cyrilzakka/clinical-trials huggingface dataset:
Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage

Disorders of consciousness (DOC) refers to the persistent loss of consciousness after 28 days in patients with brain injury caused by trauma, stroke, or hypoxia. It includes coma, vegetative state, and minimally conscious state. At present, there is no effective treatment for DOC. Only one RCT study of amantadine has proved that it may be effective for the treatment of DOC. In recent years, more evidence has shown that neuromodulation technology is beneficial to the recovery of DOC. Cervical spinal cord stimulation surgery is a new treatment method for patients with DOC. Electrodes are implanted in the high cervical spinal cord C2-C5. By adjusting different electrical stimulation parameters, it has a wake-promoting effect. In this study, patients were selected into the spinal cord stimulation group and the conventional treatment group according to the wishes of their families. The patients in the spinal cord stimulation group were given 21 days of cervical spinal cord stimulation treatment on the basis of conventional brain rehabilitation. Patients were followed up routinely and completed designated examinations at 12 months to determine the safety and efficacy of cervical spinal cord stimulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years old
* Patients with postoperative consciousness disorders after cerebral hemorrhage for more than 28 days
* CRS-R score meets the MCS diagnosis
* Signed informed consent.

Exclusion Criteria:

* Secondary brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor and carbon monoxide poisoning
* History of previous epileptic seizures
* Critical condition, unstable intracranial condition, risk of rebleeding
* Unstable vital signs requiring mechanical ventilation
* Contraindications for spinal cord surgery
* Severe sympathetic overactivity syndrome.
Engagement With Digital Mental Health (DMH) Technologies in Pediatric Primary Care

The goal of this study is to use and adapt existing digital mental health technologies to advance the engagement, assessment, detection, treatment, and delivery of services for pediatric mental health. Specifically, user-centered design methodologies and an implementation science framework will be used to guide the development and implementation of the Teen Assess, Check, and Heal (TeACH) System into a pediatric primary care clinic serving teens and families from underserved communities.

Study objectives include:

1. Collaborating with underserved teens and their parents to identify strategies to target top barriers to engagement as well as top ethical concerns and requirements for cultural relevance, usability, and usefulness of the TeACH System (Phase 1)
2. Refining the plan for implementing the TeACH System through observations, interviews, and co-design workshops with pediatric primary care pediatricians and staff (Phase 2), and
3. Implementing the TeACH System into a primary care clinics and evaluating it in a randomized trial. (Phase 3)

The team will measure engagement outcomes and satisfaction with the TeACH System.


Eligibility Criteria:
Inclusion Criteria:

* Are receiving care at specified Rush University Health System and University of Illinois at Chicago Pediatric Primary Care locations
* Are between 13-17 years of age
* Are able to speak and read in English
* Symptoms of anxiety disorder

Exclusion Criteria:

* Absence of the above inclusion criteria.
Comparison of Image Quality Between New Collimator LEHRS vs Siemens LEHR on Bone Scintigraphy

Comparison of quality image with a new LEHRS GE collimator vs standard LEHR Siemens collimator on bone scintigraphy.


Eligibility Criteria:
Inclusion Criteria:

* Refered patients for scintigraphy

Exclusion Criteria:

* Under 18 y. old patients
* Pregnancy or supposed to be pregnant patients
* Kidney failure
* Painful patients
* Patients under guardianship
* Patients in whom a standard exam is not feasible
Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !?

a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles

a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome (oocyte quality, fertilization rate, implantation rate, clinical pregnancy rate as well as the incidence of OHSS) in ICSI- antagonist cycles

Eligibility Criteria:
Inclusion Criteria:

* patients \<40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol

Exclusion Criteria:

* age: \> 40 years
* BMI \> 30 ,
* long agonist protocol
* were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity
A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage

The purpose of this study is to proactively collect customer feedback on the performance aspects and risk factors of Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older who has personally used or administered the nasal drops/spray to a child
* Has personally used or administered to a child, the Nasal Drops/Spray at least once within the past 6 months
* Able to read, write, speak, and understand German
* Has internet access to complete an on-line survey
* Intends to complete the survey
* Individual has signed the informed consent document (ICD)

Exclusion Criteria:

- Is an employee/contractor or immediate family member of the principal investigator (PI), Schlesinger group, product perceptions limited (PPL) Insights or sponsor of this study
Impact of Intraperitonael Nebulization of Local Anesthetic on Postoperative Pain Associated With Laparoscopic Surgery

Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have provided conflicting results. This randomized, double-blind study was designed to assess the effects of a novel intraperitoneal local anesthetic administration technique using nebulization on pain relief after gynecologic laparoscopic surgery.

