cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for Doxorubicin liposomal injection therapy .

This study has sequential two stage design. Bioequivalence based on encapsulated doxorubicin will be tested at the end of stage 1. Power analysis will be performed for the primary pharmacokinetic parameters of free Doxorubicin and liposome encapsulated Doxorubicin, for all completed patients before bioequivalence evaluation. If observed power will be \>= 80% then two one-sided 90% CI will be calculated for bioequivalence assessment at stage I.

If observed power will be \< 80% then bioequivalence will be evaluated at stage I. If bioequivalence met then study will be stopped and if bioequivalence not met, then required additional patients will be enrolled in stage II.

Each patient will be randomized to one of the two treatment sequences ( RT or TR ) according to a randomization scheme prepared prior to the start of the trial. Serial blood samples for determination of free doxorubicin and liposomal encapsulated doxorubicin plasma concentration for PK analysis will be obtained in each cycle .

Bioequivalence Criteria : The 94.12% confidence intervals for the ratio of geometric least squares means of ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf should be within 80.00 to125.00% to conclude the test product is bioequivalent to the reference product.

Eligibility Criteria:
Inclusion Criteria:

* Female of Indian Nationality , between 18-60n years of age
* Able to understand investigational nature of this study and give written informed consent prior to the participation in the trial.
* Patients with ovarian cancer requiring Doxorubicin and whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with reference listed drug
* ECOG performance status ≤ 2
* Cardiac function ( LVEF) ≥ 50%
* patient with life expectancy of at least 3 months
* Adequate hematopoietic, renal and liver function

Exclusion Criteria:

* Prior doxorubicin exposure that would result in a total lifetime exposure of 550mg/m2 or more after four cycles of treatment .
* Pregnant or breast-feeding female
* active opportunistic infection with mycobacteria , cytomegalovirus , toxoplasma
* Impaired cardiac function including any of the following conditions within past 6 months :

  1. Unstable angina
  2. QTc prolongation or other significant ECG abnormalities
  3. Coronary artery bypass graft surgery
* History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCl or the components of Doxorubicin Hydrochloride liposome injection.
* known brain metastasis
* HIV positive antibody or syphilis
* Patients with significantly impaired hepatic function
* Clinically significant liver and kidney disease
Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.

This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)

Group A: excision and paramedian closure according to modified Karydakis technique

Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention

Eligibility Criteria:
Inclusion Criteria:

* Pilonidal cyst requiring surgery
* Signed Informed Consent Form

Exclusion Criteria:

* Abnormal lesions
* Injuries requiring a closing with rotation flap
Swiss TrAumatic biRth Trial

This randomized controlled study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section (ECS). Women who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention plus usual care or an attention placebo control group plus usual care within the first 6 hours following the ECS. Women and their infants will be followed up at ≤ 1 week postpartum, 6 weeks postpartum, and 6 months postpartum. It is predicted that women given the brief computerized intervention will develop fewer intrusive memories and less posttraumatic stress symptoms than those who are not. This will inform the development of a simple computerized early intervention to prevent distressing psychological symptoms after a traumatic event, such as an ECS.


Eligibility Criteria:
Inclusion Criteria:

Women:

* had an ECS at ≥ 34 weeks gestation
* gave birth to a live baby
* answered with a score of ≥ 2 separately for at least two out of four screening questions regarding perceived threat
* gave written consent

Partners:

* if the woman agrees to participate
* was present at the childbirth
* gave written consent

Exclusion Criteria:

Women:

* don't speak French sufficiently well to participate in assessments
* have an established intellectual disability or psychotic illness
* severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
* infant requires intensive care
* alcohol abuse and/or illegal drug use during pregnancy

Partner:

- don't speak French sufficiently well to participate in assessments
The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery

The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections.

