cyrilzakka/clinical-trials huggingface dataset:
Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia

The goal of this clinical research study is to learn if giving CAMPATH-1H first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patients with chronic lymphocytic leukemia (CLL) who have already received standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H treatment are less severe by giving the drug first as an injection into a vein then as an injection under the skin.

The purposes of this trial are:

1. To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion followed by subcutaneous injection in patients with previously treated CLL who have failed fludarabine therapy.
2. To evaluate whether CAMPATH-1H, given as a continuous infusion followed by subcutaneous injections to patients with previously treated CLL will improve tolerability of the agent and permit higher doses to be delivered through that route.
3. To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous infusion followed by a subcutaneous injection.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years (CLL does not occur in the pediatric population).
* Signed informed consent.
* World Health Organization (WHO) performance status of 0, 1, or 2.
* Patients with B-CLL who have received fludarabine and are either refractory to frontline therapy or have relapsed within six months from receiving fludarabine-based therapy. Patients previously treated with Campath-1H are eligible.
* Serum creatinine \<= 2mg/dL, total bilirubin \<= 2mg/dL, and SGPT \<= 3x upper limit of normal (ULN) unless due to direct infiltration of the liver or kidney with malignant cells.

Exclusion Criteria:

* Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
* Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal antibodies for at least 4 weeks prior to study start.
* Pregnant or nursing women or any patient of childbearing age unwilling to practice an acceptable form of contraception.
* Patients with history of HIV positivity.
* Active secondary malignancy.
* Active uncontrolled infection or any major systemic or other illness that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety or interfere with the interpretation of study results.
The Effect of Post Ablation Medroxyprogesterone Acetate on Endometrial Amenorrhea Rates

Heavy menstrual bleeding are a common reason for consultation in gynecology and are defined by International Federation of Gynecology and Obstetrics as the perception of menstrual volume increased regardless of the frequency, duration and regularity. Some studies report that up to 30% of women will suffer from heavy periods during their lifetime. The first line treatment of heavy bleeding is medical. However, a significant proportion of women require surgery. Until the 80s, hysterectomy was one of the only surgical options and often performed as the first line treatment. Since twenty years now the endometrial ablation has become a preferred option for dysfunctional uterine bleeding and avoids hysterectomy in a significant proportion of patients suffering from this type of problem. Endometrial ablation is much less invasive and morbid than hysterectomy, however, many patients do not achieve a complete amenorrhea with endometrial ablation and about 15% may have to require a new intervention, such as hysterectomy, following the persistence of menstrual problems. A Cochrane review published in 2013 showed that the satisfaction rate following endometrial ablation is high at 70-80% and about 35% of women have amenorrhea. The complete destruction of the endometrium is the most important predictor of the success of the procedure. Studies have shown that better results are obtained when the surgery is performed when the endometrium is thin or immediately following menses or following administration of a hormonal agent causes atrophy of the endometrium. One of the agents studied to prepare the endometrium before ablation is medroxyprogesterone acetate (MPA) as injectables (DMPA) and oral. Progestins have an antiproliferative effect on the endometrium. In recent years, numerous studies have examined the use of various agents preoperatively, including MPA and DMPA to facilitate surgery by reducing the thickness of the endometrium. However, few studies have focused on the conditions of the post-operative period to promote the therapeutic response to the intervention. The investigators hypothesis is whether the MPA administered in immediate post-operative would inhibit proliferation of endometrial cells responsible for the persistence of menstruation and optimize the clinical response to endometrial ablation.


Eligibility Criteria:
Inclusion Criteria:

* endometrial ablation planned for eavy menstrual bleeding
* No abnormalities at hysteroscopy
* No evidence of hyperplasia or neoplasia in endometrial biopsy
* Hysterometry of ≤ 10 cm preoperatively

Exclusion Criteria:

* Any indication against MPA
* Intrauterine pathology causing heavy bleeding
* hormonal treatment provided during the postoperative period (during the first 4 months)
* preoperative hormonal therapy with a residual postoperative effect
* breastfeeding
* future pregnancy planned
* menopausal women
* endometrial ablation antecedent
* Suspected pelvic infection
* known Hematologic Disease
* Taking anticoagulant
* Taking progestin in the 6 months before surgery
Access HBV Assays - European Union (EU) Clinical Trial Protocol -

The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.

