cyrilzakka/clinical-trials huggingface dataset:
O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma

This phase I trial is studying the side effects and best dose of carmustine given together with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells

PRIMARY OBJECTIVES:

I. To determine the kinetics of AGT depletion in CTCL skin lesions. II. To determine the toxicity of low dose BCNU plus O6BG.

OUTLINE: This is a dose-escalation study of carmustine.

Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CTCL, stages IA-IIA
* Performance status ECOG grade 0, 1, or 2
* Patients must have recovered from toxicity of prior treatment and have received no CTCL therapy other than emoliation for at least 4 weeks
* Patients must have signed a consent form indicating the investigational nature of the treatment and its potential side effects
* WBC \> 4,000/ul
* ANC \> 2,000/ul
* Platelets \> 100,000/ul
* Bilirubin \< 1.5 mg/dL
* SGOT within normal range
* Prothrombin time within normal range
* Creatinine =\< 1.5 mg/dL or creatinine clearance \>= 70 ml/min
* Calcium and electrolytes normal
* Glucose-controlled (diet and insulin) diabetes is permitted
* DLCO \> 80% normal with the exception of patients who demonstrate clinically normal lung function based on history, physical examination, and chest x-ray as interpreted by the principal investigator
* Only those patients with biopsiable tumor and willing to undergo several biopsies will be eligible
* Must have failed 1 conventional treatment other than topical corticosteroids; this includes UVB, PUVA, topical mechlorethamine, electron beam, photopheresis, chemotherapy and immuno-modulatory agents such as cytokines

Exclusion Criteria:

* Patients with a prior treatment with a nitrosourea
* Patients with known central nervous system involvement or primary CNS malignancies will be ineligible
* Patients with performance status ECOG grade 3 or 4
* Pregnant women, women who are breast feeding infants, or women with reproductive potential not practicing adequate contraception, because of potential toxicity to the fetus or infant
* Patients with active infection
* Patients with pulmonary disease as determined by history, physical examination, chest X-ray or pulse oximetry
* CTCL patients with stage IIB-IVB disease
Independent Studies of Dextromethorphan and of Donepezil Hydrochloride for Rett Syndrome

Rett syndrome (RTT) is a disorder in which the nervous system does not develop properly. RTT generally affects girls, but there are some boys who have been diagnosed with RTT. Symptoms of RTT include small brain size, poor language skills, repetitive hand movements, and seizures. This study will evaluate the effectiveness of two drugs in treating the symptoms of RTT.

RTT is a neurodevelopmental disorder characterized by apparently normal early development followed by loss of purposeful hand use, distinctive hand stereotypies, slowed brain growth, loss of language, respiratory irregularities, GI disturbances, gait abnormalities, seizures, and mental retardation. These symptoms appear between ages 6 and 18 months (stage 2 of the disease) following apparently normal development (stage 1). Subsequently, there is gradual stabilization of severe mental retardation and motor compromise (stage 3). The majority (70% to 80%) of patients demonstrate mutations in the methyl-CpG-binding-protein-2 (MeCP2) gene, a transcription repressor located on chromosome Xq28. The disorder predominantly affects females, but a few males with mutations in MeCP2 have been identified, even though many of them do not have the classic symptoms recognized in females.

Recent studies demonstrate increased brain N-methyl-D-aspartate (NMDA) receptors in stages 2 and 3 of the disease. This age-specific increase in glutamate levels and their receptors contribute to brain damage. This first study will examine the effectiveness of dextromethorphan, an NMDA receptor antagonist, to ameliorate symptoms. Participants will be randomized to receive one of three doses of dextromethorphan. All participants will be admitted to the hospital for three days at the beginning of the study. During the hospitalization, participants will undergo physical exam, Dexascan, MRI, EEG, behavioral assessment, laboratory testing, and neuropsychological evaluations. Six months after baseline assessment, participants will be rehospitalized for 3 days for similar assessments.

Reduction in choline acetyltransferase activity in RTT patients may also contribute to disturbed cortical development and psychomotor retardation in RTT. Therefore, the second part of the study will evaluate the effect of donepezil hydrochloride, an inhibitor of acetylcholine-esterase, on acetylcholine levels. This portion of the study will not begin until pharmacokinetic data for donepezil in children is available.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of Rett syndrome
* Mutation in MeCP2 gene
* Typical EEG abnormalities (disorganized background, frontal central spikes, rhythmic theta)

Exclusion Criteria

* Features of Rett syndrome with absence of MeCP2 mutation
* Non-specific EEG changes
Immunonutrition Supplementation in Head and Neck Cancer Patients Undergoing Cancer Treatment Study

This is a prospective, randomized, open-label intervention study to evaluate the effectiveness of immunonutrition supplementation in head and neck cancer (HNC) patients during cancer treatment.