Patients will be randomized to the chlorhexidine or no additional intervention groups. Patients will be randomized to use 4% chlorhexidine cloths, while the other half receive no additional intervention. Those randomized into the chlorhexidine gluconate (CHG) home-application group will be asked to shower the night before surgery, and to use a standardized pre-packaged CHG wipe (that the patients would receive at their pre-surgical consultation) on their surgical site after thoroughly drying those areas. The patients will be asked to use a second wipe in each area the morning of surgery. The surgical sites will be analyzed in two groups: anterior cervical and posterior spine. Each of these two groups will be randomized separately. All patients will undergo a standardized preoperative cleansing regimen. Once positioned, they will be cleansed with an alcohol solution. Then, the surgical site (either the anterior portion of the neck or the posterior area of the spine) will be scrubbed with chlorhexidine soaked brushes and then painted with chlorhexidine solution. Perioperative antibiotics will be given per attending surgeon preference. Cutaneous samples will be taken from the surgical site of each patient at each time point.

To the investigator's knowledge no prior study has evaluated the effects of cleaning the skin at home before surgery in patients undergoing spine surgery. This study will investigate whether patients who use a chlorhexidine cleansing wipe have decreased amounts of bacteria on their skin when they arrive for scheduled spine surgery. Spine surgeons strive to decrease infections in their patients, so it is important to see if this intervention helps to do this.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Scheduled for elective spine surgery at Columbia University Medical Center

Exclusion Criteria:

* Unable to apply at-home chlorhexidine wipe by themselves
* Deemed "high risk" preoperatively by the treating surgeon
* Diagnosed with spine trauma
* Undergoing deformity correction surgery
* Unable to consent to the terms of the surgery
* Known infection at time of the index procedure
* Hospitalized within 1 week pre-operatively
* Allergic to chlorhexidine
* Immunocompromised
* End stage renal disease on dialysis
* Local or systemic skin disease (such as psoriasis, eczema, etc.)
* Open skin wounds
Improvement in Glycemic Response After Bariatric Surgery

decipher the role of microbiota in glycemic response change after bariatric surgery

Despite the vast knowledge linking the gut microbiome to metabolism and the glucose response, the relation still remains unclear. hopefully, a deep understanding of the mechanisms underlying metabolic improvement following bariatric surgery will make it possible to identify targets for pharmacological intervention, which will reduce the need for surgery and its risks.

Previous studies have characterized the microbiome after bariatric surgery, but most suffer from methodological limitations.

The current study has the potential to be innovative and make a significant contribution to understanding the mechanisms involved in early metabolic improvement after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* candidates of bariatric surgery or cholecystectomy
* age 18-70
* male/female

Exclusion Criteria:

* previous bariatric surgery
* type 1 diabetes
* antibiotic treatment 3 months prior to the study
* probiotic treatment 3 months prior to the study
* chronic disease - gastrointestinal disease, malignancy, psychiatric disorder, endocrinologic disorders
* any pathologic findings during endoscopy
* participants who will suffer from a post-operation complication
Combination of Hypofractionated Proton Therapy With Immunotherapy

The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using hypofractionated proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Hypofractionated radiotherapy (HFRT), also known as Stereotactic body radiation therapy (SBRT) or Stereotactic ablative radiotherapy (SABR), is a regular pattern of photon radiotherapy. HFRT could achieve comparable curative effect to surgery in variable type of tumor. With the development of proton radiotherapy technology, proton HFRT technique is available nowadays. However, proton HFRT technique is mainly effective in improving the local control rates. This study intends to observe the safety and efficacy of proton HFRT technique combined with immunotherapy in improving the overall anti-tumor effect.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Unspecified Adult Solid Tumor
* Intending to be treated with proton beam and immunotherapy
* Age ≥ 18 years old
* KPS≥70
* Signed written informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient under guardianship or tutorship
* Patients or legal guardians who are unable to understand informed consent document
Chemosensory Dysfunction and Recovery in Endoscopic Endonasal Skull Base Surgery

The investigators hypothesize that patients undergoing endoscopic endonasal skull base surgery experience clinically meaningful and modifiable disruptions in postoperative chemosensory function and quality of life, and the investigators further hypothesize that olfactory training in the postoperative period may significantly hasten normalization of patients' chemosensory perturbations. This tailored prospective study seeks to fulfill a significant gap in the understanding of the characteristics, implications, and treatment options for postoperative olfactory and gustatory impairment following endoscopic endonasal skull base surgery.


Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* preoperative diagnosis of benign sellar or parasellar skull base pathology

Exclusion Criteria:

* preoperative diagnosis of malignant sellar or parasellar skull base pathology
* history of endoscopic sinus surgery
* history of skull base surgery
* history of radiation therapy or other local treatments for the management of facial, sinonasal, or cranial pathologies
* history of chronic rhinosinusitis
* history of neurocognitive disorder
* history of intrinsic chemosensory pathology
* history of cardiac pacemaker
* history of gastrectomy
Use Electroencephalogram to Study Neural Dynamics of Fear Conditioning and Avoidance Learning Circuit in Humans

The purpose of this study is to examine which event-related potentials (ERPs) and event-related oscillations (EROs) are associated with fear conditioning, avoidance learning, and memory recall for fear and avoidance, where are the source generators of the observed scalp EEG activity, the impact of fear and avoidance learning on the decision to avoid or not to avoid conditioned stimuli , to examine the large-scale functional connectivity across distributed brain regions across experimental phases, and to examine whether spontaneous EEG data during resting-state correlate with the EEG measures during experimental tasks.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent.

Exclusion Criteria:

* History of neurologic disease
* History of seizure or significant head trauma/loss of consciousness
* Significant serious psychiatric diagnosis
* Significant suicidal ideation or behaviors
* High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process, based on investigator/clinician clinical evaluation
Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism

Hematopoietic stem cell transplantation is currently the only way to cure thalassemia, one of its main obstacles is the rejection after transplantation, chimerism continued to decline, which eventually lead to transplant failure. chimerism is a key indicator of the succession of immune response, which is a key indicator for predicting the failure of hematopoietic stem cell transplantation and provides an important basis for early detection of rejection. Transplantation of continuous chimerism can detect early unstable chimeras and rejection.The chimerism rates after transplantation were continuously monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)

,and then follow our STR different rates for early interventional therapy to prevent further reduction in chimerism leading to lead to graft failure.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of thalassemia major
2. There is no restriction on age or gender.
3. Underwent allogeneic hematopoietic stem cell transplantation, including sibling transplantation, unrelated transplantation and haploidentical transplantation.
4. On +45 day after transplantation, check patients with STR less than 80%.
5. Patients underwent reduce of dosage with a failure treatment by
6. Body condition score (ECOG score) is less than or equal to 1 point who meet follow-up conditions.

Exclusion Criteria:

Complicated with severe cardiac insufficiency and cardiac ejection fraction (EF) was lower than 50%. Complicated with severe pulmonary insufficiency (obstructive and / or restrictive ventilatory disorders). Complicated with severe liver function damage and liver function index (ALT or TBIL) is more than 2 times of the upper limit of the normal value. Complicated with severe renal dysfunction and renal function index (Cr or BUN) is 2 times of the upper limit of the normal value. Complicated with severe active bleeding
Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity

Maternal peripartum fever is a common complication of pregnancy and postpartum period associated with potentially serious obstetrical outcomes and infectious morbidity. Peripartum infections includes intrapartum intraamniotic infection (IAI) and postpartum endometritis. Both are caused by polymicrobial bacterial infection. Increased latency period from rupture of membranes (ROM) until delivery is a common risk factor. Another risk factor is pre-term delivery.

This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity.

