cyrilzakka/clinical-trials huggingface dataset:
A Study of ABT-165 in Subjects With Solid Tumors

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
* Subject has adequate bone marrow, renal, hepatic and coagulation function.
* Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).
* Women of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline prior to the first dose of study drug. Female subject considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year. Women of childbearing potential and men must agree to use adequate contraception.
* Subjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects in the combination therapy cohorts who are to receive ABBV-181, an anti-PD1 antibody, must also meet other criteria described in the Protocol.

Exclusion Criteria:

* Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.
* Subject has uncontrolled metastases to the central nervous system (CNS).
* Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
* Subject has history (within previous 5 years) of clinically significant pulmonary hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic heart failure, cardiomyopathy, myocardial infarction, unstable/severe angina pectoris, cardiac arrhythmia requiring medication, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, cerebrovascular accident, transient ischemic attack or the left ventricular ejection fraction (LVEF) less than 50%.
* Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects receiving ABBV-181 must not meet other exclusion criteria described in the Protocol.
Bioavailability of Different n-3 Fatty Acid Formulations

The aim of this study is to examine differences in short term bioavailability between four n-3 FA formulations in healthy males.

The long-chain n-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are known to positively affect the lipid profile, vascular tone and blood coagulation. Moreover, EPA and DHA possess anti-inflammatory effects and play a central role in the functioning of the brain and central nervous system. Therefore, an increased EPA and DHA intake is highly recommend. However, it is unknown whether different chemical formulations of EPA + DHA rich supplements (re-esterified triglycerides, ethyl-esters, phospholipids) have identical bioavailability. The objective of this study is to examine differences in short term bioavailability between four n-3 FA formulations:

* Supplement 1: EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules
* Supplement 2: EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG)
* Supplement 3: EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules
* Supplement 4: DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)

The study preparations are certificated supplements and available on the market.

There are no comparative investigations, which analyzed the bioavailability of these four n-3 FA formulations in a similar design.

Eligibility Criteria:
Inclusion Criteria:

* males,
* 20-50 years,
* Caucasian,
* healthy,
* body mass index (BMI) 20-28 kg/m²,
* no medical treatment,
* written confirmation of the subjects after detailed spoken and written explanation about the study contents,
* ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the study drugs according to the dosage commendation

Exclusion Criteria:

* medical treatment (especially corticosteroids, anti-inflammatory drugs, blood lipids lowering drugs (e.g. statines, fibrates, bile acid exchanger resin, phytosterols)
* taking any supplements with n-3 FAs, phytosterols, polyglucosamines (Chitosan) or other lipid binding ingredients
* daily consumption of n-3 FAs rich fish (salmon, mackerel, herring)
* heavy chronic diseases (tumors, diabetes typ 1, etc.), documented heart disease, documented blood clotting disorders, renal failure, liver diseases
* documented blood clotting disorders and consumption of coagulation-inhibiting drugs (for example Marcumar, ASS)
* allergy or intolerance to fish/fish oil or any of the study ingredients of the test products
* chronic gastro-intestinal diseases (Colitis ulcerosa, Morbus Crohn, pancreatic insufficiency)
* donation of blood in the last 6 weeks
* routine consumption of laxative
* alcohol-, drug- and/or medicament dependence
* subjects who are not in agreement with the study conditions
* refusal or rather reset of the consent from the subject
* active participation in other investigational drug or device trial within the last 30 days
A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)

This feasibility study will assess the effects of the Nativis Voyager therapy in patients with first or second recurrence of GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 32 subjects with Voyager plus lomustine with or without bevacizumab. Safety and clinical utility will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subject has histologically confirmed diagnosis of GBM.
* Subject has failed or intolerant to radiotherapy.
* Subjects has failed or intolerant to temozolomide therapy.
* Subject has progressive disease with at least one measureable lesion on MRI.
* Subject is at least 18 years of age.
* Subject has a KPS ≥ 60.
* Subject has adequate organ and marrow function.

