cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Evaluation of S (+) - Ketamine in Adults

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings.

Patients often suffer acute pain after operation ，which may affect the recovery. Opioid such as morphine is the most commonly analgesic drugs, but opioid has many obviously adverse reactions ,for example respiratory depression,circulation inhibition,tolerance, addiction, nausea, vomiting, pruritus, etc. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese patients undergoing surgery.

Objective:Evaluate the efficacy and safety of S (+) - ketamine on acute perioperative pain for chinese adult patients,and look for the best dosage, mode of administration, timing, and compatibility ,as well explore the effect of S (+) - ketamine on postoperative delirium,anxiety ,depression and cognitive dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old;
* 2. Scheduled for elective digestive tract surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or body surface surgery (thyroid surgery or breast surgery), head and neck surgery;
* 3. ASA score Ⅰ～Ⅲ;
* 4. The informed consent form was signed by the patients.

Exclusion Criteria:

* 1. The expected length of hospital stay of the patient is less than 48h;
* 2. Patients expected to be admitted to the ICU after surgery;
* 3. Patients expected to return to the ward with tracheal catheter after surgery;
* 4. Be allergic to S (+) - ketamine;
* 5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
* 6. Patients with a history of severe cardiovascular disease (congestive heart failure, severe angina attack, or unstable angina or myocardial infarction within 6 months);
* 7. Patients during pregnancy or lactation;
* 8. Patients with MMSE score \<18 points;
* 9. Patients with any of the following contraindications of S (+) - ketamine:

  1. Patients with risk of serious rise of blood pressure or intracranial pressure;
  2. Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
  3. Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
  4. Patients with untreated or undertreated hyperthyroidism.
Immersive VR for Female Orthopaedic Rehabilitation

This study compares the effects of cardiological rehabilitation enhanced with virtual reality (VR) versus conventional rehabilitation methods. It assesses the impact on both psychological parameters (including depression, stress, anxiety, and kinesiophobia) and physiological and functional parameters of cardiology patients. The aim is to analyze the efficacy and benefits of VR-supported rehabilitation in improving patients' mental and physical health compared to traditional methods.

The study will involve elderly female patients aged 60 and above who present sequentially at the Rehabilitation Department of St. Hedwig of Silesia Hospital in Trzebnica (Poland) within three months following hip joint arthroplasty surgery. Participants will be randomly assigned to one of two groups: Group A, the Virtual Reality Group, will receive 8 therapy sessions, with two sessions per week; Group B, the Control Group, will undergo conventional rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Female individuals who have recently undergone hip joint arthroplasty surgeries aged 60 years and above.

Exclusion Criteria:

* cognitive impairments that prevent independent completion of research questionnaires
* reported consciousness disorders
* bipolar affective disorder and other serious mental disorders in the patient's medical history
* use of psychoactive drugs
* ongoing psychiatric treatment or individual psychological therapy
* contraindications to Virtual Reality such as epilepsy, vertigo, serious vision disorders
* functional status preventing independent movement (orthopedic aids are allowed, e.g., crutches, walker)
* refusal to participate in the study at any stage
Effects of Post Isometric Relaxation With Scapular Stabilization Exercises

The levator scapulae is an important postural muscle that tends to shorten or become tight because of overactivity and bad posture, leading to neck and shoulder pain. Levator scapulae syndrome is usually caused by the poor shoulders posture as rounded shoulders as sitting at a computer hunched. It is exacerbated by sustained neck postures, neck movements or levator scapulae muscle palpation. The aim of study will be to determine the effects of post isometric relaxation with scapular stabilization exercises on pain, disability and range of motion in patients with levator scapulae syndrome.

