cyrilzakka/clinical-trials huggingface dataset:
Use of Cold and Compression Therapy With Total Knee Replacement Patients

The purpose of the study is to evaluate the effectiveness of a device that delivers cold and intermittent compression as compared to ice and compressive wraps on patients who have undergone knee replacement.

The use of cryotherapy with compression for orthopedic postoperative recovery has not been fully investigated. A new device has been developed that combines cold and intermittent pneumatic compression in a single system. A well-controlled clinical study evaluating the clinical effectiveness of cryotherapy with compression in an orthopedic postoperative application is the subject of this protocol. Patients diagnosed with osteoarthritis of the knee and scheduled for primary total knee arthroplasty procedure will be invited to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 but no more than 85 years of age
* Body Mass Index not greater than 40
* Diagnosis of osteoarthritis of the knee
* Medically cleared for total knee replacement surgery
* Physically and mentally able and willing to participate in and follow the study protocol and schedule
* Able and willing to have all postoperative physical therapy visits in a physical therapy clinic associated with the research site
* Signed informed consent document for the study

Exclusion Criteria:

* Rheumatoid arthritis
* Severe pitting edema in the ipsilateral limb
* History of thrombophlebitis in lower extremities
* An active systemic disease such as AIDS, HIV, hepatitis, etc.
* Is immunologically suppressed or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
* Is pregnant or planning to become pregnant during the study period
* Any condition that would contraindicate using the Game Ready
* Currently enrolled in another clinical trial that could affect outcome of this study
* Previously enrolled in this study
An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair

The purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery

This study is a prospective observational exploratory cohort study without a control group. As a single-group target value validation study, the main evaluation indicator is the primary patency rate one year after surgery. As an exploratory study, considering the enrollment ability to facilitate data analysis, 40 subjects are enrolled in the final study, and 20 are expected to be included in each study. All enrolled patients will be followed for 12 months for CTA to assess primary patency. Telephone follow-up was conducted at 1, 3, 6, and 12 months for adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with iliac aneurysms combined with or without abdominal aortic aneurysms and internal iliac arteries reconstructed with iliac branch stents;
2. Male or female ≥18 years old, ≤85 years old;
3. Life expectancy \> 2 years;
4. The patient signed the informed consent voluntarily and was able to comply with the treatment plan and complete the follow-up and examination as planned.

Exclusion Criteria:

1. Fungal or ruptured aneurysm
2. Known complications of thoracic aortic aneurysm require interventional treatment
3. American Association of Anesthesiologists (ASA) Grade V
4. Creatinine \> 2.5mg/dL or dialysis patients
5. NYHA Grade IV heart failure
6. Intercalation, severe calcification, or anchoring area with thrombosis
7. Severe curvature or narrowing of the iliac and/or femoral arteries, resulting in difficulty in stent delivery
8. Conduct another device or drug study within 1 year of treatment
9. Systemic infection
10. Combined with connective tissue disease
11. Known history of drug use
12. Known allergies or allergies to equipment materials
Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

This is a randomized, multi-site trial determining the effects of switching smokeless tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers of exposure and patterns of use. ST users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9 and 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Using a consistent and daily amount of ST with specific nicotine and tobacco-specific nitrosamine (TSNA) levels for the past year;
2. In good physical health (no unstable medical condition);
3. Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

1. Subjects must not be currently using other tobacco or nicotine products.
2. Female subjects cannot be pregnant or nursing.
DERM US and EU Validation Study

This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study,
* Male or Female, aged 18 years or above,
* Have at least one suitable skin lesion that will be biopsied due to a suspicion of skin cancer,

To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:

located on an anatomical site of different skin structure: palms of hands or soles of feet (acral lesion), mucosal surfaces (lips and eyes) or under nail (ungal lesion), a diameter greater than the diameter of the dermoscopic lenses, located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, has been previously biopsied, excised, treated or otherwise traumatised, located in an area of visible scarring or tattooing.

- In the Investigator's opinion, able and willing to comply with all study requirements.

