cyrilzakka/clinical-trials huggingface dataset:
Alternative Treatments for Menopausal Women

To investigate the reported health benefits (lipid profile, inflammatory factors, cardiovascular status and bone density) of a novel, phytoestrogen rich, Red Clover treatment on women suffering from both menopause related primary (hot flushes, night sweats, sleep disturbance and weight gain) and secondary (osteoporosis, cardiovascular and changes in lipid metabolism) symptoms.

Menopausal symptoms are a common phenomenon causing discomfort to many middle aged women throughout the world. The core symptoms are experienced as hot flushes (HF), night sweats, vaginal dryness and sleep disturbance. Other secondary symptoms are sexual dysfunction, depression, anxiety, memory loss, fatigue, headache, joint pains and weight gain. Moreover there is increased risk of further complications such as osteoporosis, cardiovascular and negative changes in lipid profile associated with the reduction in oestrogen during and post menopause.

Trifolium Pratense or Red Clover (RC) has arisen as a popular source for women experiencing HF because it contains a variety of phytoestrogen's, namely isoflavones, lignans and coumestans. Phytoestrogens are shown to have positive effects on menopausal disorders such as breast cancer, cardiovascular risk factors, osteoporosis and have been shown to exert non-hormonal antioxidant effects. Additionally these isoflavones appear to reduce bone resorbtion, help maintain bone mineral density and improve lipid profile (reducing LDL: HDL, lipoprotein A, total cholesterol and may also reduce triglycerides).

RC is particularly high in estrogenic isoflavones biochanin A, formononetin and to a lesser degree genestein and diadzein, although the two former are precursors to genestein and diadzein. Asian populations with a high intake of soy (rich in genestein and diadzein) have long shown a lower reported incidence of the symptoms of menopause.

The study will be carried out as a 3-month parallel randomized control intervention study, consisting of 61 menopausal women. During summer 2012, 61 participants will be randomised into 2 groups (\~30-31 in each group). The two groups are as follows:

1. Menopausal women receiving RC treatment - 150ml/d Red Clover (80mg/d of isoflavones as aglycone)
2. Menopausal women receiving placebo - 150ml placebo

Eligibility Criteria:
Inclusion Criteria:

* Women aged 40-65 years
* Experiencing daily hot flushes
* Body Mass Index (BMI) between 20-40
* Irregular menstrual bleeding
* FSH levels above the normal range

Exclusion Criteria:

* Simultaneous participation in other clinical trials within the last 3 months
* Severe cardiovascular, psychiatric, neurological, and/or kidney disease.
* Alcohol or drug abuse and acute illness.
* Blood pressure \> 160/110
* Pregnant and lactating women
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC

The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented metastatic non-squamous NSCLC.
* Has relapsed from or is refractory to at least one-line of anticancer treatment.
* Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing.
* WHO or ECOG performance status of 0 or 1.
* Presence of at least one measurable lesion assessed by the investigator based on RECIST 1.1.
* LVEF ≥ 50% within 28 days before enrolment.

Exclusion Criteria:

* Mixed small cell lung cancer, squamous histology NSCLC, and sarcomatoid histology variant NSCLC.
* Corrected QT interval (QTcF) prolongation to \> 470 ms (females) or \> 450 ms (males), based on average of the screening triplicate 12-lead ECG.
* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to Grade ≤1 or baseline. Participants with clinically stable chronic Grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the AstraZeneca study physician or designee.
* Has been previously treated with HER2-targeted therapies, except for pan-HER class TKIs or has received prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.
Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France

Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication.

The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy.

Numerous centers of the French research group of the national association of the hepatologists and gastroenterologists from general hospitals (ANGH) will be part of this study. Patients treated with baclofen for alcohol -dependence will be enroll prospectively from 2014 and retrospectively if they were treated between 2012 and 2014. The reported alcohol consumption, biological markers of excessive alcohol, initial and usual baclofen dosage, blood balofen dosage as well as clinical data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years old
* patient treated with baclofen therapy after 2012 for alcoholo-dependance

Exclusion Criteria:

* Baclofen therapy before 2012
* patient who refuse to participate
Clinical Study of rhTPO in Hematopoietic Stem Cell Mobilization for Autologous Transplantation in Acute Leukemia

Evaluation of the efficacy and safety of recombinant human thrombopoietin (rhTPO) at 300 U/kg/day for hematopoietic stem cell mobilization in autologous transplantation among acute leukemia patients


Eligibility Criteria:
Inclusion Criteria:

1. Age 18～65 years, regardless of gender.
2. Histopathologically confirmed acute leukemia with immunohistochemical validation
3. Sustained complete hematologic remission with documented minimal residual disease (MRD) negativity.
4. Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
5. No active infectious disease; no severe organ failure.
6. Willingness to participate with written informed consent for study enrollment.

