cyrilzakka/clinical-trials huggingface dataset:
Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy

Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available.

The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.

This is a two-center, randomized, prospective, comparative study.

The functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists.

The close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>45 years
2. Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)
3. Patient who has given his/her consent to participate in the study after being informed by the surgeon,
4. Patient living in France and able to answer the survey alone.
5. Subject affiliated to a social security system or beneficiary of such a system
6. No participation in any other clinical study

Exclusion Criteria:

1. Minor patient
2. Trapezium height \< 8 mm
3. Major subject protected by law, under curatorship or guardianship
4. Known allergy to the materials of the medical device
5. Local infection
6. Local skin necrosis or unhealed wound
7. Pregnant or nursing women
Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy

The study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. This is done by measuring local blood samples in the feet, and systemically in a vene and an artery. Measurements are done before and after cooling the feet in icewater to lower the bloodflow.

Patients will be compared with healthy diabetic controls.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 1 or 2
* Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist

Exclusion Criteria:

* Osteoporosis
* Anti-osteoporotic treatment
* Lower extremity amputation
* Lower extremity infection
Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto

The purpose of this study is to determine if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be an adult man aged between 50 and 75
* Patient must have Benign Prostatic Hyperplasia symptoms

Exclusion Criteria:

* Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection
* Patient has been subjected to surgery of the prostate, bladder or urethra
* Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening
* Patient has taken an alpha-blocker in the 2-week period preceding screening
A Mobile Application, Oncpatient, to Assist Patients Undergoing Radiation Therapy

This clinical trial determines how well the oncpatient mobile application work in assisting patients undergoing radiation treatment. Radiation therapy can be complex. The technology, daily treatments, and possible side effects can be confusing to prevent and manage. Traditional radiation patient education includes a large amount of information, including details of treatment logistics, side effect prevention, and management. However, this information is not always readily accessible or memorable through the long course of therapy, and critical details can be missed. Oncpatient is a mobile application intended to be a more convenient and accessible form of patient education and guidance that is readily available to help patients and their caretakers navigate through radiation treatment.

PRIMARY OBJECTIVE:

I. To determine the feasibility of implementing a mobile application designed to be an educational resource designed for patients undergoing radiation treatment.

SECONDARY OBJECTIVES:

I. To assess patient opinions on the usability and helpfulness of the mobile application in helping them through radiation treatments.

II. To assess satisfaction with the mobile application and radiation treatment. III. To assess opinions on existing or new features for the mobile application to be given to future patients.

OUTLINE:

Patients use the oncpatient mobile application over the course of radiation therapy. Patients also complete a survey on the final day of radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older.
* Can read and speak English and provide informed consent.
* Diagnosed with cancer, any stage, any disease site.
* Must be consented to undergo a course of radiotherapy, starting within one month. No limits on duration of radiation apply. Patients must be consented prior to initiating radiotherapy, however.
* Has regular access to a mobile device.

  * Note: This requirement unfortunately leads to the exclusion of underserved patients who cannot afford to have a mobile device. Given that the goal of this study is to establish feasibility of a mobile application, there are no true alternatives, given that these patients would require access to a mobile device if this app were commercially available. However, for impacted patients, the relevant application and resources will be made available on iPads they can access during treatment and a website they can access on any web-enabled device, to ensure they have access as much as reasonably possible. Future iterations of the application will aim to increase access to the resource however possible, but limitations will always apply due to how the core functionality of the app requires a mobile device.

Exclusion Criteria:

* Less than 18 years old.
* Non-English speaking.
* Inability to operate a mobile device.
Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

* The study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in the 12 months after a NovaSure ablation. Investigators believe this knowledge will help them to determine when to proceed with further evaluation postoperatively or when to counsel patients on expectant management based on ultrasonographic findings.
* Secondary aims include correlation of ultrasonographic findings to demographic patient data.

