cyrilzakka/clinical-trials huggingface dataset:
MEDAM (Menopur Retrospective Data prograM)

French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.


Eligibility Criteria:
Inclusion Criteria:

- Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016

Exclusion Criteria:

* Ovulation inductions
* Intra-uterine inseminations
* Fertility preservations
* Oocyte donations
Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction

Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent cognitive deficits with or without evoking postoperative delirium. In animal trials various anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular substance of pathophysiologic brain tissues of demented patients. The amount of those markers seems to correlate well with the degree of dementia \[1\]. In contradiction, a single study indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic depth is deep \[2\]. Unfortunately the study did not sum up the amount of anesthetic drug load, since this would have clarified if the amount of anesthetics used is associated to POCD and dementia. Another possibility is that stress and noxious stimulation induced by light anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit memory.

The investigators' prospective randomized trial is underway to verify the impact of anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90 day period.

The investigators' hypothesis is that the incidence of POCD and delirium and the degree of early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the BIS- guided anesthesia group with the superficial but sufficient anesthesia level.


Eligibility Criteria:
Inclusion Criteria:

* adults older than 70 years
* major surgery ( spine, orthopedic, urologic, gynecology, abdominal)

Exclusion Criteria:

* adults younger than 71 years
* major blood loss surgery
* allergy to soja oil, nuts, other ingredients of propofol
* patient wants to have spinal or regional anesthesia only
Cognitive Behavioral Therapy (CBT) Pain Prevention Intervention for Women Undergoing Surgery

This study investigates a Cognitive Behavioral Therapy (CBT) intervention for women who are undergoing elective surgery. The objective is to provide a toolkit of stress management techniques to decrease pain and opioid use following surgery.

The Investigators are doing this research to understand whether a pre-surgery virtual cognitive behavioral therapy (CBT) group intervention combined with an activity tracker can reduce pain and opioid use in women with chronic stress undergoing elective spine surgery.

Participants will be randomly divided in two groups and one of the groups will be invited to attend four weekly virtual CBT group sessions designed to improve reactions to stress, increase motivation for physical activity, develop tools for managing pain, and utilize mindfulness techniques. Two optional sessions will be available following surgery. Individuals randomized to usual care will not attend the online sessions but will continue to wear the activity tracker to provide information about their physical activity as well as the use of an App to track their pain and medication use.

The ultimate goal of this research is to enhance stress management and coping skills to help patients better manage pain after surgery and reduce their need for opioid medications.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Female Gender
3. Patients own a compatible smartphone (iPhone or Android) or tablet and can download the Fitbit app on their device
4. Planned elective spine surgery

Exclusion Criteria:

1. Cognitive impairment (judged to interfere with study participation)
2. Male gender
3. Non-English speaking
4. Pain conditions requiring urgent surgery
5. A diagnosis of cancer
6. A present psychiatric condition (e.g. DSM diagnosis of schizophrenia, delusional disorder, psychotic disorder or dissociative disorder) that would be judged to interfere with the study
7. Visual impairment or motor impairment that would interfere with study participation
To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer

The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer

Androgen Deprivation Therapy (ADT) is an important systemic therapy for prostate cancer, which plays a vital role in the treatment of various stages of prostate cancer. Gonadotropin-releasing hormone (GnRH) agonists are the most commonly used ADT treatment，including leuprolide, goserelin, and triptorelin. The goserelin implant (Zoladex®) 3.6 mg is administered subcutaneously every 28 days into the anterior abdominal wall using a pre-filled syringe with a 16G needle (outer diameter 1.6 mm), while the Goserelin microsphere (LY01005) 3.6 mg is administered every 28 days by intramuscular injection using a 21G injection needle (outer diameter 0.8 mm). Phase III study (NCT04563936) have confirmed the similar efficacy and safety between the two drugs, but patient preference for both are unknown.

