cyrilzakka/clinical-trials huggingface dataset:
Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.

In vitro fertilisation is the only current reasonable treatment for unexplained infertility. Uterine flushing, associated with a five-fold increase in pregnancy when performed preovulatory, has been proposed as a new alternative. This treatment could flush out debris or alter inflammatory factors preventing fertilisation and implantation. The objective of this study is to assess the efficacy of pre-ovulatory uterine flushing with physiological saline for the treatment of unexplained infertility. This study is a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least one year. The day of their luteinizing hormone surge, 192 participants will be randomised in two equal groups to either receive 20 millilitres of physiological saline by an intra-uterine catheter or 10 millilitres of saline intravaginally. Investigators will assess relative risk of live birth (primary outcome), as well as pregnancy over one cycle of treatment. Side effects, complications, and acceptability of the intervention will be reported.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary infertility ≥12 months.
* Diagnosis of unexplained infertility ≤24 months:

  * Anti-Mullerian hormone ≥0.4 ng/mL and/or follicle-stimulating hormone ≤13 IU/L in early follicular phase;
  * regular cycle of 21-35 days,
  * positive ovulation tests, and/or
  * luteal phase serum progesterone ≥25mmol/L in a natural cycle;
  * semen analysis with total motile sperm count ≥ 5 million;
  * normal uterine cavity;
  * patent tubes.
* Negative genitourinary test for gonorrhoea and chlamydia ≤12 months.

Exclusion Criteria:

* Body mass index ≥35 kg/m2.
* Ongoing pregnancy.
A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure

The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute Heart Failure according to Guidelines for the diagnosis and treatment of acute heart failure 2010 of Chinese Medical Association(Participants whose Heart function grade of NYHA is Ⅲ～Ⅳ).
* LVEF≤40%.
* NT-pro-BNP ≥1400 pg/mL or BNP ≥ 350pg/mL.
* Ages 18-80, male or female.
* All participants signed the informed consent.

Exclusion Criteria:

* Participants with abnormal liver function (ALT, AST≥3 times of upper limit of normal) or abnormal kidney function( Cr≥1.5 times of upper limit of normal or Cr \>3.0 mg/dl (\> 265 µmol/L)).
* SBP ≥ 150mmHg.
* Participants with severe chronic asthmatic bronchitis or acute episode of lung diseases.
* Participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery.
* Participants with advanced cancer.
* Breastfeeding, pregnant and potentially fertile women participant.
* Participants with insanity.
* Known allergies with Shenfu Zhusheye or its ingredients in the past.
* Participants who have taken part in other clinical trials in last month.
* Participants who abuse alcohol or other drugs in last year.
* Participants who are not suitable for clinical trial under doctors' consideration.
Substance Abuse and Trauma in Incarcerated Women

The proposed study will evaluate Covington's Helping Women Recover (HWR) plus Beyond Trauma (BT) curriculum with female offenders at Eddie Warrior Correctional Facility in Taft, Oklahoma. The purpose of the proposed study is to expand previous findings by including a comparison group of women that are not receiving treatment but are otherwise eligible, and by using outside evaluators to conduct the assessments. Furthermore, this study will extend the outcomes measured in previous evaluations by including measures of sleep disturbance, posttraumatic cognitions, and a more extensive assessment of trauma-related symptoms. The hypotheses for this study are listed below:

1. Incarcerated women with substance use disorders and history of trauma enrolled in the integrated treatment program (HWR plus BT) will report significantly fewer symptoms on measures of posttraumatic stress and associated cognitions, substance use, depression, and related symptoms following treatment than those in the comparison group.
2. Those in the treatment group will improve significantly more than those in the comparison group on the symptoms listed above.


Eligibility Criteria:
Inclusion Criteria:

* Incarcerated women at Eddie Warrior Correctional Center (EWCC) in Taft, Oklahoma
* The following 6 criteria are then employed at EWCC for HWR/BT treatment eligibility:

  1. An Level of Service Inventory (LSI) score of 30 or greater
  2. An LSI protective score of 15 or less
  3. 1.5 years or less remaining in prison
  4. A Case Plan identifying substance abuse treatment need
  5. Ability to read and comprehend
  6. 18 years of age or older

Exclusion Criteria:

* Under age 18
* Not incarcerated
* More than 1.5 years remaining in prison
* LSI score less than 30 or a protective of more than 15
* No identified substance abuse need
* Inability to read and comprehend
Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19

The objective of this multicenter observational study is to describe respiratory sequelae of COVID-19 patients hospitalized for severe pneumonia requiring oxygen supply.

Main objective To assess respiratory sequelae after SARS-CoV-2 infection in hospitalized patients with severe pneumonia requiring oxygen supply and followed up for 6 months after hospital discharge (see primary and secondary outcomes).

