cyrilzakka/clinical-trials huggingface dataset:
The Effect of Feedback Regarding Illness Behavior on Patient Satisfaction in Hand Surgery

The investigators of this study would like to see whether providing feedback to patients regarding their illness behavior/coping strategies, using online questionnaires, improves patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128 patients.

Psychological and sociological factors are important in the human illness experience, but biomedical factors are the focus of most office visits, particularly in hand surgery. Both patients and surgeons can feel uncomfortable discussing emotions, stress, and coping strategies. Detmar et al. randomized patients in an oncology practice to receive feedback on a HRQL assessment or not during office visits. They observed that feedback on the HRQL assessment contributed to physicians' awareness of healthy issues and patient-physician communication. There was a difference in perceived emotional support, but not in overall satisfaction with the visit\[1\]. A retrospective study observed in patients with local prostate cancer, that pre-therapy HRQL assessment is associated with a better sexual function, sexual bother and bowel function according to post-therapy HRQL scores\[2\].

The investigators propose a two arm unblended, randomized (1:1) controlled trial to assess the effect of providing feedback to patients regarding illness behavior/coping strategies (using Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Testing (CAT) instruments) on patient satisfaction and patient-physician communication in orthopaedic surgery.

If the results of the study suggest that feedback of results from the questionnaires increases patients' satisfaction, such an intervention may be used in the future to benefit future patients.

Aim:

The aim of this study is to assess the effect of feedback regarding illness behavior measured with Patient Reported Outcomes Measurement Instrument System - Computerized Adaptive Testing (PROMIS- CAT) on patient satisfaction.

Primary Null Hypothesis:

There is no difference in satisfaction between patients who receive feedback about their illness behavior, measured with PROMIS-CAT, compared to patients who do not.

Secondary Null Hypotheses:

There is no difference in patient-physician communication about patient's illness behavior between patients who receive feedback about their illness behavior, measured with PROMISCAT, compared to patients who do not.

There are no predictors for patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* All new patients visiting the Orthopaedic Hand and Upper Extremity Service
* English fluency and literacy
* Ability to provide informed consent

Exclusion Criteria:

* age \< 18
* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
Desogestrel (DSG) and Corifollitropin(FSH-CTP) Alfa for Ovarian Stimulation in Donors

Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge. It has been described the usefulness of orally administered medroxyprogesterone acetate, 10 mg to inhibit the endogenous LH surge in IVF patients during COS.

In donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response. No description of the hormonal and ovarian response under this protocol has been published

* oral desogestrel since the first menstruation day,
* a single injection of FSH-CTP on the 7th menstrual cycle day
* routine monitoring of ovarian response with transvaginal ultrasound every second day until pre-ovulatory bolus of GnRH
* Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH)
* Quality of Life questionnaire the day after the bolus

Eligibility Criteria:
Inclusion Criteria:

* Population: donors (18-35 ) from candidates of Donor program
* Fulfilling inclusión medical and legal criteria (RD -Ley de transposición de la normativa europea a la legislación española 9/2014)
* Who had had undergone previously convencional COS (controlled ovarian stimulation) with FSH-CTP and daily antagonist injections
* Given signed consent form.

Exclusion Criteria:

* Previous low response to COS
* Previous ovarian hyperstimulation syndrome.
* Ovarian cysts.
Obstetric and Perinatal Outcomes of Women With COVID-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently spreading rapidly around the globe, causing a major public health issue. There is currently very few data about the impact of COVID-19 on pregnancy, and potential in utero infection. This is a prospective observational study of COVID-19 diagnosed pregnant patients. This objective is to examine the impact of COVID-19 during pregnancy on the rates of obstetric and perinatal complications.

Clinical manifestations of COVID-19 can range from a benign upper respiratory tract infection to severe acute respiratory distress syndrome (ARDS), fatal in 1% of cases. However, pregnant women and their fetuses could particularly be vulnerable to the infection, as shown by previous human coronavirus outbreaks (SARS-CoV and MERS-CoV).

Cases will be recruited among all pregnant women aged \>18 years old who have tested positive for COVID-19 and are followed in a maternity belonging to the French South Regional Perinatology Network. Voluntary physicians will refer eligible participants to the study-coordinating center at APHM University Hospital. The participants will be followed by phone after having provided an informed consent. Clinical symptoms, laboratory and imaging findings, maternal and perinatal outcomes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Able to give informed consent
* Diagnosed with COVID-19

Exclusion Criteria:

* Patients Refusing to Participate in the Study
* Patients who do not speak French well enough to benefit from clear and intelligible information
Personal Precise Treatment on Psoriasis and Psoriatic Arthritis

Part of psoriasis and psoriatic arthritis patients treated with biologics and met primary failure. Therefore, we are going to create a cell based platform to evaluate the treatment effects of different biologics on psoriasis and psoriatic arthritis patients before prescribed by physicians

PBMCs isolated from psoriasis and psoriatic arthritis and incubated with Group A streptococcus and different biologics for 24 hours. Cytokines expression in the culture supernatants will be measured and the data can be reference for physician's prescription.

Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy control without underline disease such as psoriasis and psoriatic arthritis. 2. Psoriasis been diagnosed for over six months and PASI \>10. 3.Psoriatic arthritis been diagnosed for over six months and \>1 swallow and tender joints

Exclusion Criteria:

* nil
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction

The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
* No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
* Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
* surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.

Exclusion Criteria:

* Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
* Associated grade III injury to the MCL (medial opening \>10mm at 30 degrees of knee flexion or any medial opening in extension)
* Presence of a PCL or posterolateral corner injury
* Lack of informed consent.
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease

Examine the effects of deutetrabenazine on functional speech and gait impairment

This is a two-year, prospective, single-arm study examining the effects of deutetrabenazine on functional speech and gait impairment. Participants will undergo comprehensive evaluations of speech production, fine motor skills, gait, and balance both before and after the initiation of deutetrabenazine. The investigators will utilize a variety of standardized, well-validated assessments as well as 3D motion analysis of both speech and gait parameters to determine the functional impact of deutetrabenazine on speech and motor performance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HD with documented CAG repeat ≥ 37
* UHDRS total maximal chorea score of ≥ 8
* Able to walk at least 10 meters
* Medically stable outpatient, based on the investigator's judgment
* Willing and able to give written informed consent prior to performing any study procedures
* Have completed at least 10th grade
* Montreal Cognitive Assessment score ≥ 22 on screening
* Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion

Exclusion Criteria:

* Severe depression or suicidal ideation
* History of suicidal behavior
* Unstable or serious medical or psychiatric illness
* Renal or hepatic impairment
* Severe speech impairment or anarthria
* Inability to swallow study medication
* Women who are pregnant or breast feeding
* History of alcohol or substance abuse within the last 12 months
* Current use of VMAT2 inhibitor (tetrabenazine, deutetrabenazine, valbenazine)
* Concurrent participation in any other investigational drug trials
* EKG QTcF\> 500 mse
Study in PRE-manifest Huntington's Disease of Coenzyme Q10 (UbiquinonE) Leading to Preventive Trials (PREQUEL)

To establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10 in pre-manifest participants carrying the CAGn expansion for Huntington's Disease (HD).

secondary objectives:

1. To assess the change from baseline to 20 weeks on biomarkers of oxidative stress (8OHdG and 8OHrG) and DNA repair mechanisms (OGG1) in pre-manifest participants treated with 600, 1200 or 2400 mg per day of CoQ10.
2. To assess the dose-response relationship between CoQ10 at dosages of 600, 1200 or 2400 mg per day and 8OHdG/8OHrG and OGG1.
3. To assess the serum levels of CoQ10 at 600, 1200 or 2400 mg in pre-manifest participants and their relationship to 8OHdG/8OHrG and OGG1.
4. To assess the feasibility of implementing a preventive therapeutic trial in a pre-manifest population.
5. To assess the utility and stability of clinical measures of HD, social relations, behavior and employment in a pre-manifest sample enrolled in a treatment trial.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be positive for the CAGn expansion in the Huntingtin gene (\>36 repeats) and be pre-manifest by virtue of scoring 3 or less on diagnostic confidence level (Question 17 of the UHDRS)
* Participants will have received genetic testing prior to enrollment through a standard pre-manifest testing protocol.
* 18 years of age or older.
* Concomitant medications are permitted with the exception of CoQ10, creatine \> 5g/day and warfarin.

Exclusion Criteria:

* History of intolerability to CoQ10.
* CoQ10 use within 60 days prior to randomization.
* Unstable medical or psychiatric illness;
* Substance abuse within one year of the baseline visit.
* Pregnancy, breastfeeding or lack of reliable contraception in women of childbearing age.
* Subjects with known allergy to FD\&C #6 yellow food coloring.
Comparative Study Between Two Fecal Management Systems

The purpose of the study is to determine the prevalence of anal erosions within a 14 day period among adult ICU patients at Cleveland Clinic Main Campus who receive one of two fecal management systems (FMS).

Null Hypothesis: There is no difference in the rates of anal erosion between the twp fecal management systems in a 14 day period.

Alternative Hypothesis: One fecal management system is no worse than the second fecal management system in the development of anal erosion.

PURPOSE: To compare the incidence of anal erosion between 2 indwelling fecal management systems. Anal erosion was defi ned as localized mucous membrane tissue impairments of the anal canal caused by corrosive fecal enzymes and/or indwelling devices. DESIGN: Randomized comparative effectiveness clinical trial comparing 2 commercially available indwelling fecal management systems. SUBJECTS AND SETTING: The target population was adults cared for on medical, surgical, and neurological intensive care units (ICUs) and non-ICU units with an order for indwelling fecal management system placement. The research setting was a 1200-bed quaternary-care medical center in the Midwestern United States. 90 patients were enrolled in the study. The number who started and completed the study; 41 of 47 received system A and 38 of 43 received system B. Subjects' mean age was 64 ± 13.6 years (mean ± SD), and 52% were female.