Heavy and irregular menses affects 9-14% of gynecologic patients. Surgical can be employed intervention is sought when medical management fails. Endometrial ablation or desiccation of the endometrium using minimally invasive instruments has been utilized in this scenario. The current mainstay intervention is non-resectoscopic radio frequency ablation. These procedures have high satisfaction rates (81 to 93%) similar to hysterectomy and leave up to 47% of patients amenorrheic. Post operative complications, both short and long term, and failure rates have been well studied. A limited number of studies have been performed to assess the histologic state of the post ablative endometrium and fewer assessing the radiographic appearance of the endometrium. Therefore, this current study aims to describe the ultrasonographic appearance of the post ablative endometrium and uterus.

Eligibility Criteria:
Inclusion Criteria:

* women of premenopausal age
* 18 years and older
* intended ablative management of menorrhagia

Exclusion Criteria:

* uterine cavity anatomic abnormality
* previous uterine ablation procedure
* previous cervical procedure
* presence of submucosal fibroids
* tissue diagnosis of endometrial hyperplasia/endometrial carcinoma
* pregnancy and delivery less than 1 year before ablation.
Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy

Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.

Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.

Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes. Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices. The primary outcome measure will be the assessment of pain levels during colonoscopy, which will be quantified using the "Visual Analogue Scale." Additionally, researchers will assess anxiety levels using the "State-Trait Anxiety Inventory" both before and after the colonoscopy procedure. Vital signs during colonoscopy, procedural effects, and adverse effects would also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years of age
* Able to cooperate and complete the questionnaires independently
* Stable vital signs with no serious cardiovascular or cerebrovascular diseases
* Voluntary participation

Exclusion Criteria:

* Severely impaired in vision or hearing to accommodate VR devices
* Previous history of anxiety, depression, cognitive impairment, balance disorder, mental illness, or epilepsy
Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization

Feeding is one of the most common problems encountered by preterm infants. Besides, effective and safe feeding is one of the important discharge criteria. Feeding problems of premature infants lead to prolonged hospitalization and increased healthcare cost. SINC feeding protocol was developed based on evidence-based feeding protocol (such as cue-based, infant-driven feeding) and individualized developmental care.

The aim of the study is to determine the effect of the SINC feeding protocol on weight gain, transition to oral feeding and the length of hospitalization in premature infants according to traditional feeding method.

Randomized controlled study, including 30 infants of 28-33+6 weeks gestation receiving either Standard Feeding or SINC Feeding Protocol.


Eligibility Criteria:
Inclusion Criteria:

Having been born between 24-33+6 weeks of gestational age 28-33+6 postmenstrual weeks Monitoring with the diagnosis of healthy preterm infants

Exclusion Criteria:

* Receiving mechanical ventilation
* Congenital anomalies
* Having a surgical operation
* Having serious health problems
Effects of Local Protocols on Duration of Chest Tube Therapy Following Thoracic Surgery

The effect of local chest-tube management protocols on the duration of chest-tube therapy following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units. The primary study objective was the duration of chest tube therapy in postoperative patients.

The management of chest tubes is probably one of the most critical aspects in patient care in thoracic surgery and defines the required length of postoperative hospital stay in the majority of patients. So far, no generally accepted recommendations exist for postoperative chest tube management to streamline the postoperative stay. Instead, decision making in most thoracic surgery units is based on team preferences and individual training rather than scientific data. Therefore, digital pleural drainage systems represent a useful tool to standardize existing intradepartmental protocols for chest tube management. However, for the development of generally accepted protocol-recommendations, the diverging interdepartmental treatment protocols have to be analyzed and compared for superiority. In this IIT, the effect of different chest tube management protocols on chest tube duration is analyzed in four German Thoracic Surgery units.

Eligibility Criteria:
Inclusion Criteria:

* age 18-85
* following pulmonary wedge resection, anatomic segmentectomy, or lobectomy

Exclusion Criteria:

* surgery for spontaneous pneumothorax (primary and secondary)
* surgery for pleural empyema
* present medication with corticoids, immunosuppressive drugs or platelet aggregation inhibitors other than Aspirin
* history of chemotherapy, radiotherapy of the chest, or previous ipsilateral thoracic surgery
Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women

The purpose of this study is to evaluate the effectiveness of the behavior treatment accompanied by self-help materials in Primary health care, across the intervention of the midwifes in the pregnancy follow-up visits.

