cyrilzakka/clinical-trials huggingface dataset:
Improving Methadone Maintenance Treatment Compliance and Outcomes in China

China faces the challenge of dual epidemics of drug use and HIV/AIDS. In responding to concerns of high rates of HIV/AIDS and other medical consequences among heroin users, China has recently implemented methadone maintenance treatment (MMT) programs nationwide. One problem noted with this rapid expansion is that the dropout rates from MMT have been high. The proposed study will adapt a motivational incentives (MI) intervention developed in the United States for use in Chinese MMT settings and will pilot test its effectiveness in improving treatment compliance and outcomes. The study's primary aims are: 1. to adapt a motivational incentives intervention in MMT in China, and 2. to experimentally pilot test the motivational incentives intervention. A secondary aim is to explore factors that may influence the outcomes of MMT that incorporates a motivational incentives intervention. It is hypothesized that the MI intervention can be adapted to Chinese settings and that it will optimize the positive outcomes of MMT in reducing HIV risks among heroin abusers. The collaborative team includes researchers in American and Chinese institutes (UCLA/Johns Hopkins/Washington, Shanghai Mental Health Center, Yunnan Institute for Drug Abuse), officials from national and local Chinese Centers for Disease Control and Prevention, and providers in local MMT clinics in Shanghai and Yunnan.


Eligibility Criteria:
Inclusion Criteria:adult patients entering the participating MMT clinics during the recruitment period who are dependent on heroin and who are willing to participate in the study.

Exclusion Criteria:Patients who are diagnosed with severe mental illness will not be eligible to participate.
Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease

A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
* Patients who intend to undergo a thoracoscopic pleural biopsy to determine the cause of pleural effusion;
* Sign informed consent.

Exclusion Criteria:

* There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
* Hemodynamic instability;
* Refractory hypoxemia;
* Patients with pregnant and lactating patients
* Any illness or condition that interferes with the completion of the initial or subsequent assessment.
Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study

Purpose:

To study the impact of endometriosis on subsequent pregnancy and delivery.

Methods:

retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016; analysis of pregnancy rate, mode of delivery and complications using Clavien-Dindo-classification, role of deep infiltrating endometriosis using ENZIAN classification; data analysis using t-test with p \< 0.050% being considered significant.


Eligibility Criteria:
Inclusion Criteria:

* cases: Operation because of endometriosis at the endometriosis Center, University Hospital Muenster, child wish, wants to participate, correct age group
* controls: Operation because of sterility, exclusion of endometriosis during this Operation, child wish, wants to participate, correct age group

Exclusion Criteria:

* cases / controls: declines participation, incorrect age Group, no child wish
PT/INR Reference Interval IN Healthy Volunteers

This is a prospective, single-center study in healthy volunteers to establish a PT/INR reference interval for the Microvisk International Normalized Ratio (INR) Test System. The primary objective of this study is to establish the reference interval for the measurement of prothrombin time (PT/INR) using the Microvisk INR Test System. The second objective is to evaluate the safety of the device.

Healthy volunteers who meet eligibility criteria, have been fully informed and provided written informed consent will be enrolled into this study. Each participant will be required to donate up to 3 finger stick samples for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. This will be followed by a standard venipuncture for (1) a neutral tube (Red Top) for analysis by the on-test method, (1) one sodium citrate tube (Blue Top) for analysis by the comparative/reference laboratory method. Sample collection will take place within the clinic session. The maximum trial duration for each participant is one clinic session.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is considered a healthy volunteer
2. Subject is male or female, over 18 years of age
3. Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent
4. Subject agrees to have blood drawn (venipuncture) and finger stick

Exclusion Criteria:

1. Subject is unable to give informed consent
2. Subject is less than 18 years of age
3. Female subject is pregnant
4. Subject is on anticoagulant medication or other medication known to affect PT/INR assessment (e.g., warfarin, heparin) for a minimum of 28 days before enrolling in the trial
5. Subject has a medical condition known to affect PT/INR (e.g. vitamin K deficiency, disseminated intravascular coagulation, liver disease, decreased or defective factor I, II, V, VII, or X)
6. Subject has already taken part in the study
Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

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 flavopiridol in treating patients who have metastatic malignant melanoma.

OBJECTIVES:

* Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma.
* Assess the toxicity of this treatment in these patients.
* Assess the time to progression, early progression rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, and then every 3 months until disease progression or death.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic malignant melanoma not amenable to standard curative therapies

  * No prior regional or systemic therapy for metastatic disease
* Measurable disease

  * At least 20 mm by conventional techniques OR
  * At least 10 mm by spiral CT scan
  * Bone lesions not considered measurable
* No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 2.5 times ULN

Renal:

* Creatinine no greater than ULN

Cardiovascular:

* If history of cardiac disease, ejection fraction greater than 50%
* No clinically significant cardiac symptomology

Pulmonary:

* If history of pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted
* No clinically significant pulmonary symptomology

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent serious disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior adjuvant immunotherapy allowed
* No prior immunotherapy for metastatic disease

Chemotherapy:

* No prior chemotherapy for metastatic disease
* No other concurrent chemotherapy

Endocrine therapy:

* At least 4 weeks since prior adjuvant hormonal therapy

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered
* Must have measurable disease outside irradiated area OR
* Evidence of progression or new lesions in irradiated area
* No more than 25% of functioning bone marrow irradiated
* No concurrent radiotherapy to sole site of measurable disease

Surgery:

* At least 4 weeks since prior major surgery

Other:

* No other concurrent anticancer therapy or investigational anticancer agents
Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder

This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.

Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive neuromodulation technology, has been recommended for the treatment of patients with refractory OCD in multinational guidelines. However, due to the treatment setting and the patient's feature, nearly half of the patients have no significant changes after rTMS treatment.

In order to better predict the outcome of rTMS and improve the treatment efficiency, this project intends to look for markers that have a predictive effect at baseline or early treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before the symptoms change, thus it is possible to determine whether the patient has responded to the intervention.

In this project, the supplementary motor area (SMA) is selected as the stimulation target. The individual head magnetic resonance image positioning and navigation and rTMS compatible real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS single pulse stimulation and changes in neural networks before and after treatment. This is a preliminary exploration looking for effective predictive indicators of efficacy in EEG and the relationship between EEG and symptoms changes. In order to lay the foundation for further research and guide clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years old;
* DSM-5 criteria for OCD;
* Y-BOCS total score \> or = 16 -\>or＝9 yrs education

Exclusion Criteria:

* any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder serious suicide risk;
* the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
* any major medical disease;
* pregnancy or nursing of an infant;
* participation in current clinical study;
* current use of any investigational drug;
* TMS/DBS treatment at any point in their lifetime;
* history of long-time use of benzodiazepines
Oral Arsenic Trioxide for NPM1-mutated AML

A prospective open-label phase 2 study will be designed to assess the efficacy of oral arsenic trioxide plus azacitidine in preventing relapses in patients with NPM1-mutant AML. After screening and eligibility assessment, patients will receive treatment with oral arsenic trioxide plus azacitidine for 12 months. The recruitment period will last for 24 months and it will take approximately 36 months for study completion.

Eligible subjects with NPM1 MRD positivity will receive oral arsenic trioxide (oral-As2O3) (Arsenol ®) (5-10mg per day, from days 1-7 per cycle), ascorbic acid (1g per day, from days 1 - 7 per cycle) plus azacitidine (75mg/m2 per day subcutaneously, from days 1 to 3 per cycle). Each cycle of oral-As2O3 plus azacitidine will be given once every 28 days. The total duration of treatment is 12 months (12 cycles). Treatment will be day-care and outpatient based. Reduction in the dosage and duration of oral-As2O3 is required if the subject is experiencing adverse events (AEs). In case of grade 3 or above toxicity, the dosage of oral-As2O3 will be reduced to 5mg per day. Changes or interruption in dosages, their dates and time points will be recorded on the dosage administration record and the electronic case report form (eCRF).

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years
2. Diagnosis of AML with NPM1 mutation
3. Positive MRD for NPM1 mutation after completion of consolidation in transplant-ineligible patients
4. Positive MRD for NPM1 mutation after allogeneic HSCT
5. bilirubin ≤ 1.5 x upper limit normal (ULN); alanine aminotransferase (ALT) ≤ 2 x ULN or aspartate aminotransferase (AST) ≤ 2 x ULN; and prothrombin time versus control \<3 seconds at screening
6. Glomerular filtration rate ≥ 50 mL/min (by MDRD equation or Cockcroft-Gault formula)
7. Corrected QT interval (QTc) (by Framingham formula) \<500ms.
8. Able to give a written informed consent and fully comply to the requirements of the study.

Exclusion Criteria:

1. Patients on other investigational therapies
2. Prior exposure to azacitidine, decitabine or arsenic trioxide
3. Uncontrolled graft-versus-host disease (GVHD)
4. Eastern Cooperative Oncology Group (ECOG) performance status \> 2
Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy

The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow.

The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics.

This will be a prospective pilot study conducted at UAMS. All subjects will experience VR distraction using a crossover design in which each subject receives four rounds of brachytherapy: two rounds with VR distraction and two rounds without VR distraction. Brachytherapy will be conducted per SoC workflow. Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight.

The four treatment-sequence groups will follow the four-session treatment schedules outlined below, in which "V" denotes the sessions when VR distraction is used while "N" denotes the sessions when it is not:

* Sequence Group A will be treated according to schedule VVNN.
* Sequence Group B will be treated according to schedule VNNV.
* Sequence Group C will be treated according to schedule NNVV.
* Sequence Group D will be treated according to schedule NVVN.