The study population will be adult HNC patients receiving radiotherapy and chemotherapy treatment. The targeted number of subjects is 116 patients (58 subjects in each arm). Participants will be randomly assigned to receive standard medical nutrition therapy (individualized dietary assessment and counselling, and standard nutrition supplementation as necessary) or standard medical nutrition therapy with high energy, high protein, immunonutrient-enriched oral nutrition supplementation. Immunonutrition supplementation will begin 1 week prior to cancer treatment and continued throughout the cancer treatment, and to be taken in 3 servings/day. The study involves interviewing of subjects for dietary and nutrition assessment; measurement of weight, body composition, handgrip strength; and data collection from subjects' medical records.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Adult HNC patients, male or female, above 18 years of age
* Primary HNC diagnosis, stage I to III; including: cancer of the nasopharynx, oropharynx, oral cavity, hypopharynx, or larynx, etc.
* Referred and planned for curative-intent cancer treatment (radiotherapy and chemotherapy)
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2

Exclusion Criteria:

* Inability or unwillingness to provide written informed consent or comply with the requirements of the protocol
* Patients with metastatic stage or recurring/relapse of cancer at same site
* Planned for palliative cancer treatment
* Underlying severe hepatic failure or renal dysfunction (eGFR \< 30ml/min/1.73m2)
* Underlying severe sepsis, neutropenia, immune-deficiencies or autoimmune diseases
* Consumption of supplements or enriched foods containing immunonutrients (omega- 3, arginine or nucleotides) in the previous month prior to study; including dietary supplements such as: fish oil capsules, arginine tablets/powder, RNA capsules, etc.
* Known allergy or intolerance to components of the immunonutrition supplement (cow's milk, fish or soy)
* Enrolment in other cancer treatment trials
Incidence, Risk Factors and Outcomes of Diaphragm Dysfunction After Lung Transplantation

The study is designed to characterize the changes in diaphragm function after lung transplantation.

Diaphragm dysfunction (DD) is a well-known complication after lung transplantation. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation post-transplant - they become too weak to breathe. However, little is known about the pre-transplant predictive factors associated with diaphragm dysfunction . We have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows us to observe changes in diaphragm muscle structure and function.

The goal of the study is to determine whether pre-transplant diaphragm thickness and function are associated with diaphragmatic dysfunction after lung transplantation. This will help us to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients greater than 18 years of age
* Listed for lung transplantation

Exclusion Criteria:

* Known diagnosis of chronic neuromuscular disease
* Relisting for transplantation
* Bridging to lung transplantation with respiratory support
Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery

This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood transfusion requirement in patients of lower limb trauma undergoing surgery.

This was a single centre, parallel group, prospective randomized control study. 116 patients of lower limb trauma presented between April 2017 to August 2018 at Civil Hospital Rajpura. 16 patients were excluded due to old fracture, percutaneous wire fixation or non-consenting patient. The remaining 100 patients were randomized into two groups. 50 patients were given 1 gram of TXA before surgery and 50 patients were not given TXA. Fall in Hb, requirement of blood transfusion, number of days admitted in the hospital after surgery and evidence of deep vein thrombosis were monitored.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from lower limb trauma

Exclusion Criteria:

* Presence of old implant or infection at the fracture site,
* Any blood coagulation disorder
* Patients undergoing percutaneous wire placement procedures for fracture fixation
* Polytrauma
* Non-consenting patients
* Psychiatric patient
HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance

This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.

The study will be performed only on two sites

The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.

Eligibility Criteria:
Inclusion Criteria:

- Adult (18 Y.O. or more) women and men infected with HIV.

* Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.
* Virologically controlled (HIV-1 RNA \< 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.
* Presence of at least one major NNRTI mutation.
* No limitation on the number of previous regimens.
* HCV and HBV-infected patients are allowed

Exclusion Criteria:

High level of resistance to doravirine according to historical resistance tests.

* Level of resistance to doravirine superior to that of etravirine
* Opportunistic or serious active infection or disease
* Active and untreated malignancy.
* Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures
* Pregnancy.
* Active treatment for hepatitis C is forbidden at entry but will be allowed after 3
Zalutumumab in Head and Neck Cancer

The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx.
* Primary or recurrent disease for which no curative or established palliative treatments are amenable
* WHO performance status of 1 or 2.

Exclusion Criteria:

* Received certain other treatments within 4 weeks prior to administration of study drug
* Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).
* Skin disease requiring systemic or local corticosteroid therapy.
* Known brain metastasis or leptomeningeal disease.
* Signs or symptoms of acute illness.
* Bacterial, fungal or viral infection.
* Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases.
* Pregnant or breast-feeding women.
* Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
* Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.
Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status

The purpose of this study is to determine the safety and efficacy of sulfadoxine-pyrimethamine (SP) versus artemether-lumefantrine (Coartem) when administered to HIV+ and HIV- patients with uncomplicated P. falciparum malaria. Patients will be randomised to one of the 2 treatment and followed up (until day 14 actively) for 45 days.


Eligibility Criteria:
Inclusion Criteria:

* Man and non-pregnant women aged between 15 and 50.
* P.falciparum mono-infection of at least 1,000 parasites/µl.
* Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
* Consent from patient obtained.