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Apple Women's Health Study

This is an observational longitudinal study to advance the understanding of menstrual cycle and gynecologic health conditions including PCOS, infertility and breast cancer.The study will be hosted within the Research app(available on App Store), which allows a user to find, enroll, and participate in Apple-supported health-related research studies.


Eligibility Criteria:
Inclusion Criteria:

* Have menstruated at least once
* Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico)
* Live in the United States of America
* Be comfortable communicating in written and spoken English
* Have installed the Apple Research app on your iPhone
* Not share your iCloud account or iPhone with anyone else
* Be willing and able to provide informed consent to participate in the study
Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema

This is a Phase 2, Double-Blind, Randomized, Active-Control, Parallel Group Study to Assess the Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of SAR447537 (INBRX-101) Compared to Plasma-Derived Alpha1-Proteinase Inhibitor (A1PI) Augmentation Therapy in Adults With Alpha-1 Antitrypsin Deficiency (AATD) Emphysema.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 18-80 years of age, inclusive, at the time of screening
2. Diagnosis of AATD
3. Evidence of emphysema secondary to AATD
4. FEV1 of ≥ 30% and ≤ 80% predicted at screening
5. Current non-smoking status.

Exclusion Criteria:

1. Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of study drug
2. Known or suspected allergy to components of SAR447537 (INBRX-101), A1PI or human IgG
3. Known selective or severe Immunoglobulin A (IgA) deficiency
4. Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
5. Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days
6. On waiting list for lung or liver transplant
7. Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to or during screening
8. Evidence of decompensated cirrhosis
9. Active cancers or has a history of malignancy within 5 years prior to screening
10. History of unstable cor pulmonale
11. Clinically significant congestive heart failure
A Study of SHR-A1811 in Subjects With Ovarian Cancer

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Symptomatic, untreated or active central nervous system metastases.
2. Have uncontrolled or severe cardiovascular disease.
3. With any active autoimmune disease or history of autoimmune disease.
4. Patients with active hepatitis B or hepatitis C.
5. Severe infections prior to initiation of study treatment.
6. Patients with active tuberculosis.
Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms

First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.


Eligibility Criteria:
Main eligibility criteria (non-exhaustive list) are defined as:

* Healthy Caucasian subject of both gender, aged from 18 to 69 years
* Subject with body mass index (BMI) between 18 kg/m2 (bound included) and 30 kg/m2 (bound excluded)
* Subjects with moderate constipation defined according to ROME III adapted criteria.
* Subjects without ongoing or diagnosed gastrointestinal disease or complications.
* Subjects without previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function.
* Subjects without known gluten intolerance, lactose intolerance or allergy to milk proteins.
The Incidence of Intra-Operative Awareness in China and Analysis of Relevant Factors: a Multicentre Study

Medical literature about awareness during general anesthesia is rare in China, and some small sampled studies in China showed a significantly higher incidence (1.5～6%) of intra-operative awareness compared with western countries. The investigators sponsored this multicenter, large sampled, prospective study to determine the incidence of intra-operative awareness in China, and the preservation effect of BIS monitor on the incidence of awareness.

Background: The incidence of awareness in patients undergoing general anesthesia has been reported in as many as 0.1～0.2% in western countries. But so far，medical literature about awareness during general anesthesia is still rare in China, and some small sampled studies in China showed a significantly higher incidence (1.5～6%) of intra-operative awareness. We believed that this multicenter, large sampled, prospective study would be very necessary for us to determine the incidence of intra-operative awareness in China, and analysis of the relevant factors would help us to understand why was the incidence of awareness in China much higher than that in western countries.