Secondary objectives

To describe pulmonary sequelae according to :

* the unit in which the patient was hospitalized,
* the maximum oxygen flow rate required during hospitalization,
* McCabe score,
* age,
* tobacco consumption,
* biological data (e.g. blood count, CRP, fibrinogen, LDH, albumin, D-dimer, ferritin),
* number of days from onset of symptoms to hospitalization,
* co-morbidities (e.g. diabetes, hypertension, coronary artery disease/heart failure, mild to moderate COPD/respiratory failure, overweight),
* concomitant treatments (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, ACE inhibitors)
* specific drug treatments administered to treat COVID-19 infection,
* non-drug treatments (invasive ventilation, non-invasive ventilation, postural treatment) to manage respiratory disorders of COVID-19 infection.

To assess the impact of factors of social inequality on the severity of COVID-19 infection.

Conduct of research Patients who have been hospitalized for severe pneumonia due to CoV-2 SARS infection will be seen in consultation at approximately 3 and 6 months after hospital discharge, as per standard practice.

Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years old
* SARS-CoV-2 infection proven by RT-PCR and/or retrospective serology and/or a COVID-19 syndrome with evocative chest CT scan
* Hospitalized for severe pneumonia due to SARS-CoV-2 infection requiring oxygen supply

Exclusion criteria:

* Not hospitalized for a severe COVID-19 infection
* Absence of respiratory symptoms at V1 (3 months after hospital discharge), defined as: absence of residual exertional dyspnea and persistent pulmonary infiltrates on follow-up chest radiography at 1 month (if available), transcutaneous oxyhemoglobin saturation \>94% and normal pulmonary auscultation
* Patient with pre-existing chronic lung disease prior to the first episode of COVID-19: chronic obstructive pulmonary disease confirmed by respiratory function testing with a forced expiratory volume in one second (FEV1) \< 50% and/or a diffusing capacity for carbon monoxide (DLCO) \< 60%, fibrotic lung disease or chronic respiratory failure (on long-term oxygen therapy)
* Opposition to participation in the study
* Patient under legal protection
* Patient not affiliated to/beneficiary of a social security scheme
Endobiliary RFA for Unresectable Malignant Biliary Strictures

Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.

RFA is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. It uses bipolar electrical energy for tissue coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography (ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit for controlling tumour growth. Several cohort studies have been published and the feasibility and safety of such technique has been proved.

The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in patients with unresectable cholangiocarcinoma or ampullary carcinoma.

The objectives are

* To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients' survival as compared to the only stenting therapy.
* To assess the impact of RFA on the stent's patency.

Eligibility Criteria:
Inclusion Criteria:

* Either gender greater than or equal to 18 years of age.
* Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
* Biliary obstruction, Bilirubin \> 40umol/L at diagnosis
* Subjects capable of giving informed consent
* Life expectancy of at least 3 months
* Histologically (preferred) or radiologically confirmed cholangiocarcinoma or ampullary cancer

Exclusion Criteria:

* Cardiac Pacemaker
* Patient unstable for endoscopy
* Inability to give informed consent
* Coagulopathy (INR \> 2.0 or PTT \> 100 sec or platelet count \< 50,000)
* Performance status ECOG ≥3 (confined to bed / chair \> 50% waking hours)
* Active suppurative cholangitis
* Complex stenoses will not be eligible for the trial
* Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
* Malignant ascites
* Presence of main portal vein thrombosis
* Prior stents placement
* Prior Billroth II or roux-en Y reconstruction
* Inability to insert a guide wire across the malignant stricture
* Pregnancy
* Presence of other malignancy
* Life expectancy \< 3months
Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer

This study develops infertility survey among reproductive age women with gynecological and breast cancer. This study aims to learn how women consider whether or not to try to have a baby after surviving cancer. The advice gathered from this survey may be shared with patients and survivors in the future, so that they have information to inform their decisions about cancer treatment and family planning.

PRIMARY OBJECTIVES:

I. To tailor the National Fertility Barriers (NFB) Survey for women who have had gynecological and breast cancers.

II. To administer the tailored survey and evaluate if utilization of infertility clinics and treatments is associated with pregnancies leading to live births after gynecological or breast cancer.

SECONDARY OBJECTIVE:

I. To evaluate whether potential covariates are associated with utilization of infertility clinics and live births after gynecological and breast cancers (e.g. socio-demographic, clinical, psychological, lifestyle, and decision-making characteristics).

OUTLINE:

FOCUS GROUP: Patients attend an audiotaped focus group over 90 minutes to provide feedback for survey development.