Studies evaluating intraperitoneal local anesthetic (LA) instillation for pain relief after laparoscopic surgery have provided conflicting results. One of the factors that might contribute to failure of the instillation technique may be related to inadequate distribution of local anesthetic throughout the peritoneal surface. In contrast, nebulization should provide a uniform spread of drugs throughout the peritoneal cavity and thus may be beneficial to improve pain relief after laparoscopic procedures. The investigators reported that a microvibration-based nebulization device (Aeroneb Pro® system, Aerogen, Galway, Ireland) could be used for ropivacaine delivery into the insufflation gas required to create pneumorpeitoneum. The investigators hypothesized that intraperitoneal ropivacaine nebulization would provide superior pain relief than ropivacaine instillation after gynecologic laparoscopic surgery. This randomized, double blind, controlled clinical trial was designed to assess the analgesic efficacy of ropivacaine nebulization before or after surgery compared with intraperitoneal ropivacaine instillation and placebo after gynecologic laparoscopic procedures.

Eligibility Criteria:
Inclusion Criteria:

* Females 18-70 years old, ASA score 1 - 3;
* scheduled for laparoscopic operative surgery in the Obstetrics and Gynecology unit;
* free from pain in preoperative period, without habitual analgesic use;
* without cognitive impairment or mental retardation, who gave a written informed consent

Exclusion Criteria:

* Females under 18 or over 70;
* ASA 4 or 5;
* emergency/urgency criteria, postoperative admission in a intensive care unit with sedation or ventilatory assistance; cognitive impairment or mental retardation;
* habitual analgesic use; progressive degenerative diseases of the CNS;
* convulsions or chronic therapy with antiepileptic drugs;
* severe hepatic or renal impairment;
* pregnancy or lactation;
* allergy to one of the specific substances used in the study;
* acute infectious disease or inflammatory chronic disease, alcohol or drug addiction;
* any kind of communication problem;
* neurologic or psychiatric disease;
* no written informed consent
Influence of Weight-bearing Mechanical Axis on Foot and Ankle in Patients Following Total Knee Arthroplasty

This comprehensive scientific research will investigate the influence of the weight-bearing mechanical axis on foot and ankle following total knee arthroplasty. Few studies have monitored the outcome of surgical treatment using similair methods, and consequently the aim of this study was to evaluate the change in upper and lower leg load by analyzing radiographic recordings and pedobarographic measurements after the implantation of total knee endoprosthesis. In addition to objective instruments, knee and foot questionnaires will be used to describe the functional outcome of the operation of the subjects. The practical contribution of this research lies in the prediction of possible changes in the joints of the feet depending on the type of knee deformity (varus / valgus). Our research will consist of: analysis of postero-anterior radiographs of the lower extremity (weight-bearing) preoperatively and at the follow-up three months postoperatively, pedobarographic analyzes preoperatively and at the control examination three months postoperatively, analysis of personal data (age, gender, weight and height, operated side) and completion of functional standardized questionnaires (AOFAS, KOOS) preoperatively, and at the screening three months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* knee varus or valgus deformity 5 degrees or more

Exclusion Criteria:

* previous surgery which included corrective osteotomies, osteosynthesis or arthrodesis of the knee, ankle and foot.
China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)

The purpose of this study is to collect information on how Ryzodeg® works in real-world patients.

Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment


Eligibility Criteria:
Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on the approved Ryzodeg® label in China and independently from the decision to include the patient in this study.
3. Male or female, age above or equal to 18 years at the time of signing informed consent.
4. Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 20 weeks prior to Treatment Initiation Visit (Visit 1).
5. Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1).

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Treatment with any investigational drug within 30 days prior to enrolment into the study.
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.
RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir

This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.


Eligibility Criteria:
Inclusion Criteria:

* • Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months.

  * Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR).
  * Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes

Exclusion Criteria:

* • Female patients who are pregnant or breast-feeding.

  * Current, history or suspicion of liver disease or kidney disease.
  * HIV infected (as confirmed by positive HIV serology).

Other protocol-defined inclusion/exclusion criteria may apply.
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers

This is a single-center, open label, multiple dose study to investigate the pharmacokinetics of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of \[13C\]-labeled IV microdoses and an oral \[14C\]-labeled dose of RG1662 in healthy male volunteers. The anticipated time of study treatment is 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Volunteers who are surgically sterilized or who do not intend to father children in the future
* Absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Volunteers and their partners of childbearing potential must use two medically approved methods of contraception (e.g. hormonal contraception, IUD, barrier contraception), one of which must be a barrier method, for the duration of the study and for 3 months after last drug administration

Exclusion Criteria:

* If capable of reproduction, unwilling to use an effective form of contraception
* Suspicion of regular consumption of drug of abuse
* Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2
* Clinically relevant ECG abnormalities at screening
* Family history of congenital long QT syndrome or known congenital arrhythmia
* Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg. Resting Pulse Rate greater than 90 or less than 45 beats per minute
* Any other clinical relevant clinical abnormalities
* Participation in an investigational drug or device study within 90 days prior to screening
* Donation of more than 500 mL of blood within three months prior to screening
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the volunteer in this study
Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002

The primary objective of the study was to assess the efficacy of DA-OTC-002 as a topical cosmetic hair treatment. The investigators conducted a prospective, institution-level, interventional, single-blinded, placebo-controlled investigation to assess the efficacy of a combination an alpha-1 agonist and a TAAR receptor agonist (DA-OTC-002) as a topical cosmetic hair treatment.