The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the European Union Common Technical Specification. All samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. Pseudo-anonymised collection of samples will require documented patient consent (oral or written).

Sensitivity to final status on presumed HBV serological marker positive subjects will be calculated. Specificity will be calculated from hospitalized patients and blood donors specimens. False Initial Reactive Rate will be calculated on fresh hospitalized patient samples for Access HBsAg assay only (Qualitative).

Eligibility Criteria:
Inclusion Criteria:

* Subject aged ≥ 18 years,
* Subject who has provided consent (oral or written) or sample collected under waiver
* With sufficient volume to perform clinical trial testing
* And belonging to one of the following enrollment groups:

  * Unselected blood donors
  * Hospitalized patients
  * Presumed HBsAg positive patients by Confirmatory testing of a CE-marked assay
  * Patients having recovered from natural HBV infection, presumed Anti-HBs positive (i.e. Anti-HBs and Anti-HBc Total positive by CE-marked assays)
  * Patients having received HBV vaccination, presumed Anti-HBs positive (confirmed by testing at the time of enrollment, i.e. positive for Anti-HBs and negative for Anti-HBc by CE-marked assays).
  * Presumed Anti-HBc Total positive patients by a CE-marked assay
  * Presumed Anti-HBc IgM positive patients by a CE-marked assay with acute/recent HBV infection 8
  * Presumed HBeAg positive patients by a CE-marked assay
  * Presumed Anti-HBe positive patients by a CE-marked assay
  * Patients with chronic HBV infection

Exclusion Criteria:

* Samples from subjects already included in the study\* (\* Patient can be included only once per HBV marker study, but can potentially be enrolled for several separate HBV marker studies.)
The Efficacy and Safety of Fruquintinib Plus FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic Colorectal Cancer

RAS mutations are found in nearly half of colorectal cancer patients. However, there is no targeted driver gene drugs have been approved for RAS-mutated patients. For RAS mutant metastatic colorectal cancer, the commonly used treatment regimen is bevacizumab combined with chemotherapy.

This is a single-center, open, single-arm study exploring the efficacy and safety of fruquintinib combined with FOLFIRI/FOLFOX in the treatment of RAS-mutated metastatic colorectal cancer (mCRC) who failed standard therapy. Patients will receive fruquinitinib combined with chemotherapy (FOLFOX or FOLFIRI regimens), which depend on the previous chemotherapy regimen (chemotherapy switch).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Histological or cytological confirmed colorectal cancer;
* RAS mutation
* Expected survival \>12 weeks;
* Fail in previous standard therapy, which must include FOLFOX/FOLFIRI;
* ECOG PS 0-1;
* At least one measurable lesion (according to RECIST1.1);
* Adequate hepatic, renal, heart, and hematologic functions;
* Negative serum pregnancy test at screening for women of childbearing potential.

Exclusion Criteria:

* Received other investigational drugs within 4 weeks prior to treatment;
* Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc;
* Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable);
* Severe infection (e.g., requiring intravenous antibiotics, antifungal drugs, or antiviral drugs) within 4 weeks prior to treatment;
* Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
* Patients who had active bleeding or coagulopathy within 2 months before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
* Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction \< 50%, arrhythmia control is not good;
* The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* Allergy to the study drug or any of its excipients;
* The patient is unable to take the drug orally, or the patient has a condition judged by the investigator to affect the absorption of the drug;
* Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;
* Urine routine showed urine protein ≥2+, and 24-hour urine protein level \>1.0g;
* Other conditions deemed by the investigator to be ineligible for inclusion in the study.
The Post-operative Effect of Applying Drainage on Total Knee Arthroplasty

This multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.

