cyrilzakka/clinical-trials huggingface dataset:
Shoulder Functional Performance After Shoulder Surgery

Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.

Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. In the acute period after arthroscopic RC repair, shoulder joint range of motion (ROM), muscle strength and shoulder functionality are decreased and daily activities are adversely affected. In the long-term, many studies have reported that these symptoms gradually decreaced.

Many studies investigating postoperative treatment of RC rupture have mostly focused on parameters such as postoperative pain, functionality, muscle strength, ROM and quality of life.Evaluation of these clinical parameters is necessary for patient follow-up in the early period. However, it is unclear whether the biomechanical etiologic factors continue that lead to RC rupture in the advanced period after surgery.

Therefore, the objective of this study was functional performance of shoulder after arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.

Design: observational Cross-sectional study.

Eligibility Criteria:
Inclusion Criteria:

* With the same RC surgical procedure and technique,
* With acromioplasty and/or tenodesis with RC repair,
* Undergoing arthroscopic RC repair from the upper extremity of the dominant side,
* Having completed the 12th week after surgery,
* Performing 90° and above active shoulder elevation movement

Exclusion Criteria:

* Having undergone revision surgery or previous shoulder surgery, a history of fracture of the upper extremity
* Having undergone surgery causing limitation of motion in the spine,
* Having a neurological and/or vestibular and/or rheumatologic disease,
* Participants with diabetes mellitus, hypertension, cardiovascular and chronic respiratory disease that may cause problems during the test
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder
* Must have visible tumor by cystoscopy within 12 weeks prior to first dose
* Has intermediate-risk NMIBC defined as 1 or more of the following risk factors:

  * Multiple tumors
  * \>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening
  * Early recurrence (\<1 year) of the initial diagnosis of low-grade disease
  * Solitary tumor \>3 cm
  * Failure of prior intravesical treatment
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder
* Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
* Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
A Study of Teriparatide in Japanese Osteoporosis Patients

The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients.

This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria

Exclusion Criteria:

* Prior treatment with parathyroid hormone (PTH) or any PTH analog
* History of metabolic bone disorders other than primary osteoporosis
* Fractures caused by diseases other than osteoporosis
* Abnormal thyroid function
* Hyperparathyroidism or hypoparathyroidism
* Severe or chronically disabling conditions other than osteoporosis
* Currently has or has a history of spruce, inflammatory bowel disease, or malabsorption syndrome
* Currently has, or a has a history of, nephrolithiasis or urolithiasis in the 2 years prior to screening
* Clinically significant abnormal laboratory values or electrocardiogram
* Treatment with oral bisphosphonates at any time in the 3 months prior to enrollment, treatment with any bisphosphonate for more than 60 days in the 6 months prior to enrollment, or with intravenous bisphosphonates at any time in the 24 months prior to enrollment; or in case of oral bisphosphonates administered once a week, the equivalent as the above
* Treatment with injectable calcitonin in the 3 months prior to enrollment
* Treatment with raloxifene hydrochloride for more than 3 months in the 6 months prior to enrollment
* Treatment with systemic corticosteroids, except for orally inhaled or nasally inhaled corticosteroids, in doses \<= 800 micrograms per day (µg/day) beclomethasone dipropionate or equivalent in the 3 months prior to screening, or for more than 30 days in the 12 months prior to enrollment
* Treatment with anticonvulsants, except for benzodiazepines, in the 6 months prior to enrollment
* Prior treatment with strontiumranate or denosumab (anti-RANKL antibody)
* Prior external beam radiation therapy involving the skeleton
* Current or a history of malignant neoplasm in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that had been definitively treated
Durapore vs. Hy-Tape to Secure The Endotracheal Tube

While adhesive tape is commonly used to secure endotracheal tubes (ETT) during general anesthesia, its use is also associated with facial skin injuries. Although a variety of adhesive tapes are used in clinical practice, few studies have investigated the likelihood of adhesives in producing injury. The purpose of this randomized, controlled, non-inferiority study was to compare the proportion of facial skin injury with Durapore™ vs. Hy-Tape®.

