cyrilzakka/clinical-trials huggingface dataset:
CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer

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

PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.

OBJECTIVES:

* Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with CT-2103.
* Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive CT-2103 IV over 10 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

If no more than 1 of the first 6 patients experience dose-limiting toxicity, then the remaining patients receive a higher dose of CT-2103.

Patients are followed between 1-3 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

  * Recurrent disease following prior initial therapy with platinum-based regimen

    * No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease
    * No more than 1 prior non-platinum, non-taxane regimen
* At least 1 site of radiographically measurable disease AND/OR
* CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT less than 1.5 times ULN
* Alkaline phosphatase less than 1.5 times ULN

Renal

* Creatinine no greater than 1.5 mg/dL

Other

* No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs
* No active uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

* At least 4 weeks since prior immunotherapy and recovered

Chemotherapy

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy

* At least 4 weeks since prior endocrine therapy and recovered

Radiotherapy

* At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered

Surgery

* Not specified

Other

* At least 4 weeks since other prior investigational drugs and recovered
Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.

The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.

After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

Eligibility Criteria:
Inclusion Criteria:

* Subfoveal CNV secondary to AMD.
* Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
* Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.

Exclusion Criteria:

* History of any vitreous hemorrhage within 4 weeks prior to Day 1.
* Aphakia.
* Significant subfoveal atrophy or scarring.
* Prior treatment with the following in the study eye:

  * Subfoveal thermal laser therapy.
  * Submacular surgery or other surgical intervention for the treatment of AMD.
  * Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1.
  * Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
  * Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
  * Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
  * Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
  * Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
* Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.
Efficacy Comparison Study of Steroids to Control Post-operative Inflammation

Phacoemulsification is a quick method with less complication for cataract surgery. Due to the use of ultrasonic energy, it produced more post-operative inflammation than other methods. Many routes of steroid had been used to control post-operative inflammation. The investigators here compare the efficacy of single depot steroid subtenon injection (20-mg triamcinolone) with four-time-a-day steroid eye drop (0.1% dexamethasone) in controlling inflammation after uneventful phacoemulsification.

Cataract is one of the most common causes of blindness in the world. Surgical removal of lens is the only treatment for cataract, which now shifts from extracapsular cataract extraction to phacoemulsification. Although phacoemulsification provides faster operating time and gives better optical result and rapid recovery to the patient, it causes more inflammation post-operatively compare with extracapsular cataract extraction. Corticosteroids eye drops are mainly use to control intraocular inflammation after the surgery.

Other routes of corticosteroids have been introduced to increase the intraocular level and to increase the patient's compliance. Subtenon triamcinolone injection is easy and safe. Antiinflammatory effect of single subtenon triamcinolone injection lasts about 4-6 weeks. This method has been used in combination with corticosteroid eye drop to control the inflammation after cataract surgery in uveitic patients. It shows potency in controlling of intraocular inflammation with lower rate of increasing the intraocular pressure. The investigators here quantitatively compare the efficacy of subtenon 20-mg triamcinolone injection with 0.1% dexamethasone eye drop in controlling intraocular inflammation after uneventful phacoemulsification.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years old
* Uncomplicated cataract patient scheduled for phacoemulsification and posterior chamber intraocular lens implantation
* No History of prior intraocular procedures or any eye diseases such as uveitis, glaucoma, diabetic retinopathy
* No History of systemic autoimmune diseases
* No History of allergy to corticosteroids or to any component of the study medications
* No History of using corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), or immunomodulating agents within 3 months prior to surgery

Exclusion Criteria:

* Complications occurred during cataract surgery such as ruptured posterior capsule, vitreous loss, or dropped nucleus
* Pregnant and lactating women
Risk Stratification Procedure for Thromboembolism Prophylaxis

The main objective for this study is validation for the proposed risk stratification tool, by evaluating the clinical outcomes for its use post TKR Surgeries. For this objective, the design that is used is Randomized Trial.

All patients that will have total knee replacement, in a given period of time in both medical centers; Prince Sultan Military Medical City (PSMMC) and King Abd Allah University Hospital (KAAUH) in Princess Noura University, will be randomly separated into 2 groups; in the first group (A): Venous thromboembolism (VTE) risk stratification tool (which is prepared by a clinical pharmacist) will be applied to choose the tailored extended VTE prophylactic agent. While in the second group (B), the risk stratification tool will not be used, rather it will follow the routine hospital protocol for choosing the VTE prophylactic agent, which is Caprini: a standard validated model. Then each group of patients will be followed till 35 days post-operation, during which all VTE or bleeding events should be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female patients who are planned for elective TKR surgery (primary only).
2. Agreed to sign the Informed consent form (ICF).
3. Patients aged older than 18 years.

