cyrilzakka/clinical-trials huggingface dataset:
Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer

Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.

In the context of IVF treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy.

In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone (MVP) is mostly prescribed.

Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy.

Based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.

But, until now, there is no publication evaluating the effectiveness of an addition of Dydrogesterone to the standard of care.

The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.

The trial is a randomized controlled study, open label. Participants will receive either standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer until 10 weeks of gestation or until pregnancy test is negative.

Study participation will be proposed to every woman going through fresh embryos transfer in Laniado IVF unit, who meets the inclusion/exclusion criteria.

The investigators aim to include 150 patients in each arm of the study, during 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented history of infertility who underwent IVF with or without ICSI, going through embryos transfer (having in the past up to 2 previous embryos transfer) and who gave written informed consent.
* Body mass index ≥18 to ≤35 kg/m2
* LH, prolactin (PRL), testosterone and thyroid-stimulating hormone (TSH) within normal clinical limits or not considered clinically significant within 1 year prior to or at screening
* Normal transvaginal ultrasound at screening (or within 14 days prior to screening)
* Planning a transfer of 1 or 2 fresh embryos.

Exclusion Criteria:

* Previous participation in this trial
* Subjects with \>2 unsuccessful IVF attempts
* Evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders;
* Recent major surgery (within 3 months);
* Current or recent substance abuse, including that of alcohol and tobacco;
* History of chemotherapy;
* History of recurrent pregnancy loss (≥3 previous miscarriages)
Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

This study evaluates the benefits of short-term training via telehealth for post-lingually deafened adult cochlear implant users. Half the participants will receive aural rehabilitation and the other half cognitive training. The hypothesis is that short-term aural rehabilitation via telerehab technology will improve outcomes for post-lingually deafened cochlear implant users

Aural rehabilitation training (AR) has been demonstrated to improve outcomes for adult cochlear implant users. There are both financial and non-financial barriers to AR service delivery including accessibility (mobility, distance and transportation problems), accommodation (time off work impossible, caring for family) and availability (limited providers in rural areas, financial constraints, and lack of transportation. In this study the investigators will measure the impact of telerehab delivery on optimizing speech recognition, communication function, goals, social participation and hearing handicap.

Twenty-four participants will be randomly assigned to one of two treatment groups: aural rehabilitation (AR) and cognitive training (CT). Participants will complete six 90-minute treatment sessions in their home or office via a telerehab platform. Participants will come to a center for three 90-minute assessment sessions: pre-treatment, 1 week, and 2 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Speech Tracking rate of at least 20 words per minute
* Sentence recognition scores (CasperSent) between 10% and 85%
* Passing score on cognitive screener (Callahan et al., 2002)

Exclusion Criteria:

* Less than 18 years of age
* Pre-lingually deafened
* Prior Aural Rehabilitation with cochlear implant
* Greater than three years post-activation of CI
ATN 151 Work-to-Prevent: Employment as HIV Prevention

The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.

Work2Prevent will advance the science by adapting, tailoring, and pilot-testing a novel social and structural-level HIV intervention for YMSM and YTW of color ages16-24 aimed at increasing economic stability (i.e., employment) through youth empowerment and asset development, and decreasing HIV risk behaviors (i.e., sex work) associated with social and economic marginalization.

Eligibility Criteria:
Phase 2 Inclusion Criteria:

1. Being male or assigned male at birth (YTW)
2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman
3. Identifies as African American/Black or Hispanic/Latino
4. 16-24 years old
5. English-speaking (primary)
6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk)
7. Is able to attend a 4-session employment program

Phase 2 Exclusion Criteria:

1. Individuals identifying as non-Hispanic White
2. Individuals not assigned male at birth
3. Individuals with a known HIV positive-status at time of consent

Phase 3 Inclusion Criteria:

1. Being male or assigned male at birth (YTW)
2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman
3. Identifies as African American/Black or Hispanic/Latino
4. 16-24 years old
5. English-speaking (primary)
6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk)
7. Is able to attend a 4-session employment program
8. Did not participate in Phase 2

Phase 3 Exclusion Criteria:

1. Individuals identifying as non-Hispanic White
2. Individuals not assigned male at birth
A Multicentre, Retrospective Study of Clinical Characteristics and Long-term Outcomes of Patients With Brucellosis

This is a multicenter, retrospective clinical study, in patients with brucellosis, to analyze the clinical characteristics, complications, and the impact of different treatment options on long-term prognosis of patients with brucellosis. All hospitalized patients diagnosed with brucellosis between 2016 and 2021 were included from the electronic medical record systems of eight centers, collecting demographics, hospitalization information, clinical information, laboratories, imaging studies, treatment regimens, and disease outcome and other information.