The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients older than 18 years
2. Histologically confirmed prostate adenocarcinoma
3. Suitable for ADT treatment
4. ECOG≤2
5. Prior treatment without GnRH agonists
6. Expected survival \>1 year
7. Good compliance
8. Adequate organ or bone marrow function as evidenced by:

   * Hemoglobin \>/= 10 g/dL
   * Absolute neutrophil count \>/=1.5 x 109/L,
   * Platelet count \>/=100 x 109/L,
   * AST/SGOT and/or ALT/SGPT \</=1.5 x ULN;
   * Total bilirubin \</=1.5 x ULN,
   * Serum creatinine \</=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded

Exclusion Criteria:

1. Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for \< 6 months and discontinued for more than 6 months were allowed
2. Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions
3. A history of cardiovascular events, uncontrolled hypertension, gastrointestinal disease that interferes with treatment absorption, active viral hepatitis, or human immunodeficiency infection (HIV) within the past 6 months
4. Any medical conditions that the investigators believe make the patient ineligible to participate in the study
Self-acupressure and Zhan Zhuang for Symptom Cluster Management

The proposed study will be a 3-arm, parallel-group randomized controlled trial on the effects of self-acupressure and Zhan-Zhuang for alleviating pain, fatigue, and sleep disturbance in breast cancer survivors. Subjects will include 54 breast cancer survivors who have experienced a moderate level of pain, fatigue and sleep disturbance. All eligible subjects will be randomized into one of the three groups in a 1:1:1 ratio: Zhan Zhuang group, or self-acupressure group, or wait list control group. Subjects in the Zhan-Zhuang group will receive up to 8 weeks of the intervention consisting of a training course over two weeks followed by self-practice for 6 weeks. Those in the self-acupressure group will attend an acupressure training course for two weeks and then, will be asked to practice self-acupressure for 6 weeks. The wait list control group will be provided with delayed self-acupressure or Zhan Zhuang at the end of the study. Outcome assessment will be conducted at baseline, week 8 (post-intervention) and week 12 (4 week follow-up). Primary outcomes include pain, fatigue and sleep disturbance. Secondary outcomes include psychological distress and health-related quality of life. Qualitative data will be collected from selected participants who have received the intervention.


Eligibility Criteria:
Inclusion Criteria:

* a female adult aged 18 and older;
* a diagnosis of early-stage (Stage I, II, or III) breast cancer;
* completion of surgery, and/or chemotherapy and/or radiotherapy;
* have at least a moderate level of pain, fatigue and sleep disturbance as measured on 0-10 numerical rating scales, with a score of ≥ 3 for each symptom during the past one month;
* willing to use WhatsApp messenger for follow-ups;
* being able to communicate in Chinese

Exclusion Criteria:

* prior use of acupuncture, acupressure, Zhan Zhuang, or other types of Zhan Zhuang within the past three months;
* currently receiving progressive muscle relaxation, mindfulness-based stress reduction, and other body mind exercise (e.g. yoga) for the treatment of pain, fatigue, and sleep disturbance;
* mentally incapable of participating in the study as indicated by the Hong Kong version of Montreal Cognitive Assessment score;
* inability to perform self-care as indicated by the Karnofsky Performance Scale score\<70
A Structured Walking Program or Standard Therapy in Cancer Patients Undergoing a Donor Bone Marrow Transplant

RATIONALE: A walking program may improve the ability to carry out daily activities after donor bone marrow transplant.

PURPOSE: This randomized clinical trial is studying a structured walking program to see how well it works compared with standard therapy in cancer patients undergoing a donor bone marrow transplant.

OBJECTIVES:

Primary

* Compare the effects of a structured walking regimen vs normal standard care on functional status at day 100 after allogeneic bone marrow transplantation in patients with cancer.

Secondary

* Compare the effects of these regimens on patient survival at day 100 and at 1 year after transplantation.
* Compare patient satisfaction with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention arms.

* Arm I: Beginning 2-3 days after allogeneic bone marrow transplantation, patients walk on a treadmill or in the hospital hallways twice daily for ≥ 15 minutes. After discharge and continuing for up to 100 days post-transplantation, patients walk once daily for ≥ 30 minutes. Patients record their walking times daily in a journal.
* Arm II: Patients receive no special instructions regarding exercise other than the normal standard of care.

All patients complete questionnaires at discharge and at day 100 post-transplantation measuring daily exercise activities, satisfaction with the recommended walking regimen, and functional status.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following malignancies:

  * Acute lymphocytic leukemia
  * Chronic myelogenous leukemia
  * Acute myeloid leukemia
  * Hodgkin's lymphoma
  * Non-Hodgkin's lymphoma
  * Myelodysplastic syndromes
  * Other malignancy
* Undergoing concurrent allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

* Able to walk

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma

The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.

