cyrilzakka/clinical-trials huggingface dataset:
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia

This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201 (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial.

No statistical hypothesis tests will be performed.

Eligibility Criteria:
Inclusion Criteria:

Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.

* Subject has completed Study SEP361 201 through Week 4
* Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201.
* Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
* Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration

Exclusion Criteria:

* Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
* Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
* Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201.
* Subject is pregnant or lactating.
* Subject is at high risk of non-compliance in the Investigator's opinion.
* Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.


Eligibility Criteria:
Inclusion Criteria:

1. The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).
2. The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).
3. Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.
4. The patient is at least 5 years of age.
5. The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.
6. The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).
7. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).
8. In the opinion of the investigator, the patient and/or guardian must be able to:

   1. Understand the full nature and purpose of the study, including possible risks and adverse events,
   2. Understand instructions, and
   3. Provide voluntary informed written consent.

Exclusion Criteria:

1. Not able to understand English or Spanish.
2. The area requiring autografting sustained a burn injury.
3. The treatment area has previously failed to heal subsequent to surgical intervention for closure.
4. The patient is unable to follow the protocol requirements.
5. The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives.
6. Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives.
7. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
8. The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
9. Life expectancy is less than 1 year.
Study Evaluating Management of Patients With Community-Acquired Pneumonia (CAP) or Complicated Skin Infections

This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised with CAP or cSSSI

  1. CAP: Radiographically-confirmed bacterial pneumonia AND Requiring treatment with IV antimicrobials as start-up therapy
  2. cSSSI: Affecting deeper soft tissue and/or requiring significant surgical intervention or developing an abcess/ulcer/cellulitis in a lower limb AND Having at least two local signs and one systemic sign of cSSS AND Treatment with antimicrobials

Exclusion Criteria:

* Patients already participating in clinical trials or any other interventional study.

  1. CAP: CAP suitable for outpatient therapy with an oral antimicrobial agent.
  2. cSSSI: Uncomplicated SSSI. Skin and skin-structure infections with a high cure rate after surgical incision alone or after aggressive local skin care.
Treadmill With Biofeedback on Gait Symmetry After Stroke

This study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Single stroke experience
* Chronic stroke phase: stroke duration ≥ 6 months
* Independent gait: Functional Ambulation Category (FAC) ≥ 3

Exclusion Criteria:

* Cognitive problem (MMSE \< 24)
* Visual or audio deficiency that might affect training
* Severe heart insufficiency or uncontrolled arterial hypertension
* Orthopedic disorders that affecting their gait
Essential Voice Tremor: A Study of Botulinum Toxin Treatment and Injection Augmentation

Botulinum toxin is the common treatment of choice for patients with Essential Voice Tremor (EVT), but results are not universally beneficial to all patients. Inconsistent results are noted in the literature and are consistent with the PI's clinical experience. Injection augmentation, a well-established treatment for glottic insufficiency, which is a prominent factor in the clinical presentation of Essential Voice Tremor (EVT), has not been studied. By treating patients at separate times with botulinum toxin and injection augmentation in an unblinded prospective crossover treatment study, we can assess functional outcomes of these two treatments with the population of patients with Essential Voice Tremor (EVT).

The purpose of this study is to compare treatment with botulinum toxin to treatment with injection augmentation in patients diagnosed with essential voice tremor.

Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.

Injection augmentation is the injection of a filler material into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.

Periodic injections with botulinum toxin (Botox) is the current standard of care for patients diagnosed with essential voice tremor, but studies show only about 60% of patients benefit substantially enough to continue treatment. Poor vocal fold closure, a common characteristic of essential voice tremor, is treated in other situations (such as vocal fold paralysis or paresis) with injection augmentation; thus there is reason to think that it may be helpful to patients with essential voice tremor, perhaps even to a greater extent than botulinum toxin.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ages 18-100 who have been diagnosed with essential tremor of the voice (EVT) Diagnosis Code 478.75 Laryngeal Spasm.

Exclusion Criteria:

* WCMC subjects under age 18
* Pregnant patients
* Patients with laryngeal pathology besides tremor, including but not limited to polyps and other benign lesions, precancerous or cancerous changes, vocal fold paralysis, or other laryngeal disorders of mobility
Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring

The purpose of this research is to use 2 devices to compare the difference in the amount of time it takes for each device to register complete muscle relaxation after the muscle relaxing medication is given. The comparison will be made by using electromyographic (EMG), such as TetraGraph, and acceloromyographic (AMG), such as TOFScan, monitors at the time of insertion of breathing tube.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents; i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm into the sterile field.
* Patients receiving a rapid sequence induction.
Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

The purpose of this study is to investigate the relationship between the side effects of cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of cyclophosphamide.

Cyclophosphamide is a widely applied agent in treatment of systemic lupus erythematosus. As an alkylating agent, cyclophosphamide is able to induce several side effects, including thinned hair, loss of appetite, nausea, vomiting, infection, myelosuppression, etc. However, the remarkable variability of the reactions to the drug -- the incidence of side effect or the outcome of the treatment -- has been observed among patients. Cyclophosphamide is a pro-drug, which require some enzymes in the liver to transform it into an active chemical to arouse alkylating function. And then it undergoes a series of detoxification steps catalyzed by the specific metabolic enzymes. This study is designed to explore the genetic variation among individuals in the key processes of the activation and elimination of cyclophosphamide in order to find out whether these genetic factors are associated to the side effects or efficacy. The further understanding into the factors concerning on the drug might imply possible solution to minimize the incidence of side effects in patients of systemic lupus erythematosus.