Exclusion Criteria:

* Subject has received bevacizumab (Avastin).
* Subjecting has any condition, including compromised pulmonary function, that would preclude the use of lomustine.
* Subject is currently being treated with other investigational agents.
* Subject has received other investigational therapy within the last 28 days.
* Subject has received surgery within the last four weeks.
* Subject is within 12 weeks of completion of radiation.
* Subject has an active implantable or other electromagnetic device.
* Subject has a metal implant, including a programmable shunt, in the head or neck that is incompatible with MRI.
* Subject is known to be HIV positive.
* Subject is pregnant, nursing or intends to become pregnant during the course of the study.
Excretion of Rivaroxaban in Human Breast Milk

The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

The aim of our study is to perform a phase 1, single arm clinical trial to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic maternal doses. Our goal is to enhance the limited, although positive, data regarding the safety of rivaroxaban in breastfeeding. Our novel contributions to the existing body of literature will be in our investigation of rivaroxaban at both prophylactic and therapeutic doses, in repeated doses over time, and in a larger sample of participants. These results will provide physicians and national societies with safety data needed to properly counsel patients and advance clinical guidelines for postpartum care.

Eligibility Criteria:
Inclusion Criteria:

1. Postpartum within 6 weeks of delivery
2. Greater than 18 years old at expected date of delivery
3. English speaking
4. Hemodynamically stable without concern for ongoing blood loss
5. Non-breastfeeding
6. Or breastfeeding an infant born at or equal to 37 weeks' gestation, weighing \>2600g at birth and is not requiring intensive care
7. Meet inclusion criteria for prophylactic rivaroxaban dose: pre-pregnancy BMI \>/= 40 and/or any personal history of VTE. Or \>/= 2 of the following: pre-pregnancy BMI 30-39, immobility, pregnancy complications, cesarean delivery, hysterectomy
8. Or meet inclusion criteria for therapeutic rivaroxaban dose: have an indication for therapeutic anticoagulation per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196, or other indication per their primary team, and recommended for such anticoagulation per their primary practitioner.

Exclusion Criteria:

1. Pregnant
2. Less than 18 years old at estimated date of delivery
3. Hemodynamic instability and/or concern for ongoing blood loss
4. Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period
5. Abnormal maternal renal or liver function (creatinine clearance \< 30 mL/min and/or liver function tests greater than lab normal)
6. A contraindication to rivaroxaban: hypersensitivity to rivaroxaban; active pathological bleeding
7. Breastfeeding an infant admitted to neonatal intensive care unit, infant gestational age at birth \<37w0d or weighing \<2600g.
8. If all of the following are met: age less than 40, ambulating, body mass index (BMI) less than 30, no active history of malignancy.
9. If patient lacks indication for therapeutic anticoagulation in the postpartum period per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196
Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study

Evaluation of clinical outcome and economical aspects in the treatment of patients with peritoneal carcinomatosis.

Peritoneal carcinomatosis is a dooming finding with no hope for cure and a steadily decrease in quality of life. Cytoreductive surgery with intraperitoneal chemotherapy (CRS HIPEC) offers a small but proven chance for cure. The implementation of a CRS HIPEC and PIPAC programme in a Swiss tertiary care hospital is evaluated.

When a patient is deemed non resectable, pressurized intraperitoneal aerosol chemotherapy (PIPAC) administered laparoscopically may confer effective palliation.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women \>18 years
* Tumour board decision for CRS and intraoperative chemotherapy

Exclusion Criteria:

* Missing Tumour board decision for CRS and intraoperative chemotherapy
* Pregnancy
* Age \<18 years
Adaptive Treatment for Adolescent Anorexia Nervosa

The investigators are conducting a randomized controlled trial using an adaptive design for adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do not reach expected milestones by session 4 of treatment, participants may be randomized to receive additional IPC or continue treatment as usual with regular FBT.

Potential subjects aged 12 to 18 with anorexia nervosa (AN) will be recruited from Stanford University, University of California, San Francisco, other bay-area medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview (about 2 hours in duration) during which the investigators will conduct interviews and collect questionnaire measures. Then, participants and participants' families will begin Family Based Treatment (FBT) with a study therapist at Stanford University or University of California, San Francisco, respectively. All assessments and treatments are conducted through tele-health.