This study is designed as a randomized phase II study. Patients will be randomized between current standard of care treatment (Arm 1) vs. TOS (Arm 2) in a 1:1 ratio. Additionally, patients will be stratified according to T stage (T1 vs. T2); N stage (N0/1 vs. N2/3)

The randomized phase II design is required for three reasons:

1. The randomization will provide an appropriate control group to serve as a comparator for the experimental arm. Historical or contemporaneous non-randomized controls would not be appropriate due to the multitude of biases that could be introduced by patient selection and other confounders.
2. A small sample size will allow for adequate power to assess for progression-free survival, and also an assessment of quality of life, overall survival and toxicity.
3. The results will allow for a decision as to whether a multi-institutional phase III trial is warranted, and inform the design of such a trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed squamous cell carcinoma
* HPV-negative tumor, as determined by: negative p16 status, real time PCR or in-situ hybridization. Central confirmation is not required prior to randomization. Equivocal/uncertain HPV status will be allowed on trial.
* Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
* Tumor stage: T1 or T2, with likely negative resection margins at surgery
* Nodal stage: N0-3. Patients with positive nodal disease and extranodal extension on imaging may be included at the surgeon's discretion, if the nodal disease is deemed resectable by the operating surgeon.
* Eligible for curative intent treatment, with likely negative resection margins at surgery. For patients where adequate transoral access is in question, they will first undergo an examination under anesthesia prior to randomization to ensure adequate exposure can be obtained.
* Blood work obtained within 4 weeks prior to randomization, with adequate bone marrow function, hepatic, and renal function, as determined by the investigator.
* Patient assessed by a radiation oncologist and surgeon and presented at multidisciplinary tumor board prior to randomization. If not feasible, case can be discussed with study Principal Investigator.

Exclusion Criteria:

* Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
* Prior history of head and neck cancer within 5 years
* Prior head and neck radiation at any time
* Metastatic disease
* Inability to attend full course of radiotherapy or follow-up visits
* Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
* Unable or unwilling to complete QOL questionnaires
* Pregnant or lactating women
Effects of a Mediterranean Style Diet on Vascular Health in Type 2 Diabetes

In this study we will compare the effects of a Mediterranean diet, high in fruit and vegetables with the more conventional diet recommended for diabetes therapy (a high carbohydrate, low fat diet) on glycaemic and lipid control and on markers of inflammation, in people with newly diagnosed Type 2 diabetes. The hypothesis is that, over a six-month intervention period, a HVM diet will be more effective than a conventional HCLF diet in improving glycaemic and lipid control, and in reducing markers of vascular inflammation in people with Type 2 diabetes.

Chronic inflammation affecting both small and large blood vessels is an important factor increasing the risk of heart disease in people with Type 2 diabetes. Good markers present in the blood are now available to detect this inflammatory state. Recent evidence suggests that a Mediterranean-type diet, high in plant foods and with monounsaturated fat from olive oil has beneficial effects on blood vessels as well as on blood glucose and blood lipid control.

In this study we will compare the effects of a Mediterranean diet, high in fruit and vegetables with the more conventional diet recommended for diabetes therapy (a high carbohydrate, low fat diet). Twenty-four people with Type 2 diabetes will be randomised to one of these diets and followed for six months. At the end of this time, the effect of the diets on markers for inflammation will be compared.

Eligibility Criteria:
Inclusion Criteria:

-English speaking people with newly diagnosed Type 2 diabetes (within 3-12 months of diagnosis) who are attending the Alfred Hospital, Diabetes Education Outpatient Clinic.

Exclusion Criteria:

* age \<30 years or \> 75 years;
* body mass index (BMI) \< 25 kg/m2 or \>37 kg/m2;
* on corticosteroid or insulin therapy;
* presence of established renal and/or liver disease (serum creatinine more than 0.12 mmol/L/albumin excretion rate greater than 300 µg per minute or ALT more than twice the upper limit of normal respectively).
Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and female of non-childbearing potential;
* Body Mass Index 17.5-30.5 kg/m2;
* Body weight \>50 kg;

Exclusion Criteria:

* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing
Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer

To explore whether adding olanzapine to paclitaxel chemotherapy could improve chemotherapy tolerance and improve patient quality of life and prolong treatment failure time (TTF) in advanced gastric cancer after failure of first-line chemotherapy.

This is a multi-center prospective randomized controlled open clinical study. Patients will formally be enrolled after they had been screened and signed informed consent. Baseline examinations will be started after entry into the group. Those who meet the criteria for inclusion and exclusion were dynamically randomized at 1: 1. The experimental group will receive olanzapine and paclitaxel until treatment failure and the control group will receive paclitaxel until treatment failure.