Aim: To evaluate the efficiency of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on tobacco abstinence at the conclusion of the pregnancy self referred and validated with cooximetry.

Secondary objectives:

1. To evaluate the effectiveness of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on the tobacco abstinence 6 months after the childbirth.
2. The effectiveness of the intervention values on the weight of the newborn child, the number of childbirths pre-term and the perinatal mortality.
3. To study the effectiveness of the intervention in smoking on the maintenance of the breast-feeding to 3 and 6 months.

Method:

Design: cluster randomized controlled trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service.

Sample size adjusted for design effect: number of smoking women in every branch would be of 350.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* pregnant at 20 weeks or less of gestation
* attending her first prenatal visit with any of the participating prenatal care teams (this first prenatal visit takes place usually around 6-12 weeks of pregnancy)
* defining herself as a current cigarette smoker or recent ex-smoker (see below for a definition of these terms)
* being able to meet the requisites of the trial:
* being available for the next 15 months
* defining herself as fluent in reading and speaking Spanish to understand the study procedures and to comply with them

  * meeting no exclusion criterion; and
  * willing and able to give informed consent for participation in the study

Exclusion Criteria:

* communication barrier;
* active addictions to other psychoactive substances
* involved in any other formal smoking cessation program or in another trial during the study period; or
* does not consent to participate in the study
Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China

Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies.

Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies. In the present study, a multicenter, 1-day point cross-sectional study about the sedation and analgesia among patients in China, particularly brain-injured will be investigated. The objectives are to investigate sedation and analgesia among patients in China and to compare sedation and analgesia between brain injuries and other patients.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the participating ICUs on the investigation day

Exclusion Criteria:

* Age under 18 years
* Less than 24 hours of ICU stay before screening
* Taking part in other studies
Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children

To determine the most cost effective way to treat children with perforated appendicitis we will randomize all children presenting with perforated appendicitis to initial operation, with in 24 hours of admission, or to initial antibiotics, with or without percutaneous drainage, and subsequent interval appendectomy after 8 weeks. Our outcomes will include cost, complications, length of stay, and quality of life measures.


Eligibility Criteria:
Inclusion Criteria:children

* Age 2-17 with a diagnosis of perforated appendicitis

Exclusion Criteria:

* Age \<2 and \>18
* Pregnancy
* Immunocompromise
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement

The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.


Eligibility Criteria:
Inclusion Criteria:

Each subject to be included into the study must fulfill the following inclusion criteria:

* Subjects receiving a cement free hip prosthesis due to coxarthrosis because of primary or dysplastic arthrosis grade 1 - 3 according to Crowe or rheumatoid arthritis as well as subjects receiving a cement free hip prosthesis due to femur head necrosis (Crowe classification).
* ASA and NSAIDs have been discontinued one week prior to surgery
* Written informed consent
* Male and female at least 19 years of age

Exclusion Criteria:

Subjects fulfilling the following exclusion criteria will not be recruited into the study:

* Impaired coagulation
* Previous hip surgery
* Acetabular roof plastic
* Known hypersensitivity to aprotinin or other components of the product
* Immunodeficiency
* Increased red cell production
* Pregnant or lactating women (positive urine or serum pregnancy test; this test is required of any female subject who is not post menopausal or surgically sterilized).
* Subjects concurrently participating in another clinical trial or having received another investigational drug within the last 30 days.

Also patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.
At-risk and vulNerable Individuals To Infection With COVID-19 and ProActive inTervention With intEgrated Health and Social Care

This randomized control trial aims to explore a data-driven, proactive approach to identifying patients at greatest risk during the pandemic, and assess the impact of an embedded System Navigator in a primary health care setting. The System Navigator works one-on-one with patients to identify and provide support to their biological, psychological and social needs (e.g. income, housing, food security). Investigators are doing this study to find out whether proactive identification of vulnerable patients and linking to a System Navigator leads to reduction in emotional distress associated with managing complex health conditions and unmet social needs during COVID-19, compared to usual care.