At session 4, if participants have not gained 2.4kg, an indicator of early treatment response, participants and participants' families will be randomized to receive either treatment as usual (FBT) or an adaptive form of FBT, during which families will receive additional Intensive Parental Coaching (IPC). If participants have reached weight milestones (i.e., 2.4kg at session 4), participants will continue FBT as usual.

At 3 months of treatment and end of treatment, the investigators will collect the same measures taken at baseline. The investigators also ask that families participate in 6- and 12-month follow-up, respectively.

Eligibility Criteria:
Inclusion Criteria:

* 12-18 years of age and living with participants' families
* meeting DSM-5 criteria for AN (both subtypes) except for the amenorrhea requirement
* medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.

Exclusion Criteria:

* associated physical illness that necessitates hospitalization
* psychotic illness, mental retardation, or any other mental illnesses that would prohibit the use of psychotherapy
* current dependence on drugs or alcohol
* physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* previous FBT
* currently taking medication for co-morbid disorders that cannot be safely discontinued on a stable dose for less than 2 months
* in the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment.
Effect of Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy

Investigator researched that the effect of trunk and lower extremity muscle strength on hamstring flexibility in children with Duchenne Muscular Dystrophy.

Thirty children were asessed by physical therapist. Nineteen children was Level 1 and eleven children was Level 2 according to Brooke Lower Extremity Functional Classification Scale.

Eligibility Criteria:
Inclusion Criteria:

* Getting a Duchenne Muscular Dystrophy diagnosis,
* Being in ambulatuar phases and independently climbing four stairs
* To be cooperate to physioterapist's directions

Exclusion Criteria:

* Having severe contracture in the lower extremity
* Having undergone surgery in the past 6 months
Endoscopic Band Ligation Vs APC in Management of GAVE

* overall aim: To compare the efficacy and safety of endoscopic band ligation and endoscopic argon plasma coagulation for the management of gastric antral vascular ectasia.
* Secondary aims:

  1. Study risk factors of GAVE.
  2. Prevalence of GAVE among causes of non-variceal gastrointestinal bleeding.

Gastric antral vascular ectasia (GAVE) is a capillary-type vascular malformation characterized endoscopically by red, angiomatous lesions originating in the antrum and organized either in stripes or in a diffuse pattern.

GAVE may cause chronic iron-deficiency anemia with or without the presence of overt gastrointestinal bleeding, manifested commonly by melena, may account for about 4% of the causes of non-variceal bleeding.

GAVE can be isolated or associated with systemic conditions, especially in patients with liver cirrhosis, scleroderma, chronic renal failure, and after bone marrow transplantation.

Multiple mechanisms have been proposed as the origin of its development. These have included gastric dysmotility leading to chronic mucosal trauma and subsequent fibromuscular hyperplasia and vascular ectasia or an autoimmune reaction to gastric blood vessels among the main contributing factors.

Management of GAVE-related gastrointestinal bleeding is a clinically challenging issue. In the last two decades, many therapeutic options and modalities have been applied for GAVE including medical, endoscopic, and surgical management.

Endoscopic management including different options such as cryotherapy, argon photo coagulation (APC), Neodymium-yttrium-aluminum garnet laser coagulation, radiofrequency ablation and endoscopic band ligation.

The first case using endoscopic band ligation as salvage treatment for GAVE was reported in 2006. After two sessions of EBL with a Multi-Band Ligature, hemoglobin became stable and serum ferritin normalized in 16 months of follow up.

Some studies show that management of GAVE with endoscopic band ligation superior to APC in bleeding cessation and fewer treatment sessions.

Eligibility Criteria:
Inclusion Criteria:

* • Both sexes will be included.

  * Age above 18 years old patients will be included.
  * With overt or occult bleeding from GAVE.
  * Characteristic endoscopic findings of GAVE: GAVE was limited to the antrum and its appearance either watermelon stomach or diffuse pattern.

Exclusion Criteria:

* • All causes of emergence upper GIT bleeding other than GAVE.

  * Patient with contraindication to general anesthesia
Inter Costal Catheters for Video-Assisted Thoroscopic (VATS) Lobectomy

A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS lobectomy.

