cyrilzakka/clinical-trials huggingface dataset:
Effect of Acupuncture on Postoperative Nausea and Vomiting

In this study, the hypothesis that bilateral acupuncture needling at the Neiguan (PC6) point during the intraoperative period, in addition to the 0.15 mg/kg dose of ondansetron (5-HT3 antagonist) frequently used for postoperative nausea and vomiting (PONV) prophylaxis in patients undergoing lumbar disc herniation surgery, would reduce the incidence of PONV was investigated. PONV was defined as the presence of nausea and vomiting within 24 hours postoperatively.

The study will include patients aged 18 years and over, with (American Society of Anesthesiologists) ASA physical status I to II, and scheduled for one or two-level lumbar disc herniation surgery under general anesthesia. Patient characteristics (age, gender, body mass index, etc.) and postoperative nausea and vomiting (PONV) risk factors such as history of PONV, motion sickness, and history of not smoking will be recorded. The primary outcome parameter will be the incidence of PONV within 24 hours postoperatively. The severity of nausea in patients who develop nausea in the postoperative period will be assessed using a Likert scale between 0 and 10. PONV will be defined as vomiting, significant nausea (numerical rating scale \[NRS\] ≥4), and/or need for rescue medication. Patients will be assessed for PONV at 0, 2, 4, 12, and 24 hours using a Likert scale. Emetic attacks, pain and severity of pain, nausea and severity of nausea, need for additional analgesics, and administration of antiemetic rescue medication will be assessed as secondary outcome parameters. The severity of pain and nausea in patients who develop postoperative pain will be assessed using an 11-point numerical rating scale, where '0' indicates the absence of symptoms and '10' indicates the maximum severity. PONV within the first two hours will be defined as 'early', and within 2-24 hours after awakening will be defined as 'late'. Nausea will be defined as the desire to vomit, and vomiting will be defined as the forceful expulsion of stomach contents.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* ASA physical status I to II
* One or two level lumbar disc herniation surgery under general anesthesia

Exclusion Criteria:

* body mass index \>35 kg/m²)
* history of drug use
* nausea and vomiting before surgery
* psychiatric disorders
* use of antipsychotic or antiemetic drugs
* severe heart disease
* central nervous system diseases
* vertebrobasilar artery insufficiency
* cytostatic therapy
* vestibular diseases
* renal and/or hepatic dysfunction
* presence of fistula, neuropathy and paralysis in the extremity to be treated
* patient's refusal to accept acupuncture
* pregnant patients
* presence of bleeding diathesis
* patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)
Cognitive Effects of Interferon in Patients With Melanoma

Interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed with high risk malignant melanoma (stage 2 or 3). There is evidence that interferon has some adverse cognitive effects on patients, but there are limited data. The investigators hypothesis is that compared to patients with melanoma who do not receive interferon, patients who have melanoma and are treated with interferon will show an objective decrease in performance on neurocognitive assessment.

This study will enroll patients with melanoma who qualify for interferon, and either decide to undergo interferon treatment or choose watchful waiting instead. All patients will be assessed with a cognitive testing battery twice. Observation patients will undergo testing at their first appointment in which they consent to the study, as well as at their next physician visit, approximately 3 months from the first visit. Interferon patients will be tested immediately prior to starting interferon, as well as immediately after completing high dose interferon.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with high risk malignant melanoma (defined as American Joint Committee on Cancer Stage IIb or greater) electing to undergo treatment with either adjuvant interferon alpha-2b, or observation only.
* Age 18 years or older.
* Karnofsky performance status greater than 60.
* Fluent English speaker.

Exclusion Criteria:

* History of neurologic or psychiatric disease that will affect patient's ability to complete protocol tests.
* Clinical or radiological evidence of brain metastasis.
* Any condition, which in the opinion of the investigator makes the subject unsuitable for study participation.
The Effects of Caffeine on Human Spinal Motoneurons

This study evaluates the effects of orally ingested, commercially available, coffee (3 mg/kg of caffeine) on the excitability of human spinal motoneurons of the lower leg.

