cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046

The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.

Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL) of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104 mg/0.65 mL Depo-subQ 104 per the assigned sequence.

Eligibility Criteria:
Inclusion Criteria:

* Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device \[IUD\], or consistent use of condoms)
* Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
* Participant had a normal mammogram within the last year, if 40 years or older
* Participant has no skin disorders or skin allergies

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participant has hypertension
* Participant has ischemic heart disease or a history of ischemic heart disease
* Participant has a history of stroke
* Participant has a history of thromboembolic event(s)
* Participant has systemic lupus erythematosus
* Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
* Participant has migraine with aura
* Participant has unexplained vaginal bleeding
* Participant has diabetes
* Participant has a strong family history of breast cancer
* Participant has cervical cancer or a history of cervical cancer
* Participant has severe cirrhosis (decompensated) or liver tumors
* Participant has known significant renal disease
* Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
* Participant is currently using hormonal contraception
* Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
* Participant is chronically using pain medication
* Participant has a plan to move to another location in the next 18 months

  * Additional criteria apply, please contact the investigator for more information
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery

Breast cancer is one of the three most common cancers worldwide, and the primary treatment method is surgery.Since most patients are non-smokers who use opioids in the postoperative period, which are known risk factors for postoperative nausea and vomiting (PONV) according to the Apfel Risk Score. Breast surgery was identified as a strong risk factor for PONV. According to the previous studies, the incidence of PONV is 30-70% in patients undergoing the breast cancer surgery, which not only gives patients unpleasant and painful experience, but also prolongs the hospital stays and delay patient discharge and adds to hospital costs. We compared the effects of dexamethasone alone vs. in combination with Pericardium 6 (P6) electrical stimulation or granisetron for inhibition of PONV in women undergoing breast cancer surgery.

186 patients who are planed to undergo elective breast cancer surgery under general anaesthesia into the following three groups: acupoint stimulation+dexamethasone (Group Acu, n=62), granisetron +dexamethasone (Group Gra, n=62), and dexamethasone alone (Group Dxm, n=62). The incidence of nausea, vomiting, and need for rescue antiemetics was recorded 2, 6, 24, and 48 h after surgery.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing breast cancer resection under general anesthesia
* aged between 18 to 65
* American Society of Anesthesiologists grade I-II

Exclusion Criteria:

* using antiemetic drugs within 24 h before operation,
* nausea or vomiting within 24 h before operation;
* Alcoholic or drug abuse,
* abnormal liver and/or kidney function, diabetic or peripheral neuropathy patients, cardiovascular disease (excluding those with controlled hypertension).
* refuse to participate clinical trial
Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal

This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.

Background： Traditional physiological measurement methods often require subjects to remain immobile or have various devices attached to their bodies, causing discomfort, especially unsuitable for neonatal care. However, with the development of electronic technologies, these methods have improved. ballistocardiography (BCG) presents a possible solution for monitoring neonates' physiological signals. BCG is a non-invasive and non-contact instrument that measures the body's reactive motion pressure changes caused by cardiac contraction. These sensors do not require direct attachment, allowing for long-term physiological signal measurement without disturbing the subject.

Methods： The study will be conducted in the neonatal intensive care unit on the seventh floor of Fu Jen Catholic University Hospital, with an expected enrollment of 60 participants. The subjects will be grouped and stratified based on weight and the use of invasive respiratory support. During the hospitalization, daily output of ventilator data and physiological monitor data will be collected and analyzed for correlation.

Effect： This trial is expected to confirm the application of BCG in the neonatal population, demonstrate its correlation with current conventional physiological monitors, and assess its applicability in low-weight preterm infants. Additionally, the study will investigate whether continuous BCG monitoring during hospitalization can predict the possibility of bronchopulmonary dysplasia.