Pain and satisfaction with pain treatment is investigated in a population after VATS lobectomy.

Eligibility Criteria:
Inclusion Criteria:

Age of consent (ie age\>=18) Eligible for lobectomy Able to comply Willing to register postoperatively

-

Exclusion Criteria:

* do not understand DAnish
Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing .

To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction after free gingival graft harvesting.

To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction , Color match , Wound size closure after free gingival graft harvesting.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mucogingival defects scheduled for free gingival graft
* Systemically healthy

Exclusion Criteria:

* Smokers
* Occlusal trauma at site of graft
* Pregnancy and lactation
* Patients allergic to the used agents
* Severe gagging reflex
Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

This research study will evaluate if specific blood, stool and MRI tests can tell the difference between bowel wall inflammation without scarring and bowel wall inflammation with scarring that can cause bowel blockages requiring surgery.

This multi-center study will test the accuracy of individual and combined MRI and blood-based diagnostic tools in both children and adults with small bowel CD. We will determine the accuracy of a composite tool (including its multiple individual biomarkers) for defining the relative amounts of intestinal inflammation versus scarring in patients at the time of surgery (B2 disease) and in patients at an early stage of disease prior to complications (B1 disease).

Eligibility Criteria:
Inclusion Criteria:

* Aim 1 (CD participants)

  1. Aged 8-70 years
  2. Undergoing first surgical distal (ileal) small bowel resection for structuring (B2 phenotype) Crohn's disease as determined by CTE or MRE or ileocolonoscopy
  3. English speaking
* Aim 2 (CD participants)

  1. Age 8 to 70 years
  2. Uncomplicated inflammatory small bowel CD based on clinical CTE or MRE or ileocolonoscopy performed within 6 months prior to enrollment (CD participants only)
  3. English speaking
* Aim 2 (Control participants)

  1. Age 8 to 70 years
  2. English speaking

Exclusion Criteria:

* Aim1 (CD participants)

  1. B1 or B3 (i.e., fistula, abscess, phlegmon/inflammatory mass) CD phenotype
  2. Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture
  3. Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water)
  4. Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening)
  5. Contraindication for MRI (e.g., surgical implant, claustrophobia). Note: To be determined based on local procedures.
* Aim 2 (CD participants)

  1. Stenotic ileocecal valve at colonoscopy
  2. Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture
  3. Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water)
  4. Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening)
  5. Contraindication for MRI (e.g., surgical implant, claustrophobia). Note: To be determined based on local procedures.
* Aim 2 (Control participants)

  1. Any known gastrointestinal tract disease
  2. Any known inflammatory/autoimmune disease involving another organ system (e.g., rheumatoid arthritis, scleroderma, multiple sclerosis).
  3. Fecal calprotectin level of ˃100 mcg.gm will be excluded from further analysis and replaced.
Postoperative Pain After Root Canal Disinfection Via Diode Laser

The prevention and control of post-treatment pain is of great importance for the comfort of the patient as well as for the clinician's prestige. In this study, the effect of 940 nm diode laser disinfection on the postoperative pain of retreatment cases was evaluated.

From the fact that microorganisms are the most common factors causing pain, this study aimed to evaluate effect of 940 nm diode laser disinfection performed in addition to conventional irrigation on postoperative pain of retreatment cases. Eighty-four patients with chronic apical periodontitis were treated. Root canal fillings were removed using rotary files. Root canals were irrigated using sodium hypochlorite between instrument changes. Final irrigation was performed using sodium hypochlorite and ethylenediaminetetraacetic acid (EDTA). The cases were randomly allocated into 2 groups: Group 1: Diode laser disinfection group, Group 2: control group. Root canal fillings were applied and crowns were restored. All treatments were completed in a single appointment. Patients were given a pain scale and they were requested to mark the code that reflects their pain intensity during 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Only asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic periodontitis (minimum size 2x2 mm)

Exclusion Criteria:

* teeth with root canal fillings newer than 4 years, overfilled teeth, teeth with intraradicular posts, existence of a sinus tract, consumption of antibiotics within 1 month, consumption of analgesics in last 5 days, systemic disease, pregnancy, history of trauma, traumatic occlusion