Exclusion Criteria:

1. Liver dysfunction (alanine aminotransferase or bilirubin greater than two times the normal upper limit).
2. Renal dysfunction (creatinine or urea higher than 1.5 times the normal upper limit).
3. Any disease that could put patients at high risk, including but not limited to unstable cardiac disease, uncontrolled atrial fibrillation or hypertension, severe diabetic retinopathy
4. rhTPO aller- gies.
5. Severe prior thrombosis-event.
6. History of other malignancy, unless cured for more than 3 years
7. Pregnant or lactating women
8. Severe infectious disease (uncured tuberculosis, pulmonary aspergillosis)
9. Epilepsia, dementia or any mental disease requiring treatment.
10. Other conditions deemed inappropriate for study participation by the investigator.
Drug-eluting Balloon in Acute Myocardial Infarction

The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function.

The goals of this study are:

1. To compare 6-month angiographic outcome after primary angioplasty using drug eluting balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.
2. To compare stent apposition and stent endothelialization after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
3. To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.


Eligibility Criteria:
Inclusion Criteria:

* STEMI within 12 hours of onset of complaints
* Candidate for primary PCI with stent-implantation
* Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow more or equal 1

Exclusion Criteria:

* Unable to give written informed consent
* Diabetes and Type C- coronary lesion
* Previous PCI or CABG of infarct related vessel
* Left main stenosis more than 50%.
* Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
* Target vessel reference diameter less than 2.5 and more than 4.0 mm
* Target lesion length more than 25 mm
* Intolerance for aspirin or clopidogrel
* Life expectancy less than 12 months
* Women with child bearing potential
Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.

Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective urologic laparoscopy surgery.

Exclusion Criteria:

* Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents.
* Cases in which surgical gauzes were used, including conversion to open surgical technique. - Patients who have received transfusions of RBCs during the perioperative period.
* Patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of blood loss.
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.

Eligibility Criteria:
Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females
2. Age ≥18 years
3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
4. Serum phosphorus ≥6.0 mg/dL for study entry
5. Taking less than 3-18 pills/day of current phosphate binder
6. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
7. Willing and able to give informed consent
8. Life expectancy \>1 year

Exclusion Criteria:

1. Parathyroidectomy within six months prior to Screening
2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
3. History of multiple drug allergies or intolerances
4. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
5. Previous intolerance to oral ferric citrate
6. Intolerance to oral iron-containing products
7. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
8. Inability to tolerate oral drug intake
9. Intolerance to calcium acetate and sevelamer carbonate
10. Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
11. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
12. Inability to cooperate with study personnel or history of noncompliance
13. Unsuitable for this trial per Investigator's clinical judgment.
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.

Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Age \>18 years
* HbA1c 6.5-8,5%

Exclusion Criteria:

* Pregnancy
* Lactation
* Acute infection
* Liver disease
* Treatment with cortisol
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life

Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS

Quality of life and risk factors for developing major LARS are explored using the EORTC QLQ C30. Therapeutic options were explored in the cohort experiencing major LARS

Eligibility Criteria:
Inclusion Criteria:

* low anterior resection for rectal cancer between 2006-2016
* Adults

Exclusion Criteria:

* abdomino perineal resection
* patients who do not understand Dutch
Lifestyle Modification in Psoriatic Patients With Fatty Liver

Several recent reports have shown an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in those with psoriasis, which may reflect the increased occurrence of metabolic syndrome in this patient population.

the recruitment of 60 fatty live men with chronic disease, psoriasis, will be classified to lifestyle modification group (foe 12 weeks, this patients will take supervised energy or diet restriction program plus their usual immunosuppressive drugs ) and control group will continue their drug program only)

Eligibility Criteria:
Inclusion Criteria:

* psoriasis obese patients with coexisting fatty liver
* chronic plaque psoriasis
* patients who will not show any change in immuno-modulating psoriasis therapies for at least five months before participation in the study.

Exclusion Criteria:

* no metabolic syndrome
* no renal or cardiac or pulmonary disorders
* other types of psoriasis
A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab vedotin in combination with rituximab.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 12 weeks
* History of one of the following histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), Grade 3b follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
* All participants (NHL and B-cell chronic lymphocytic leukemia \[B-CLL\]) must have at least one bi-dimensionally measurable lesion
* For all men or women of childbearing potential (unless surgically sterile): use of adequate methods of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly

Exclusion Criteria:

* Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
* Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse events from any previous treatments must be resolved or stabilized prior to Cycle 1, Day 1, except for neuropathy
* Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
* Prior allogeneic stem cell transplant
Educational Storytelling, an Innovative Interdisciplinary Program Against Child Maltreatment

Educational Storytelling, an Innovative Novel Interdisciplinary Program Against Child Maltreatment, is developed for dental personnel. The program aims at increasing dental personnels ability to detect, report and treat patients being victims of child abuse or neglect.

