cyrilzakka/clinical-trials huggingface dataset:
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer

The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not been confirmed. Many treatment modalities like chemotherapy, interferons and other biological agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha, however, the functioning status and immune system may get worse, which subsequently has a negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomized controlled study was conducted to compare CIK cells with best supportive care as maintenance therapy for SCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven small cell lung cancer
* Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a platinum-based drug as first-line therapy in the absence of disease progression
* Age between 18-75
* Performance status ≤2
* No uncontrolled metabolic disease, infection, and neurological disorders
* No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease
* Life expectancy more than three months.
* Without contraindication of immunotherapy with autologous cytokine-induced killer cells
* No other malignancies
* Signed study-specific consent form prior to study entry

Exclusion Criteria:

* Patients receiving other anti-tumor therapy (like thermotherapy)
* Pregnant or lactating women
* Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells
* Uncontrolled mental disorder
* Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
AVONEX® Combination Trial - "ACT"

The purpose of this study is to determine the efficacy and safety of combination therapy with AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55, inclusive
* Diagnosis of MS
* A relapsing-remitting course
* Expanded Disability Status Scale (EDSS) score 0.0-5.5 inclusive at Baseline
* Currently receiving AVONEX® therapy
* Treated with AVONEX® for at least 6 consecutive months prior
* Breakthrough disease (clinical relapse or gadolinium-enhancing MRI lesion) during the prior 12 months, at least 6 months after initiating AVONEX therapy.

Exclusion Criteria:

* History of cirrhosis, chronic hepatitis, or currently active hepatitis
* History of poorly-controlled hypertension, diabetes mellitus, or peptic ulcer disease
* History of aseptic bone necrosis, osteoporosis, or osteoporosis-related bone fracture
* History of steroid-induced psychosis.
* History of or abnormal laboratory results indicating significant illness
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity or intolerance to MTX, IVMP, or AVONEX®.
* History of allergy to albumin
* History of any episode of suicidal ideation or severe depression within 3 months of the Screening Visit.
* History of seizure within 3 months prior to the Screening Visit.
* Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
* MS relapse with onset within 60 days prior to the Baseline Visit
* Any metallic or electronic material or device in the body, or condition that precludes the subject from undergoing MRI with gadolinium administration
* A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the Screening Visit
* Abnormal blood tests, performed at the Screening Visit, which exceed any of the limits defined by the study.
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty

Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected around the knee joint.

Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been shown to result in minimal thigh weakness.

The investigators aim to study if the analgesia provided by ACB is superior to LIA while preserving quadriceps strength.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary TKA under single shot spinal anaesthesia, between ages 45-85 years old, American Society of Anesthesiologists (ASA) physical status 1 to 3 and BMI 18-35 kg/m2

Exclusion Criteria:

* Patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, allergy to local anaesthetics or any drugs included in the study, patients with lower limb surgery in the preceding year, patients with pre-existing neurological deficits and patients who have contraindications for spinal anaesthesia.
Role of the Intrapartum Grobman Nomogram in the Indication of Attempted Vaginal Delivery After Cesarean Section

The rate of pregnant patients with a history of cesarean section is increasing. Caesarean section is a surgery which is not without risk and in particular concerning the risk of uterine rupture and malplacentation during a new pregnancy.

Considering the outcome of a new birth following a cesarean section is not easy. There is no reliable score to predict the success rate of vaginal delivery with a history of scarred uterus. The aim of our study would be to validate the intrapartum Grobman nomogram within the population of the Nancy University Hospital and thus to target the population for whom vaginal delivery could be offered.


Eligibility Criteria:
Inclusion Criteria:

* Vertex singleton pregnancy
* Full-term delivery (beyond 37 weeks)
* A history of cesarean section (segmental transverse scar)

Exclusion Criteria:

* Fetal death in utero
Better Sleep in Psychiatric Care - ADHD.

Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with ADHD is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the ADHD itself and to the use of ADHD medication. In a previous pilot study, the investigators developed a version of CBT-i that would target sleep problems in this population. The basis was CBT-i, but with more emphasis on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep disturbing habits (e.g. not winding down before bed time), that are also common in patients with ADHD. This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and symptoms of ADHD in patients at the ADHD-clinics, Northern Stockholm Psychiatry, Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Being a patient at the ADHD-clinics Northern Stockholm Psychiatry
* Experiencing sleep problems (subjective report)

Exclusion Criteria:

* None
Opioids, Low Nicotine Cigarettes, and Chronic Pain

The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).