Eligibility Criteria:
Inclusion Criteria:

* Using invasive ventilation support with flow sensors or non-invasive ventilation support
* The legal representative signs the informed consent form

Exclusion Criteria:

* Refusal to participate in the study
Evaluate the Benefit of an Individualised Treatment Plan (VitalCare) VS SOC in OSA Patients Treated With CPAP/APAP

According to a stratification procedure, the objective of a personalised care plan (VitalCare) is to identify points for improvement since the early stage of the patient's pathway of CPAP/APAP treatment and to adjust patient follow-up .

It is a prospective, exploratory, randomised, multi-centre, open, controlled study with a 1:1 ratio of two parallel groups, with obstructive sleep apnoea patients starting CPAP/APAP therapy, and receiving by the homecare provider, either an individualised treatment plan (VitalCare) or national standard of care.

This study will be conducted in 5 hospital centres in Portugal..

During a regular medical consultation, eligible patients who have signed their informed consent will be randomised by their investigator.

Two study groups will be set up:

1. Standard of care group
2. VitalCare group

Two medical visits in the hospital centres will be scheduled in the context of the study for all participating patients:

1. A screening/inclusion visit before CPAP/APAP initiation at home;
2. An end-of-study visit planned at 12 months (± 1 month) after CPAP/APAP initiation at home. All visits done in the hospital centres at the discretion of the investigators between patient's screening/inclusion visit and end-of-study visit will be recorded in the eCRF with the reason for the visit and change in CPAP/APAP prescription, if applicable

The primary objective of this study is to evaluate adherence to CPAP/APAP treatment at 3 months in patients with individualised treatment plan (VitalCare) compared to patients with standard of care

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with Obstructive Sleep Apnoea Syndrome (OSAS) who is newly prescribed CPAP or APAP therapy at inclusion
* Patient agreeing to the collection of data from their CPAP/APAP device via teletransmission
* Patient equipped with a device compatible with the ResMed telemonitoring data platform
* Patient who has signed the informed consent form for the study

Exclusion Criteria:

* Obese patient presenting hypoventilation
* Patient at risk of other sleep disorders (e.g. severe insomnia)
* Patient with physical, mental or cognitive inability to use all components of the remote medical monitoring project and individualised treatment plan, as determined by the investigator wishing to include the patient
* Patient with severe COPD (FEV1 ≤ 50% predicted or modified Medical Research Council (mMRC) dyspnoea scale \> 2)
* Patient with severe Chronic Heart Failure (NYHA stage III or IV)
* Patient's refusal of CPAP/APAP treatment support
* Previous CPAP/APAP treatment for Sleep Apnoea
* Patient with ongoing Mandibular Advancement Device (MAD) or in the 12 previous months
* Patient with no permanent place of residence
* Patient participating in another drug or device study within the previous 30 days
Kinesio Taping and Inhibitory Treatment Techniques

Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS).

Study Design: A single-blind randomized controlled trial was conducted on patients with FMS.

Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving kinesio taping and inhibitory treatment techniques, or to a control group for exercises and electrical stimulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Fibromyalgia Syndrome.
* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
* Agreement to attend evening therapy sessions.
* Non-practice of regular physical activity.

Exclusion Criteria:

* A history of surgery.
* The presence of comorbid conditions (e.g., morbid obesity, inflammatory diseases, irritable bowel syndrome and interstitial cystitis).
* A history of whiplash injury.
* Severe physical disability.
* uncontrolled endocrine disorders (e.g., hyperthyroidism, diabetes); 6) illness (e.g., schizophrenia or substance abuse).
* The use of medication other than as-needed analgesics (excluding long-term narcotics).
* Malignancy.
* Psychiatric disorders.
* A score of ≥ 9 points in the Beck depression inventory.
Theta Burst Stimulation for Motor Recovery

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.

High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.

This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* 1.Unilateral ischemic or hemorrhagic stroke
* 2.Stroke within 3 months
* 3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
* 4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
* 5.Patient could sit over 15 minutes
* 6.Age over 20

Exclusion Criteria:

* 1.Previous stroke, traumatic brain injury, brain tumor
* 2.With central nervous system disease (spinal cord injury, Parkinson's disease)
* 3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
* 4.Patients unable to cooperate the treatment
* 5.Pregnancy
* 6.Depression
Manual Therapy and Proprioceptive Neuromuscular Facilitation in Field Hockey Players.

