cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery

The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal.
* Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery.
* Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator.

Exclusion Criteria:

* Surgery performed under general anaesthesia, or sedation.
* Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator.
* Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation.
* Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs.
* Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration.
* Hepatic or renal impairment.
* Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension.
* Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components.
* Patients under chronic treatment with topical or systemic analgesics/NSAIDs.
* Patients under treatment with any medication that may affect the treatment efficacy evaluation.
* Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention

Determine the feasibility, acceptability and efficacy of an adapted digitally delivered CMAP (CMAP-SI) intervention (CAMI) compared to treatment as usual (TAU) for patients presenting with suicidal ideation.

The reported suicide rates in South Asia are high compared to the global average. These figures are likely to be an underestimate since suicide data from many LMICs such as Pakistan is lacking and what is available is not reliable (Jordans et al., 2014). According to an estimate, 5,000 to 7,000 suicides take place each year in Pakistan (Hafeez, 2016) and at least 10 to 20 suicide attempts happen for every suicide.

Mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance.

The proposed study will be carried out in two phases; Stage 1) adaptation of an already existing culturally adapted manual assisted problem solving intervention (CMAP) for patients with suicidal ideation presenting to primary care in Pakistan and further adaptation into a digital intervention.

Stage 2) feasibility Randomised Control trial.

Eligibility Criteria:
Inclusion Criteria:

Individuals (aged 18-64) screened and identified as having suicidal ideation

* Able to give written informed consent
* Living within the catchment areas of participating hospitals
* Have a smart phone and able to operate it
* Able to read and speak Urdu
* Not requiring in-patient psychiatric treatment.

Exclusion Criteria:

* Presence of a diagnosed physical or intellectual disability as it can prevent individuals from engaging with the intervention. This will be assessed by the research team at screening stage. Any disabilities will be identified by a relevant clinician (e.g. Psychiatrist).
* Temporary resident unlikely to be available for follow-up (b) participants with a diagnosis of DSM-IV mental disorder due to general medical condition or substance misuse, dementia, delirium, alcohol and drug dependence, schizophrenia, or bipolar disorder.
A Study of LY4065967 in Healthy Japanese Participants

The purpose of this study is to obtain safety and tolerability data of the study drug known as LY4065967 and rosuvastatin in healthy Japanese participants. Blood tests will be performed to check how much LY4065967 and rosuvastatin get into the bloodstream and how long it takes the body to eliminate it. This is a 3-part study and will last approximately 2 weeks excluding screening period for each part.


Eligibility Criteria:
Inclusion Criteria:

* Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
* Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2)
* Have a body weight of:
* ≥ 40 kilograms (kg) for individuals assigned female at birth
* ≥ 50 kg for individuals assigned male at birth

Exclusion Criteria:

* Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation
* Have an abnormality in the 12-lead echocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may hamper participation in the study
* Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antigen and/or antibodies.
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* Show evidence of syphilis or have a positive syphilis test.
* Have an abnormal blood pressure (supine) as determined by the investigator
* Are pregnant or intend to become pregnant or to breastfeed during the study.
* Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission
* Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
* Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes
* Are unwilling to comply with the dietary restrictions required for this study
CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors

A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596 and AG-13736.


Eligibility Criteria:
Inclusion Criteria:

* Be ≥18 years old and with histologically or cytologically confirmed advanced solid tumors refractory/resistant to currently available therapies or for which there is no standard therapy.
* Patients with primary brain tumors are not eligible.
* Have at least one site of measurable disease.

Exclusion Criteria:

* Received chemotherapy (including targeted agents such as erlotinib), radiotherapy, immunotherapy or any investigational therapy within 3 weeks of study entry (within 6 weeks for previous treatments with nitrosoureas or mitomycin C).
* Received tamoxifen within 4 weeks prior to study entry.
Dynamic Congruence Total Knee Replacement vs Posterior-stabilized

This study compares and evaluates differences in movement analysis, patient-reported outcome between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen with posterior stabilization and Bioimplanti K-Mod cruciate-retaining with dynamic congruence

The aim of this study is to assess and compare kinematic and time-space gait parameters in patients after total knee arthroplasty, who will undergo the surgery with the use of either posterior-stabilized (PS) or dynamic congruence (DC) implants.

Materials and methods To this study 56 consecutive patients undergoing total knee arthroplasty will be recruited. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization \[1:1\]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.

Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity and VAS (Visual Analogue Scale).