Exclusion Criteria:

* Pregnancy.
* Severe P. falciparum malaria .
* Documented intake of SP or Coartem two weeks or less prior recruitment.
* Other cause(s) of fever.
* Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
* History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.
Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate

Interventional Clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a population of postmenopausal women, lasting 1 month.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman
* Low contribution of elemental calcium in the daily diet

Exclusion Criteria:

* Hypersensitivity to the active substances or to any of the excipients
* Renal insufficiency
* History of kidney or urinary stones
* Use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones
* Use of any other drug or experimental device during the 30 days prior to the selection
Cemented vs Cementless in Bilateral TKA

To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.

To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* ASA status 1 or 2
* Diagnosed with bilateral osteoarthritis of the knees
* Participant understand and consent to the protocol of the trial

Exclusion Criteria:

* Morbid obesity (BMI \>40)
* Inflammatory arthritis
* Osteoporosis
* Metabolic bone disease
* Bone defect that seen from radiographs
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
* Maximum PSA value of 20 ng/ml.

Exclusion Criteria:

* Evidence of distant metastasis (M1).
* Prior systemic chemotherapy for any reason.
* Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
* Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
* History of hip replacement.
* Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
* Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

The purpose of this two-year mixed methods study is to develop and test an intervention to improve cancer family caregivers' knowledge of care options (curative, palliative, and hospice care) and goals of care communication as part of a self-management (SM) training program.

The two specific aims of this project are to:

1. Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's Guide (MCC-CG), for family caregivers of patients with breast cancer to increase knowledge of care options, goals of care communication, and other SM skills.
2. Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized controlled trial compared with an attention-control condition (symptom management education) on knowledge of care options, goals of care communication, and other key SM skills (engagement in SM, management of transitions and uncertainty, increasing self-efficacy, appropriate use of health care resources).

The investigators will address and accomplish aim 1 by taking the following steps:

1. Conduct development focus groups with family caregivers of women with breast cancer.
2. Develop the MCC-CG intervention prototype.
3. Conduct feedback focus groups with family caregivers to evaluate the prototype.
4. Revise the MCC-CG.

To address and accomplish aim 2, the investigators will do the following:

1. Conduct a pilot RCT to evaluate the feasibility of recruiting and retaining a sample of family caregivers.
2. Assess the initial efficacy of the MCC-CG to improve knowledge of care options, goals of care communication, and other SM skills.
3. Estimate power and determine the best measures for a large RCT testing the MCC-PT and MCC-CG together.

Eligibility Criteria:
Inclusion Criteria:

* A family member of an individual with any stage of breast cancer receiving curative, palliative, or hospice care
* Aged 18+
* English speaking
* Live in Connecticut
* The patient for whom the participant is a caregiver has a six-month prognosis
Rate Control in Atrial Fibrillation

This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart rate control in patients with atrial fibrillation and a rapid ventricular rate.


Eligibility Criteria:
Inclusion Criteria:

* Permanent atrial fibrillation
* Baseline ventricular rate (prior to treatment) \> 110 bpm

Exclusion Criteria:

* History of accessory tract re-entry tachycardia
* Ejection fraction \< 35% or history of NYHA Class III/IV stage C/D heart failure
* Acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery in the past 2 months
* Child-Pugh class B or C hepatic dysfunction
* Uncontrolled hypertension
* Thyroid disease
* Intolerance to beta-blockers
* History of lung disease resulting in hospitalization in the past year
The Effect of Obesity on Venous Puncture Pain

Before surgery, patients will fill the Beck anxiety, distress tolerance test and Pain katastrophizing test. Patients will be divided into two groups according to BMI\> 30kg / m2 (Group A) and BMI \<30kg / m2 (Group B). Compared to body weight, venous vascular pain of the groups will be compared.

Seventy patients will be randomized to two groups(BMI\> 30kg / m2 (Group A) and BMI \<30kg / m2 (Group B) during peripheral venous cannulation (PVC). The patients' visual analog scores will be measured during peripheral venous cannulation.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery

Exclusion Criteria:

* Patients with a history of anxiety disorders or hearing problem and preoperative pain, emergency surgery
Comparison of MBR + Suture Tape, MBR, and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years

Exclusion Criteria:

* Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study
Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery

The purpose of this study is to determine the effect of intrathecal oxytocin on speed of reduction in pain for the first 60 days after hip surgery.

This is a single-center, NIH funded clinical study at Wake Forest Baptist Medical Center. The investigators anticipate that intrathecal oxytocin will speed recovery from pain after major surgery (hip arthroplasty). For this study, the investigators will use a randomized, controlled and blinded study of intrathecal oxytocin in patients scheduled for hip arthroplasty, with primary outcome being the slope of change in pain over the first 60 days following surgery, using growth curve modeling and a ln(time) function.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral, primary total hip replacement
* American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* Pregnancy
* Currently Workman's Comp litigation related to hip replacement
* Taking greater than 100 milligrams of morphine (or equivalent)
* Suffering from a psychotic disorder or a recent psychiatric hospitalization