Recently, it has been shown that human spinal motoneurons do not simply act as a binary control system. Instead, they are regulated by intrinsic properties that can elicit lingering effects on the descending motoneuron. Caffeine, one of the world's most popular over-the-counter supplements, can potentially augment these characteristics of motoneurons. Using decomposition software and non-invasive, high-density surface electromyography, it is possible to extract the characteristics of these motoneurons. This project will utilize a double-blind, inactive-placebo controlled, crossover design study to examine and quantify the effects of caffeine on motoneuron excitability.

Eligibility Criteria:
Inclusion Criteria:

● Between 18 and 70 years of age

Exclusion Criteria:

* Significant neurological or orthopedic injuries, which may limit volitional torque generation in the tested muscles.
* Significant change in the subjects' health or treatment in the past month.
* Known history of cardiovascular pathology (to include: uncontrolled hypertension, cardiac arrhythmias) or medical restrictions to caffeine ingestion.
* Allergies or dislike of coffee.
* Women who are pregnant will be excluded due to potential forces at trunk from pelvic safety harness and due to potential adverse effects of caffeine on the developing child.
* Women who are breastfeeding will be excluded due potential adverse effects on the breastfeeding infant from caffeine administration.
* Adults unable to consent, minors, pregnant women, and prisoners will not be included.
Natural History Study Protocol in PMM2-CDG (CDG-Ia)

Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG)

This is a natural history (observational) protocol designed to collect clinical and biological information in patients with PMM2-CDG (CDG-Ia).

Subjects enrolled in this natural history study will be thoroughly examined for signs and symptoms of PMM2-CDG. Medical history, physical examination, laboratory testing and imaging studies will be performed during a single consultation. Follow-up will occur every 3- 6 months at a minimum, depending on the standard of care at the investigator's institution as well as the clinical status of the individual patient. All medical procedures are routine. No new therapy is offered as part of this study, and no change in the patients routine therapy is dictated by this protocol. The International Co-Operative Ataxia Rating Scale (ICARS) is to be performed every 3 months as an optional assessment. No randomization will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent by the patient and/or their legally authorized representative
* Confirmed diagnosis of PMM2-CDG, based on enzymatic or molecular tests
* Willing and able to adhere to study requirements described in the protocol and consent/assent documents

Exclusion Criteria:

* Known or suspected differential diagnosis of any other known CDG (not PMM2-CDG)
* Currently using investigational drug
* Blood loss of ≥ 250 mL or donated blood within 56 days, or donated plasma within 7 days before study screening
Intraosseous Transcutaneous Amputation Prosthesis

Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).

The core ITAP™ design comprises of three discrete sections, the proximal section, which is the intramedullary stem secured into the medullary canal, the soft tissue integration flange and the transcutaneous component that passes through the skin. The device has been designed to be surgically implanted in a one stage procedure. In greater detail:

Intra-medullary stem - this component is designed to match the natural shape of the canal and is designed using the same principles established and used for the fixation of massive endo-prosthetic replacements. In certain cases a hydroxyapatite ceramic (CaPO4) coating is used, providing enhanced uncemented fixation. In other cases, depending on the geometry of the intramedullary canal, the stem can be fixed in place using acrylic bone cement.

Eligibility Criteria:
Inclusion Criteria:

* Trans-femoral amputation
* 6 months or more attempted prosthetic rehabilitation (use of walking aids not relevant)
* Between the ages of 18 to 60 inclusive
* Length of stump: Sufficient bony stock for bony integration (at the investigator's discretion) and sufficient clearance (at the investigator's discretion) from medial joint line to accommodate failsafe device/ adaptor and knee mechanism
* Suitable soft tissues to perform the operative procedure
* Flexion Deformity (FFD) at hip no more than 15°
* Normal range of flexion and adduction other than FFD
* Oxford Grade 4 muscle power in all groups around hip
* Normal contralateral leg function
* Psychologically suitable (as deemed by screening process)
* Sufficient standard of English to understand the Patient Information Sheet and general study requirements
* Ability to understand and comply with study requirements - notably study timelines and additional clinic visits
* Patients willing to take part in the study and sign the Informed Consent form