Exclusion Criteria:

1. Patients receiving anticoagulant for treatment.
2. Patients with a history of DVT or PE were excluded from the study due to the marked increase in the risk of recurrent VTE compared to the general risk of (7% vs. 0.1%); (Fahrni, 2015).
3. Patients with renal or hepatic failure, renal failure is defined as end-stage kidney disease (on dialysis); hepatic failure is defined as complete liver cirrhosis.
4. Pregnant woman.
5. Revision surgeries.
Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction

This study is investigating the normal range of maximal diaphragm thickness during a sniff inspiratory manoeuvre using ultrasound in healthy subjects stratified by age and gender.

Diaphragm dysfunction is associated with poor clinical outcomes in critically ill patients but is difficult to diagnose. Traditionally, diaphragm function is measured by evaluating inspiratory muscle strength via maximal inspiratory pressure (MIP). However, this technique relies on a volitional maximal effort and can be challenging for patients to perform.

An alternative to measuring inspiratory muscle strength is the sniff inspiratory pressure approach. During short, sharp sniffs, the diaphragm is maximally activated.

Currently, there are no reported values of the normal range of maximal diaphragm thickness during a sniff maneuver. This study will define the normal range of values for sniff maximal diaphragm thickening fraction, maximal thickening against an occluded airway, and diaphragm thickening during resting tidal breathing in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Antecedent history of neuromuscular or cardiorespiratory disease
Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation

Despite relevant clinical and/or familial presentations suggesting a hereditary predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic analysis based on the phenotype are often non contributive. As somatic cancer genes are limited, the hypothesis is that the targeted next-generation sequencing of 200 genes, selected for their implications in cancers may contribute to the understanding of many selected patients' presentation by the identification of germline deleterious mutations, and may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.


Eligibility Criteria:
Inclusion Criteria :

* Older than 18 or parental agreement in case of children.

For patient with early-onset breast cancer :

* Invasive breast cancer, regardless of histological type or stage, diagnosed before 31 years.
* Sporadic or familial presentation
* No genomic alterations of BRCA1, BRCA2 or TP53

For patient with early-onset ovarian cancer :

* Invasive ovarian cancer, regardless of histological type or stage, diagnosed before 41 years.
* Sporadic or familial presentation
* No genomic alterations of BRCA1, BRCA2

Patient with early-onset colorectal cancer :

* Invasive colorectal cancer diagnosed before 31 years.
* Sporadic or familial presentation
* No genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation
* No genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation

Patient with pediatric cancer :

* Non haematological tumour diagnosed before 16 years, with Li-Fraumeni presentation.
* No genomic alteration of TP53

Patient with Multiple primary malignant tumours :

* Multiple synchronous or metachronous primary malignant tumors with early-onset
* No syndromic presentation

Exclusion Criteria:

* Any already known deleterious mutations according to the patient's phenotype
Minnesota RETAIN Impact Evaluation

This study is a randomized control trial (RCT) to evaluate the impact of RETAIN program expansion and services on workforce retention and reduction of future workplace disability in the state of MN. Collaboration between partners to implement best practices in early intervention to support injured or ill employees in stay at work and return to work will be implemented.

MN RETAIN is a collaborative program led by the Minnesota Department of Employment and Economic Development (DEED), Minnesota Department of Health (MDH), Department of Labor and Industry (DLI), Mayo Clinic, and Workforce Development Inc (WDI) and includes stakeholders throughout MN.

Eligibility Criteria:
Inclusion Criteria:

* Must have been unable to work for no more than 6 months prior enrollment; 80% of participants must be within 3 months of their last day of work
* 18 years or older
* Minnesota resident
* Works in Minnesota
* Employed or currently in the labor force
* Meets one of the following:

  1. Diagnosis of a work related or personal injury or illness that impacts employment
  2. Invasive procedure (e.g., surgery) within the past 12-weeks or anticipated within the next 8-weeks that impacts employment

Exclusion Criteria:

* Legal representation/litigation at the time of enrollment related to their medical condition.
* Does not have the capacity to give appropriate informed consent
* Employed by a RETAIN healthcare recipient or subrecipient with an existing return to work program for employees (i.e. Mayo Clinic employees)
* Worker's compensation recipients that have a qualified rehabilitation consultant (QRC) or a disability case manager (DCM)
Quality of Life Comparison in Patients With Different Types of Alopecia

Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Numerous studies have assessed the impact of some types of alopecia on patients' quality of life. One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. However, none have assessed the impact on the patient partner quality of life. In addition, few treatments for alopecia are covered by national health insurance in France. The main objective is to compare the impact on the quality of life in different types of alopecia. By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia.