Eligibility Criteria:
Inclusion Criteria:

* Age and gender are not limited;
* Discharged patients diagnosed with brucellosis
* Specific reference to the People's Republic of China's health industry standard "Diagnosis for brucellosis" (WS269-2019) diagnosed as a patient with brucellosis, that is, the patient meets a suspected or clinically diagnosed case and passes the confirmatory test mentioned below at the same time Either to prove:

  1. Brucella is isolated from any pathological material culture such as blood, bone marrow, other body fluids and excreta of patients.
  2. The test tube agglutination test (SAT) titer is 1:100++ and above, or the patient's course of disease lasts for more than one year and still has clinical symptoms, and the titer is 1:50++ and above.
  3. Complement fixation test (CFT) titer is 1:10++ and above.
  4. Anti-human immunoglobulin test (Coomb's) titer is 1:400++ and above.
* Volunteer to join this study.

Exclusion Criteria:

* History of severe lumbar spine trauma before the diagnosis of brucellosis;
* Have undergone lumbosacral surgery before the diagnosis of brucellosis;
* Scoliosis;
* Currently participating in clinical trials of other drugs or medical devices;
* The researchers think it is not suitable for inclusion.
Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?

Investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent USG-assisted obturator nerve block with distal approach


Eligibility Criteria:
Inclusion Criteria:

* age between 18-75
* ASA1, ASA2, ASA 3 physical status

Exclusion Criteria:

1. The patient's refusal
2. Active infection in the area to be blocked
3. Kidney failure
4. Liver failure
5. Heart failure
6. BMI less than 18 and a BMI greater than 40
Measuring Change in Overcoming Implicit Biases in Behavior by Emergency Care Center Providers

Implicit bias is a form of bias in which a person's automatic and unintentional thoughts of another person or group influence either positively or negatively their behavior or the decisions they make. Studies show that healthcare providers have the same amount of bias as any other person and that it can affect patient care. However, in the emergency room, which is fast-paced and there is a high number of patients, implicit bias may be higher. Therefore, this study will look at emergency care center (ECC) providers' willingness to change their implicit bias behaviors. After, it will provide implicit bias education designed for the ECC to the healthcare providers at SMHCS Sarasota campus and assess whether it improved their willingness to change implicit bias behaviors when compared to the providers in the SMHCS Venice campus who did not receive the education.

Studies have shown that implicit bias is present in healthcare providers, including those in the emergency room, it is necessary to understand whether emergency providers are willing to change their implicit bias behaviors and provide them with the education and resources tailored to it so that they can be aware of it and make a positive change towards improving it even when they are pressured by time and never-ending tasks.

The observational study will use a two-group pretest-posttest design to assess willingness to change implicit bias behaviors among healthcare staff in the ECC. Healthcare providers will be recruited from two SMHCS clinical sites: Sarasota Memorial Hospital's (SMH) -Sarasota Campus ECC and SMH's-Venice Campus ECC.

Participants are expected to fill out the initial surveys, complete the implicit bias education, and do the posttest (re-administer the Measuring Change in Overcoming Implicit Biases in Behavior by Emergency Medicine Personnel questionnaire), which is expected to take approximately 6-18 months.

Eligibility Criteria:
Inclusion Criteria:

* Individuals will be eligible for the study if they are 18 years or older and are active emergency medicine staff in the SMH-Sarasota or the SMH-Venice campus ECC. Participants must also be able to understand the requirements of the study, be willing and able to provide informed consent, and participate in all required study activities.

Exclusion Criteria:

* N/A
Improving Non-invasive Ventilation

A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.


