cyrilzakka/clinical-trials huggingface dataset:
Anti-inflammatories and Adolescent Schizophrenia

A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia

Patients will be evaluated to confirm the diagnosis of schizophrenia, duration of the disease and record a history of atopic diseases or recurrent infections throughout life. The PANSS, PSP, and MCCB battery scales will be administered. A blood sample will be taken for the determination of markers of inflammation before the start of pharmacological treatment.

Patients will start the antipsychotic medication assigned by their treating physician. They will also be assigned randomly to the treatment arm. The study drug will be provided by the research team under the presentation of capsules containing Celecoxib 200 mg, Minocycline 100 mg or Placebo, and patients will be instructed to take one capsule every 12 hrs daily.

The patient will be reassessed with PANSS, PSP, and MCCB after completing 6 weeks of pharmacological treatment, type and dose of medication will be recorded and serum markers of inflammation will be determined again.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizophreniform disorder.
* Patients in their first psychotic episode or previously diagnosed
* No specific pharmacological treatment (antipsychotic at therapeutic doses in regular doses) in the previous two weeks.
* Have a responsible parent or guardian.

Exclusion Criteria:

* Active infection

  * Chronic somatic diseases, including autoimmune diseases
  * Comorbidity with anorexia, substance use disorders
  * Pregnancy
  * Use of anti-inflammatory medications or antibiotics
Effects of Maternal Body Composition on Offspring Brain Structure and Function

The specific aim of this study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers.


Eligibility Criteria:
Inclusion Criteria:

* the participant must be enrolled in the Arkansas Children's Nutrition Center (ACNC) Glowing study and be about 2 weeks of age +/- 3days

Exclusion Criteria:

* none specified
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.


Eligibility Criteria:
This clinical trial was custom designed for one patient
Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention

This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.

The purpose of this research is to study the effectiveness of an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning. This study consists of attending a group educational session followed by a one-on-one telephone counseling session.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with Stage1-IV ovarian cancer
* Prognosis of at least one year to live (as assessed by provider)
* Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
* English speaking
* Signed informed consent

Exclusion Criteria:

* History of pelvic radiation
* Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)
M-2018-334 in Hematological Malignancies

This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available

Exclusion Criteria:

* \<3 months after preceding autologous transplantation or prior AlloHCT
* History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
* Active fungal infections with radiological and clinical progression
* Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
* Chronic active viral hepatitis
* Cardiac dysfunction: adult patients ejection fraction \<50% on echocardiography
* Patients with uncontrolled, \>grade II hypertension (per Common Toxicity Criteria, CTC)
* Creatinine clearance \<60 mL/min/1.73m2
* Respiratory failure necessitating supplemental oxygen
* HIV infection
* Positive anti-donor HLA antibody
* Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
* Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
* Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
* Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
* Patients unwilling or unable to comply with the protocol or unable to give informed consent
* Treatment with any investigational product within 4 weeks prior to study treatment
High Intensity Laser and Exercises in Knee OA

The purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.

Adding HILT to the traditional physical therapy program may reduce pain and improve the functional status of the affected joints. This may provide clinicians with an understanding of the different treatment modalities that may improve the quality of life of patients suffering from chronic knee OA. Which may benefit a wide range of individuals affected by this chronic and widespread disease all over the world.

Although little is known about the efficacy or mechanism of action of what has been termed ''high-intensity laser therapy'' using Nd: YAG lasers it has become commercially available in veterinary practice and is being marketed for the treatment of musculoskeletal disease. clinical research specific to Nd: YAG high-intensity laser therapy is required, as it is being used with little supporting evidence.

As there was no evidence about the best protocol for the treatment of knee OA as each study was using different doses, different sites of application, different number of phases, frequency of sessions, and the interval between sessions that make it difficult to have the best results. Specifically, the dosage range in literature was ranged from 1250 to 3000 J as total energy transmitted during one treatment session. The current study is an attempt to answer the question of which dosage of the energy of high-intensity LASER is more effective on pain and functional activities in patients with chronic knee OA at the third degree of osteoarthritis as determined by (Kellgren/Lawrence grading system) as it was recommended that LASER is an ideal treatment for subjects in the later stages of OA .

