cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Bisphosphonates in Patients With Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) Syndrome

This study is designed to evaluate long term efficacy of intravenous bisphosphonates for bone marrow edema in patients with SAPHO syndrome.

The study will evaluate the long term efficacy at 3 days, 3 and 6 months after pamidronate disodium administered. Patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 months (up to month 6).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients between the ages of 18 and 70 years
2. Only 1 of the 4 inclusion criteria is sufficient to arrive at a diagnosis of SAPHO syndrome：

   * Osteo-articular manifestations of acne conglobata, acne fulminans, or hidradenitis suppurativa
   * Osteo-articular manifestations of PPP
   * Hyperostosis (of the anterior chest wall, limbs or spine) with or without dermatosis
   * CRMO involving the axial or peripheral skeleton with or without dermatosis Palmoplantar pustulosis(PPP); chronic recurrent multifocal osteomyelitis(CRMO)
3. MRI shows bone marrow edema in affected site in patients
4. Blood serum of patients show the normal white blood cell count, liver and renal function
5. Patients who like to be followed up for 1 years
6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

1. Women in pregnancy or lactation.
2. Septic osteomyelitis
3. Infectious chest wall arthritis
4. Infections PPP
5. Palmo-plantar keratodermia
6. DISH except for fortuitous association
7. Osteoarticular manifestations of retinoid therapy
8. Other protocol defined exclusion criteria may apply
Extension Study for 43USSA1705

To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.


Eligibility Criteria:
Inclusion Criteria:

* Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705

Exclusion Criteria:

* Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
* Other condition preventing the subject from entering the study in the Investigator's opinion
* Participation in any interventional clinical study throughout the duration of the study
Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis

To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Suspected endocarditis: Patients with Duke-Li-ESC 2015 classification as a major morphological criterion or at least two minor criteria, other than a microbiological criterion, will be considered suspicious of infectious endocarditis.
* Not objecting to their inclusion in the study after delivery and explanation of the information form.
* Absence of microbiological documentation sought or available at the time of inclusion (a patient having already had negative blood cultures or being identified during the screening can be included).

Exclusion Criteria:

* Antibiotherapy adapted to a situation of endocarditis, introduced more than 24 hours or stopped for less than 7 days in case of therapeutic window.
* Any previous antibiotic therapy in the 7 days preceding the inclusion leading to an improvement in the clinical symptomatology.
* State of consciousness not allowing loyal information.
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Hodgkin's Disease

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 arsenic trioxide in treating patients who have relapsed or refractory Hodgkin's disease.

OBJECTIVES: I. Determine the efficacy of arsenic trioxide in terms of rate of response (complete or partial remission), duration of response, relapse free survival, and overall survival in patients with relapsed or refractory Hodgkin's disease. II. Evaluate the toxicities of this agent in this patient population. III. Elucidate the mechanism of action of this treatment by measuring induction of apoptosis and caspace activation when given to these patients.

OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 1-2 hours daily for up to 60 days. After 4-6 weeks of rest, patients receive up to 5 additional courses of therapy of 25 days each followed by 4-6 weeks of rest. Patients with a complete response (CR) receive 1 additional course of 25 days after achieving CR. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 12 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory Hodgkin's disease Relapsed after prior first line treatment with at least 2 regimens, such as: Mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) Doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) MOPP/ABV Stanford 5 OR Refractory to a second line regimen, such as: Mesna, ifosfamide, mitoxantrone, and etoposide (MINE) Etoposide, methylprednisolone, high dose cytarabine, and cisplatin (ESHAP) High dose chemotherapy and autologous or allogeneic stem cell transplantation At least 1 measurable lesion

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Unless documented bone marrow involvement: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other prior malignancies within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biologic agents No concurrent monoclonal antibodies No concurrent bone marrow transplantation Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent anticancer agents
Prevalence of Lower Cross Syndrome Among Female College Students and Its Relation With Dysmenorrhea

The purpose of the study is to find out the prevalence of lower cross syndrome among female college students and its relation with dysmenorrhea.