Exclusion Criteria:

* Radiotherapy to target limb at any time
* Chemotherapy within the preceding 12 months
* Cognitive impairment likely to affect participation
* Pre-existing ipsilateral hip pathology
* Limited cardiorespiratory reserve / inability to walk at normal pace
* Any significant co-morbidity that, in the investigator's opinion, is likely to affect outcome (e.g. osteoporosis, heart disease, peripheral vascular disease, obesity or unrelated cancer)
* Any co-morbidity in the contra-lateral leg that precludes walking
* Any significant previous infection within the previous 12 months, such as apical stump sepsis or dental sepsis
* MRSA
* Using another silver-dosed medical device/treatment
* Patients with hypersensitivity to silver
* Concurrent medico-legal proceedings taking place
* Patients currently included in other clinical trials
Regulation of Craving in Internet Gamers

This project aims to investigate (1) the behavioral and neural mechanisms of regulation of craving in Internet gamers; (2) effects of tDCS over the dorsal lateral prefrontal cortex (dlPFC) on craving and regulation of craving and aversive emotions in this population. (3) effects of tDCS over dlPFC on attentional bias towards gaming related cues.This project will be conducted in Beijing, China, based on a large sample of Internet gamers.

As with the experiment about tDCS effects on regulation of craving and aversive emotions, the experiment aims to test whether tDCS over dlPFC will enhance cognitive regulation of craving and aversive emotions. It is a within-subject, sham-controlled, double-blind design. Each participant receive both active and sham tDCS of dlPFC in a randomized order separated by one week. During both active and sham tDCS sessions, participants will perform regulation of craving (ROC) and emotion regulation (ER) tasks. In the ROC task, participants will be asked to downregulate and upregulate craving elicited by gaming pictures using cognitive reappraisal. In the ER task, participants will be asked to downregulate and upregulate aversive feelings elicited by negative pictures using cognitive reappraisal. During these tasks, self-report ratings and skin conductance responses (SCRs) will be recorded. The cognitive regulation ability is indexed by rating and SCRs differences between the up- and downregulation conditions.

As with the experiment about tDCS effects on attentional bias, the experiment aims to test whether tDCS over dlPFC will enhance inhibitory control of attentional bias towards gaming related cues. The inhibitory control of attentional bias will be measured by a cognitive task in which participants will perform a number classification task with gaming pictures and non-gaming pictures being distractors. The experiment is a within-subject, sham-controlled, double-blind design. Each participant will receive both active and sham tDCS of dlPFC in a randomized order separated by one week. After each tDCS session, participants will complete the cognitive task assessing inhibitory control of attentional bias. During the task, reaction times (RTs) wil be recorded. The attentional bias is indexed by RTs differences between trials with gaming pictures and trials with non-gaming pictures.

Eligibility Criteria:
Inclusion Criteria:

* engagement in a popular Internet game (Arena of Valor) for over 14 hours per week for a minimum of 6 months.

Exclusion Criteria:

* current or history of use of illegal substances and gambling;
* current or history of psychiatric or neurological illness;
* current use of psychotropic medications.
mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Although FOLFIRINOX regimen was recently presented to be effective as adjuvant chemotherapy for resectable pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating resectable pancreatic cancer patients in China. Since for many tumors, different races may show different responses to the same regimen, we design this open phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as adjuvant chemotherapy for resectable pancreatic cancer in China.

This is a phase II study. Patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of FOLFIRINOX for 6 months.

Primary endpoint is the disease free survival. Secondary endpoints are overall survival, safety and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the pancreas without distant metastases.
* Receive radical resection of pancreatic cancer
* No prior cytostatic chemotherapy
* Female and male patients \> 18 and \<=79 years using contraception
* ECOG ≤ 1
* Patient has adequate bone marrow and organ function
* Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L Platelets ≥ 90 x 109/L Hemoglobin ≥ 90 g/L
* Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 1.2 x ULN Creatinine ≤ 1.25 times ULN
* Good compliance
* Written informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Distant metastasis.
* Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
* Refuse to take appropriate contraceptive measures (including male patients).
* Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
* Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
* Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
* Psychiatric illness that would prevent the patient from giving informed consent.
* Patient is concurrently using other antineoplastic agent
* Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
* Known HIV-positivity.
* No history of chronic diarrhea, nausea or vomit.
* No ≥ grade 2 sensory peripheral neuropathy.
* A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
* Infectious disease or inflammation with body temperature ≥ 38 ℃.
Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume

The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. Investigators will include patients with normal or low EF, and across the spectrum of pulmonary hypertension severity.