SURVEY VALIDATION: Patients complete an online survey over 15-30 minutes at baseline and 2 days later.

TELEPHONE SURVEY: Patients complete a telephone survey.

Eligibility Criteria:
Inclusion Criteria:

* FOCUS GROUP: Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program who are 18-45 years old at the time of cancer diagnosis
* SURVEY VALIDATION: Women seen at the MD Anderson Oncofertility Clinic and Adolescent and Young Adult Program who are 18-45 years old at the time of cancer diagnosis
* TELEPHONE SURVEY: Women in the California Cancer Registry
* TELEPHONE SURVEY: Are 18-45 years old
* TELEPHONE SURVEY: Were diagnosed with early-stage ovarian (IA and IC), endometrial (IA), cervical (IA1-IB1), or breast cancer (I-III)
* TELEPHONE SURVEY: Are 5-12 years post diagnosis between the years of 2007-2014
* TELEPHONE SURVEY: Underwent fertility-preservation treatments

Exclusion Criteria:

* FOCUS GROUP: Do not speak English or Spanish
* SURVEY VALIDATION: Do not read and understand English
* TELEPHONE SURVEY: Do not speak English or Spanish
Clinical Study of Vitamin B5 in Adjuvant Treatment of IBD

Patients with IBD are randomized to oral administration of vitamin B5 and placebo based on the standard treatment, exploring whether Vitamin B5 can increase the clinical remission rate of IBD patients and improve the treatment effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with IBD according to the consensus on the diagnosis and treatment of inflammatory bowel disease (Beijing, 2018, DOI:10.19538/j.nk2018090106);
* Have complete medical history data;
* Volunteer to participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

* Hemophilic patients;
* There are abdominal abscesses, toxic megacolon, fulminant colitis, partial colectomy, or total colectomy;
* Other autoimmune diseases, hematological diseases, tumors, acute infection, severe liver and kidney insufficiency, serious diseases such as severe anemia, neutropenia, heart failure, organic heart disease, hepatitis B, liver cirrhosis, kidney disease and mental diseases;
* Take calcium pantothenate preparation in recent 3 months;
* Have a history of abuse of psychoactive substances;
* Pregnant or lactating women, or plan to be pregnant in the next 6 months;
* Nervous system diseases: such as Alzheimer's disease, stroke, Parkinson's disease;
* Participate in other clinical trials in the past 6 months;
* Incomplete medical record information (including gender, age, diagnosis information, colonoscopy results, pathological diagnosis results and other demographic data)
Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Pharmacokinetics of cefazolin in children undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing cardiac surgery with cardiopulmonary bypass
* minimum weight 1.8 kg
* intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)

Exclusion Criteria:

* no catheter in place for blood sampling
* absence of parental/patient consent
* known hypersensitivity to cefazolin
Comparison of 2 Body Oil in Prevention of Striae Gravidarum

The effect of elasticity Belly® oil and Clarins® Tonic Body Treatment Oil in prevention of striae gravidarum: A randomized controlled clinical trial.

Objective: To compare the clinical efficacy of Elasticity Belly® oil and Clarins® Tonic Body Treatment Oil on the occurrence and severity of striae gravidarum.

Design: Parallel randomized controlled clinical trial. Setting: Gynaecology and Obstetrics department, Shanghai Changning Maternity and Infant Health Hospital, China Interventions: We will enroll about 50 Nulliparous women randomly, who are in their second trimester of pregnancy. Volunteer's abdomen skin are divided into two parts through medioventral line, half of the abdomen skin will receive the elasticity Belly® oil to prevent striae gravidarum, and the other side will use the Clarins® Tonic Body Treatment Oil. Volunteers apply these two kinds of oil daily until gestational age of 38-40 weeks. We'll take abdomen pictures before and after interventions, and the occurrence of striae on abdominal skin and its severity will be evaluated as our primary outcome of the study.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous females
* gestational age of 14-20 weeks
* 20 to 35 years old
* body mass index (BMI) from 18.5 to 25
* Clear consciousness, intelligence is normal,stable vital signs
* Voluntary participation, and sign the informed consent

Exclusion Criteria:

* allergy to skin care products
* twin pregnancies or polypregnancies
* polyhydramnios
* miscarriages
* development of a skin disease
* corticosteroid usage
* application of any other cream on the abdominal skin
* did not received allocated intervention
* drop out or lost to follow-up
Expectations and Experiences With Virtual Reality Training Among ICU Physicians and Nurses

The goal of this observational study is to describe the expectations and experiences with virtual reality in physicians and nurses working in the European ICUs. The main questions it aims to answer are:

What emotions and worries does the expected training with virtual reality evoke? What are the potential factors causing negative emotions and fear from expected training? What is the institutional approach to the online training approach regarding participation in working hours and covering the costs? How does the experience of training using virtual reality spread among the population of ICU physicians and nurses? Participants will fill out an electronic survey.