After the surgery 1 to 3 years postoperatively three-dimensional gait analysis will performed with use of BTS SMART device. This device uses passive markers technology and registers the movement by six cameras. To perform full gait analysis several data concerning patients anthropometry will be collected (lower limb length, knee and ankle joint width, width and depth of the pelvis). Whole gait analysis will be performed by experienced single clinical biomechanist accordingly to the Davis protocol. Markers will be installed on the patients' limbs on the following points: base of sacral bone, greater trochanter of the femur, lateral femoral condyle, head of the fibula, lateral malleoli, head of the V metatarsal bone).

Participants will walk barefoot for 10 meters quadruple times. Following time-space and kinematic parameters will be assessed:

Time-space parameters Single stance time (T1) \[%\] Swing time (T2) \[%\] Double-stance time (T3) \[%\] Step length (SL) \[m\] Mean gait velocity (Vm) \[m/s\] Cadence (C) \[number of steps/min\]

Kinematic parameters:

Operated knee range of flexion during swing phase \[°\]

Eligibility Criteria:
Inclusion Criteria:

* agreement to participate in the study
* BMI (kg/m2) less than 40
* ability to walk for 10 meters
* knee flexion more or equal of 90 degrees

Exclusion Criteria:

* unwillingness to participate in the study
* osteoarthritis due to the rheumatological disease
* disorders associated with nerve-muscle signal transmission
* neurological disorders associated with dizziness, nystagmus or other conditions that might influence balance during activity
Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults

The objective of this pilot study is to determine the effects of wheat germ (WG) supplementation on gut health and subsequent effects on markers of inflammation and insulin resistance in overweight individuals. WG is a by-product of wheat processing and an excellent source of omega-3 fatty acids, vitamin E, and fiber. A few studies have shown the health benefits of WG including gut modulatory potential, but the prebiotic functions of WG in humans remain in question and warrant further investigation.

Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) between 18 to 45 years old regardless of gender will be recruited. They will be randomly assigned to receive two energy balls containing 30 grams of wheat germ or corn meal (control) in a 4-wk randomized controlled pilot trial. The energy balls will contain wheat germ or corn meal, peanut butter, honey and milk. Participants will be asked to consume two energy balls daily for 4 weeks. Anthropometric measures, questionnaires (medical, diet, physical activity and bowel habits), blood and fecal samples will be collected at baseline and at the end of the four week study. The investigator's primary outcome variables will be changes in fecal bacteria, immunoglobulin A, zonulin and short chain fatty acids while secondary outcome variables will be alterations in plasma markers of inflammation and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) 18-45 years old

Exclusion Criteria:

diagnosed diabetes, heart disease, and cancer tobacco use excessive alcohol use taking mega-doses of antioxidant/vitamin supplements or medications that could interfere with study endpoints such as antibiotics, anti-inflammatory, and glucose-lowering medications major surgery occurring within 6 months pregnant or lactating previous high intake of wheat germ or sensitivity to gluten and wheat products.
Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses

AGN-190584 has gone through many clinical trials showing its safety and effectiveness in individuals from 40-55 years of age. There has been no published data on the use of this product in individuals corrected with contact lenses for distance vision. There are many other applications AGN-190584 could be used for and further studies will show the effectiveness for each.

The study is a single center open label, single arm study with no control and no randomization. Investigators will enroll 30 presbyopic patients between the ages of 40-55 years old who have undergone successful contact lens fitting in single-use, daily, contact lenses between the spectacle lens powers of -4.00 -to +1.00, in both eyes for best distance correction by the primary investigator. Investigators will measure change in letters read at near and intermediate vision from baseline. Subjects will be required to apply AGN-190584 drops once daily OU. Subjects will be applying the drops on their own every day including the day of visits. During treatment investigators will measure changes in letters read from baseline in intermediate and near vision at the days 7, 14 and 21. These visits will be conducted between 2 and 4 hours after instillation of AGN-190584, with 3 hours being the target time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects from age 40-55
* Prescription range: -4.00 - +1.00
* Correctable to 20/25 or better for distance
* Adapted single use contact lens patients
* Subjects able to understand the consent agreement and willing to participate

Exclusion Criteria:

* Non-contact lens wearer
* Previous use of AGN-190584
* Out of age range
* Out of prescription range
* Any corneal abnormality
* Any eye pathology
* Iritis
* Know allergy to pilocarpine
Efficacy of Nicotine Acid on Dyslipidaemia in Patients With Metabolic Syndrome

Placebo controlled evaluation of effectiveness of nicotine acid in treatment of postprandial dyslipidemia in patients with metabolic syndrome. Nicotine acid decreases postprandial hyperlipidaemia in patients with metabolic syndrome which reduces the low-grade inflammation and the risk of atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* dyslipidemia (triglycerides \>= 150 mg/dl and/or decreased levels of HDL-cholesterol \<40 mg/dl in men or \< 50 mg/dl in women)
* further components of the metabolic syndrome: Hypertension: blood pressure \>= 130/85 mmHg or/and Hyperglycemia: fasting plasma glucose \>= 100 mg/dl or/and 2 hour plasma glucose after 75g glucose load (OGTT) \>= 140 mg/dl or/and Obesity: waist circumferences \> 102 cm in men or \>88 cm in women