Exclusion Criteria:

* Patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.
* Prior adverse reaction to echo contrast administration
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy

Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo

Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal women
2. Patients have following indication for diagnosis hysteroscopy

   * Abnormal uterine bleeding
   * Unexplained infertility
   * Recurrent pregnancy loss
   * Chronic pelvic pain
   * Late postpartum hemorrhage
3. Patients provided written informed consent

Exclusion Criteria:

1. Postmenopausal women
2. Patients who have contraindication for Misoprostal as following

   * Allergic to Misoprostal
   * Medical illnesses such as cardiovascular diseases, Asthma, Renal disease
3. Patients who have contraindication for Hysteroscopoy as following

   * Pregnant women
   * Pelvic inflammatory disease
   * Infection at cervix and vagina
   * Cervical cancer
Individualized Maternal Milk Fortification for Feeding the Preterm Infants

Neonatal nutrition has to face a contradictory and conflicting nutritional regimen like a high percentage of amino acids from the first day of life in order to achieve normal neurodevelopment versus metabolic complications (insulin resistance, hyperglycemia, increased visceral fat) that this type feeding, in conjunction with complexity of prematurity, is likely to cause. Current study aims to investigate is whether individualized fortification of breast milk protein, based on the mother's milk protein content and targeting the recommended daily protein requirements, is associated with better nutrition, growth, biochemical and endocrine markers associated with the nutrition of preterm low birth weight neonates, compared to the standard fortification of human milk.

Proteins are of the most important macromolecules in living organisms participating in almost all biological processes. Premature infants are forced to adapt to a new (extrauterine) environment where supply of nutrients, including amino acids, from mother ceases abruptly. Consequently, the aim of neonatologist is the appropriate, quantitatively and qualitatively nutritional support, to promote brain development, achieve normal endocrine and metabolic function, maintain a growth rate similar to the intrauterine one avoiding extrauterine growth restriction during postnatal period and at the same time encouraging the analogue modulation of body composition (increased muscle mass, decrease body fat, hydration).

Malnutrition or inadequate nutrition of preterm infant which remains undiagnosed and without proper treatment could have serious consequences on psychomotor development and metabolic activity. Indeed, 75% of low birth weight premature infants exhibit extrauterine growth restriction at discharge, even when they have achieved growth equal to the considered satisfactory, ie 15g/kg/day.

Beyond anthropometrics differences between preterm and full-term newborns, body composition varies as well. Preterms have higher percentage of body fat and decreased muscle mass at term time compared with full term neonates. However, it has not been clarified whether this differentiation is harmful predisposing to chronic diseases later in childhood or adult life (eg. obesity, metabolic syndrome).

Eligibility Criteria:
Inclusion Criteria:

* Infants with gestational age ≤ 34weeks
* very low birth weight (≤ 1500g)

Exclusion Criteria:

* maternal health problems contradicting breastfeeding
* genetic or chromosomal abnormalities
* metabolic contraindications for increased amount of protein
Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.

BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months

Eligibility Criteria:
Inclusion Criteria:

* 16-65 Years cirrhotic patient
* Approved cirrhosis by elastografy ,biopsy, sonography
* Serum ALT 1/5 times more than normal
* MELD score 12 or Child score B or C

Exclusion Criteria:

* Portal vein thrombosis
* Hepatic encephalopathy, score 3\&4
* ALT \& AST 3times more than normal
* Serum Cr more than 1/5mg/dL
* (Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
* Hepatocel carcinoma
* Primary sclerosing cholangitis (PSC)
* Esophageal varices grade 4
* Addiction