A Randomized Controlled Trial will be conducted at Tehsil Headquarter Hospital Sharqpur Shareef, Sheikhupura through consecutive sampling technique on 30 patients with levator scapulae syndrome which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with post isometric relaxation, scapular stabilization exercises along with baseline treatment. Group B will be treated with post isometric relaxation along with baseline treatment. Baseline treatment includes hot pack, TENS, upper trapezius stretch, levator scapular stretch and pectoralis major stretch. Both groups will come thrice per week for a total of 4 weeks. Outcome measures are NPRS, universal goniometer and NDI. Data will be analysed during SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Keywords: Disability, Levator Scapulae, Range of Motion, Pain

Eligibility Criteria:
Inclusion Criteria:

* Both Males and females
* Age range of 18-40 years
* Neck and medial border scapular pain for at least 3months
* Examination - Increased muscle tone and tenderness at neck
* Reduced Side flexion and Rotation of neck
* Positive Levator Scapular length Test

Exclusion Criteria:

* Neuropathies
* Vertebral fractures
* Pregnancy
* Previous cognitive and functional disorders
* Traumatic neck injury
* Fibromyalgia
* cancer
11C Methionine PET for the Detection of Hyperfunctional Parathyroid Tissues

The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and conventional SPECT-CT for the detection of abnormal parathyroid glands.

STUDY OBJECTIVES Primary: To compare the accuracy, sensitivity and specificity of 11C-methionine (MET) PET/CT and 99mTc-MIBI SPECT-CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.

Secondary:To compare the accuracy, sensitivity and specificity of 11C-MET and 18F-FDG PET/CT scans in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.

STUDY DESIGN A phase II diagnostic imaging, single-centre study to compare the accuracy of 11C-MET PET/CT with standard 99mTc-MIBI SPECT-CT and with 18F-FDG PET/CT imaging in patients with primary hyperparathyroidism.

STUDY POPULATION Number of Subjects: 50 patients Number of groups: 1: 50 with primary hyperparathyroidism. Age/Gender: Age greater than or equal to 19 years / Male and Female Study specific requirements: Subjects with clinically suspected primary hyperparathyroidism who require 99mTc-MIBI SPECT-CT parathyroid imaging.

INVESTIGATIONAL PRODUCT Product: 11C-Methionine Route of administration: Intravenous Dosage(s) and frequency: Radioactive dose of 11C-Methionine of 6 MBq per kilogram body weight per injection (maximum dose of 555 MBq); one injection per patient.

COMPARATOR PRODUCTS Product: 99mTc-Methoxyisobutylisonitrite; 18F-Fluorodeoxyglucose Route of administration: Intravenous Dosage(s) and frequency: (1) Radioactive dose of 99mTc-Methoxyisobutylisonitrite of 555 - 740 MBq per injection; one injection per patient. (2) Radioactive dose of 18F-Fluorodeoxyglucose of 296 - 521 MBq per injection; one injection per patient.

EVALUATION CRITERIA Efficacy: The comparison of the accuracy, sensitivity, and specificity of 11C-MET PET/CT with 99mTc-MIBI SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.

Safety: Vital signs before and following 11C-MET administration; adverse events collection.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> age 18;
* Able to provide written informed consent;
* Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism.

Exclusion Criteria:

* Subjects with previous successful parathyroidectomy and parathyroid tissue reimplantation;
* Pregnancy;
* Subjects who are unable to tolerate the physical/logistical requirements of completing two PET/CT scans, including lying still for a prolonged period of time and receiving two intravenous injections.
* Subjects who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT machine (diameter 70cm).
Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns

This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive.

The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed.

A prospective study comparing two treatment groups:

Group 1 (treatment group) - 60 infants. Group 2 (control group) - 30 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fennel)), etc.


Eligibility Criteria:
Inclusion Criteria:

1. Parents / guardians speak Russian, understand the essence of study, are informed about the purpose of the study, understand their rights and signed informed consent form (ICF).
2. Vaginal delivery.
3. Full-term newborn.
4. Age at the time of the signing of informed consent form 1-4 months 28 days.
5. Breast- and formula-fed infants.
6. Colic , constipation , diarrhea, regurgitation (single symptom or combination of several symptoms).
7. Infant does not have other deviations in health, which would require the appointment of a specialized diet
8. Parents / guardians can and ready to regularly fill out the proposed diary form.