Exclusion Criteria:

* Contraindication and incompatibility of nicotine acid
* Patients with ulcus ventriculi or ulcus duodeni
* Intake of lipid lowering drugs \< 6 weeks before randomization
* therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit) - no acceptable therapy of diabetes with levels of HbA1C\>=8.0%
* cardiovascular events in the last 6 months
* chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
* ALAT elevation 2.5 times more than the normal limit
* pregnancy
Dietary Intake, Eating Behavior, Physical Activity Level and Their Relationships With Glycemic and Weight Control in Hong Kong Chinese Type 2 Diabetic Patients

The objective of this study is to describe and examine the dietary intake, eating behavior and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association with weight and glycemic control at baseline and 1 year follow-up. The investigators hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern and low physical activity level are associated with poorer glycemic and weight control, and there will be no improvement with weight and glycemic control under usual care after 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female of Chinese ethnicity
2. Diagnosis of T2DM
3. Able to read Chinese and give informed written consents

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. End-stage renal failure requiring dialysis or chronic kidney disease (CKD) stage 4 or above
3. Malignancy diagnosed within 3 years
4. Pregnancy or lactation
5. Any medical illness or condition as judged by the investigators as ineligible to participate the study
CAR T Cells for Refractory B Cell Malignancy

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.

The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. The treat history meeting the following criteria:

   * Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
   * Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
   * One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
2. There is a measurable lesions before treatment at least;
3. ECOG score≤2;
4. To be aged 1 to 70 years;
5. More than a month lifetime from the consent signing date

Exclusion Criteria:

* Serious cardiac insufficiency, left ventricular ejection fraction\<50;
* Has a history of severe pulmonary function damaging;
* Merging other malignant tumor;
* Merging uncontrolled infection;
* Merging the metabolic diseases (except diabetes);
* Merging severe autoimmune diseases or immunodeficiency disease;
* patients with active hepatitis B or hepatitis C;
* patients with HIV infection;
* Has a history of serious allergies on Biological products (including antibiotics);
* Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.


Eligibility Criteria:
Inclusion Criteria:

* With at least a 3-month documented history of bilateral dry eye
* With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
* With at least one objective sign of tear deficiency
* With Ocular Surface Disease Index (OSDI) score of ≥ 18

Exclusion Criteria:

* Refractive surgery within 12 months prior to selection
* Any other ocular surgery or ocular trauma within 6 months prior to selection
* Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs
Evaluation of Well-being Interventions in Adults With TBI

The purpose of this research is to evaluate the potential benefits of two Intervention programs in adults with TBI to improve well-being and other outcomes that are maintained over time.

The current study will examine the efficacy of Signature Strengths in adults with TBI to improve self-concept and other outcomes that are maintained over time. Preliminary evidence suggests that after a TBI, an individual can experience significant alteration to their personal identity and a perceived loss of their pre-injury self. By using this Signature Strength intervention, adults with moderate to severe TBI will be able to become aware of their most used "signature" strengths, explore how these strengths are used in everyday life, and apply them in future situations to bring well-being and to better cope with stressors.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Have a diagnosis with moderate to severe TBI
* At least one year post injury
* Able to speak and read English fluently

Exclusion Criteria:

* Have a history of multiple sclerosis, stroke, seizures or another nervous system injuries disease in the past (like brain tumor or epilepsy)
* Have a significant psychiatric illness (like, schizophrenia or psychosis)
* Currently taking steroids and/or benzodiazepines as determined by study staff review of medications
* Significant alcohol or drug abuse history (requiring inpatient treatment)
* History of stroke, schizoaffective disorder, bipolar disorder, personality disorder or severe depression determined by extensive screening by a trained staff member
* Previous participation in a Signature Strengths program
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients with Chronic Hepatitis B

This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.

Refer to key Inclusion and Exclusion criteria.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or women of non-child bearing potential
* BMI 18.0 to 35.0
* Good overall health deemed by the study Investigator
* CHB infection documented at least 12 months prior to screening
* HBeAg-negative CHB
* Must be virologically suppressed on current NA treatment

Key Exclusion Criteria:

* No history of cirrhosis of the liver
* No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
* No signs of hepatocellular carcinoma
* Not received an organ transplant
* No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
* No investigational agent received within 6 months of screening