Adhesive tapes are often used on the patient's face during general anesthesia. They are used to fix the tracheal tube, nasopharyngeal temperature probe, nasogastric tube, and nerve stimulator electrodes. An adhesive tape used in anesthesia needs to provide fast, secure adhesion to prevent dislodgement of critical devices. The tape should be secure over time, with changes over temperature, humidity, or exposure to fluids as occurring in the operating room. However, the tape should be gentle enough that removal should not cause skin trauma to the face. While the skin irritation is generally limited to mild erythema that resolves on its own within a day or two of receiving anesthesia, the irritation may affect patient satisfaction. Furthermore, serious injury, including full-thickness epidermal loss with purpura has occurred at Tufts Medical Center with the use of 3MTM Durapore tape, requiring several doctor visits in follow up.

Medical adhesive related skin injuries are estimated to impact at least 1.5 million patients annually in the US with significant costs per incident. (1) At Tufts Medical Center, a variety of adhesive tapes are used to secure the endotracheal tube during anesthesia, including 3MTM Durapore (acrylate- based tape) and the Hy-Tape® Pink tape (zink-based tape) with no preference for one or the other.

Hy-Tape's zinc oxide-based adhesive is claimed to be soothing to delicate skin, and removes with minimum trauma, thereby reducing the chance of skin tears and tape burns. It also has the unique quality of providing maximum adhesion when it reaches body temperature, without getting more aggressive or breaking down over time as acrylic-based adhesive tapes do. However, there is no scientific evidence to support this claim.

The purpose of this study is to compare the proportion of skin erythema after general anesthesia with the use of DuraporeTM vs. Hy-Tape®.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Surgeries scheduled for anesthesia of duration more than 30 minutes after induction.

Exclusion Criteria:

1. Any patient that does not consent
2. Patients \< 18 years old
3. Surgery in the prone position
4. Surgery on the head, brain, neck, teeth, mouth, eyes, or face

   Any patient who has:
5. Pre-existing skin erythema or other skin trauma
6. Lips piercings
Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona

The overall objective of this clinical study is to determine the feasibility of breast CT for breast density assessment and association of CT-derived density measures with metabolic syndrome in overweight/obese Mexican-origin women in Southern Arizona. These evaluations will help support follow-up clinical research utilizing breast density acquired by breast CT as a surrogate endpoint biomarker to evaluate breast cancer preventive strategies. The long-term goal of these research efforts is to develop safe and effective preventive strategies to reduce obesity-associated breast cancer burden in our catchment area.


Eligibility Criteria:
Inclusion Criteria:

* Women with BMI of 25 kg/m2 or greater
* 40-65 years of age
* Must self-identify as Mexican-origin living in Southern Arizona
* Ability to understand and the willingness to sign a written informed consent document in English or Spanish

Exclusion Criteria:

* Women who are pregnant or lactating
* Women who have undergone treatment of chemotherapy and/or radiation for any malignancies within the past 2 years, excluding non-melanoma skin cancer or cancer confined to organs with surgical removal as the only treatment
* Women who have breast implants
* Women who have used selective estrogen receptor modulators, aromatase inhibitors, and /or hormone replacement therapy within the past 12 months.
* Women who have undergone bilateral mastectomy
* Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
* Women who are unable to tolerate study constraints, frail, or unable to cooperate
* Women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system
* Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for Hodgkin's disease
* Women who have received large number of diagnostic x-ray examinations of the horax for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.
Heart Rate Variability and Orthostatic Hypotension in Stroke Patients Evaluated by Intelligent Biosensor System

This research investigated the heart rate variability (HRV) and stroke patients' orthostatic hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting angle controlled by tilting table with intelligent biosensor.