Eligibility Criteria:
Inclusion Criteria:

* treatment with non-invasive ventilation
* informed consent

Exclusion Criteria:

* refusal of informed consent
Colonoscopy in the Prone Position for Patients With BMI Greater Than 30

In the United States, colonoscopy has become the most commonly used screening test for colorectal cancer. Colonoscopy is typically performed with the patient starting in the left lateral decubitus position, however there is little data to support this practice and starting position is variable amongst individual gastroenterology physicians.

The investigators plan to randomize patients with Body Mass Index \>30 that are presenting to the University of Virginia for colonoscopy to either the prone or left lateral decubitus position. The investigators will then record and compare cecal intubation times as well as amount of sedation used and complications to help determine which position is superior for this patient population.

Patients that have been scheduled for colonoscopy will undergo chart review. Patients who meet inclusion criteria will be invited to participate at the time consent is obtained for the colonoscopy. Participants will then be randomized to one of two colonoscopy starting positions.

After randomization, patients will begin the colonoscopy in either the prone position or left lateral decubitus position.

It is common practice to re-position the patient during endoscopy (including supine and prone positions) and some endoscopists commonly employ prone starting position for obese patients, although there is no estimate in the literature as to the prevalence of this practice.

No additional interventions will be performed for research purposes. During the colonoscopy, the endoscopist will be allowed, as usual, to adjust patient position as needed to complete the procedure. Cecal intubation time, amount of sedation used, and any intra-procedural complications (hypoxia, hypotension, etc) will be recorded for data analysis. This information is standardly recorded in the procedure report in the patient's medical record. The study will not affect any interventions performed during the colonoscopy such as polyp removal or biopsies as, clinically indicated. Per endoscopy unit protocol, patients will be monitored in the recovery area and discharged home with supervision. The study requires no further direct patient interaction after the colonoscopy is completed. Charts will be reviewed at 30 days to assess for any delayed and unexpected complications.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>30
* Undergoing screening or diagnostic colonoscopy with conscious sedation

Exclusion Criteria:

* Pregnant women (self reported).
* Cognitively impaired patients
* History of colonic resection
* Cannot lay in prone position
* History of colon malignancy
* Procedure aborted due to inadequate bowel prep
* Severe pulmonary problems (including baseline oxygen use)
* Inability to provide consent for themselves
Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy

The purpose of this study is to evaluate the safety and efficacy of botulinum toxin-A in salivary glands as a treatment for decrease drooling in patients with cerebral palsy and evaluate the long-term effects and tolerance . To assess whether patients with cerebral palsy have hypersalivation comparing with patients without treatment and healthy volunteers and if botulinum toxin may reduce the volume of drooling without altering the swallowing function.

Patients with cerebral palsy (CP) and other neurological diseases ( Parkinson´s disease (PD), bulbar amyotrophic lateral sclerosis, neurodegenerative diseases, idiopathic hypersalivation, head and neck carcinomas, etc) frequently have lifelong issues with oral motor control that may present as eating, drinking difficulties, drooling and/or speech problems.

Inadequate saliva control occurs in approximately 30% of patients with CP. Drooling usually caused by swallowing dysfunction and can lead to choking, salivary aspiration, pneumonia, chest infections,chronic irritation of the facial skin, and /or dehydration, in some cases the person loss of self esteem and impede community inclusion.

Numerous therapies, anticholinergic medication, surgery, etc, have all been used to reduce drooling with varying side effects and degrees of success, but none with optimal results.

Systemic anticholinergics may reduce salivary secretion but are frequently not tolerated by the patients because they have multiple side effects. Recently Botulinum toxin type A has been used in the treatment of sialorrhea, in clinical studies have found that botulinum toxin type-A may have a good response with fewer side effects.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cerebral palsy ( medical history, neurological examination,magnetic resonance
* Patients with disorders for eating, drinking, pneumonia, irritation of the skin face, social exclusion
* Score of \>3 on drooling severity and frequency scale

Exclusion Criteria:

* Patients under 18 years
* Swallowing disorders
* Diagnosis of Myasthenia, Eaton Lambert Syndrome, Amyotrophic lateral Sclerosis or diseases that interfere with the function neuroglandular
* Pregnant or lactating period
* Patients without informed consent
Misoprostol Prior to IUD Insertion in Nullipara

The use of misoprostol at a dose of 400 µg administered vaginally four hours prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure, although the frequency of cramps increased following misoprostol use.