Introduction: Field hockey is a contact sport. Semiflexion asymmetric position, along with other theories such as the weakness of the extensor muscles of the back or hamstring injury, can be causes or aggravating that suelan hockey players suffer back pain. Objectives: To observe the effectiveness of manual therapy techniques and post-isometric stretching (PNF) after three treatment sessions. In turn, know which of the two treatments have a greater benefit and longer. Methods: The population consists of grass hockey players and senior category aged between 16-30 years. They were randomly divided into two treatment groups. Group 1 corresponded to manual therapy techniques and group 2 to PNF stretching. The study duration for each subject was 5 sessions that included 3 treatment and 3 assessments. Each evaluation consisted of goniometry, balance test using the Sit and Reach, and Roland Morris questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* field hockey players (HH) (senior category).
* between 16 and 30 years.
* suffered injuries and microtraumatic not prevent them from sports.

Exclusion Criteria:

* subjects with structural abnormalities of the spine.
* plantar alterations.
* other moderate or severe musculoskeletal previous injuries in the last 6 months and prevented them make sport normally.
Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement

Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males,
* 21 to 65 years of age,
* Seeking enhancement of their penile width and girth.

Exclusion Criteria:

* Patient with a history of psychological or psychiatric illness,
* Congenital or acquired penile malformation,
* Previous plastic surgery or non-invasive treatments of their penis,
* Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy.
* Patients with a history of allergic reactions to hyaluronic acid derivatives
* Individuals with penises measured less than 6 cm in length in the flaccid position
* Individuals with penises greater than 12.5 cm in length in the flaccid position.
* Individuals with uncircumcised penises
Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis

A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial.

The general aim of this study is to evaluate the clinical outcome of the treatment of peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a conventional mechanical treatment in patients with a diagnosis of peri-implantitis.

Eligibility Criteria:
Inclusion Criteria:

* at least one implant with peri-implantitis
* no serious mobility of the implants
* written informed consent of the voluntary participant in the study
* availability of participant for control visits for a follow-up of at least 12 months without interruptions

Exclusion Criteria:

* serious systematic disease
* pregnancy
* current use of photosensitive drugs, bisphosphonate medication or antibiotics
* patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits
PDT vs Peels for Treatment of Actinic Keratoses

The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities.

This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Interested in receiving treatment for actinic keratoses on the bilateral upper arms
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Patient pregnant or nursing
2. Patient with extensive concurrent skin conditions (such as eczema, psoriasis, etc) on upper extremities that would interfere with treatment as determined by the treating physician
3. Subject unwilling to sign an IRB approved consent form
4. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible
Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension

The aim of this study is to investigate whether the change in pleth variation index (PVI) according to preoxygenation can predict hypotension during anesthesia induction.

In patients with hypovolemia or dehydration, pulse pressure variation can be increased by spontaneous forced inspiratory breathing. PVI is a noninvasive method of indicator of fluid responsiveness like purse pressure variation. We expected that the amount of change in PVI between at the time of entering operating room and after preoxygenation with forced inspiration method could be different depending on the patient's volume status.

After entering operating room, monitoring devices, anesthesia depth sensor, and Radical-7® Pulse CO-Oximeter® are attached. Patients rest for 5 minutes, and then baseline systolic blood pressure, diastolic blood pressure, mean blood pressure, and heart rate are collected every 1-minute. Pleth variability index (PVI), perfusion index (PI) are also measured continuously. For pre-oxygenation of anesthesia, take 8 deep breaths at flow 10 l/min of 100% oxygen for 1 minute with maximally forced inspiration. After that, for 2 minutes, patients breathe as usual while maintaining oxygen supply. until tracheal intubation or laryngeal mask insertion. Anesthesia is induced with target concentration infusion of 4.0 ng/ml of remifentanil and 4.0 ug/ml of propofol. When the patient loses consciousness, rocuronium 1.0 mg/kg is administrated and endotracheal tube or laryngeal mask is inserted 2 minutes after. PVI, PI, blood pressure, and heart rate are measured until tracheal intubation or laryngeal mask insertion. Anesthesia induction-related hypotension is defined as a decrease in mean arterial pressure below 60 mmHg at any timepoint from baseline parameter collection to until airway device insertion. The parameters are analyzed by comparing between groups with and without anesthesia induction-related hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective surgery under general anesthesia