Exclusion Criteria:

1. Born by Cesarean section.
2. Premature newborn.
3. Congenital abnormalities or other clinical manifestations that may interfere with the study.
4. Lactase food supplements.
5. Other probiotic drugs, antibiotics, enteric antiseptics, antifungal and antiprotozoal drugs.
MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer

The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up, broken down and eliminated by the body.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis (recent or remote) of prostate adenocarcinoma
* Radiographic evidence (recent or remote) of metastatic prostate adenocarcinoma
* 18 years of age or older
* Progressive prostate cancer as defined by the presence of one or more of the following despite castrate levels of testosterone (testosterone \<50 ng/dL):

  1. Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI)
  2. Progressive bone metastasis (presence of new lesion(s) on a bone scan)
  3. Progressive PSA levels (as defined in Section 3.6.1)
* Subjects who have received an anti-androgen must have shown progression of disease following discontinuation of the anti-androgen
* Subjects must remain on luteinizing hormone-releasing hormone (LHRH) analog therapy for the duration of the trial unless surgically castrate
* Agree to use an effective barrier method of contraception.

Exclusion criteria:

* Testosterone \>50 ng/dL
* Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of dosing
* Use of PC-SPES within 4 weeks of dosing
* Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of dosing
* Use of anti-androgen therapy (eg, flutamide, bicalutamide, nilutamide) within 6 weeks of dosing
* Prior monoclonal antibody administration, including Prostascint®
* Peripheral neuropathy of \> Grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE)
* History of CNS metastasis, including incompletely treated epidural disease
* History of Hepatitis B or C
* History of seizure disorder requiring active treatment and/or stroke
* History of HIV infection
* Platelet count \<100,000/mm3
* Absolute neutrophil count (ANC) \<1,500/mm3
* Hematocrit \<27 percent
* Abnormal coagulation profile (elevated PT, and/or INR, PTT)
* Serum creatinine \>2.0 mg/dL, or creatinine clearance \<60 mL/min if serum creatinine \>2.0 mg/dL
* AST or ALT \>1.5 x ULN
* Bilirubin (total) \>1.25 x ULN
* Serum calcium \>12.5 mg/dL
* Active serious infection not controlled by antibiotics
* Active angina pectoris or NY Heart Association Class III-IV heart disease
* Karnofsky Performance Status \<60%
* Life expectancy \<6 months
* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems that might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
Oral Immunotherapy for Peanut Allergy (PMIT)

The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral mucosal immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages 1 to 18 with peanut allergy will be randomized to peanut OIT or placebo. Subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Subjects will undergo a double-blind, placebo-controlled food challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects will then complete at least 36 months of peanut OIT therapy after which once skin prick (\<5 mm) and IgE (\<15 kU/L) criteria are met, they will then complete the end of study DBPCFC. Dosing will continue up to a maximum of 60 months after which even if criteria are not met, the subject will undergo the end of study DBPCFC. Outcome variables of interest include response to DBPCFC, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Subject between 1 and 18 years of age
* EITHER history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts greater than 6 months ago AND peanut specific IgE \>15 kU/L
* OR history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts within the past 6 months AND peanut specific IgE \> 7 kU/L
* A family that will be able to be compliant with all study visits
* All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

* Subjects with a history of severe, anaphylaxis to peanut
* Medical history that would prevent a double blind placebo controlled oral food challenge (DBPCFC/OFC) to peanut
* Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
* Diagnosed oat allergy
* Pregnancy or lactation
Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study

The Phase III main study is a randomized, controlled, multicenter, double blind, trial to evaluate the efficacy and safety of TP-03 (lotilaner ophthalmic solution, 0.25%), for the treatment of Demodex blepharitis in Chinese patients. The PK sub-study is a single-arm, open-label trial to evaluate systemic TP-03 in whole blood following topical ocular administration

The main study is designed to demonstrate the superiority of TP-03 compared to vehicle for the treatment of Demodex blepharitis in Chinese patients. The vehicle of TP-03 was selected as the control since there are no approved pharmaceutical treatments for Demodex blepharitis. The vehicle as the control will provide evidence that the active ingredient is responsible for the response, not the vehicle alone.