Methods: This is a prospective, nonrandomized descriptive cohort study that was conducted at 25 academic medical centers in China. 11,197 patients (age\>12, intubation or LMA during anesthesia) form 25 medical centers were enrolled to be interviewed by research stuff for evaluation of awareness at the 1st and 4th day after their general anesthesia. The structured interview questions were:⑴What is the last thing you remembered before you went to sleep? ⑵What is the first thing you remembered when you woke up? ⑶Can you remember anything between these two periods? ⑷Did you dream during your operation? ⑸What was the worst thing about your operation? An evaluation committee independent from the research stuff was constituted to verify the data from the medical centers. And then the incidence of intra-operative awareness in China was determined. General condition and details of the anesthesia procedure of the patients were also recorded during the anesthesia for a binary logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients received general anesthesia with tracheal intubation or LMA
* Apparently normal mental status

Exclusion Criteria:

* Pediatric patients (\<12 yr)
* Those who could not be interviewed in 24 hours after the operations
* Those unable to communicate in common spoken Chinese
Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index

Since December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection.

Even though we have had great victories in the war against this pandemic, there is still a very large number of deaths early on. As research progresses, vaccines for this infectious disease are already being developed. There are currently two vaccines in widespread use worldwide: mRNA vaccines and inactivated vaccines. In China, inactivated vaccines are more commonly used. At present, some studies believe that mRNA vaccine does not affect the pregnancy rate and abortion rate of women, but the study sample size is small, and the conclusions are limited. The effects of inactivated vaccines on fertility are still in the blank. We now hope to conduct prospective studies, mainly to study the effect of inactivated vaccine injection on male semen, and whether it has an effect on the quality of embryos in IVF patients


Eligibility Criteria:
Inclusion Criteria:

1. The man's semen quality is normal,
2. The couple meets the indications for IVF,
3. injected with the covid-19 vaccine

Exclusion Criteria:

1. In vitro fertilization due to male factors
2. Azoospermia
3. The quality of the man's semen is abnormal
4. unvacced
Does Glaucoma Cause Loss of Brain Function?

The purpose of the study is to determine if glaucoma is associated with neurodegenerative changes in areas of the brain other than the occipital lobe. This will help guide the direction of further research in the use of neuroprotective agents in preventing or controlling such changes. The final goal is to improve the quality of life for patients with glaucoma.

Death of retinal ganglion cells causes loss of neurons in areas other than just the visual cortex. These neurodegenerative changes decrease the patient's ability to perform the activities of daily living. Tensor-based morphometry analysis of magnetic resonance imaging (MRI) brain scans will reveal areas of cortical degeneration in glaucoma patients, and the extent of damage in these areas should correlate with patients ability to perform vision-dependent tasks, as measured by the Assessment of Ability Related to Vision (AARV).

Patients with glaucoma who were outliers in two previous studies, Assessment of Ability Related to Vision (AARV) or Assessment of Disability related to vision (ADREV), in that they had poor performance-based measure scores despite having midrange visual field scores.

Mini-Mental State Exam and T-1 weighted MRI brain scan and will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma who were participated in other studies Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV) and were found to be outliers in that they have poor performance-based measure scores (≤ 40) despite having midrange visual field scores (mean deviation of -6 to -20).
* Age-, gender- and race-matched controls who do not have glaucoma, and who do not have loss of vision for any reason other than cataract or refractive error.

Exclusion Criteria:

1. Patients with any type of neurological disease.
2. Patients with a cognitive deficit which would affect visual functioning, as revealed by score of less than 25 in the mini mental status examination.
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients

Background: The aim of this prospective study was to evaluate the effect of magnesium on the reversal of rocuronium-induced neuromuscular block by sugammadex.

Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II, undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane. The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv was administered. Patients were observed until a TOF ratio of 0.9 was achieved. Patient-controlled analgesia with intravenous morphine was used postoperatively.

Inclusion criteria:

* American Society of Anesthesiologists physical status I or II
* 18-60 years of age
* undergoing elective gynecological surgery
* requiring endotracheal intubation

Exclusion criteria:

* Patients who had body mass index \> 35
* gastroesophageal reflux
* a history of allergy
* used medication known to interact with the drugs being used in this trial
* who experienced expected or unexpected difficulty during intubation or ventilation
* had neuromuscular disease
* hepatic or renal insufficiency
* pregnant
* were American Society of Anesthesiologists III or IV
* had a family history of malignant hyperthermia
* detection if low or high control plasma magnesium levels

Eligibility Criteria:
Inclusion Criteria:

* female patients
* American Society of Anesthesiologists (ASA) physical status I or II
* 18-60 years of age who were undergoing elective gynecological surgery
* requiring endotracheal intubation were enrolled in this prospective study.