Eligibility Criteria:
Inclusion Criteria:

1. Sign written informed consent;
2. Age more than 18 years of age;
3. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
4. Locally advanced recurrent or metastatic disease;
5. Have received systemic first-line chemotherapy and confirmed first-line treatment failure (platinum combined with fluorouracils);
6. Subjects' baseline blood routine and biochemical indicators meet the following criteria Hemoglobin ≥90g/L The absolute neutrophil count (ANC) is ≥1.5×10\^9/L. Platelets ≥100×10\^9/L ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastasis) ALP≤2.5 times normal upper limit, ≤ 5 times normal upper limit (with liver or bone metastases) Serum total bilirubin \<1.5 times normal upper limit Serum creatinine \<1.5 times normal upper limit Serum albumin ≥30g/L
7. KPS score ≥ 60 points;
8. Life expectancy ≥ 3 months.

Exclusion Criteria:

1. Does not meet the above selection criteria;
2. The first-line treatment uses paclitaxel-based drugs;
3. Pregnancy and lactation women;
4. Allergies to research drugs or people with metabolic disorders;
5. History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
6. Those who have been receiving systemic steroids for a long period of time (Note: Short-term users may be discontinued \>2 weeks for inclusion);
7. Brain metastasis;
8. With severe infections need treatment;
9. Accompanied by dysphagia active peptic ulcer complete or incomplete intestinal obstruction active gastrointestinal bleeding perforation etc;
10. Severe liver diseases (such as liver cirrhosis etc.) kidney disease respiratory diseases or chronic diseases such as diabetes high blood pressure that cannot be controlled;
11. Having other malignant tumors within 5 years except non-melanoma skin cancer and cervical cancer in situ;
12. Heart disease with markedly abnormal electrocardiogram or clinical symptoms such as congestive heart failure marked coronary heart disease uncontrolled arrhythmia high blood pressure or previous myocardial infarction within 12 months or cardiac function Class III or IV.
An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation

Objective(s):To investigate the efficacy and safety of afatinib in EGFR, HER 2 and HER3 mutated cancers, regardless of cancer type, excluding EGFR mutated non-small cell lung cancer.

Methodology:Open label, genomic driven trial (basket trial)

No. of patients total entered:Optimal Simon two stage design for the three genetic driven cohorts: 10 patients will be enrolled per cancer type in the first stage and an additional 19 in the second stage (maximum total 87 patients)

Indication : cancers harbouring an EGFR mutation(excluding non-squamous non- small cell lung cancer, a registered indication), a HER2 mutation or a HER3 mutation

Test product(s) : Afatinib At progression paclitaxel will be added for those patients that have no contra-indications

dose: Starting dose of afatinib at 40 mg/day. Dose increase to 50 mg in the absence of adverse events. Stepwise dose reduction to 30,20, 10 mg/day according to drug-related adverse events.

At progression, addition of paclitaxel 80 mg/m2 weekly 3w/4 to afatinib 40 mg/day .

mode of admin. : Oral for afatinib Intravenous for paclitaxel

Duration of treatment: Continuous treatment until progression or unacceptable adverse events or withdrawal of consent.

At disease progression, add paclitaxel until progression or unacceptable adverse event or withdrawal of consent if no contra-indications.

Criteria for efficacy: Primary Endpoint:

• Response rate (CR+ PR) via RECIST v1.1

Secondary Endpoints:

* Disease control rate (CR+PR+SD)
* Progression free survival
* Overall survival
* To correlate tumor response with findings on tumor biopsies
* To investigate resistance mechanisms
* response rate (CR+ PR) determined by RECIST and progression free survival on the combination therapy of afatinib and paclitaxel

Criteria for safety: Incidence and intensity of adverse events according CTCAE v4.0


Eligibility Criteria:
Inclusion Criteria:

* Women and men with locally advanced or metastatic cancers harboring either an activating EGFR mutation or a HER2 mutation or a HER3 mutation
* Failure of at least one line of standard systemic therapy
* No eligibility for other open genomic driven phase I, II or III trial available for these tumor genotypes
* ECOG performance status ≤2
* Patient with a life expectancy \>3 months
* Patients able to provide written informed consent prior to enrollment into the clinical trial.
* Adequate organ function

Exclusion Criteria:

* Non squamous non-small cell lung cancer harbouring an EGFR mutation (registered indication)
* Chemotherapy, biological therapy or investigational agents within four weeks prior to the start of study treatment
* Known hypersensitivity to afatinib or the excipients of any of the trial drugs
* Prior treatment with afatinib