Eligibility Criteria:
Inclusion Criteria:

1. All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
2. Aged between 50- 70 years
3. Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
4. Body mass index (BMI) ≤30 kg/m2.
5. Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
6. All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university

Exclusion Criteria:

Patients will be excluded if they have the following conditions:

* History of joint replacement.
* Symptoms or signs suggestive of another cause of knee pain.
* Rheumatoid arthritis.
* Steroid injection or knee surgery (previous six months).
* acute inflammation around knee joint.
* Underlying disease such as malignancy.
* Infection or systemic disease of musculoskeletal system
Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk

Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.

This study is designed to evaluate the prophylactic efficacy of HCQ in COVID-19 cases with mild to moderate symptoms and in the hospital staff engaged in attending infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years of age at the time of enrollment
* COVID-19 test positive patients with mild-moderate symptoms including fever \>37.50 F
* Consecutive consenting staff at ICU, ER and COVID-19 unit that have never been diagnosed with COVID-19

Exclusion Criteria:

* Exclusion criteria:
* Hepatic cirrhosis or active hepatitis B or C
* Severe renal disease
* Hospitalized for severe symptoms of COVID-19 (ARDS), on mechanical ventilation or ECMO
* Contraindication to HCQ
* Using HCQ for some other condition (i.e. SLE, rheumatoid arthritis)
* Pregnant or breast feeding
* Known history of long QT syndrome (QTc \>500 ms on electrocardiogram)
* Seizure disorder
* Body weight \<50kg
* Psoriasis
* Unwilling to provide informed consent
The Biological Specificity of Acupoints Between Major Depressive Disorder Patients and Healthy Controls

Evidence-based medicine suggests that acupuncture can improve major depressive disorder (MDD). However, the prevalent reliance on experiential acupoint selection lacks scientific underpinning. The investigators conducted a comparative study involving MDD patients and healthy subjects, employing modern techniques to discern biological specificity in MDD-related acupoints. Additionally, the investigators investigated potential correlations between acupoint biological specificity and MDD severity.

A final total of 134 eligible subjects were included. Among them, 50 healthy subjects were assigned to the healthy control (HC) group and 84 MDD participants were assigned to the MDD group.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the healthy control participants:

* provided a recent depression screening report, and be free of any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
* 18 ≤ age ≤60 years, male or female;
* had clear consciousness and could communicate with others normally; - understand the full study protocol and have high adherence;
* signed the written informed consent.

Inclusion criteria for the MDD participants:

* consistent with the diagnosis of MDD in the International Classification of Diseases 10th Edition (ICD-10);
* 18 ≤ age ≤ 60, male or female;
* had clear consciousness and could communicate with others normally;
* understand the full study protocol and have high adherence;
* signed the written informed consent.

Exclusion Criteria:

* The exclusion criteria of the HC participants were as follows: (1) had serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases; (2) pregnant or lactating; (3) had scars, hyperpigmentation, red and swollen of the skin at the test site; (4) were participating in other trials; (5) had a mental illness, alcohol dependence, or a history of drug abuse. Exclusion criteria for the MDD participants: (1)-(4) same exclusion criteria as healthy subjects; (5) MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances; (6) had psychiatric disorders other than MDD; (7) with suicidal tendencies. In addition, IRT is not be performed on female subjects during their menstrual and ovulatory periods.
A Non-Interventional Study To Assess Sweating

To evaluate the gravimetric sweat measurements in subjects who meet the subjective criteria for a diagnosis of palmar hyperhidrosis compared to subjects without hyperhidrosis.

This is a Non-Interventional Study To Assess Sweating, As Measured By Gravimetry, In Subjects With Primary Hyperhidrosis And In Healthy Individuals .

The objective of this study is to determine the threshold gravimetric measurement for subjects with palmar hyperhidrosis.

Eligibility Criteria:
Inclusion Criteria:

* Females should not be pregnant or lactating.
* For subjects with palmar hyperhidrosis: Primary palmar hyperhidrosis of at least 6 months's duration and Hyperhidrosis disease severity score of 3 or 4 at baseline
* For healthy participants: no history or current report of hyperhidrosis and Hyperhidrosis disease severity score of 1 at baseline

Exclusion Criteria:

* Recent therapeutic interventions or treatments for palmar hyperhidrosis
* Any major illness within 30 days before the screening
* Females who are pregnant, lactating, or planning a pregnancy
Venclose digiRF System Post Market Study

A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is age 18 and older
2. Subject has CEAP clinical class C2 and higher.
3. Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
4. GSV/SSV or IPV to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.
5. For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
6. For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
7. For IPV only: IPVs must be located under a healed or active ulcer.
8. Is able to ambulate.
9. Is able to comprehend and has signed the Informed Consent Form (ICF) to participate in the study.
10. Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule.