Eligibility Criteria:
Inclusion Criteria:

* patients affiliated to social security
* patients able to understand and fill out a questionnaire
* patients over 18 years old
* patient consulting in the dermatology department of Amiens University Hospital for a primary alopecia

Exclusion Criteria:

* minors
* patients under guardianship, deprived of liberty
* scalp affections other than alopecia
* secondary alopecia
Aripiprazole in the Treatment of Bipolar Depression

A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

Study is 6 weeks long with 7 clinical visits.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of bipolar disorder, any subtype; MADRS \>16; MRS \< 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control

Exclusion Criteria:

* Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations
Medical Therapy of Prostatic Symptoms

The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH).

MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Peak urinary flow rate at least 4 ml/sec but not greater than 15 ml/sec; and voided volume is at least 125 ml.
* American Urological Association Symptom Score is greater than or equal to 8 and less than or equal to 30.
* Voluntarily signed the informed consent agreement prior to the performance of any study procedures.

Exclusion Criteria:

* Serum prostate specific antigen level greater than 10 ng/ml.
* Supine blood pressure less than 90/70 mmHG. Orthostatic hypotension.
* Any prior medical or surgical intervention for BPH.
* Received any prior experimental intervention (either medical or surgical) for prostate disease or enrolled in any other study protocol.
mDixon TSE MRI Sequence And Conventional MRI Sequences In Dysimmune Orbitopathies (DDX)

The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor muscles and the orbital fat.

If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional contribution to the clinic, guiding the therapeutic management by detecting inflammatory lesions not found on clinical examination in 1/3 of cases.

The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal analysis oculomotor abnormalities as well as the orbital fat.

Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous fat removal.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 90 years, suffering from thyroid dysfunction proved by clinical and laboratory tests, with a bilateral clinical dysthyroid orbitopathy and undergoing an eye MRI

Exclusion Criteria:

* Absolute or relative contra-indication to MRI or to a contrast agent gadolinium injection (including pregnant or likely to be, breastfeeding women)
* Patient under guardianship
* Patient not willing to participate.
* Lack of affiliation to social security or medical state aid (AME) or universal health coverage (CMU)
* Motion artifact on the sequences, not corrected by the repeat sequences
* Metal artifact prohibiting the analysis of the region of interest
Corticosteroids in Community-acquired Pneumonia

The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in children hospitalized with community-acquired pneumonia.

The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia.

Community-acquired pneumonia (CAP) is a common problem in pediatric practice. The lower respiratory tract infections, particularly pneumonia, are a frequent cause of morbidity in children and is the leading cause of mortality in developing countries.

In the last 20 years, despite several research, only a small decrease in morbidity and mortality has been achieved.

Corticosteroids have an immune-modulation effect, not completely elucidated. Most likely, this effect is due to down regulation of pro-inflammatory cytokines.

We postulate that adding corticosteroids to antibiotic treatment of CAP might change the immune response and thereby reduce morbidity, leading to a decrease in patients hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized for community-acquired pneumonia
* 2-18 years old

Exclusion Criteria:

* Pulmonary chronic disease (including asthma)
* Immunodeficiency
* Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases)
* Wheezing in current disease
* Previous hospitalization (14 days prior to admission)
* Pleural effusion on admission
* Malnutrition
A Clinical Trial of Three Fixed Orthodontic Appliances

This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.

The effects of three different types of train-track will be assessed with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.

This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.

The effects of three different types of train-track will be assessed in this clinical trial with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.

Eligibility Criteria:
Inclusion Criteria:

* Young adults aged 16 years and over;
* Fit and well and on no medication;
* In the permanent dentition;
* Undergoing orthodontic treatment in preparation for combined orthodontic-surgical care

or

* Subjects considered suitable for non-extraction maxillary arch treatment if not undergoing combined orthodontic-surgical treatment;
* Crowding less than 6mm

Exclusion Criteria

* Cleft lip and palate and other craniofacial anomalies.