Primary outcome-peripartum infections- chorioamnionitis, endometritis and surgical site infection secondary outcome- obstetrical outcome- mode of delivery, Apgar score, cord blood pH, peripartum fever, maternal length of admission, postpartum maternal antibiotic treatment, Surface swab cultures were obtained from the placenta, amnion and umbilical cord (birth cultures) and uterine swab cultures, maternal blood culture, placental histologic evaluation neonatal outcomes-NICU admission, length of admission, neonatal morbidity-ventilation support, early neonatal sepsis

Eligibility Criteria:
Inclusion Criteria: maternal age \> 18 years singleton pregnancy vertex presentation prolonged \>18 h prom or preterm delivery

-

Exclusion Criteria:

* GBS carrier
* preterm premature rupture of membrane for conservative treatment
* intra-uterine fetal death fetal major anomaly
* drug allergy for the antibiotic in use in this study
* women receiving antibiotic treatment for other infection such as urinary tract infection
Efficacy and Safety of AZD7009 in the Treatment of Atrial Fibrillation

The current study is designed to assess the efficacy and safety of iv AZD7009 in conversion from AF


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for cardioversion of Atrial Fibrillation. Effective oral anticoagulation according to local routines or a TEE without any finding of intracardial thrombus or signs of thrombogenecity

Exclusion Criteria:

* Clinically significant sinus and/or AV node dysfunction. Serum or plasma potassium \<3.8 mmol/L or \>5.0 mmol/L. QTc(Bazett) \>450 ms. Any QRS duration \>150 ms
Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain

Pregnancy-related pelvic girdle pain (PPGP) is a common musculoskeletal problem for women during pregnancy and after delivery. The main purpose of this study was to investigate the effects of integrated training for pelvic floor muscles (PFMs) and stabilization with and without transabdominal ultrasonography (TAUS) imaging-guided biofeedback on pain, disability, and physical function, and muscle functions for the abdominal muscles and PFMs in postpartum women with PPGP.

Many women have pregnancy-related pelvic girdle pain (PPGP), and about 30% with PPGP women still complain of pain after 1-year postpartum. Both physical and mental functions of PPGP women are impaired. Pelvic stabilization exercise with pelvic floor muscle training is believed to be effective for reducing pain and improved pelvic stability. However, intervention studies on PPGP women is limited and current evidence are controversial. Incorrect pelvic floor muscle activations may be partly contributed to these results. One previous study has showed about 60% of women cannot activate pelvic floor muscles correctly. Transabdominal sonography-guided biofeedback by observing bladder movements is no-invasive and benefit learning correct muscle contraction. Therefore, the main purposes for this study are to investigate the effects of pelvic stabilization training using transabdominal sonography-guided biofeedback in postpartum women with PPGP. A total of 50 postpartum PPGP women will be randomized into one of the two groups: (1) biofeedback group, (2) exercise group, (3) control group, and (4) health group. Subjects in the biofeedback group and exercise group will perform the same exercise training for 8 weeks except the subjects in the biofeedback group will receive transabdominal sonography-guided biofeedback of bladder movement for the first 4 weeks. The outcome assessment will include the muscle thickness of abdominal muscle and pelvic floor muscle control, functional performance of ASLR fatigue task, timed up and go and fast walking, pelvic girdle questionnaire (PGQ), and numeric rating scale (NRS). It is anticipated that the biofeedback group will have more improvements that the exercise group.

Eligibility Criteria:
Inclusion Criteria:

* postpartum : ≥ 3 months
* pregnancy-related pelvic pain
* pain location is located between posterior iliac crest and gluteal fold
* Clinical screening test for pelvic pain: ASLR : positive and SI joint ≥ 2 (+ symphysis ≥ 1)

Exclusion Criteria:

* lumbar or pelvic surgery
* lother causes of pelvic pain (such as fractures)
* lRadiculopathy
* lother health problems, such as cancer, cardiovascular disease, rheumatism , etc
* ldaily activities limited , unable to complete the experiment
* lcommunication disorders
* lmental disorder
* lpregnancy
* lhave been trained in stable muscle strength in the past.