Exclusion Criteria:

* (1) American Society of Anesthesiologists (ASA) physical status classification III or higher (2) Patients with cognitive impairment who are unable to follow instructions (3) Patients with pulmonary dysfunction (4) Other patients who are judged inappropriate to the experiment by the researcher
PROPPER Prospective Registry of Outcomes With Penile Prosthesis

The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.

A prospective, multi-center, observational registry to be conducted at multiple sites throughout the United States and Canada, to collect "real-world" penile prosthetic outcomes according to investigators' standard of care. Using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five year period. The physician researchers have identified key metrics for the study including effectiveness, durability, complications, and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.

Eligibility Criteria:
Inclusion Criteria:

Men diagnosed with erectile dysfunction (ED) for whom an AMS penile prosthesis is recommended by their physician are eligible for inclusion. Potentially eligible men should also meet the following inclusion criteria for study enrollment:

* Willing and able to provide written informed consent prior to enrollment (if applicable).
* Willing to be seen or contacted by phone by the investigator and answer at least 2 questions related to satisfaction and device use 1 year following implantation of an AMS penile prosthesis.

Exclusion Criteria:

- Men who are deemed by their physician to be not suitable for a penile implant will be excluded.
Restart TICrH Alpha Pilot Protocol, Restarting DOACs After Traumatic Intracranial Hemorrhage

Randomized pilot trial of restarting DOACs at 1 week versus 4 weeks after traumatic intracranial hemorrhage

Restart TICrH two-center pilot trial will assign patients with anticoagulant-associated traumatic intracranial hemorrhage to restart anticoagulation at 1 week or 4 weeks. Entry into the trial is primarily driven pragmatically by clinician intent to restart any Direct Oral Anticoagulant (DOAC, i.e. apixaban, rivaroxaban, edoxaban, dabigatran. There is no head to head evidence of superiority of any drug) after anticoagulant-associated traumatic intracranial hemorrhage and equipoise concerning restart of anticoagulation at the specified time intervals. DOAC will be at label dose with label adjustments for creatinine clearance. DOAC will be at continuation dose, i.e. not initial therapy high doses in the setting of VTE.

Eligibility Criteria:
Inclusion Criteria:

1. Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE)
2. Patient is higher risk for stroke or other thrombotic events as witnessed by having a CHA2DS2-VASc score of \> 3 (at least 3 of the following risk factors: age greater than 65, (age \> 75 counts for 2 points), history of stroke or TIA (2 points), history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female biological sex, history of hypertension)
3. DOAC prescribed at label dose with creatinine clearance adjustments. DOAC at continuation dose, i.e., not initial therapy high doses in the setting of VTE

Exclusion Criteria:

1. Mechanical Valve or Ventricular Assist Device (VAD)
2. SDH \>8 mm maximum width or any midline shift at any time point or more than one SDH
3. Physician plan to start/restart antiplatelet therapy during trial period
4. Abbreviated Injury Scale other than head \>3
5. Pregnancy
6. Inability to understand need for adherence to study protocol
7. Renal function below DOAC label exclusions
8. Any active pathological bleeding (e.g. no acute blood on most recent CT)
9. Hypersensitivity to drug or other label contraindication
10. Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks
11. Completion of DOAC therapy expected prior to 60 day primary endpoint, e.g. 3-6 month VTE treatment
12. Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
13. Low body weight (\<45kg)
14. Inability to swallow