cyrilzakka/clinical-trials huggingface dataset:
Hypnopuncture for In Vitro Fertilization (IVF)

Infertility is a common and distressful problem for many couples, with assisted reproductive techniques (ART) such as IVF and ICSI, with slightly more than 34% pregnancies per cycle. Acupuncture is an ancient Chinese treatment in which thin needles are inserted into various points along the skin, harmonizing" the body's "energy. Acupuncture has been found to increase pregnancy rates following IVF/ICSI treatments, and is believed to affect ovulation and fertility through elevation of beta-endorphin release and GnRH secretion, as well as reduced sympathetic response with increased blood flow to the uterus. The sympatho-inhibitory properties and impact on beta-endorphin levels of acupuncture, as well as its efficacy in treating depression, may be helpful in reducing stress among women undergoing fertility treatments as well. Hypnosis is a mind-body technique which uses suggestions during a relaxed state to promote healing. Hypnosis can also significantly reduce the sympathetic response, and is believed to produce uterine relaxation and quiescence during embryo transfer (ET), which may lead to a reduction in embryo displacement from the uterine cavity. No research has been published on the use of hypnosis with acupuncture (hypnopuncture) in ART.

This is a pilot study to evaluate the effect of a combined regimen of hypnopuncture on clinical pregnancy rates in women undergoing IVF/ICSI following two failed cycles. During the initial pre-treatment meeting, participants who fulfill all inclusion criteria and none of the exclusion criteria will undergo hypnotic induction, followed by suggestions for increased uterine blood flow. On the day of embryo transfer, participants will be randomly divided into either treatment or no-treatment groups. Treatment will consist of the insertion of acupuncture needles into pre-determined points, to be followed by a hypnosis pre-recorded hypnosis session, as described above. Patients in the control group will receive standard care without hypnopuncture and those participants in this group who do not conceive following the 3rd cycle will be treated with hypnopuncture during the 4th cycle, following ET. A total of 100 women will be enrolled, 50 in each arm of the study.


Eligibility Criteria:
Inclusion Criteria:

* Females patients age 18 years and older
* Primary infertility with negative endocrinology and US findings on evaluation
* Following two failed cycles of either IVF or ICSI, defined as no clinical pregnancy (presence of fetal sac on ultrasound examination 6 weeks after embryo transfer).
* No underlying Axis 1 psychiatric disorder
* Ability to comply with study protocol

Exclusion Criteria:

* Patients displaying symptoms of overt Axis-1 psychopathology such as schizophrenia or severe depression.
* Current use of any CAM therapy
* Current use of any fertility treatment other than those prescribed by the fertility clinic.
* Inability to comply with the study protocol
Hepatic Sugar Metabolism Measured by PET/CT in Patients and Healthy Subjects

The investigators wish to determine the lumped constant (LC), which is a correction factor necessary for converting measurements of hepatic FDG metabolism (measured by PET) to those of regular glucose in patients with cirrhosis and healthy subjects.

Working hypothesis

* LC for FDG in liver tissue is not significantly different from unity in healthy subjects
* LC for FDG in liver disease is significantly different from LC in healthy liver
* Insulin changes the LC for FDG in liver tissue, but not by the same factor in liver disease and healthy subjects.

The LC for FDG is determined in 8 patients with liver disease and 8 healthy volunteers with and without glucose-clamp on two different days at 3-5 week intervals. The individual order of the two examinations will be randomized. The subjects fast overnight before the examination but are allowed to drink water and take usual medication.

When arriving at the PET centre, venflons are placed in a cubital vein in both arms and an ICG infusion is started in one of them. On the day with the glucose-clamp, an infusion of insulin and glucose is started in the second venflon. Next, an artflon is placed in one radial artery and a lever vein catheteter is placed via an introducer catheter in the left femoral vein under sterile conditions and local anesthetic (Lidocaine). The position of the liver vein catheter is checked with fluoroscopy.

On each experimental day, a bolus of 200 MBq FDG + 25 μCi \[3H\] glucose (diluted with saline up to 10 ml) is given intravenously at the start of a 60-min PET scan of the liver. Blood samples from a peripheral artery and a liver vein are collected for determination of blood concentrations of FDG and \[3H\]glucose at appropriate intervals.

In the experiment with glucose-clamp, an intravenous infusion of insulin (0.6 mU/kg/min) is given and blood glucose is measured every 10 min and kept constant at around 5 mM by infusing 20% glucose (infusion rate adjusted according to blood glucose).

During each study, the hepatic blood flow rate is measured by giving an intravenous infusion of indocyanine green (ICG) and collecting arterial and liver vein blood samples (Fick's principle).

Blood samples are analyzed for concentrations of FDG (gammacounter), \[3H\]glucose (liquid-scintillation counter), glucose (enzymatic assay) and ICG (spectrophotometric).