76 female subjects were included in the study. Subjects were otherwise healthy females, aged 18 years are older, and had ample hair on the scalp to allow application of test article. Subjects with an interfering dermatologic disease or procedure, who were pregnant, lactating, or planning to become pregnant during the study, had experienced a clinically important medical event within 90 days of the visit, who were actively treated for hypertension, or had known allergies to any excipient in DA-OTC-002 were excluded from the study. This study was conducted in compliance with Good Clinical Practice, including the archival of essential documents. All subjects gave informed consent during the study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Females Age 18 or older
* Willing and able to apply the treatment as directed, comply with study
* Subject has ample hair on the scalp to allow application of test article
* Otherwise healthy.
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives.
* Subjects with any dermatologic disease in the treatment area.
* Women who are pregnant, lactating, or planning to become pregnant during the study period.
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
* Subjects who are actively treated for hypertension.
* Subjects who have known allergies to any excipient in DA-OTC-002
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation.
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation.
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation.
* Subject is unable to provide consent or make the allotted clinical visits.
Impact of Exercise on Ashtma in Adults

The aim of this study is to evaluate if physical activity could improve asthma control and management in adults. With this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second no educational intervention will be done. All patients will use a step counter in order to evaluate their activity during the study. Spirometric values and questionnaries about asthma control and quality of life will be recorded for all patients. Finally 2 groups will be comparated in order to search any difference in quality of life and asthma control.

52 asthmatic will be enrolled and randomized into 2 groups. All patients will send a weekly summary of their physical activity (mean number of steps and time of physical activity). All patients will be undergone to a medical visit at month 1 and 3 since study start. In each visit a spirometry, a FeNo, ACQ and AQLQ questionnaires will be done.

The patients of the intervention group will receive 3 workshops about asthma and physical exercise in order to provide information, medical support, and to resolve any question or difficulty about it. The workshops will be al week 1, 2 and 4 since study start.

Eligibility Criteria:
Inclusion Criteria:

* asthma well controlled
* sedentarism (\<150 min physical activity/day and/or \<7000 daily steps)

Exclusion Criteria:

* pregnancy
* cardiological, not well controlled deseases
* other cronic pulmonary deseases
* bad asthma control
* not sign IC
* unable to practice physical activity (for cognitive or physical conditions)
* no devices able to count steps and physical activity
The Efficacy and Safety of the 1,414 nm Nd:YAG Laser System for Alleviating Back Pain in a Lumbar Disc Patient

This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 19-79 years old
* Patients with moderate disability based on the Oswestry Disability Index (ODI), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks
* Patients who have language skills enough to answer questionnaires
* Patients who agree to voluntarily participate in this study and to sign the Informed Consent Form, and who are able to participate for the entire period of this study

Exclusion Criteria:

* Patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc
* Patients who use an electronic medical device for their cardiovascular system
* Patients who have spondylolisthesis in the relevant lesion
* Patients with neurological defects
* Patients who had undergone surgery on the relevant lumbar vertebra
* Patients with cauda equina syndrome
* Patients with congenital spinal deformity
* Patients with spinal fracture
* Patients with spinal infection, tumor, or other form of inflammatory spondylopathy
* Patients with coagulation disorder
* Patients with a history of malignant tumor (except those with a cured tumor and no re- occurrence for the last five years)
* Patients who had participated in another clinical study within 30 days from their screening visit
* Female patients with child-bearing potential who do not agree to use a medically acceptable contraceptive method\* for up to 24 weeks after the use of the investigational medical device during this study

  * Medically acceptable contraceptive method: Condom, oral contraceptive pills taken continuously for more than three months, contraceptive injection or implants, intra- uterine contraceptive device, etc.
* Patients who are pregnant or breastfeeding
* Other patients who are considered unfit to participate in this study with clinically significant findings based on the investigator's judgment
Addition of Homeopathy in Patients With Resistant Arterial Hypertension

Resistant hypertension (RHTN) is a common clinical problem faced by both primary care clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular events and mortality compared with patients with more easily controlled hypertension. In addition, RHTN is often complicated by metabolic abnormalities.

Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the impact on resistant hypertension. The aim of this trial was to evaluate individualized homeopathy on BP in patients with resistant hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years with resistant arterial hypertension.
* Office systolic BP \>140 mm Hg or diastolic BP \>90 mm Hg despite being treated with at least 3 antihypertensive drugs, including a diuretic.
* Patients with diabetes or chronic kidney disease (defined as serum creatinine \>133 μmol/L or proteinuria \>300 mg/day) if the office BP was \>130/80 mm Hg.

Exclusion Criteria:

* Severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg) who needed an immediate adjustment of treatment,
* Renal insufficiency with serum creatinine \>180 μmol/L or glomerular filtration rate \<40 mL/min calculated by the Modification of Diet in Renal Disease formula,15 hyperkalemia \>5.4 mmol/L, hyponatremia \<130 mmol/L, and porphyria;
* Pregnant or lactating women or women of fertile age not using effective contraception;
* Patients with known prior hypersensitivity to the drug Verospiron (spironolactone; Richter Gedeon Ltd) or who are currently using any aldosterone antagonist.