cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer

To determine:

* Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer.
* Group A - subjects who have not previously received chemotherapy
* Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy.
* Clinical response will be determined by PSA and radiological response

IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. Inhibition of HSP-90 leads to the proteasomal degradation of these proteins.

In patients with HRPC,there are several proteins that are important in the progression of HRPC, including AR, AKT and Her-2. All of these are client proteins of Hsp90 and in response to Hsp90 inhibition are degraded by their proteasome. Preclinical studies have shown that Hsp90 inhibition causes a dose dependent degradation of these client proteins and growth inhibition of prostate cancer in xenograft tumors.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate
* Resolution of acute toxic side effects of prior chemotherapy
* Castration resistant disease despite ongoing chemical or surgical castration
* ECOG 0-1
* PSA greater than or equal to 2
* Group A -

  * No Prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out)
* Group B

  * Radiographic evidence of metastatic disease
  * Prior tx with docetaxel-minimum of 2 cycles with progression by RECIST or PSA or intolerant of tx
  * Maximum of 3 prior chemotherapies

Exclusion Criteria:

* Small cell carcinoma of the prostate
* Treatment within 2 weeks with approved, investigational, or small molecule
* Treatment within 4 weeks with biologic or external beam radiation
* ANC \<1,500 cells m3; Platelets \<100,000 mm3; Hemoglobin \<9.0g/dL
* AST/ALT \>2.5 ULN
* Serum creatinine \>3.0mg/dL
* Active keratitis or keratoconjunctivitis
* Previous treatment with 17-AAG, DMAG; or any other HSP-90 inhibitor
* Baseline Qtc \>450 mses
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD

Investigating the efficacy of a form of TMS called theta-burst stimulation for restricted and repetitive behavior in ASD.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Autism Spectrum Disorder (ASD), Asperger's or Autism.
2. Meet criteria for ASD on clinical assessments (ADOS-2 or CARS/BOSA if conducted remotely \& ADI-R)
3. Aged between 12-45 years old
4. Have a reliable informant who can complete relevant questionnaires
5. Must have previously not responded or not tolerated 2 treatments.

Exclusion Criteria:

1. Any contraindications for TMS e.g. history of seizures
2. Pregnancy
3. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
4. Active substance use (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
5. Showing symptoms of withdrawal from alcohol or benzodiazepines
6. DSM-5 diagnosis of bipolar disorder or a psychotic disorder e.g. schizophrenia.
7. Significant sensory impairments such as blindness or deafness.
8. Any other indication the PI feels would comprise data
9. Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)
10. IQ\<50 or not testable using IQ measures and no historical IQ score available
11. Currently taking Clozapine or another medication that the PI determines increases the risk of TMS or may disrupt the efficacy.
12. A motor threshold that is too high to allow safe/tolerable treatment.
Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial

Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint.

Rationale for conducting the research:

The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet .
2. Muscles spasm causing TMDs.
3. Patients who failed to improve on conservative measures or highly hyperactivity patients.
4. Female and male patients age range from 20 to 60 years old.

Exclusion Criteria:

1. Patients who refused to be included in the research.
2. Patients with a systemically diseases or inflammation whether local or generalized.
3. Patients with bleeding disorders.
4. Patients with unknown dextrose allergy.
The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients

This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section.

The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.

Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may have difficulties in determining the poorly palpable surface landmarks in morbidly obese pregnant women.

Manual palpation technique, which is preferred in neuraxial anesthesia, may be difficult in obese pregnant women due to the difficulty in identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease number of attempts in obese parturients.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. Patient, the anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups.Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 150 ultrasound-guided neuraxial blocks.

Eligibility Criteria:
Inclusion Criteria:

* Parturient who will receive selective cesarean delivery under spinal anesthesia
* ASA 2-3 scheduled for elective sections
* BMI≥40 kg/m2
* normal singleton pregnancy
* ≥37 weeks of gestation

Exclusion Criteria:

* Multiple gestations
* Emergency C-section
* exist contraindications of spinal anesthesia
* Local anesthetics allergy
* BMI\<40 kg/m2
* history of lumbar spinal diseases and lumbar surgery
* Parturient refusal
Comparative Tolerability of Protease Inhibitors

This study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV) patients treated with cART regimens including one of four different protease inhibitors \[Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)\] and the impact of these identifiable tolerability problems on PI persistence, healthcare utilization, and healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* Initiated treatment with a Protease inhibitor (PI)-based Combination antiretroviral therapy (cART) regimen
* Between 18-64 years of age on the index date
* At least 6 months of continuous enrollment and pharmacy benefits prior to the index date
* At least 6 months of continuous enrollment and pharmacy benefits following the index date
* At least 1 medical claim during the 6-month follow-up period
FMT for MS Patients

This is a placebo-controlled, double-blinded, randomized trial design, whereby all patients are eligible to start an injectable therapy, and then randomized to either placebo or FMT for approximately 1 year.