Eligibility Criteria:
Inclusion Criteria:

1. The patients must have been diagnosed as SLE according to the American College of Rheumatology (ACR) criteria published in 1997.
2. The patients must sign the informed consent. And for the patients who are under 18 years old, both the signatures of their legal guardians and that of the patients are required on the written informed consent.
3. The patients are receiving the standard regimen of 0.2g cyclophosphamide given as intravenous injection once every two days.

Exclusion Criteria:

1. Pregnant women, women in breast-feeding period and the women who refuse to take contraception measures during treatment.
2. Patients with poor compliance.
3. Patients who are also diagnosed of cancer or who are receiving cyclophosphamide in treatment of cancer, or other anti-cancer therapy.
Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?

This is a prospective randomized multi-center non-inferiority trial conducted through the Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair compared with penile nerve block.

Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis:

There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block.

The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.

Exclusion Criteria:

* prior hypospadias surgery,
* proximal or penoscrotal hypospadias,
* abnormal caudal anatomy or spinal dysraphism,
* cyanotic congenital heart disease,
* infection or rash at the block injection site.
Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition

The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.

Assuming the availability of some food in the household, the caregivers were instructed on how best to use the food they have and the quantity of supplementary food distributed was calculated to provide about 50% of child energy requirement.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-59 month
* Weight-for-height between -3 and -2 z-scores without edema
* Good appetite
* Stable clinical conditions

Exclusion Criteria:

* Weight-for-Height Z-score \< -3
* Presence of bilateral pitting edema
* Unstable clinical conditions
* Not showing appetite
PREPARE- Prehabilitation for Patients Awaiting Liver Transplantation: Feasibility and Acceptability Testing.

This is a study developing a prehabilitation intervention and then testing the acceptability and feasibility of the intervention.

Start date Aug 2022 for Focus groups and Feb 2023 Co-design workshops and feasibility study date pending

This study is using focus groups and experience based co-design workshops to co-design a remote multicomponent prehabilitation intervention for patients awaiting liver transplantation.

Once the intervention is developed it will then be tested for acceptability and feasibility with the liver transplantation cohort in Belfast Northern Ireland.

Eligibility Criteria:
Inclusion Criteria:

* on the transplant waiting list
* grade 3 below for encephalopathy

Exclusion Criteria:

* grade 4 above encephalopathy
* Known adverse reaction to exercise
* New stroke
* lacks capacity to consent
Auditory Prediction and Error Evaluation in the Speech of Individuals Who Stutter

Stuttering negatively impacts communication and reduces the overall quality of life and well-being of individuals who stutter. This study will provide a strong foundation for developing neural and behavioral interventions for stuttering. Participants will be asked to name pictures, read words/sentences silently or aloud, and listen to speech and nonspeech sounds while their speech, muscle, and brain signals are collected. Some participants may also receive brain stimulation while reading and speaking.


Eligibility Criteria:
Inclusion Criteria:

* being a monolingual, native speaker of American English
* absence of developmental, psychological, neurological, or communication disorders (other than developmental stuttering) as confirmed by a certified research SLP
* normal (age-appropriate) binaural pure-tone hearing threshold (0.5-4k Hz; ≤25 dB HL for younger than 70 years, and ≤35 dB HL for older than 70 years)
* not taking any medications that affect the central nervous system
* absence of safety contra-indication for tDCS, TMS and MRI (for adults)
* scoring at the 20th percentile or higher on standardized speech-language tests (for children)

Exclusion Criteria:

-
REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)

Despite an improvement regarding morbidity and mortality since 30 years, especially in expert centers, pancreatic surgery remains currently associated to a significant postoperative morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital stays. The main risk factors associated to the occurrence of pancreatic fistula are represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of the main pancreatic duct (\<3mm). Looking for new means of reducing the occurrence of pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue. Currently, no formal recommendations concerning the optimal technical for closure of the distal stump in DP are available. In fact, manual closing by elective suturing or stapling of the main pancreatic duct give similar results. The use of a reinforcing stapling potentially represents a simple way to decrease the occurrence of pancreatic fistula and requires evaluation by a prospective randomized study.


Eligibility Criteria:
Inclusion Criteria:

* All patients who undergo DP whether made by open or laparoscopic surgery
* Patients 18 years of age or older,
* Benefiting from a social security scheme,
* Having given his free, informed and written consent.

Exclusion Criteria:

* History of pancreatic abdominal surgery
* Severe co-morbidity type renal failure requiring hemodialysis, unbalanced diabetes, major respiratory insufficiency, heart failure ≥ stage 3 NYHA;
* Persons of full age who are subject to legal protection, persons deprived of liberty.
* Pregnant or nursing women
* Patients participating in or participating in another study
Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237 in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* With moderate to severe stable COPD (Stage II or Stage III).
* Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
* Post-bronchodilator FEV1 ≥30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/FVC \< 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium).
* Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3

Exclusion Criteria:

* With a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
* Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years. Patients without asthma but who have a blood eosinophil count \>600/mm3 at Visit 2 are excluded.
* Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder.
* Patients with lung lobectomy or lung volume reduction or lung transplantation.
* Patients with known history and diagnosis of α-1 antitrypsin deficiency.
* Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.