Exclusion Criteria:

* Patients who had body mass index \> 35
* gastroesophageal reflux
* a history of allergy
* used medication known to interact with the drugs being used in this trial
* who experienced expected or unexpected difficulty during intubation or ventilation
* had neuromuscular disease
* hepatic or renal insufficiency
* were pregnant
* had a family history of malignant hyperthermia
* detection if low or high control plasma magnesium levels
Luteal Support in Artificial Vitrified/Warmed Cycles With Low Progesterone

The study aims to evaluate the effect of an increased dose of vaginal progesterone supplementation on the incidence of ongoing pregnancy for patients with a suboptimal serum progesterone level (defined as \< 10 mcg/l) on the day of blastocyst transfer.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form (ICF) dated and signed
* Age ≥ 18 and \< 43 years old
* Body Mass Index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2
* Less than 4 previous Assisted Reproductive Technologies (ART) cycles
* Current pregnancy wish
* Patients undergoing a single vitrified/warmed single transfer in an artificial prepared endometrium cycle (IVF or ICSI)

Exclusion Criteria:

* Simultaneous participation in another clinical study
* Previous participation in this study
* Known reasons for impaired implantation (specifically: presence of a hydrosalpinx; presence of a type I, II or III fibroid; Asherman's syndrome; uterine malformations, intrauterine adhesions, ≥ grade 3 endometriosis according to the ASRM classification, endometrial tuberculosis)
* Repeated miscarriages (\> 2 miscarriages)
* Untreated and uncontrolled thyroid dysfunction
* Tumors of the ovary, breast, uterus, pituitary or hypothalamus
* Abnormal vaginal bleeding without a known/diagnosed cause
* Ovarian cysts or enlarged ovaries
* Fibroid tumors of the uterus incompatible with pregnancy
* Malformations of the reproductive organs incompatible with pregnancy
* Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin)
* Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia
* Active smoking
* Ongoing pregnancy
* Use of carbamazepine, rifampicin or phenytoin
* Those unable to comprehend the investigational nature of the proposed study
The Impact of Covid 19 Pandemic on Ureteric Stents Complications.

The pandemic of coronavirus disease 2019 (COVID-19) has serious implications on urology practice and raises particular questions for urologists about the management of different conditions. It was recommended to cancel most of the elective urological surgeries. (1) The least invasive intervention modalities that can be completed in local or regional anesthesia will serve the best interest of patients and urologists. 10 14 Endoscopic surgery is considered relatively safe.(2) After end of pandemic we facing complication of this era, one of most common complication was JJ stents complications as most of patient and doctors prefers to defer most of elective management by just JJ insertion and postpone definitive treatment. (3) In this study we discuss retrospectively the complication of JJ stenting during Covid 19 pandemic.

Type of the study: retrospective clinical study

* Study Setting: Qena University Hospital 3- Study subjects:

  a. Inclusion criteria: all patients performing JJ stent placement during Covid 19 pandemics b. Exclusion criteria: Patients refuse to participate in this study c. Sample Size Calculation: all patients performing JJ stent placement from March 2020 to December 2021
* Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...):

  * Medical history
  * Complete physical examination.
  * All patents presented was investigated by

    1. Abdominal U.S
    2. Plain X Ray
    3. Non contrast CT
    4. Serum Creatinine
    5. Urine Analysis
* Research outcome measures:

  1. Primary (main): determine effect of urological malpractice during Covid 19 on patient complications
  2. Secondary (subsidiary): determine JJ stent complications during Covid 19 pandemics

Eligibility Criteria:
Inclusion Criteria:

* all patients performing JJ stent placement during Covid 19 pandemics

Exclusion Criteria:

* Patients refuse to participate in this study