The need for constant training envelopes every medical speciality. Anesthesiology and Intensive Care or Critical care are no exceptions. Virtual reality is a very modern and fast-growing field with huge potential for education and training. The investigators hypothesise that virtual reality and online education could improve healthcare professionals' education feasibility. The survey was developed based on a trial version carried out only in the Czech Republic on 120 participants without any comments about questions clarity. The questionnaire contains a descriptive part and an explorative part about expectations and experiences with virtual reality in training. The study will aim for European ICUs. After that, the responses will be interpreted using statistical methods that fit. The investigators aim to publish our findings in a journal in WoS.

Eligibility Criteria:
Inclusion Criteria:

* HCPs working in ICU.

Exclusion Criteria:

* HCPs not working in ICU.
Safety Assessment of Repeated Administration of TK006 in Patients With Breast Cancer-related Bone Metastases

This is an open labelled study. It was designed to evaluate the safety of multiple-dosing of TK006 in patients with breast cancer-related bone metastases. This trial is the extension of a core study: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmacodynamics in Patients With Breast Cancer-related Bone Metastases (NCT 03239756).

This trial is the extension of a core study: Phase 1 Trial of a Fully Human Monoclonal Antibody of Receptor Activator for Nuclear Factor-κ B Ligand (RNAKL, TK006) Safety, Pharmacokinetics, and Pharmacodynamics in Patients With Breast Cancer-related Bone Metastases (NCT 03239756). It's an open labelled study, aimed at evaluating the safety of repeated administration of TK006 in patients with breast cancer-related bone metastases. The qualified subjects would be those completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core study. Also, these patients should be well-tolerated with TK006 at the core study and are deemed to further benefit from this extension phase estimated by the researcher and sponsor. The subjects would receive 120 mg TK006 every 4-week over a period of 84 days.

Only safety profile and immunogenicity assessment would be assessed in this extension stage, and no further study on pharmacokinetics and pharmacodynamics would be done.

Eligibility Criteria:
Inclusion Criteria:

1. Patients provide written informed consent voluntarily.
2. 18\~65 years old, male or female.
3. Patients who completed the entire observation in either 60 mg, 120 mg or 180 mg single dose arm at the core phase (NCT 03239756). Also, these patients should be well-tolerated with TK006 and would further benefit from continued treatment estimated by the researcher and sponsor.
4. ECOG≤2.
5. Albumin-adjusted calcium≥2.0mmol/L, ≤2.9mmol/ L.

Exclusion Criteria:

1. Women in pregnancy or nursing.
2. Central nervous system metastasis that is symptomatic or require treatment.
3. Patients with grade III or IV adverse events considered related to TK006 at the core phase (NCT 03239756).
4. Patients with important organs dysfunction and not suitable for further treatment with TK006 judged by the researcher.
5. Imaging confirmed progression in bone metastasis compared with core phase (NCT 03239756).
6. Previous or existing osteomyelitis or osteonecrosis of jaw, toothache or jaw diseases which are in active or require invasive operations, unhealed wound of oral surgery, or planned invasive dental operations during this trial.
7. Patients who have been selected for the study of other test devices or test medicine.
8. Other situations which are not suitable for participation judged by the researcher.
Feasibility of a Self-Management + Peer Mentoring Intervention for Adolescent and Young Adult Childhood Cancer Survivors

The goal of this project is to evaluate the feasibility of the "Managing Your Health" online self-management skills+peer mentoring intervention that focuses on overcoming survivor barriers to self-management of their survivorship care. We will conduct a pilot randomized controlled trial (RCT) of the intervention versus usual care with adolescent and young adult survivors of childhood cancer ages 18-25 years. Participants will complete survey measures at baseline, Time 2 (about 2 months after baseline), Time 3 (about 5 months after baseline), and Time 4 (about 12 months after baseline).

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of the online self-management+peer mentoring program in a pilot RCT.

II. Assess preliminary efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

Young Adult Survivors:

* age 18-25;
* at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
* low self-reported responsibility for healthcare as indicated by reporting parent is primarily responsible for healthcare or low score (1 or 2) on two or more items from Readiness for Transition Questionnaire - Survivor Version.

Peer Mentor:

* age 21-29;
* at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
* self-reported primary responsibility for healthcare and "complete" readiness to assume responsibility or high scores (3 or 4) on all items from Readiness for Transition Questionnaire - Survivor Version.

Exclusion Criteria:

• Documented or self-reported cognitive delay to prevent self-management of healthcare.