In individuals with lower cross syndrome (LCS), there is often a notable tightness in the hip flexors and the lower back musculature, which is typically accompanied by a corresponding weakness in the abdominal muscles and the gluteus maximus. This imbalance is not merely a matter of discomfort; it fundamentally disrupts the normal distribution of biomechanical forces within the lower back. When the muscles that support the pelvis and spine are not functioning optimally, it can lead to altered movement patterns and increased strain on the lumbar region.

The positioning of the uterus can also be adversely affected by this muscular imbalance. Anterior or posterior displacement of the uterus can occur as a result of the altered pelvic alignment associated with LCS. This displacement can create additional tension within the surrounding soft tissues and muscles, leading to a cascade of physiological responses.

One notable consequence of this tension is the excessive secretion of prostaglandins, which are hormone-like substances that play a key role in the regulation of inflammation and pain. Elevated levels of prostaglandins are often linked to dysmenorrhea, or painful menstruation, which can further exacerbate discomfort and impact the daily lives of those affected.

To date, there is only one previous study in India investigating the prevalence of LCS among female college students and its relation with dysmenorrhea. There is lack of literature evidence, which can show the prevalence of LCS among female college students in Egypt. So, this study aims to fill a critical gap in existing literature by providing valuable insights into the prevalence and associated factors of LCS in this population in Egypt.

Eligibility Criteria:
Inclusion Criteria:

* They were virgin, healthy female college students.
* They had regular menstruation (3-8 days in duration, with 21-35 days in-between).
* Their ages ranged from 18 to 25 years old.
* Their body mass index (BMI) will range from 18 to 24.9 Kg/m2.
* Their waist- hip ratio was less than (0.8).

Exclusion Criteria:

* History of back or lower limb surgery
* Trauma to back or lower extremity
* Rheumatoid arthritis
* Spinal deformity such as kyphosis and scoliosis.
* Any neurological disease
* Uncooperative volunteers.
Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.

This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing dextromethorphan and placebo for the treatment of chemotherapy-induced peripheral neuropathy, assessed with a (0-10) numerical scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.

The influence of CYP2D6, CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will be measured.

Eligibility Criteria:
Inclusion Criteria:

* - Age ≥ 18 years
* Breast cancer patients suffering from chemotherapy-induced peripheral neuropathy for at least 3 months after the end of their last cancer chemotherapy
* Numerical rating scale ≥ 4
* Patient in stable clinical situation on the next month (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled in the month following the enrollment)
* Patients affiliated to the French Social Security
* Patients with free and informed consent has been obtained

Exclusion Criteria:

* - Hypersensitivity to the active substance or to any of the excipients
* Hypertension
* History of stroke
* Severe heart failure
* Severe hepatic impairment
* Shortness of breath
* Congenital galactosemia, glucose-galactose malabsorption, lactase deficiency
* Association with linezolid
* Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy
* Diabetes (type I and II)
* Medical and surgical history incompatible with the study
* Patient receiving treatment with amantadine, ketamine, memantine, L-Dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, Monoamine oxidase inhibitor, dantrolene or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, amiodarone, fluoxetine, paroxetine, propafenone, thioridazine, ritonavir, nicotine, hydrochlorothiazide, warfarin
* Present or past psychotropic substances and alcohol dependence
* Childbearing age, no use of effective contraceptive method, pregnancy or lactation
* Patient exclusion period, or the total allowable compensation exceeded
* Patients undergoing a measure of legal protection (guardianship, supervision ...)
Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities

Individuals have a significant capacity to adapt to different environments by changing their core metabolic pathways. This adaptation is especially important in regards to diet. Epidemiological research over the last several decades have shown that diets high in saturated fats have a greater ability to cause insulin resistance and the 'metabolic syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as compared to high carbohydrate or high saturated fat diets, result in increased insulin sensitivity and improved lipid profiles.