Fecal Microbiome Transplants: Patients will undergo pretreatment with Amoxicillin/Clavulinate (or matched placebo) for 5 days followed by a bowel cleanse with PEGLYTE. Patients will undergo allogeneic or autologous fecal transplants. Patients will be dosed with FMT oral capsules approximately 48 hours after antibiotic treatment has stopped. Following the FMT capsule treatment on day 1, patients will be administered a repeat oral capsule or placebo dose at 3 weeks. Oral omeprazole or omeprazole placebo will be given 1 hour prior to the baseline and 3 week dose. This will be done to ensure full engraftment of the transplant.

Participants will be seen at baseline, 3 weeks, 6 weeks, 3 months, 6 months and 12 months. A series of neurological tests will be performed for safety measures. In addition to this, MRIs will be completed at baseline, 6 weeks and 12 months. Blood, urine and stool samples will also be collected for data analysis and safety measures.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 55 years of age
* Have an expanded disability status scale (EDSS) of \< 6
* Have a diagnosis of relapsing multiple sclerosis
* Have evidence of radiographic activity within the 12 months on MRI (new/enlarging T2 lesion or gadolinium enhancing lesion)
* Eligible to start/starting an injectable DMT
* Not on a DMT currently and/or not on a DMT in last 6 months
* Ability to swallow capsules

Exclusion Criteria:

* Unable to provide informed consent
* Does not pass the standard MRI screening questionnaire
* Other disease that can affect GI permeability (such as Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis, indeterminate colitis or microscopic colitis, celiac disease)
* Expected requirement for antibiotics within 3 months (chronic suppressive therapies, elective prosthetic joint insertion)
* Toxic megacolon, small bowel ileus
* Penicillin allergy
* Omeprazole allergy
Laryngeal Mask Supreme™ Versus the I-gel™

We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.

The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 patients undergoing elective operation

Exclusion Criteria:

* Not speaking german or refusing to participate
* BMI \>35, \<50kg
* Planned operation time \>4h
* High risk of aspiration
* Cervical spine disease, known difficult airway, mouth opening \<20mm
* Upper respiratory tract symptoms in the previous 10 days
* Preoperative sore throat
* Poor dentition with high risk of damage
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line.


Eligibility Criteria:
Inclusion Criteria:

* De novo multiple myeloma
* ECOG 0-2
* No serious co-morbid illnesses and adequate organ function
* \> 4 weeks from systemic steroids

Exclusion Criteria:

* No existing secondary malignancies and no history of secondary malignancies in the past 5 years
* No active autoimmune disease
Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China

Appropriate gestational weight gain (GWG) is a key factor in balancing maternal and neonatal needs of nourishment and health, which is especially important in women with gestational diabetes mellitus (GDM). However, there are no specific guidelines for GWG in Chinese pregnant women and even for GDM pregnant women.This project intends to fill in the gaps of this field through multi-center large sample prospective cohort study.

Inappropriate gestational weight gain (GWG) is an important risk factor affecting adverse pregnancy outcomes. However, the current guidelines for GWG are based on American population and may not apply to pregnant women in China, especially for those with gestational diabetes mellitus (GDM) who have high risk factors. The big gaps in academic-related fields need to be filled.

Our research group has previously found the heterogeneous relationships between GWG and adverse outcomes in GDM women with different abnormal glucose metabolism. Therefore, based on the principles of precision medicine, this project intends to establish for the first time the GWG standard for Chinese pregnant women to optimize the GWG management through a multicenter prospective cohort study. At the same time, specific GWG guidelines applicable to GDM women with different glucose metabolism abnormalities were innovatively constructed. Our study will provide strong evidence for stratified management and precise intervention of GDM pregnant women, which is of great significance to ensure health of both mothers and their offspring.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age: 20-49 years;
* Natural conception;
* Single pregnancy;
* Plan to have routine prenatal examinations and give birth in the research center;
* No plan to move within two years;
* No second pregnancy within two years;
* Willing to cooperate with the hospital to follow up after childbirth.

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, AIDS, etc.;
* Assisted reproduction;
* Multiple pregnancy;
* Fetus has a known deformity or genetic defects;
* Incomplete clinical data.
Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis

This is a prospective, multi-center single arm registry to assess the use of the OmniWave Endovascular System in subjects presenting with either lower or upper extremity acute (symptoms have been present for greater than or equal to 14 days) DVT.