When the experiment is finished, all infusions are terminated and the liver vein catheter is removed and hemostasis ensured by manual compression (10 minutes) and bed rest for 30 minutes before the subject is allowed to stand. The artflon is then removed and hemostasis ensured by manual compression (10 minutes). Finally, the venflons are removed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 70 years
* BMI between 20 and 26

Exclusion Criteria:

* Diabetes mellitus
* Glucose intolerance
* Medical treatment of portal hypertension
* People who have underwent surgery for obesity
* Pregnancy
Mass Balance Study of [14C]LC350189 in Healthy Volunteers

This is a Phase 1, open-label, single-dose, mass balance study designed to evaluate the absorption, metabolism, and excretion of \[14C\] radiolabeled LC350189 after oral administration.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male 18 to 55 years of age, inclusive.
* The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
* The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram results, and physical examination findings at screening.
* The subject is able to provide written informed consent.

Exclusion Criteria:

* The subject has a medical history of any issues affecting absorption or metabolism, as judged by the investigator.
* The subject has a medical history of any problems affecting venous access or bowel/bladder function.
* The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
* The subject has used any prescription or over the counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days before the first dose of study drug.
* The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or during the study.
* The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
* The subject is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or during the study.
* The subject has donated blood or blood products \>450 mL within 30 days before the first dose of study drug.
* The subject has a history of relevant drug and/or food allergies (ie, allergy to study drug or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).
Research of Brachial Plexus Anatomy

The research aims at analyzing the sonographic anatomy characteristics of the interscalene brachial plexus.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class I or II
* Scheduled for elective surgery

Exclusion Criteria:

* Skin lesion or infection of neck
* Any known peripheral neuropathy
* Brachial nerve plexus injury
* Previous injury or operation on neck
* Pregnancy or breast feeding
* Allergic to ultrasound gel
Study of Inupadenant (EOS100850) with Chemotherapy As Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer

The study will first determine the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving first line anti-PD(L)1 treatment for locally advanced or metastatic non-small cell lung cancer. The efficacy and safety of the combination is then compared to standard of care carboplatin and pemetrexed in the same populations.

The study is composed of two parts. Part 1 follows an open-label, dose-finding design where individual cohorts are treated with various dose levels of inupadenant combined with standard of care dosing of carboplatin and pemetrexed. The recommended phase 2 dose is determined prior to initiation of Part 2 which then compares inupadenant to placebo with both arms treated in combination with standard of care carboplatin and pemetrexed.

Participants in both parts are enrolled from two populations of patients with nonsquamous NSCLC that have progressed after first line treatment as follows: non-resectable patients treated with chemoradiotherapy followed by anti-PD-(L)1 or metastatic patients treated with anti-PD-(L)1 therapy without chemotherapy.

Imaging, safety and PRO assessments are performed during the treatment and follow-up phase as well as pharmacokinetic and other exploratory analyses.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable (Stage III) NSCLC of nonsquamous pathology
* Measurable disease as defined by RECIST v1.1
* PD-L1 expression status available at or after the time of diagnosis. All levels of expression are eligible.
* Existing biopsy taken within 4 years prior to entering trial or provide fresh biopsy where safe and feasible
* At least 12 weeks of treatment with only 1 anti-PD-(L)1 agent (mono or with IO combo) in the metastatic setting, OR at least 12 weeks of anti-PD-(L)1 agent (mono or with IO combo) following CRT in the unresectable, Stage III setting
* ECOG performance status of 0 to 1.

Exclusion Criteria:

* Symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
* EGFR, ALK, or ROS1 mutation.
* Autoimmune disease requiring systemic treatment or immunodeficiency requiring concurrent use of systemic immunosuppressants or corticosteroids
* Hepatitis B or C infection unless adequately treated with no detectable viral load; Human immunodeficiency virus (HIV) unless well-controlled disease on therapy.
* History of life-threatening toxicity related to prior immune therapy
* Uncontrolled or significant cardiovascular disease
* Pregnant or breast-feeding
* Lack of agreement to use highly effective method of contraception during treatment and for 6 months after the last administration of chemotherapy
Alteplase for Blood Flow Restoration in Hemodialysis Catheters

We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.

Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.

Eligibility Criteria:
Inclusion Criteria:

1. Adults \> 18 yrs old
2. Hemodialysis patients
3. Vascular access with a permanent catheter
4. No prior rt-PA use in the catheter over the previous 21 days
5. One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)

Exclusion Criteria:

1. Critically ill patients in the ICU setting.
2. Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (\<48 hours), recent biopsy (\<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
3. Hemodialysis catheter has been in the patient less than 14 days.
SGB in Management of Patients With PDPH Using TCD

This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial Doppler is also used as an measure to assess the block success by detecting the variability in the cerebral hemodynamics before and after the block.

This clinical trial is performed in postoperative orthopedic unit. In this study, 120 patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined the treatment group (A) and received the SP block. They are assessed before the procedure by NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed by TCD before and after the block. The control group (B) included 60 patients with no PDPH.

