cyrilzakka/clinical-trials huggingface dataset:
Ovarian Tissue Transplantation

Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.


Eligibility Criteria:
Inclusion Criteria:

* Female patient between the ages of 18 and 45 years
* Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
* Ovarian insufficiency defined as an elevated FSH over 10
* Inability to conceive after 6 months of unprotected intercourse with male
* Reasonably good health
* Candidate for pregnancy
* Written clearance for the procedure from the patients oncologist

Exclusion Criteria:

* Patients considered to be high risk for surgical complications will be excluded from the research protocol
* Women who are known to be positive for the BRCA mutation
* Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
* Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
* Current pregnancy
Obesity's Impact on the Effect of Hip Arthroplasty

The purpose of this study is to investigate whether there is a correlation between hip arthroplasty patients' preoperative weight and the patients quality of life and the clinical effect one year postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* All patients recommended for primary total .

Exclusion Criteria:

* Rheumatoid arthritis.
Electroconvulsive Treatment Followed by Cognitive Control Training

Major depressive disorder (MDD) is worldwide one of the most prevalent and disabling mental health conditions. Electroconvulsive therapy (ECT) is a safe and effective treatment even though 6-month relapse rates are high. Cognitive side effects of ECT, such as reduced cognitive control, might trigger mechanisms that increase relapse in patients. As such, cognitive control training (CCT) holds promise as a non-pharmacological strategy to improve long-term effects of ECT (i.e., increase remission, and reduce depression relapse).

Eighty-eight participants aged between 18-70 years with major depressive disorder who start electroconvulsive treatment (ECT) will be included in this randomized controlled trial (RCT). Following (partial) response to ECT treatment (at least a 25% reduction of clinical symptoms), participants will be randomly assigned to a computer based CCT or active placebo control. A first aim of this RCT is to assess the effects of CCT compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. Secondly, participants will be monitored every two weeks for a period of six months following CCT/active placebo, allowing the detection of potential relapse of depression. Thirdly, the investigators will assess participant evaluation of the addition of cognitive remediation to ECT using qualitative interview methods (satisfaction, acceptability and appropriateness). Finally, in order to further advance the understanding of the mechanisms underlying effects of CCT, exploratory analyses may be conducted using facial video footage collected during the CCT/active control phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 70 years old
* current major depressive episode with treatment resistance
* eligibility and consent for ECT treatment
* ability to provide consent to study

Exclusion Criteria:

* neurodegenerative disorder or Montreal Cognitive Assessment (MOCA) \< 18
* catatonia
* schizophrenia
* alcohol use disorder in previous year
* prior ECT treatment
* insufficient computer knowledge or analphabetism
Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

This study is a single-centered, double-blind, two-arm randomized study to determine if oral glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving Therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject have been diagnosed with Stage I or II invasive breast cancer
* Subject will undergo Accelerated Partial Breast Irradiation (APBI) as part of Breast Conserving Therapy (BCT)
* Subject is eligible for APBI based on American Society of Therapeutic Radiation Oncology (ASTRO) criteria
* Subject is 18 years of age or older
* Subject is female

Exclusion Criteria:

* History of uncontrolled, clinically significant lung, heart, endocrine, liver, or renal disease
* Subject has been diagnosed with any other cancer
* Subject has a known hypersensitivity reaction to the following: oral glutamine (GLN), glutamate, monosodium glutamate (MSG) (i.e., Chinese restaurant syndrome)
* Subject has history of collagen vascular disease
* Subject has been diagnosed with Diabetes mellitus I or II
* Subject has had any prior breast radiation
* Subject is pregnant or breastfeeding
Explain Pain in Fibromyalgia Patients

Education of pain physiology is described as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. There is compelling evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophization, and physical performance in chronic musculoskeletal pain disorders. Although pain physiology education has been studied in patients with chronic low back pain, chronic whiplash, and chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM) are limited to a 2013 study with limited results.

The investigators propose a study with a higher dose of education of pain physiology (i.e. a higher number of educational sessions and total education time) to study if this generates a larger treatment effect in patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* American College of Rheumatology classification criteria for FM, both 1990 and 2010
* Reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries
* On stable doses of medications for FM ≥ 4 weeks

Exclusion Criteria:

* Suffer from an inflammatory rheumatic conditions
* Have a planned elective surgery during the study period
* Have ongoing unresolved disability claims
* Experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis
* Do not speak Spanish fluently
A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients

The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.

Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.

Introduction: A comprehensive geriatric assessment (CGA) can identify functional and psychosocial issues in older cancer patients, which in turn can inform interventions to prevent/postpone adverse outcomes and maintain/improve the functional status and well-being of this population. However, few randomized controlled trials (RCTs) have been completed showing the evidence.

OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care plan on quality of life and functional status for older adults with advanced breast, gastrointestinal or genitourinary cancer METHODS -

A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above, diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a multidisciplinary geriatric oncology team followed by an integrated care plan to address any issues identified. Participants in the intervention group are seen at baseline for the CGA and for initiation of the integrated care plan, and again at 3 and 6 months to assess intervention fidelity and measure outcomes. The co-primary outcomes are: 1) maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.

Recruitment has been completed November 2015

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of advanced (stage 2, 3 or 4) Gastrointestinal, Genitourinary, or breast cancer
* Referred for first-line chemotherapy
* Ability to speak English
* Physician estimated life expectancy \>6 months
* An Eastern Oncology Group Collaborative (ECOG) Performance Score of 0-2
* Ability to provide informed consent

Exclusion Criteria:

* Previous chemotherapy for current stage of disease
Optimal TCI Regimen for Sedation of Elderly Undergoing Fiberoptic Bronchoscopy

Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious sedation in flexible bronchoscopy (FB) .However, the target setting of "effect-site" concentration (Cet) of propofol is still unclear in the elderly population .The aim of this study was to compare two induction Cet of propofol in elderly patients undergoing flexible bronchoscopy.

BACKGROUND:Bronchoscopy is nowadays a very common and widespread technique that allows the physician to proceed for both diagnostic and therapeutic interventions. The risks of this procedure are low and depend mostly on the health of the patient. In our study we only considered the elderly ( age \> 65 years old) which makes the risks even higher.

Target-Controlled Infusion (TCI) of Propofol has been proved to be a safe agent for conscious sedation in flexible bronchoscopy (FB) due to its fast onset of action and rapid recovery time. By virtue of an aging population, the number of bronchoscopy performed will likely increase in the elderly patients , however, the target setting of "effect-site"concentration (Cet) of propofol is still unclear among this population.

The aim of this study was to compare two induction Cet of propofol in elderly patients undergoing flexible bronchoscopy.

METHODS: Seventy patients were randomly divided into 2 groups . All patients were of American Society of Anesthesiologists (ASA) physical status of I-III, aged more than 65 years old and between 45 and 100 kg in weight. The induction Cet was targeted respectively at 1 and 2 ug/ml. Upon reaching the modified observer's assessment of alertness/sedation(MOAA/S) score 0-3, the Cet was increased or reduced during the procedures and the Ce level was set for the maintenance of sedation. Induction time, diagnostic procedures as well as the occurrence of adverse events such as apnea , hypotension or hypertension, heart rate, oxygen saturation (SpO2) ,any cardiac event, cough score, frequency of adjustments of drug doses were recorded.

The patient will be monitored during the procedure with periodic blood pressure checks, respiratory rate, continuous electrocardiogram monitoring of heart and oxygen measurement.

Eligibility Criteria:
Inclusion Criteria:

* body mass index \< 30 in males or \<28 in females
* an ASA physical status I and III

Exclusion Criteria:

* severe sleep apnoea syndrome (apnoea-hypopnea index \> 40)
* bradycardia
* hypotension
Shunt Evaluation With ALPE System in Thoracic Surgery

. The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (OLV) at different levels of positive end expiratory pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during OLV.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus.
* patients American Society of Anesthesiologists Physical Status Classiﬁcation score of 1-3

Exclusion Criteria:

* Patients with hemodynamic instability,
* Patients with severe chronic respiratory failure
* Patients with preoperative anemia (hemoglobin \<10 g 100 ml-1)
* Patients requiring unplanned conversion to thoracotomy
Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers

The goal of this clinical trial is to learn if acupuncture works to treat mild-to-moderate Alzheimer's disease, as well as the difference of its effect in APOE e4 carriers and non-carriers. It will also learn about the safety of acupuncture.

Researchers will compare acupuncture to a placebo (sham acupuncture) to see if acupuncture works to relieve the cognitive impairment and improve the ability of daily living and the quality of life. In addition, the plasma and neuroimaging biomarkers will be included as objective indexes.

Participants will:

Experience acupuncture or sham acupuncture 3 times per week for 12 weeks, and receive a 52-week follow-up.

Visit the clinic at Week 12, Week 38 and Week 64 for checkups and tests.

This is a two-centre randomized controlled trial. A total of 176 participants with mild-to-moderate Alzheimer's disease, 88 APOE e4 carriers and 88 non-carriers, will be randomly assigned to either an acupuncture combined with donepezil group or a sham acupuncture combined with donepezil group with a ratio of 1:1. The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39. There will be 12 weeks of 3-session treatment for each participant, and a 52-week follow-up in total. The primary outcome is the change and effective rate from baseline in the ADAS-cog score measured at Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 50-85 years
* Diagnosed by the criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA)
* Cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease, 11≤primary school degree≤22, 11≤junior high school degree or above≤26
* Magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume, MRI manifestation of high possibility of Alzheimer Disease
* The Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (≥2 for those under 75 years, and ≥3 for those over 75 years)
* Voluntarily joining this study with informed consents

Exclusion Criteria:

* Cognitive impairment caused by other factors (e.g. vascular dementia, dementia with Lewy bodies, frontotemporal dementia, hormone or metabolic abnormalities, hypothyroidism, folic acid or vitamin B12 deficiency, delirium or other mental and emotional disorders (such as schizophrenia and depression))
* A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
* Aphasia, disturbance of consciousness, or failure to cooperate with the related examinations due to physical disability
* Contraindications to undergoing an MRI scan such as claustrophobia or pacemaker implantation.
* Anticoagulant treatments such as warfarin or heparin
* Use of pacemakers or receiving acupuncture in the past 2 weeks
Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin naive
* Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets
* HbA1c between 8% - 10.5%

Exclusion Criteria:

* Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
* Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)
* Proliferative retinopathy, maculopathy requiring treatment,
* Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
* End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
* Acute disease with poor prognosis
* History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
* Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator
* Legal incapacity or limited legal capacity (patients under guardianship or curatorship)
* Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique treatment)
* Participation in another clinical trial less than one month before inclusion in this trial
* Illness requiring repeated hospitalisation
* Known or suspected allergy to the insulin or any compositional component
* Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
* Terminal illness
Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Survey

The purpose of this study is to characterize the accompanying symptoms, evaluation and management of patients with chronic vestibular dysfunction presenting with nausea and vomiting.

Based on prior study, a significant portion of patients referred for refractory gastroparesis in fact have signs suggestive of vestibular dysfunction as the cause of chronic nausea and vomiting. Our prior retrospective study identified a population of said subjects.

The aim of this study is to further characterize the concomitant symptoms, course of diagnosis, treatment and long-term follow up (up to 5 yrs) of this condition.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms of nausea and vomiting for at least 4 weeks
* Abnormal modified Fukuda stepping test on examination (\>90 degree rotation from midline while marching in place for 60 seconds) or nystagmus or abnormal Rhomberg test

Exclusion Criteria:

* Pregnancy
* Unable to complete questionnaire survey
CHiR Therapy for Elderly DLBCL Intolerant to Chemo

The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.


Eligibility Criteria:
Inclusion Criteria：

1. Age ≥ 70 years;
2. ECOG score of 0-3;
3. Rated as unfit or frail on the simplified geriatric assessment (sGA);
4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma (diagnostic criteria according to WHO 2016), excluding transformed type 2 DLBCL;
5. Immunohistochemically confirmed positive expression of MYC and BCL2 (MYC ≥ 40%, BCL2 ≥ 50% by immunohistochemistry);
6. Previously untreated patients;
7. Cardiac, hepatic, and renal function: creatinine \< 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 2.5 ULN; total bilirubin \< 2 ULN;
8. At least one measurable lesion;
9. Unable to tolerate standard CHOP regimen chemotherapy or unwilling to receive chemotherapy;
10. Adequate understanding and voluntary signing of the informed consent form. Exclusion Criteria：

1.Patients with central nervous system involvement at the time of onset; 2.Known human immunodeficiency virus (HIV) infection; 3.Pregnant or lactating women; 4.Other tumors requiring treatment; 5.Uncontrollable active infection; 6.Active hepatitis with HBV-DNA copy number not controlled within 2\*1000/mL despite antiviral treatment; 7.Inability to understand, comply with the study protocol, or sign the informed consent form.
Neuroanatomy of Reading in Congenital Deafness.

The aim of the research is to investigate phonological processing in deafness and to examine its influence on the neuroanatomy of reading.The basic hypothesis is that insofar as the ability to read is closely related to the ability to segment and represent speech units, the neuroanatomy of reading in deaf would be different from the one of hearing readers.


Eligibility Criteria:
Inclusion criteria:

* adult
* full education

Exclusion criteria:

* reading impairment
* fMRI
Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies

The primary objective of this study was to assess the steady-state zanubrutinib pharmacokinetics (PK) when co-administered with moderate and strong cytochrome P450 family 3 subfamily A (CYP3A) inhibitors.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed CLL/SLL, MCL, WM, or MZL.
2. Relapsed or refractory disease after at least 1 prior line of systemic therapy. Participants with MZL are required to have failed an anti-CD20 monoclonal antibody-containing chemotherapy regimen.
3. Baseline Eastern Cooperative Oncology Group performance status of 0 to 1.
4. Meet protocol guidelines for adequate bone marrow, kidney, liver, and cardiac function.

Key Exclusion Criteria:

1. Requirement of chronic treatment with strong and moderate CYP3A inhibitors or inducers or with drugs that are not allowed to be used in combination with diltiazem, clarithromycin, fluconazole, or voriconazole.
2. History of stroke or intracranial hemorrhage (within 6 months of treatment start).
3. Known hypersensitivity or contraindication to zanubrutinib, diltiazem, clarithromycin, fluconazole, or voriconazole.
4. Prior exposure to zanubrutinib or other Bruton tyrosine kinase inhibitor
5. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.