous study, if there are 3 or more "minor" risk factors, the 3-year recurrence rate was 55%. This outcome was far inferior to patients who had minor risk factors less than 3. Thus, we believe that current postoperative radiotherapy is insufficient for patients with multiple minor risks. A clinical trial should be raised to help these patients. However, the patient number of this group is not enough for large scale, phase 3 trial. So we arranged this phase II trial of postoperative chemoradiation to test and prospectively observe the treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* Primary squamous cell carcinoma of head and neck, after tumor excision and neck dissection, pathology has confirmed three or more of the following adverse prognostic factors, including:

  1. Marginale surgery but a safe distance from the residual tumor ≦ 4mm.
  2. The tumor is located in the hard palate or the retromolar region.
  3. Poorly differentiated cell type.
  4. Tumor invasion to the nerve.
  5. Tumor invasion to lymphatic vessels.
  6. Tumor invasion to the small blood vessels.
  7. Tumor invasion to the bone.
  8. Tumor invasion to the skin.
  9. Depth of tumor invasion ≧ 10mm.
  10. Occurred in single lymph node metastasis.

Exclusion Criteria:

* No or presence of adverse prognostic factor but less than 2.
* Presence of either one conditions listed here: positive resection margin, resection margin negative but less than 1 mm, pathologic N2 or N2, or presence of nodal metastasis with extracapsular spreading.
* ECOG performance status \> 2.
* Previous cancer history (except basal cell or squamous cell skin cancer) or other synchronous malignant disease.
* Women during pregnancy.
Efficacy of Remineralizing Products Used in Molar Grooves: Evaluation With Diagnodent Pen and Diagnocam

To evaluate the efficacy of enamel remineralization by biomimetic hydroxyapatite contained in microRepair-based Biorepair Total Protection toothpaste compared to the use of Bio Enamel Caries and Erosion toothpaste based on Fluoro-Hydroxyapatite and BioActive Complex, evaluated with Diagnodent Pen and Diagnocam.

The recruited patients will be divided into:

Group 1: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Biorepair Total Protection toothpaste 2 times/day

Gruppo 2: Active group 20 patients undergoing quarterly oral hygiene sessions and home treatment using Curasept Biosmalto Caries and Erosion toothpaste 2 times/day

For both groups, Diagnodent Pen will be used to evaluate the degree of demineralization, while Diagnocam will be used as qualitative evaluation.

Other clinical indices to be collected are: plaque index (PI), bleeding index (BOP), basic erosive wear examination (BEWE), Schiff Air Index (SAI).

The time frames of the study are:

* T0: baseline
* T1: after 1 month
* T2: after 3 months
* T3: after 6 months

Eligibility Criteria:
Inclusion Criteria:

* First permanent molars erupted and completely healthy
* Patients presenting C1 values 0-12 and C2 values 13-24 of the Diagnodent Pen

Exclusion Criteria:

* Patients with Diagnodent-stimulated value \> 25
* Patients with groove sealings of sealed permanent first molars or composite restorations
* First molars with extensive demineralizations (Molar Incisor Hypomineralization, fluorosis, white/brown spots)
Acute and Chronic Pain, Especially Neuropathic Pain, After Thoracotomy and Continuous Application of Ketamine.

Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.


Eligibility Criteria:
Inclusion Criteria:

* posterolateral thoracotomy for lung parenchyma resection
* informed consent
* ASA (American Society of Anesthesiologists) Status I-III

Exclusion Criteria:

* history of chronic pain
* history of neuropathic pain
* pregnancy or breastfeeding
* participation in another trial
* hypersensitivity for ketamine
* medication with can influence neuropathic pain (gabapentin, clonazepam)
* history of neurological or behavioral illness
* history of alcohol abuse
* history of chemotherapy or radiation
* opioid medication
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement

Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral hip replacement

Exclusion Criteria:

* Patients scheduled for bilateral hip replacement in same procedure
* Patients with increased risk of bleeding
* Uncontrolled hypertension (BP greater than 180/100 mmHg)
* Patients less than 111 lbs or more than 243 lbs
* Patients on long-term anticoagulants
* Patients with contraindications to venography
* Patients with medical history of venous thromboembolism
* Patients with impaired hepatic function
* Known to be pregnant
* Lactating women
Trace Element During Anesthesia Insertion and Surgery-

Trace elements are micronutrients that are of vital important importance to human health and are involved in the process of many key human functions including the immune response, antioxidant defense and wound healing. Deficiency in a single element can manifest with multiple systems and can have significant organ impact.

Research has shown correlation between deficiencies in trace elements and increased risk for infections, sepsis, multi organ failure and mortality. However relatively few studies examined the impact of perioperative changes in trace elements and patients' postoperative outcomes.

In this prospective observational cohort study, we aim to examine the impact of perioperative changes in trace elements on postoperative outcomes, morbidity and mortality.

This study will include patients aged 18 and above undergoing elective surgeries under general anesthesia at Rabin Medical Center. In the operating room blood samples will be collected from all study participants in the beginning of surgery and at the end of surgery.

Collected samples will be sent for analysis of periodic table elements to assess the perioperative period changes in trace elements measured in whole blood. Participants intraoperative and postoperative data will be collected. All postoperative complications will be documented. Perioperative changes will be correlated with participants' postoperative outcomes using computer analytical correlations.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 and above
* Patients undergoing elective surgeries (as detailed above) under general anesthesia.
* Patients who can read and write Hebrew

Exclusion Criteria:

1. Emergency surgery
2. Regional anesthesia only