Eligibility Criteria:
Inclusion Criteria:

* DVT confirmed by venographic and ultrasound imaging, which has been symptomatic for a maximum of 14 days, or diagnosed within past 14 days defined as either first episode (no prior history in affected segment), or recurrent episode.
* Written informed consent
* Agreement to comply with follow up requirements

Exclusion Criteria:

* Known R-L shunt, pulmonary A-V malformation
* Excessive tortuosity and/or sharp angulation in target treatment zone
* Isolated calf vein thrombosis
* Isolated DVT in veins peripheral to axillary vein
* Thrombus in peripheral vessel smaller than 5 mm
* Target treatment zone cannot be adequately accessed within the 100 cm working length of device
Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification

To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac 0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract extraction.

This prospective randomized clinical trial study included patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract. Exclusion criteria were previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded.

Study Protocol Preoperatively, patients had an extensive ophthalmologic examination, including measurement of corrected distance visual acuity (CDVA), refraction, slitlamp examination, intraocular pressure (IOP), fundoscopy, corneal endothelial cell count by noncontact specular microscopy (Noncon Robo, Konan), central corneal thickness (CCT) measurement (Pentacam, Oculus, Inc.), and biometry with the IOLMaster partial coherence interferometry device (Carl Zeiss Meditec AG). The targeted postoperative refractive error was 0.0 D. The visual acuity measurements were recorded with logMAR UDVA and CDVA.

In addition, a baseline spectral-domain OCT (SD-OCT) scan was performed before surgery and postoperatively after 1, 4 and 12 weeks. All SD-OCT imaging was performed with a spectral-domain Heidelberg Spectralis OCT devise (Heidelberg Engineering, Inc., Heidelberg, Germany).

Patients were assigned in a 1:1 ration to 1 of 2 treatments groups using a computer-generated randomization list. The study medications were ketorolac tromethamine 0.4% (Acular LS, Allergan) in group 1, and nepafenac 0.1% (Nevanac, Alcon) in group 2. Patients were instructed to instill ketorolac tromethamine 0.4% 1 drop in the operative eye 4 times a day (breakfast, lunch, dinner, and before bedtime), and nepafenac 0.1% 1 drop 3 times a day.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.

Exclusion Criteria:

* Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded
Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia

The purpose of this study is to determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy potentiates the neuroprotective effect of treatment with hypothermia.

Neonatal hypoxic-ischemic encephalopathy, due to perinatal asphyxia, is one of the leading causes of cerebral palsy, whose incidence, despite improvements in perinatal practice and neonatal care, has remained essentially unchanged over the recent past decades. It occurs approximately in 2-3 newborns every 1000 live births with a mortality rate of 10% for mild degrees and 60% for severe degrees. About 30% of survivors with mild hypoxic-ischemic encephalopathy and 100% with severe hypoxic-ischemic encephalopathy exhibit variable degrees of neurological disability.

Several studies have demonstrated the therapeutic effects of whole-body or selective head cooling to treat neonates with hypoxic-ischemic encephalopathy. Mild hypothermia, (rectal or esophageal temperature 33-34°C), started within 6 h after birth and protracted for 48-72 h, can significantly improve primary outcome measures such as death or disability at 18 months or improve the neurological outcome in survivors. Consequently, mild hypothermia is at present recommended for the treatment of moderate degrees of encephalopathy.

Topiramate an anticonvulsant agent widely used in adults and children, has been demonstrated to posses neuroprotective properties against hypoxic ischemic brain damage, both in vitro and in animal models and has been included in neuroprotective strategies for ischemic stroke and neonatal hypoxic-ischemic cerebral injury. Recently, topiramate treatment in asphyxiated newborns has been reported safe.

Aim of the present study is to confirm the safety and to evaluate whether the association of topiramate enhances the neuroprotective properties of hypothermia for the treatment of neonatal hypoxic-ischemic encephalopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age \> 36 weeks and birth weigh \> 1800 g with at least 1 of the following: a) Apgar score \< 5 at 10 minutes; b) persisting need for resuscitation, including endotracheal intubation or mask ventilation 10 minutes after birth; c) acidosis (pH \<7.0, base deficit \>-16 mmol/L in umbilical cord blood or arterial, venous or capillary blood) within 60 minutes from birth;
2. moderate to severe encephalopathy, consisting of altered state of consciousness (irritability, lethargy, stupor, or coma) and \> 1 of the following sings: a) hypotonia, b) abnormal reflexes, including oculomotor or pupil abnormalities, c) absent or weak suck, d) clinical seizures.
3. abnormal aEEG

Exclusion Criteria:

congenital abnormalities, congenital viral infections or evidence encephalopathy other than HIE.

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