Eligibility Criteria:
Inclusion Criteria:

* patients are considered who had an epidural anesthesia
* Patients with ASA 1 and 2
* Patients' age ranged from 18 to 60 years.

Exclusion Criteria:

* Patients with septal perforation, nasal septum deviation,or nasal bleeding.
* Patients have recent nasal trauma
* Patients have recent nasal surgery
* Patients have a nasal infection
* Patients within ASA 3 and 4
* Patients older than sixty yrs or younger than eighteen yrs.
Influence of Triathlon on the Electrolyte Balance

Aim of the study is examining the incidence of the occurrence of hyponatremia during a Triathlon

Studies in similar endurance sports (e.g. marathon) could already indicate a high incidence for the appearance of hyponatremia during competitions. The loss of sodium through sweating and the excessive fluid intake during the competitions is a primary risk factor for the development of hyponatremia.

Based on the known occurrence of hyponatremia in marathon runners, participants of the Ironman European Championship between the years 2005 and 2014 were screened for the occurrence of hyponatremia after finishing the race for safety reasons. Subjects were approached at random in the athlete's garden and invited to participate. All participants were 18 years or older.

Eligibility Criteria:
Inclusion Criteria:

* finisher of a long-distance triathlon
* \> 18 years
* \< 60 years

Exclusion Criteria:

* not finished a long-distance triathlon
* \< 18 years
* \> 60 years
Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery

This study aimed to evaluate the possible protective effect of anesthetic technique balanced (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion injury in microvascular flap in plastic surgery. The investigators will evaluate the viability of the flap using tissue oximetry monitoring and the level of biochemical markers in a circle at the end of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yr
* ASA (American Society of Anesthesiology) I-II

Exclusion Criteria:

* Known unusual reaction to anesthetic drugs
* Evaluation of anesthesia increased risk for malignant hyperthermia.
* History of vascular disease.
* History of bleeding diathesis.
* Tabagism
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial

A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel, the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).

A phase II, multicentric,randomized, controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* at risk for pregnancy and desiring contraception
* having regular menstrual cycle (21-35 days)
* at low risk for HIV or other sexually transmitted infection
* sexually active
* use the test products as their primary method of contraception
* keep a diary of coital activity, product use, and adverse events

Exclusion Criteria:

* diagnosis of any vaginal infection or any symptom of STDs at baseline
* known allergy or hypersensitivity to N-9 or BZK
* menopause for more than one month
* breastfeeding
* vaginal bleeding with unknown reasons
* genitourinary system anomaly
* hysteroptosis II or severe cystocele
* moderate to severe erosion of cervix
* malignant reproductive system tumors
Toxins and Delivery in e-Cigarette Users

Electronic cigarettes or "e-cigarettes" (EC) may have a potential public health benefit as a safer alternative to smoking and possibly also as an aid in tobacco dependence treatment. However, there are concerns about their safety and whether they can deliver nicotine consistently and in doses necessary for such effects.

To be able to consider the safety of ECs and their potential in harm reduction, data are needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional cigarettes, users of EC, and people who use both products at the same time.

To accurately assess EC nicotine delivery, data are needed from people who use them regularly, as there is some evidence of higher and faster nicotine absorption in experienced users compared with naïve users who try them once in an artificial laboratory setting.

This study will provide information on both of these issues. Forty smokers will be given EC to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of acrolein and nicotine will be measured before and after 4 weeks of EC use.


Eligibility Criteria:
Inclusion Criteria:

* Smokers who want help in quitting
* Aged 18 or over

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* People with any current serious illness
IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Age\<=18 years
* Undergoing ERCP (defined as cannulation of the major or minor papilla) for any indication

Exclusion Criteria:

* Age\>18
* Pancreatitis within the 72 hours preceding ERCP
* Allergy or hypersensitivity to Aspirin or NSAID medications
* Pregnancy or breastfeeding mother
* Cr \>1.4
* Gastrointestinal hemorrhage in preceding 72 hours
* Heart disease reliant upon a patient ductus arteriosis
* History of sickle cell disease
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA

This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.


Eligibility Criteria:
Inclusion Criteria

- Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition (Petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an onset of disease \< 16 years of age: Arthritis in one or more joints, with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following: Rash due to SJIA, lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis

* Active disease at the time of baseline defined as follows:
* At least 2 joints with active arthritis
* Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day during the screening epoch and within 1 week before first canakinumab dose
* C-Reactive Protein (CRP) \> 30 mg/L(3 mg/dL) (normal range \< 10 mg/L(1 mg/dL))
* Negative TB screen (Chest X-ray and T-SPOT test)

Exclusion Criteria:

* With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or anti-HBc antibody).
* With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
* With neutropenia (absolute neutrophil count \< 1500/mm3) at screening.