This is a multicenter,open-label randomized controlled trail. A total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. Among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.Data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Ready to receive single-side TKA
* Be evaluated as ASA 1-2 degree before operation

Exclusion Criteria:

* coagulation disorder
* peripheral vessel diseases
* contraindication of surgery
Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

This study is designed to evaluate the efficacy and safety of Camrelizumab plus pyrotinib in combination with chemotherapy in patients with HER2-positive gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma.
3. Patients have not received systemic treatment in the past but had disease progression more than 6 months after receiving neoadjuvant therapy or the last of adjuvant therapy could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months.
4. HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with fluorescent in-situ hybridization (FISH+ is defined as HER2:CEP17 ratio≥2.0), as assessed by central review on primary or metastatic tumor.
5. ECOG performance status 0-1.
6. At least one measurable lesion exists as defined by RECIST 1.1 .
7. Life expectancy of more than 12 weeks.

Exclusion Criteria:

1. Hypersensitivity to Camrelizumab, pyrotinib and study chemotherapy agents and/or to any components.
2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, Cluster of Differentiation 137 \[CD137\]).
3. Has an active autoimmune disease that has required systemic treatment in past 2 years.
4. Has a known history of Human Immunodeficiency Virus (HIV) or active hepatitis B and C virus infection.
5. Has had major surgery within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment.
6. Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
7. Evidence or history of coagulation disorders such as a grade ≥ 3 (CTC-AE) bleeding event.
8. Known history of psychotropic substance abuse or drug use.
Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD

This will be an open label study of escitalopram. Patients not responsive to citalopram will be switched directly to escitalopram.

Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they either achieve remission (MADRS \<9) or fail to tolerate the dose.

Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they either achieve remission (MADRS \<9) or fail to tolerate the dose.

Visit 1 - (Initial visit) - escitalopram 10 mg Visit 2 - (Week 2) - escitalopram 20 mg Visit 3 - (Week 4) - review visit Visit 4 - (Week 6) - MADRS \<12 - continue 20 mg MADRS \>12 - escitalopram 30 mg Visit 5 - (Week 8) - MADRS \<8 - continue current dose MADRS \>8 - escalate dose (20 mg to 30 mg or 30 mg to 35mg)

Thereafter, Patients who have achieved remission will be maintained on the remission dosage and reviewed at four weekly intervals. At any subsequent visit where the MADRS is \>8 they will have a dosage increase

Patients who have not achieved remission will have dosage escalated by 5 mg at two weekly intervals until remission, a maximum dose of 50 mg is achieved or the dosage is intolerable when they will be reduced to the previous tolerable dose.

Patients will be followed up until eight months from their initial visit.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent will be obtained from each patient
* aged 18 to 65 inc
* suffering from MDD as defined by DSM IV
* have been taking citalopram in a dose of at least 20mg for at least six weeks
* an inadequate response -- defined as failure to achieve a MADRS score of \<12

Exclusion Criteria:

* Significant other psychiatric disorder which would interfere with trial assessments. Co-morbid generalized anxiety disorder (GAD) and panic will be permitted where MDD is considered the primary diagnosis .
* history of mania or bipolar disorder
* Known contraindication for the use of citalopram or escitalopram.
* Significant bleeding disorder
* Prominent suicidal ideation (score more than 4 in the MADRS "suicidal thoughts" item)
* Alcohol or substance dependence in the past 6 months
* Major physical illness
* Significant liver or renal function abnormality
* Significant ECG abnormalities
* Pregnant or lactating females
* Inadequate contraception
Comparison Of Coughing and Active Cycle of Breathing Technique to Improve Pulmonary Functions in Post-Surgical Patients

To find out the Comparison Of Coughing and Active Cycle of Breathing Technique to Improve Pulmonary Functions in Post-Surgical Patients


Eligibility Criteria:
Inclusion Criteria:

* Both male and female between the age of 18-50 years who reported post-surgical complications related to pulmonary will be selected in this study

Exclusion Criteria:

* If patient is unresponsive, psychologically disturbed and does not want to participate, teenagers will be excluded from this study
Effect of a Program of Deep Inspiration Combined to Expiratory Positive Airway Pressure in Asthmatic

The purpose of this study is to determine the effects of a deep inspiration combined to expiratory positive airway pressure protocol on respiratory function, quality of life, exercise tolerance and heart rate variability in adults with severe asthma.