Eligibility Criteria:
Inclusion Criteria:

* Female, ≥ 18 years of age
* Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
* Able to provide written consent

Exclusion Criteria:

* Severe vision or hearing problems that may hinder the ability to see or hear clearly through the VR headset or other condition that may interfere with the placement of the VR headset such as a head, ear or facial wound
* History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras
* Known history of elevated intraocular pressure
* Claustrophobia, thalassophobia, cleithrophobia or similar phobias
* Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen
Phase 3 Clinical Study for the Treatment of Cold Sore

To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.


Eligibility Criteria:
Inclusion Criteria:

* History of recurrent herpes labialis lesions where:

  * At least 50% of previous episodes produced classical lesions to the vesicular stage (i.e. episodes that progressed through macula, papule, vesicle, crust and healed);
  * Prodromal symptoms (itching, tingling, pain etc.) should precede herpes labialis lesions in at least 50% of the previous herpes episodes
* Good general health (ECOG \< 2), immunocompetent
* Signed and dated written informed consent
* Women of childbearing potential must have effective contraception method

Exclusion Criteria:

* More than 50% of recurrences that aborted spontaneously in the past 12 months
* Primary herpes lesion outside the lips (e.g. nose, chin, etc.)
* Abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g. eczema, psoriasis...)
* Oral diseases whose prodromal symptoms may mimick those of herpes labialis, including recurrent oral aphthous disease
* Oral diseases that might interfere with the evaluation of the efficacy or safety of the treatments, including gingivitis, parondotis, mucositis, oropharyngeal candidiasis...
* History of infection known to be resistant to acyclovir family agents
* Previous vaccination against herpes
* Concomitant treatment likely to interfere with acyclovir
* Allergy to any acyclovir containing agents
* Immunocompromised condition, including HIV+
* Unability to properly understand protocol requirements, to follow the study procedures, to complete the patient diary or to start the self-initiation of the treatment
* Upper full or partial dentures with acrylic border in the canine fossa
* Milk allergy or known history of hypersensitivity to one of the components of the products
* Rare hereditary problems of galactose intolerance.
* Lactase enzyme deficiency or glucose galactose malabsorption
* Clinically significant abnormal level of serum creatinine
* Patients whose occupations make them unlikely to return to the clinic within 24h of treatment initiation
* Pregnancy or breast-feeding
* Investigational drug or immunomodulator treatment in the 30 days prior randomisation
* Prior enrollment in this study
* Participation in another therapeutic trial evaluating new drugs or which could interfere with the evolution of herpes labialis or the evaluation of the drug in the study within preceding 30 day.
The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery

Postoperative delirium is a delirium that occurs within 7 days after surgery or before hospital discharge. It has been shown that combined POD can increase the incidence of postoperative pulmonary infections, deep vein thrombosis and decubitus ulcers, and increase the incidence of disability and mortality. The incidence of postoperative delirium in geriatric orthopedics is high.

Investigators conduct a prospective clinical study on geriatric orthopedic surgery patients to investigate the effect of oxytocin nasal spray on the prevention of postoperative delirium in geriatric orthopedic surgery. Cases were included according to the inclusion and exclusion criteria, and induction, maintenance and resuscitation were performed according to the standard protocol for general anesthesia. Before the end of surgery, the Investigators administered oxytocin nasal spray (Oxytocin) that was 3 sprays in each nostril (4 IU each) for a total of 24 IU. Beginning 1 day postoperatively, administer 24 IU of oxytocin nasal spray 2 times/day in the morning and in the evening. Until 7 days after surgery or discharge. The sample size are 77 cases in phase I and 143 cases in phase 2, total 220 cases.


Eligibility Criteria:
Elderly patients undergoing orthopedic surgery under general anesthesia

Inclusion criteria:

1. Age ≥ 65 years;
2. Patients who were to undergo elective orthopedic surgery under general anesthesia with tracheal intubation;
3. ASA class I-III;
4. Estimated duration of surgery ≥ 1 hour; (5) The patient himself/herself or his/her legal representative;
5. Informed consent from the patient or legal representative;
6. Proficiency in the use of Chinese language for communication.

Exclusion criteria:

1. Nasal cavity occupation, patients with fillers in the nose
2. Oxytocin allergy;
3. Patients with previous psychiatric and neurological disorders, such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease.

   Goldson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, and so on;
4. Pregnant and lactating women
5. Patients with severe hepatic insufficiency (Child-Pugh class C);
6. patients with severe renal insufficiency (dialysis is required before surgery)
7. Severe heart failure (METS\<4);
8. Preoperative inability to communicate (coma or dementia);
9. Severe preoperative blindness, deafness, or inability to understand Mandarin to complete preoperative delirium screening;
10. Preoperative cognitive impairment as determined by a MoCA evaluation prior to surgery;
11. Patients who are scheduled for 2 surgeries within 7 days of surgery;
12. Patients with bone malignancy
13. Currently participating in other clinical trials.