Stroke patients readily accompany with the occurrence of orthostatic hypotension. To earlier predict patients occurring dizziness during the tilt table test, this study utilized a self-developed integrated intelligent biosensor system to assist clinical staff efficiently and immediately assessing stroke patients with orthostatic hypotension. Further purposes were to survey the relationship between the orthostatic hypotension and heart rate variability (HRV) and find the predicted models of orthostatic hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are first time to get stroke.

Exclusion Criteria:

* unstable physiological conditions, serious joint spasticity, use cortisol or calming drugs, other neurological diseases
A Prospective Study of the InterFuse T(tm),

The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.

The primary objective of this post-market study is to collect data to asses the long term outcome of the InterFuse T (tm) device in \[patients undergoing interbody fusion.

The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices and to the control device used concurrently in the study

Eligibility Criteria:
Inclusion Criteria:

* meets indications for an interbody fusion (determined by the study investigator)
* Has documented conservative (non-operative ) treatment for at least 3 months
* Has a VAS back pain of \> or = 60mm
* Has an ODI \> or = 40%
* at least 18 years of age and skeletally mature
* Willing and able to comply with study requirements
* Patient's condition is appropriate for surgery
* Agreed to participate in study

Exclusion Criteria:

* Has severe osteoporosis or osteopenia
* Grade 3 or higher Spondylolisthesis
* Diffuse multilevel neoplastic disease such that no adjacent normal segment exists for engagement or instrumentation
* Body Mass Index (BMI) \> 40
* Patient has active infection
* Patient is pregnant or planning to become pregnant
* Patient is mentally ill or has history of drug abuse
* Patient has known allergy to Polyetheretherketone (PEEK), stainless steel or Tantalum
* Patient is currently enrolled in an investigational spine study
* Has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease
* patient bhas symptomatic fibrous arachnoiditis
A Clinical Study of Inhaled Nitric Oxide in Moderate-to-Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the influence of exercise capacity and safety of iNO at doses of 10 ppm or 40 ppm for 2 hours per day after continuous treatment for one week, which is of great significance for finding safe and effective methods for treating COPD.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years, ≤ 75 years;
2. Previous smoking history ≥ 10 pack-years, and had stopped smoking for one month before study entry;
3. Met the diagnosis criteria of moderate and severe COPD: a post-bronchodilator FEV1/FVC \< 0.7, and 30%\< FEV1 \< 80% predicted;
4. Signed informed consent and performed all the study mandated procedures.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Current or recent month user of nicotine-like substances (including nicotine patches, etc.);
3. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator;
4. Lack of patency of nares upon physical examination;
5. Experienced during the last month an exacerbation requiring start of or increase in systemic oral corticosteroid therapy;
6. Left ventricular systolic dysfunction: left ventricular ejection fraction (LVEF) \< 50%;
7. Clinically significant valvular heart disease, including aortic valvular disease (moderate or severe aortic stenosis or regurgitation) and/or mitral valve disease (moderate or severe mitral stenosis or regurgitation), or status post mitral valve replacement;
8. Use within 30 days of screening or current use of approved pulmonary hypertension medications such as sildenafil, bosentan or prostacyclines;
9. Use of investigational drugs or devices within 30 days prior to enrollment into the study;
10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study.
Recovery Guide Intervention for Recurrent Psychiatric Hospitalization

The purpose of this study is to determine whether Recovery Guide support services are effective in promoting recovery and social integration among psychiatrically disabled individuals who experience high rates of inpatient hospitalizations.

The paradigm shift in mental health treatment from a deficit-and institution- based framework to a recovery and community integration frame necessitates new models of "case management" practices. The Recovery Guide model is just such a model. Beyond theoretical frameworks, the effectiveness of Recovery Guides has not been well studied. It is the intent of this study to conduct a randomized trial examining the effects of Recovery Guides on community tenure and integration. Furthermore, it is the intent of this study to to establish fidelity criteria.