In this application, the investigators propose to systematically assess the effects of two diets enriched in either saturated or unsaturated fatty acids and determine the cellular and molecular mechanisms of the apparent increase in insulin sensitivity. The investigators hypothesize that individuals will 'adapt' to the different diets and the investigators will be able to generate predictive alterations in gene expression and metabolites that underlie the alterations in metabolism. In parallel, the investigators will test the ability of these different diets to affect the release of gastrointestinal hormones that may be critical to modulation of appetite.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal females with BMI range of 25-32 kg/m2

Exclusion Criteria:

* Evidence of metabolic or cardiovascular disease, Fasting plasma glucose concentration \> 125mg/dl, Abnormal EKG, Hyperlipidemia (plasma triglyceride concentration \> 150mg/dl), Pregnancy, Hematocrit \<34%
Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to compare the efficacy and safety profile between Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
* 2.Without drug treatment for RCC or chemotherapy/cytokine therapy failure or resistant patients)
* 3.With measurable disease (using RECIST1.1)
* 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
* 5.Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks
* 6.main organs function is normal
* 7.Signed and dated informed consent

Exclusion Criteria:

* 1.Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
* 2.patients has many influence factors toward oral medications
* 3.Known brain metastases
* 4.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\>10mmol/L);urine protein≥++,etc.
* 5.patients failed to heal wounds or fractures for Long-term
* 6.patients occurred venous thromboembolic events within 6 months
* 7.patients has HIV-positive or organ transplantation
Breast Cancer Trials Education Program

The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

Knowledge and participation in clinical trials is disproportionately low among minorities. The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.

A validation study was also conducted to validate several measures for the Hispanic American and African American populations.

The experimental group watched an education program concerning breast cancer clinical trials while the control group watched an education program on neighborhood safety.

To examine willingness to participate in research was assessed by a post-intervention invitation to complete a sleep diary.

Eligibility Criteria:
Inclusion Criteria:

* Self-Identified as an African American or a Hispanic American female
* Speak English and/or Spanish
* Mentally and Physically capable of completing the consenting process

Exclusion Criteria:

* None
PSMA PET and MRI in Gynecological Cancers

The goal of this research is to determine the accuracy of PSMA positron emission tomography (PET) and multi-parametric magnetic resonance (MR) imaging to detect the presence of gynecological cancer cells in the body.

The investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, to determine the presence or absence of cancer, the accurate distribution of cancer and the normal biodistribution of PSMA in the abdomen and pelvis on PET imaging.

PSMA, also known as folate hydrolase 1 and glutamate carboxypeptidase II, is an enzyme associated with prostate cancer but has been also found to be expressed in the tumor neovasculature of many different types of non-prostate cancer tumors. PSMA-based 18F-DCFPyL PET demonstrates very high tumor-to-background ratio when studied in other tumors, including prostate tumors.

MR imaging is a highly sensitive and specific imaging modality that can be used for gynecologic cancers. MR images can be obtained in conjunction with PSMA PET, adding additional anatomic and multi-parametric MRI information without the need for a second imaging appointment.

Eligibility Criteria:
Inclusion Criteria for healthy female controls N=12 (includes up to 6 Dosimetry participants):

* Women with no suspected gynecological cancer.
* No contraindications for MR or PET imaging.
* Greater than or equal to 18 years of age.
* Scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

Inclusion Criteria for female controls (Dosimetry):

* Women with or without suspected gynecological cancer.
* No contraindications for MR or PET imaging.
* Greater than or equal to 18 years of age.