Investigators will involve approximately 180 patients from primary care clinics that are a part of the University of Toronto Practice-Based Research Network (UTOPIAN). The information from this study will be used to help us understand how proactive engagement within a primary health setting can help to improve the health of patients during COVID-19, and beyond.


Eligibility Criteria:
Inclusion Criteria:

* At-risk and vulnerable patients of primary care organizations who are 60+ AND have one or more of:

  1. chronic condition (diabetes, CHF, CAD, COPD or asthma)
  2. serious mental illness (schizophrenia or bipolar disorder)
  3. anticipated to live in poverty and/or be homeless/underhoused

Exclusion Criteria:

* patients unable to provide informed consent
PWP1's Expression in Gastric Cancer.

Background：Gastric cancer is a globally important disease and the fifth most diagnosed malignant cancer in the world. Because it is usually diagnosed at an advanced stage, gastric cancer has a high mortality rate, making it the third most common cause of cancer-related death. Hot spots of gastric cancer incidence and mortality exist in East Asia, Eastern Europe and South America. It is still an urgent problem to find new diagnostic and prognostic markers and better understand the molecular mechanism of gastric cancer. Although radical resection and systemic chemotherapy have shown great improvement, the prognosis of gastric cancer (GC) patients is still depressing due to malignant proliferation and metastasis. Therefore, it is urgent to clarify the potential molecular mechanism of gastric cancer progression, which will contribute to the development of targeted therapy. Effective induction of tumor cell apoptosis is the most important feature of a new chemical agent for cancer treatment. There is increasing evidence that the cell cycle can act in concert with apoptosis to cause cell death under certain cellular stress conditions. A comprehensive understanding of the relationship between apoptosis and cell cycle is essential for developing effective cancer therapies.

PWP1 is also known as endonuclein, which contains five WD40 repeated domains and belongs to the WD40-repeated superfamily. It is highly expressed in human pancreatic adenocarcinoma, where it functions as a cell-cycle regulator. However, the normal function of Pwp1 is largely unknown. Previous research data show that PWP1 plays a key role in regulating biological functions such as RNA processing, signal transduction, gene expression, vesicle transport, cytoskeleton assembly and cell cycle progression. Whether the high expression of PWP1 is ubiquitous in tumors, the relationship between the high expression and clinicopathological factors of tumors, and the mechanism of PWP1 in tumors are still unclear. Further exploration of the molecular mechanism of PWP1 in GC may provide new ideas and therapeutic targets for GC treatment in the future, and benefit clinical patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as gastric cancer
* Performing gastric cancer resection surgery
* Informed consent signed prior to surgery.

Exclusion Criteria:

* Emergency surgery
* Preoperative and intraoperative detection of distant organ metastases or extensive
* No standard chemotherapy for tumor-node-metastasis (TNM) staging II or III after surgery
* Incomplete case data.
GABA and Beta-cell Regeneration

GABA(gamma-Aminobutyric acid) may be used for decreasing anti-gad antibodies and leads beta-cell regeneration.

100 patients with type I diabetes were in 2 groups, had been monitored in a private clinic, number 50 each group, with 30 females and 20 males after the written consent of all patients.

All the patients Lied between 18-25 years old with 5-10 years of diabetes onset.

The first group was on insulin therapy in the form of toujeo once daily and Novorapid 3 times daily and they received GABA nutritional supplement 750mg per day.

The second group was only on insulin injection in the form of toujeo once daily and Novorapid 3 times daily.

In the first group;the investigator measured fasting c peptide levels before and after 6 months of GABA 750mg daily.Also,the investigator measured anti gad antibodies before and after 6 months of treatment.

In the second group,the investigator measured c peptide levels and anti-gad antibodies at the beginning of the trial and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

- type 1 diabetes patients age from 18 to 25 years on basal bolus insulin

Exclusion Criteria:

thyroid problems liver disease kidney disease