Eligibility Criteria:
Inclusion Criteria:

* Aged 21+ years who smoke cigarettes daily
* Chronic non-cancer musculoskeletal pain secondary to structural changes (e.g., low back pain, osteoarthritis)
* Have received stable office-based buprenorphine treatment for opioid use disorder for at least 30 days
* Self-report smoking at least 10 cigarettes/day
* Expired breath carbon monoxide (CO) level \>8 ppm
* Have a smartphone capable of running software for ecological momentary assessment
* Open to exploring the possibility of quitting smoking

Exclusion Criteria:

* Pain specifically due to cancer
* Other significant health problems
* Major surgery within the past 6 months or planned surgery within the timeframe of the study
* Current disability litigation
* Use of electronic cigarettes or other non-cigarette tobacco products \> 9 of the past 30 days
* Current use of nicotine replacement therapy or other cessation treatment
* Current daily or near-daily cannabis use
* History of psychotic disorder
* Acute suicidality or current unstable psychiatric disorder
* Positive pregnancy test
* Actively seeking smoking cessation treatment
New Orleans Pulmonary Hypertension Biobank

Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure \>=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR
* Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR
* Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR
* Undergoing outpatient right heart catheterization

Exclusion Criteria:

* Age\<18
* Pregnant
* Unable to understand English
* Currently incarcerated
* Unwilling or unable to sign informed consent
PEACE: Comparing Chronic Pain Treatment Options

The purpose of this study is to compare two types of acupuncture with usual care on treating chronic pain. This study has three groups. Two groups will received acupuncture. One group will receive usual standard of care for 12 weeks and then will receive acupuncture. Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. Each group will undergo a different method of needle administration.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Age \>/= 18 years or older
* Having musculoskeletal pain, defined as regional (joints, extremities, back, neck) or more generalized (fibromyalgia or chronic widespread pain)
* Having a pain rating of 4 or greater in worst pain on a 1-10 numerical rating scale in the preceding week (Patients with a neuropathic component to their pain that involves the extremities or back will be eligible)
* Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days
* A diagnosis of cancer with no restrictions placed on type of cancer, other than that patients with metastatic disease will be excluded. Eligibility criteria are not restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites.
* Complete active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment will not be excluded).

Exclusion Criteria:

* Have non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) if these are the sole source of pain, but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined s above.
* Inflammatory arthritis that require disease modifying drugs (e.g. rheumatoid arthritis)
* Phantom limb pain
* Patients with a history of metastatic cancer who are not currently NED
* Have a pending pain-related VA or social security or worker's comp disability claim by self-report
* Have an implanted electronically charged medical device
Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair

to study the benefical audiological and/or otological effect by mordified restoration of tensor veli palatini in cleft palate repair compared to traditional Langenbeck's repair and merely levator veli palatini restoration.

71 patients with cleft palate received surgery were divided into 3 groups. Group 1: patients who received Langenbeck surgery without specific restoration of levator veli palatini or tensor veli palatini. Group 2: patients who received palate surgery with special levator veli palatini restoration. Group 3: patients who received palate surgery with modified tensor veli palatini restoration. The conductive auditory brainstem response and 226 Hz tympanometry were used to test the audiological and otological status of the three groups. Preoperative and postoperative results were compared intragroup and intergroup.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cleft palate.
* Primary palate repair.

Exclusion Criteria:

* Severe general disease
* Confirmed hereditary hearing loss or neuropathic hearing loss.
* Received any kind of audiological or otological therapy before.
* Patients and/or his/her don't want to continue the clinical trial.
The Influence of Different Concentrations of Glucose in Culture Media on In Vitro Fertilization (IVF) Outcome of Sibling Oocytes

The importance of glucose in culture media on fertilization and embryo development is still controversial. Although it has been reported that glucose is essential for fertilization process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of glucose in culture media may cause developmental arrest of cleavage stage embryos. The aim of this retrospective study is to examine whether exposure of sibling oocytes to different concentrations of glucose in culture media has any further effect on IVF outcome.

This retrospective study will include data from either standard IVF or Intracytoplasmic Sperm Injection (ICSI) cycles, in which sibling oocytes were equally divided and incubated separately in one of the following pairs of culture media:

1. Universal IVF medium vs. ISM1 medium ( Origio, Medi-Cult)
2. P1 medium vs. ECM medium (Irvine).

Fertilization rate,as well as embryo cleavage rate and morphology will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Sibling oocytes from cycles where at least 4 oocytes were retrieved

Exclusion Criteria:

* Less than 4 oocytes retrieved
* Partner has undergone testicular sperm extraction (TESE)
Nexium Dyspepsia/AST

The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

* At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment.
* Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach)

Exclusion Criteria:

* Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment.
* Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD).
* Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.
Evaluating the Episodic Future Thinking Intervention for Reducing Cigarette Consumption in Cigarette Smokers

This clinical trial evaluates the effectiveness of active episodic future thinking (EFT) stimuli for reducing cigarette consumption in cigarette smokers. EFT is an innovative framing method shown to significantly activate brain regions involved in future thinking, planning, and other executive functions. Active EFT stimuli are positive events, unrelated to smoking, that participants anticipate, look forward to, and can vividly imagine happening up to 1 year in the future. Control EFT stimuli are positive past events, unrelated to smoking, that participants can vividly remember happening in the recent past. Active EFT stimuli may help reduce cigarette consumption among cigarette smokers by exposing them to personally relevant future oriented stimuli.