Inclusion Criteria for gynecological cancer patients (N=40):

* Women with known or suspected gynecological cancer
* No contraindications for MR or PET imaging.
* Greater than or equal to 18 years
* Have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy

Exclusion Criteria:

* Women that are pregnant or breast-feeding.
* Age \<18
* Inability to provide informed consent on their own behalf
* Severe kidney dysfunction (GFR \<30 mL/min/1.73m2)
Invisalign® System with Mandibular Advancement

The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks


Eligibility Criteria:
Inclusion Criteria:

• Subject must be eligible for Invisalign treatment with mandibular advancement

Exclusion Criteria:

* Subject's dentition not compatible with device or allergy to device materials
* Subject who is pregnant, has active caries, periodontal disease, TMD, root resorption, has HAE (hereditary angioedema), has been diagnosed with epilepsy or any other seizure disorder
Effects of Lutein in Retinitis Pigmentosa

Phase I/II double-masked, randomized, placebo-controlled, cross-over trial to determine effects of lutein on vision in retinitis pigmentosa, including safety and effective dosage assessment

Retinitis pigmentosa (RP) is a group of congenital retinal degenerations affecting over 100,000 individuals in the US, characterized by nightblindness, gradual loss of peripheral vision, and eventually total vision loss. Despite surgical and medical efforts it has not been possible to slow down, let alone reverse, the process of photoreceptor degeneration in RP. However, a recent patient-initiated pilot study demonstrated that RP patients may respond to a nutrition supplement (lutein) with a modest, but statistically significant gain in visual acuity and central visual field area; demonstration of these effects relied critically on frequent home vision tests using a letter chart on the screen of a personal computer and a wall chart to measure the central visual field. Supporting the reliability of the data was a highly significant correlation between eye color and vision changes; eye color has earlier been shown to influence macular pigment changes following lutein supplementation.

At this state, a study of long-term lutein benefits would be costly and, without placebo-controlled pilot data, premature. We are proposing to prepare for a long-term clinical trial through an exploratory study, investigating the effects of lutein and creating PC-based home vision tests. In the initial 6 months of the study, we will develop and adapt standard clinical vision tests for use on a personal computer, and recruit two study groups: 1) 42 RP patients to study the effects of lutein on vision, using placebo and 20 dosages in a randomized, double-masked crossover design (Latin Square, 2x16 weeks), testing for possible adverse effects through serum hepatic panels every 4-6 weeks, and measuring compliance through baseline and end-value serum carotenoid tests and frequent macular pigment density tests; 2) 31 other volunteers (10 normally signed, 21 RP patients) who, along with the first group, will monitor their vision every 1-2 weeks at home using the PC-based tests. Results will be validated against those obtained with standards tests during multiple visits to our center.

The results and tools produced by this study will enable a long-term lutein supplementation trial with vision as its principal outcome measure, and the study can serve as a model for other supplement trials. Moreover, by virtue of the PC-based home vision tests developed as part of this study, such future trials may, under proper safeguards, enroll remote participants who would download test software, perform frequent outcome tests at home, submit test results via e-mail, and be examined periodically by local physicians to detect potential adverse effects.

Eligibility Criteria:
Safety and Efficacy of LCL161 in Patients With Solid Tumors

The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.


Eligibility Criteria:
Inclusion Criteria:

* Solid tumor
* ECOG performance status 0-2
* Life expectancy greater than or equal to 12 weeks
* Must meet certain blood laboratory values
* Must meet criteria for time since the last dose of prior therapy
* Must provide written informed consent to participate in this study

Exclusion Criteria:

* Active and/or symptomatic brain tumors or brain metastases.
* Patients with unresolved nausea, vomiting, or diarrhea
* Any ongoing severe and/or uncontrolled medical condition that could compromise participation in the study including heart, lung or inflammatory disease
* Any disease that may significantly alter the absorption of the study drug (for example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or removal of small bowel)
* Patients who are currently receiving treatment with steroids at a certain dose or other immunosuppressive treatment that cannot be stopped prior to starting study drug
* Patients who are currently receiving treatment with certain medications
* Patients who have received radiation therapy or have undergone major surgery within the last 4 weeks
* Women of child-bearing potential who are pregnant or breast feeding.
* Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
* Patients unwilling or unable to follow the protocol

Other protocol-defined inclusion/exclusion criteria may apply