A pharmacokinetics (PK) sub-study is included in the overall study design to evaluate systemic PK parameters of TP-03 in Chinese participants with Demodex blepharitis. The PK sub-study sites are separate from those of the Phase III study as described above.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged ≥ 18 years of age.
2. Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
3. Has blepharitis
4. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. Have used lid hygiene products (e.g., lid scrubs) within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study.
2. Have initiated treatment with an ocular topical prostaglandin analogue within 30 days of Screening or have any plans to change or discontinue treatment during the study
3. Pregnancy or lactation.
4. Any intraocular surgery (including ocular surface surgery, cataract surgery and intravitreal injection) or periocular surgery within 60 days prior to randomization, or any planned ocular surgical procedure during the study period
5. Have any unstable or uncontrolled, cardiac, pulmonary, renal, oncological, neurological, metabolic or other systemic condition that, in the opinion of the investigator, would possibly require the participant to seek emergent medical treatment during the course of this study. This includes, but is not limited to, unstable or uncontrolled cardiac arrhythmias, hypertension, coagulopathies, renal failure or advanced diabetes mellitus.
DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.

The purpose of this observational study is to evaluate the amount of contrast media saved using DyeVert Plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo CAG and/or PCI
* Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2

Exclusion Criteria:

* Acute ST-elevation myocardial infarction or known coronary artery fistulas
* Body mass index (BMI) \>40
* Currently pregnant
* Undergoing a chronic total occlusion procedure or optical coherence tomography analysis
* Planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure
* A condition known to require large volumes of contrast (\>10 mL) for each injection
Luspatercept in Metastatic AGCT of the Ovary

This is a single participant study of luspatercept for the treatment of a patient with dult granulosa cell tumor (AGCT) of the ovary.

This patient has AGCT driven by a somatic oncogenic FOXL2 mutation identified through a molecular profiling study. One of the ways in which this mutation drives tumorigenesis is via increased activity of SMAD3, which results in decreased expression of follistatin and allows increased signalling of activin, a TGFB ligand that activates the TGFB pathway. Anti-TGFB approaches have shown promise in preclinical studies of AGCTs and several early phase trials are investigating different levels of TGFB pathway inhibition1.

As an activin receptor ligand trap, luspatercept has been shown to reduce SMAD2/3 signaling and improve anemia in disorders characterized by ineffective erythropoiesis, such as B-thalassemia and myelodysplastic syndromes (MDSs). This study aims to determine if we can apply this rationale to a patient with recurrent AGCT with oncogenic FOXL2 mutation known to drive TGFB/SMAD pathway overactivity.

Luspatercept has not been investigated in AGCT and therefore the efficacy of this specific agent as a cancer therapeutic is not yet known. Other TFGB ligand-trapping agents are in development and early phase clinical trials. One such example is AVID200, a TGFB ligand trap and selective inhibitor of TGFB1 and advanced solid tumors. There were 19 patients included in a phase I study of AVID200 monotherapy in patients with advanced solid tumors. A best response of stable disease for over 12 weeks seen in two patients (adenoid cystic carcinoma and breast carcinoma). The maximum tolerated dose was not reached; no Grade 3 adverse events were seen and only three adverse events were reported overall including diarrhea and lipase elevation.

Eligibility Criteria:
Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A

This patient's case was recently discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and gynecologic medical oncology departments. The discussion surrounded the best next therapeutic option in this rare cancer subtype without clear standard of care guidelines. The recommendation from this discussion was to investigate targets of the TGFβ pathway, such as luspatercept. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.