Asthma is associated with high morbidity and significant mortality. This disease has functional impact on activities of daily living (ADLs) and according to some studies in the United States and Europe, the percentage of asthmatics who have significant restrictions in their ADLs is quite significant. Asthma is characterized as a major public health problem, not only in Brazil but worldwide. Currently there are few studies reporting the effects of a domiciliary program of deep inspiration associated with positive expiratory pressure in the airways of asthmatics. This study aims to analyze the benefits of this program on lung function, quality of life and response to exercise.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 80
* Severe asthma

Exclusion Criteria:

* Disagreement with consent form
* Other respiratory disease
* Acute severe asthma
* Pregnancy or breastfeeding
* Current smoking
* Lack of capable of conducting the study visits
The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism

Despite the strong association of hyperparathyroidism with arachidonic acid related lipid signals, little research has been performed over the years. A better understanding of the link between arachidonic acid remodeling, prostaglandin and endocannabinoid production with primary hyperparathyroidism in primary tissue/cells might open up new avenues for biomarker and thus to a potential therapeutic target.

Arachidonic acid remodeling might also have an impact on depression and elevated cytokines in patients with primary hyperparathyroidism. The investigators therefore will assess the correlation between postoperative improvement of PHQ-9 and cytokine levels with arachidonic acid remodeling.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Primary hyperparathyroidism with planned surgery
* Written informed consent

Exclusion Criteria:

* Age \<18 years
* Secondary/tertiary hyperparathyroidism
* Renal insufficiency
* Participant is pregnant
* Participant is incapable of giving an informed consent
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety

The incidence of cesarean deliveries (CD) worldwide is increasing, around 30% in United States. Although very common surgery women undergoing non emergent CD still experience fear and anxiety. It is known that increased levels of stress can negatively affect pain perception and the usage of analgesics postoperatively as well as lactation.

this present study investigate the effect of exposure to informative video before cesarean delivery on maternal anxiety.

A multi-center randomized control trial the will examine the effect of exposure to informative video before cesarean delivery on maternal anxiety and satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Hebrew speaking
* Informed consent
* First cesarean delivery
* Non emergent elective CD

Exclusion Criteria:

* Non Hebrew speaking
* Refuse to participate
* Emergency CD
DONATE-Pilot Study on ICU Management of Deceased Organ Donors

The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that observes the ICU management of consented deceased organ donors at 4 high volume centres over a period of 12 months each. The pilot study will be followed by a 1-year prospective national observational study a 15-20 ICUs across Canada.

This prospective observational cohort pilot study enrols consented organ donors admitted to 4 high volume centres over a period of 12 months. Various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery.

The main objectives of the DONATE-Pilot reflect the objectives of the national study which correspond to the steps in developing a platform for future clinical trials.

1. Form research teams at participating ICUs that will include an ICU physician-researcher, a local organ donation champion, ICU research coordinators and (in a limited role) a local coordinator from the provincial Organ Donation Organization (ODO);
2. Observe, record, and describe ICU practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future RCTs.
3. Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.
4. Investigate the comparative effectiveness of various ICU interventions in deceased donor care (e.g. the potential for hormonal therapies to improve transplant rates, the potential of heparin therapy to improve peri-operative graft function);
5. Produce specific knowledge translation tools that will serve in the future as both clinical tools to enhance ICU care and research tools to facilitate future RCTs.

As part of the DONATE-Pilot we also aim to assess feasibility. Specifically the objectives are to:

1. Refine data collection procedures for deceased donors in ICU;
2. Estimate time requirements for data collection;
3. Develop efficient links to post-transplantation data and;
4. Share data as it accrues with clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to a critical care area (ICU, PICU, CCU, ER)
* Consented deceased organ donors (DND and DCD)

Exclusion Criteria:

* Neonate \<36 weeks gestation