PRIMARY OBJEECTIVE:

I. To evaluate the efficacy of episodic future thinking (EFT) for smoking cessation.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (ACTIVE): Participants receive the active EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

ARM II (CONTROL): Participants receive the control EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

Eligibility Criteria:
Inclusion Criteria:

* Smoke \>= 10 cigarettes daily
* \>32 on the Vividness of Visual Imagery Questionnaire (VVIQ)
* No regular use of other tobacco products
* In possession of a smartphone with text messaging capabilities

  * Willing to quit smoking in the next 30 days
  * Low socioeconomic status
  * Veteran of the US armed services

Exclusion Criteria:

* Unable or unwilling to provide verbal consent
* Unable or unwilling to provide data to the research team
* Current use of nicotine replacement therapy, bupropion, or varenicline
* Use of drugs of abuse in the past 30 days
* Living in the same household as a participant already enrolled in this study
* Unable or unwilling to use nicotine patches
Using HandTutor With Traumatic Hand Injuries: Characterizing the System

HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with optic sensors detecting the movements of the wrist and the fingers with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.

The HandTutor has been used and tested with a stroke population, and it seems potential to be used with hand injuried population. As a first step, it is important to investigate the characteristics of the system and how it is matching the hand injuried population.

The purpose if this study is to characterize the HandTuror system and the focused objectives are:

1. To examine the test-retest reliability of the system when measuring the range of motion (ROM) of the the fingers among healthy people (control group).
2. To examine the correlation between the ROM measured by the HandTutor and the ROM measured by conventional assessment tools (goniometer).
3. To examine the ability of the system to distinguish between healthy people and hand injured people.
4. To examine the correlation between the performance in the HandTutor (in the games part), and the performance in functional activities.
5. To examine the participants feedback for using the HandTutor (degree of enjoyment).


Eligibility Criteria:
Inclusion Criteria:

* Hand Injuries causing a disfunction of one finger or more of the fingers 2nd-5th.
* Six weeks at least after the injury/surgery.
* Allowed to exercise their fingers with no contraindications according to the orthopedic surgeon instructions.
* With no open wounds.

Exclusion Criteria:

* Peripheral nerves injuries.
* Digital nerves injuries.
* Sensation problems.
* CRPS-complex regional pain syndrome.
* Cognitive impairments.
* Head trauma.
The Brain Symphony For Post-Stroke Rehabilitation

Music listening intervention has made great strides in improving the condition of stroke survivors. Thus, this research explores the effects of music listening intervention on post-stroke survivors during rehabilitation by using P. Ramlee songs.

Objective: Music listening intervention has made great strides in improving the condition of stroke survivors. Thus, this research explores the effects of music listening intervention on post-stroke survivors during rehabilitation by using P. Ramlee songs.

Materials \& Methods: In the first phase, surveys were conducted to determine the selection of songs to be used in the second phase. The second phase is applying music listening intervention on a small sample of 20 subjects, aged 55 years old and above. The participants were categorized into two groups: stroke survivors and healthy individuals and randomized into control group (without music) and experimental group (with music). The second phase consists of three stages. Stage one is to pre-screen and select potential subjects before the experiment. The second stage aims to determine the effect of P. Ramlee music on stroke survivors during their rehabilitation through augmenting their brain neuroplasticity with measurement of the MEP using TMS. The final stage compares the effects of MEP between lesion and non-lesion areas.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No history of seizures or epilepsy
* Able to hear well
* Able to attend experiment sessions without scheduling conflicts
* No contraindications to undergoing TMS

Exclusion Criteria:

• None
Chinese Acute Ischemic Stroke Treatment Outcome Registry

This is a multi-center registry study. The investigators will include 10,000 patients with confirmed acute ischemic stroke in China. The aim of the study is to survey current treatment situation in China and compare the effectiveness and safety between different intervention regimens.

Stroke is a common disease in China. Compared to western countries, there are many treatment regimens used in clinical practice in China. But their treatment effects are not well validated. The aim of the study is to survey current treatment situation in China and compare the effectiveness and safety between different intervention regimens.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 yesrs
2. confirmed diagnosis of an ischemic stroke
3. admission within 1 week after onset of stroke or within treatment time window for patients of thrombolysis treatment
4. signed informed consent

Exclusion Criteria:

1. with intracerebral hemorrhage
2. with severe morbid (estimated survival duration less than 3 months)
3. could not provide follow-up information