Nulligravidas women of reproductive age were submitted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, Brazil. A total of 179 women were randomly allocated to two groups: 86 to use 400 µg of misoprostol vaginally four hours prior to IUD insertion and 93 to use placebo. Risk ratios (RR) were calculated as measures of relative risk, together with their 95% confidence intervals (95%CI). The number needed to treat (NNT) and the number needed to harm (NNH) were also calculated.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* No chirurgical procedure in the cervix
* Wish to use IUD as a contraceptive method

Exclusion criteria are as follows:

* Presence of active cervical infection visible upon speculum exam (purulent cervicits)
* Pelvic Inflammatory Disease (PID) or other uterine infection diagnosed within the last 3 months (based on self-report or clinical documentation)
* Pregnancy ending less than 6 weeks prior to enrollment in study
* History of prior IUD placement
* History of uterine cavity abnormality including Mullerian tract anomalies and leiomyomas distorting uterine cavity shape
* History of uterine surgery
* Allergy or intolerance to misoprostol or other prostaglandin
* Undiagnosed abnormal vaginal bleeding
* Malignancy of the genital tract
* Allergy to any component of the IUD or Wilson's disease (for copper- containing IUDs)
* Pre-procedure use of anesthesia or analgesia (including use of narcotics, benzodiazepines, or use of anesthetic beyond use at the tenaculum site)
Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas

A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas

Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT).

Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax).

Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).

Eligibility Criteria:
Inclusion Criteria:

* Refractory to or relapsed after at least 1 prior treatment line.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Patients must be ≥18 years of age
* Able to give a written informed consent.

Exclusion Criteria:

* Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1).
* Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection
* Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months.
* Patients with graft versus-host disease (GVHD)
* Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity .
* Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV);
* Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec;
* Patient with angina not well-controlled by medication;
* Women who are pregnant or lactating.
A Prospective Randomized Study on Vanguard Cruciate Retaining Versus Vanguard High Flex Posterior Stabilized Total Knee System in the Early Range of Motion

Main Objectives are: Test Difference in terms of early ROM between Vanguard FB CR and Vanguard FB PS. Knees; Demonstrate the comparable ROM of high flex PS to CR.


Eligibility Criteria:
Patients need total knee replacement
Improving Medication Adherence in Post-ACS Patients

Many post Acute Coronary Syndrome(ACS) patients do not take their medications (including aspirin) as prescribed, leading to an increase in mortality. Patients enrolled in this study will be enrolled into one of two groups. Patients in the first group will have their medication adherence measured, but will receive all other care as usual. Patients in the second group will also have their medication adherence measured, but they will receive telephone-delivered problem solving therapy (PST) in addition to their usual care. The two groups will be combined to determine the Minimally Effective Dose (MED) and the Maximally Tolerated Dose (MTD) for adherence to aspirin. The medication adherence of the PST group will improve by 20% (\<55% to \>75%).


Eligibility Criteria:
Inclusion Criteria:

1. Medical eligibility:

   1. Patient presenting for staged intervention with positive cardiac history OR
   2. Patient with stable CAD who received cardiac admission but does not report chest pain. OR
   3. Patient with stable CAD who has had a cardiac admission in the past.
2. Patient is non-adherent to prescribed medication.

The following exclusion criteria have been set for either safety concerns or concerns that patients will not be able to complete the protocol:

1. inability to communicate in English or Spanish
2. unwilling to be randomized or to have aspirin in a separate bottle if they use a pill box
3. unavailability for the 1 month period of the study (including being unavailable by phone and/or traveling out of the country)
4. medically unable to receive aspirin (e.g. allergy, contra-indicated, etc)
5. deemed unable to comply with the protocol (either self selected or by indicating during screening that s/he could not complete all requested tasks). This includes patients with a level of cognitive impairment indicative of dementia, and patients with current alcohol or substance abuse.
6. deemed to need immediate psychiatric assessment (e.g., must be hospitalized, or have some other psychiatric intervention conducted within 72 hours).
7. active psychosis, bipolar disorder, or any overt personality disorder