The objectives of the program is to contribute to the fulfillment of the Norwegian:

* Dental health services act

  §1-3 c The dental health service responsibility to prevent, detect and avert violence and sexual abuse
* Health Personnel act §33 Obligation to report suspected cases of child maltreatment to child welfare services.

The Educational Storytelling program aims to increase the dental health personnels knowledge and competence related to:

* Detecting child abuse and neglect.
* Reporting suspected cases of child maltreatment to child welfare services.
* Treatment of patients with known and unknown history of child abuse and neglect, trauma sensitive dental treatment.

The aim of this trial is to evaluate if the educational program has any effect.

Educational Storytelling, an Innovative Novel Interdisciplinary Program Against Child Maltreatment, is a blended mode learning tool. The program combines a digital platform including documentary film, expert interviews and research findings with on site teaching, group work, reflections and discussions delivered by moderators. The program has a collective focus, contributing to the development of a shared understanding and social norm at the workplace.

The digital program consists of 7 chapters which covers different topics.

1. Introduction.
2. Documentary film, All that I am.
3. The dental health personnels role in detection of child abuse, and neglect.
4. Trauma sensitive treatment.
5. Learn more about trauma.
6. Childrens advocacy center and ethical platform for professionals.
7. Wrapping up.

The chapters include interview with different experts, group work, reflection tasks, research findings and supplementary material.

Each program participant gets an unique access to the digital program for two years.

The programs estimated completion time, including lunch is 7,5 hours. The program gives 6 continuing education credits from the Norwegian dental association (Norsk tannlegeforening) .

The educational program has been developed based on research findings from the public dental health service in Norway, in regard to their experience with detection of child abuse and neglect, reporting to and collaborating with child welfare services.

In order to measure if the program has any effect, a cluster randomized controlled trial has been conducted.

Eligibility Criteria:
Inclusion Criteria:

Working in the public dental health service in Vestland county

-

Exclusion Criteria:

Not working in the public dental health service in Vestland county
Diagnosis of Primary Ciliary Dyskinesia

Primary ciliary dyskinesia is an inherited respiratory disease caused by various functional and ultrastructural abnormalities of respiratory cilia. The genetic heterogeneity underlying PCD is extremely important and only few genes are clearly implicated in PCD. Their mutations account for about 20% of patients. For all the other PCD patients, the genes responsible for their ciliary defect remain to be identify.

1/ Evaluating the frequency of mutations of the two main genes implicated in PCD, in a large cohort of patients with PCD confirmed by ciliary investigations.2/ Identifying and testing new candidate genes responsible not only for typical PCD and related disorders of the axoneme, but also for so far-unexplored "syndromic forms of PCD", taking advantage of data obtained through comparative genomic approaches between different species, ciliated or not.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected or confirmed primary ciliary dyskinesia after ciliary investigations who accepted to participate to the genetic studies.

Exclusion Criteria:

* Patients with exclusion of primary ciliary dyskinesia after ciliary investigations.
Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals in Breast Cancer

This research study will examine how patients with advanced breast cancer and their oncology team communicate and plan ongoing care.The purpose of this study is to find out more about care planning during advanced breast cancer. The study will see if certain aspects of communication make a difference in how patients understand their illness.

The new communication practice (T-PAT) is a team approach for discussing prognosis and treatment goals. T-PAT is specifically designed to a) increase understanding of the prognosis and treatment goal, b) decrease illness uncertainty, and c) help the patient preserve hope for the future.This dedicated clinical visit features a structured discussion of prognosis, treatment goals and options, and end of life concerns. The planned team discussion will include information contributions for the treating medical oncologist, an oncology nurse and social worker who currently work together to provide breast cancer care.

Primary Objectives:

1. Assess the feasibility of implementing the T-PAT prognosis discussion intervention.
2. Compare the effects of T-PAT vs. usual care on pertinent patient reported outcomes including: a) understanding of the prognosis and treatment goal, b) illness uncertainty, and c) hope.

   * First, a survey will be administered to patients in the waiting room before the next office visit. This should take 15-20 minutes.
   * The second part involves participating in a scheduled appointment that will be audio-recorded and focus on sharing information about the patient's illness. Patients will be randomized to either participate in an appointment featuring new communication practices (T-PAT)or a regular care appointment.
   * The third part involves a 20 minute survey, after the appointment, with a member of the study staff. This will take place over the telephone one or two days after the appointment.
   * The fourth part is completion of a written reflection on the patients participation in the study, which will be returned in a pre-addressed, stamped envelope. Generally, this should take about 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Women newly or currently diagnosed with stage 4 or recurrent breast cancer
* Patients of Dr. Paula Silverman at Seidman Cancer Center
* Ambulatory
* Able to understand and participate in a discussion about their disease progression

Exclusion Criteria:

* Hospitalized
* Unable to speak English
* Unable to attend an office visit
* ECOG performance score of \>3