Eligibility Criteria:
Inclusion Criteria:

* Bedfast patients who need to have liquid or semi-liquid stool contained away from the body to prevent skin breakdown or contamination of existing wounds

  * Liquid to semi-liquid stool incontinence for past three days that is expected to last for extended period due to poor response to anti-diarrheal treatment
  * Absence of contraindications listed in Exclusion Criteria
  * If on subcutaneous anti-coagulation to prevent deep vein thrombosis, then can be included in study

Exclusion Criteria:

* Allergic to product components

  * Rectal or anal injury or active bleeding
  * Severe rectal or anal stricture or stenosis (distal rectum cannot accommodate the balloon), diseases of the rectal mucosa (i.e. severe proctitis, ischemic proctitis, mucosal lacerations)
  * Rectal or anal tumors
  * Severe hemorrhoids
  * Fecal impaction
  * Loss of rectal tone or prolapsed anal sphincter
  * History of Ileo-anal anastamosis or internal rectal pouch (e.g. S or J pouch)
  * Large Bowel (Colon) surgery or rectal surgery within the last year
  * Currently on heparin drip
Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography

The goal of this retrospective study is to quantify the physiological lens tilt of the phakic eye.

The main question it aims to answer is:

-What influence does misalignment or tilting of IOLs have on visual quality?

Preoperative biometry data are compared with anterior segement OCT data.

Measurements were obtained using high-resolution swept-source optical coherence tomography. The influence of biometric measurements on tilt is analyzed.

The human (crystalline or phakic) lens is located in the capsular bag which is attached to zonules. Zonules are fibres, that hold the lens in place. In the course of life, an opacification on the lens occurs, which is called cataract. To replace the cloudy lens, cataract surgery is being performed and an artificial intraocular lens (IOL) is implanted in the eye, after the phakic lens is removed. Misalignment or tilting of IOLs can result in reduction of visual quality, therefore prediction of the position may be beneficial. Modern optical coherence tomography (OCT) devices already provide profound information about phakic lens tilt. Still there is little data on the values that influence the tilt of the crystalline lens. Before each cataract surgery, each eye is measured using biometry (IOL Master 700). However, a statement about the tilt cannot be made on the basis of the results of IOL Master 700. For this purpose, an anterior segment OCT is required (CASIA 2). In this study, preoperative biometry data are compared with anterior segment OCT data. A statistical analysis will then be performed to identify the biometric parameters that can predict phakic lens tilt.

Eligibility Criteria:
Inclusion Criteria:

* Planned cataract surgery in one or both eyes
* Minimum age of 21 years

Exclusion Criteria:

* Opacities of the refracting media
* Measurement error in the context of preliminary investigation
* pseudophakia
A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening
* Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening
* Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors
* Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)

Exclusion Criteria:

* History or presence of pancreatitis (acute or chronic)
* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
* Subjects presently classified as being in New York Heart Association Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in
The Treatment of 2 Chinese Medicines in Clozapine-induced Hypersalivation in Schizophrenia

The goal of this research is hoping to combine traditional Chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.

Clozapine, an antipsychotic drug, is an important clinical medicine which is used for schizophrenia and preventing for its relapse; clozapine is better than some other atypical antipsychotics. However, in clinical uses, clozapine often could induce hypersalivation, it is not only influencing patient's appearance, also deteriorating sleeping quality which could deter patient discontinuing to take medicine.

In previous researches, Suo Quan Wan and Wu Lin San had been proven effective for hypersalivation and no significant side-effects, nevertheless, it still lack of systematical scientific trial reports. The ingredients of Suo Quan Wan are Wu Yao, San Yao and Yi Zhi Ren; the ingredients of Wu Lin San are Gui Zhi, Fu Ling, Zhu Ling, Ze Xie and Bai Ju, both have bi-directional regulatory functions for body fluid and saliva.

The goal of this research is hoping to combine traditional Chinese medicine medication and find out how to solve clozapine-induced hypersalivation, also reduce side-effect, medication compliance, improving life quality, improving social-function and reducing neopathy.

Eligibility Criteria:
Inclusion Criteria:

1.20 year and older. All genders. 2.Psychiatry doctor diagnosed schizophrenia or schizoaffective disorder will be recruited for participation in this study.

3.Using clozapine as an antipsychotic drug and has a side-effect of hypersalivation.

4.Testee agree and sign informed consent forms to do this experiment.

Exclusion Criteria:

1. Use clozapine as an antipsychotic drug not over 8 weeks.
2. Testee have other diseases could influence saliva secretion, such as Parkinson's disease.
3. Pregnant, prepare to pregnant within half a year or in the lactation period.
4. Add or alter following medicines within 2 weeks:

   4.1 Central acting 2-adrenergic receptor agonist 4.2 anticholinergic/antimuscarinic drugs 4.3 b-adrenoreceptor blockers, diphenhydramine, botulinum toxin injection
5. Testee's lever function test (AST/ALT) is higher than 3 (4 weeks medication).
6. Testee's kidney function test (Cr) is higher than 2.5mg/dl (4 weeks medication).
7. Testee have participate other medicine trial within one month.