Comparison(s): Recovery Guide services in addition to treatment as usual, compared to treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Currently admitted in the Yale-New Haven Psychiatric Hospital (YNHPH)
* A history of two or more prior admissions within the past 18 months
* Proficient in the use of the English language
* A DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, or Major Depressive Disorder with Psychotic Features

Exclusion Criteria:

* Inability to give signed, written consent
* Primary DSM-IV diagnosis of substance abuse/dependence
Assessment of Postoperative Pain in Children With Facial Expression Analysis

The present study was conducted to evaluate the use of computer-aided facial expression analysis to assess postoperative pain in children. The study population consisted of patients in the age group of 7-18 years who underwent surgery at Bursa Uludağ University Faculty of Medicine Health Application and Research Hospital Pediatric Surgery Clinic between November 2019 and June 2021. The sample of the study consisted of total 83 children who agreed to participate in the study and who met the sample selection criteria. Data were collected by the researcher using the Wong Baker Faces (WBS) pain rating scale and Visual Analog Scale (VAS). Data were collected from the child, mother, nurse, and one external observer. Facial action units associated with pain were used for machine estimation. OpenFace was used to analyze the child's facial action units and Python was used for machine learning algorithms. Intraclass correlation coefficient, Kappa coefficient, and linear regression analysis were used for statistical analysis of the data. The pain score predicted by the machine and the pain score assessments of the child, mother, nurse, and observer were compared.


Eligibility Criteria:
Inclusion Criteria:

* The patient is awake and oriented after the surgery,
* The patient must be within the first 12 hours after the operation and not be discharged before the first 36 hours after the operation,
* The patient is between the ages of 7-18,
* It is the mother's staying with the patient as a companion.

Exclusion Criteria:

* Presence of any facial anomalies that may alter facial expression analysis,
* The patient has neurological and mental disorders,
* Having regular opiate use in the last 6 months,
* These are surgical procedures that require the patient to be in a prone position.
Ulipristal Emergency Contraception Used Before or After Ovulation

This was a prospective, open-label, single-drug, uncontrolled, observational clinical study.

Women attending the Family Planning Association of Hong Kong (FPAHK) for emergency contraception within 120 hours of UPSI were recruited. Subjects were recruited from both the Birth Control Clinics and Youth Health Care Centres of the FPAHK.

Depending on the timing in relation to ovulation in the current menstrual cycle at the time of presentation, the women were classified into two groups:

Group 1: pre-ovulatory Group 2: post-ovulatory

After counseling and obtaining informed consent, eligible subjects received a single dose of ulipristal acetate 30 mg (ellaOne®) under direct supervision. A baseline blood test for hormonal profile (LH, oestradiol and progesterone) and ultrasound scan for ovarian follicle assessment were carried out by a designated doctor or research nurse at the clinic visit.

The subjects were advised not to have further acts of coitus before the return of menstruation. They were given a diary chart to record vaginal spotting and bleeding, possible side effects and further acts of intercourse, if any, and the contraceptive method used. A follow-up appointment were be arranged about 1-2 weeks after the expected next menstruation. Any events of unplanned pregnancy and adverse effects were recorded for analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy women aged 18 years or above;
2. Regular menstrual cycles (every 21-35 days) within the past three cycles;
3. Requesting emergency contraception within 120 h of a single act of unprotected intercourse in the current menstrual cycle;
4. Willing to abstain from further acts of unprotected intercourse and;
5. Available for follow-up over the next 6 weeks

Exclusion Criteria:

1. Post-abortion or postpartum patients whose period had not yet returned
2. Regular use of prescription drugs before admission to the study and
3. Intercourse during the treatment cycle more than 120 h before admission into the study.
4. Found pregnant at the time of presentation
5. Breastfeeding women
6. Women who have been sterilized (or partner being sterilized) or have intrauterine contraceptive device in-situ
7. Uncertain about the date of the last menstrual period
8. Women who had used hormonal contraceptive in the current or past one cycle