Exclusion Criteria:

1. Has had previous treatment for venous insufficiency in the same target vein.
2. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
3. Has thrombus in the vein segment to be treated.
4. Has untreated critical limb ischemia from peripheral arterial disease.
5. Is undergoing active anticoagulant therapy for acute Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
6. Subjects with known bleeding and/or clotting disorders.
7. Has ABI \<0.8
8. Subject is pregnant or breastfeeding
9. For GSV/SSV only: has a BMI \>35.
10. For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
11. Unable to ambulate, or restrictive ambulation.
12. Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
13. Has undergone or is expected to undergo any major surgery within 30 days prior to or following the study procedure.
14. Has a condition, judged by the treating physician, that may jeopardize the subject's well-being and/or confound the results or the soundness of the study.
Study on the Treatment of Prurigo Nodularis With Stapokibart Injection

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.

Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
* 18 ≤ Age ≤ 75 years old.
* Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.

Exclusion Criteria:

* With drug-induced prurigo nodularis.
* With clinically significant diseases.
* With severe liver and kidney function damage at the screening.
* With malignant tumors within the first 5 years before the screening.
* Plan to undergo major surgical procedures during this study.
A Registry Study of Shuxuening Injection Used in Hospitals in China

The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.

Ginkgo leaf is major component of Shuxuening injection. Although some western countries product similar injections and use them, Shuxuening injection also regarded as Chinese medicine injection. As a TCM injection, the most important thing is how to safety use it in practice.

In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of allergic reaction.

Calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December 2014.

Data will be collected for three departments as following:

Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system.

Eligibility Criteria:
Inclusion Criteria:

* Patients using Shuxuening injection from 2012 to 2014

Exclusion Criteria:

* none
A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions and attend all study visits
* Positive history of ocular allergies
* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy, or lactating
* Use of disallowed medications
Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients.

The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.

Traumatic brain injury patients have been increasing due to various accidents. After acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. However, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. Cell therapy like Umbilical cord blood (UCB) transplantation has showed promising results in many animal studies. The mechanism of such neurological improvement is not fully understood. Stem cells included in UCB are expected to secrete neurotrophic factors to enhance brain function. In addition, anti-inflammatory effects of UCB are suggested. Autologous UCB are not available in most of the cases in fact. The aim of this clinical trial is to determine the safety and efficacy of allogeneic UCB.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)
* Glasgow Outcome Scale: 2, 3, 4, 5

Exclusion Criteria:

* High risk of pneumonia or renal function deterioration after immunosuppressant
* Possibility of drug hypersensitivity which is related to this study remedy
* Intractable seizure disorder
* Poor cooperation of guardian,including inactive attitude for rehabilitation
Postoperative Pain in Endodontic Therapy

The goal of this clinical trial is to evaluate the change in postoperative pain in mandibular premolar and first molar teeth with asymptomatic apical periodontitis when using EDDY and passive ultrasonic irrigation activation methods.

The null hypothesis is: "There is no difference in postoperative pain after root canal treatment between the irrigation activation systems in mandibular first molars and premolar teeth."


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 55 years, medically healthy, and free from systemic diseases.
* Patients without pregnancy or breastfeeding status.
* Patients diagnosed with asymptomatic apical periodontitis confirmed through radiographic and clinical examination.
* Patients not having a regular intake of analgesic or anti-inflammatory drugs within the last 12 hours.
* Patients lacking a history of drug allergies.
* Teeth free from calcifications, resorptions, periodontal problems, incomplete root development, a history of endodontic treatment, traumatic occlusion, or severe coronal destruction.
* Teeth with a root canal curvature of 5° or less.
* Mandibular premolars and first molars.

Exclusion Criteria:

* Teeth where the apical area could not be reached with a #8K file.
* Teeth with an apical diameter larger than #20K file.
* Patients with a Periapical Index (PAI) score of 1 or 2.
* Teeth having extra canals.
* Teeth requiring a second local anesthesia during treatment.
* Teeth where a file fractured within the canal during preparation.
* Vital teeth.
* Patients reporting preoperative pain.
* Teeth showing clinical symptoms such as percussion or palpation sensitivity.
* Teeth with persistent purulent discharge.