cyrilzakka/clinical-trials huggingface dataset:
A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) who remain symptomatic despite the use of H1-antihistamines.

There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

Eligibility Criteria:
Key inclusion criteria:

1. Males and females, \>/= 18 years of age.
2. Diagnosis of chronic ColdU or SD \>/= 3 months.
3. Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

   1. Recurrent pruritic wheals with or without angioedema due to ColdU or SD for \>/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment and agree to stay on through trial.
   3. UCT \< 12 during the 14 days prior to treatment.
4. Positive provocation test

   1. for ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3)
   2. for SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3)
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.

Key exclusion criteria:

1. Women who are pregnant or nursing.
2. Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that may interfere with study assessments.
3. Active, pruritic skin condition in addition to CIndU.
4. Medical condition that would cause additional risk or interfere with study procedures.
5. Known active HIV, hepatitis B or hepatitis C infection.
6. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
7. History of anaphylaxis

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Number of participants with Adverse events will be covered in Adverse Events section.

The statistical analysis tests for the efficacy variables will be performed hierarchically. The comparisons ciprofloxacin DPI vs. pooled placebo (according to statistical analysis plan defined for FDA registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic or post infectious bronchiectasis
* Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1) \<30% or \>90% predicted
* Active allergic bronchopulmonary aspergillosis
* Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
* Primary diagnosis of Chronic obstructive pulmonary disease (COPD)
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
ViDES Trial (Vitamin D Extra Supplementation)

The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).


Eligibility Criteria:
Inclusion Criteria:

* Infants born at \< 28 weeks gestational age (GA) or \<1000 grams birth weight (BW)
* Inborn
* Informed written consent in an Institutional Review Board (IRB)-approved manner

Exclusion Criteria:

* GA \>32 weeks regardless of birth weight (BW)
* Any major congenital anomaly
* A known congenital nonbacterial infection
* Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
* Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.
Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers

This study will be conducted to evaluate:

1. The remineralization potential of natural agents (egg shell powder and clove extract) versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH cycling using microhardness test.
2. The clinical efficacy of all agents in patients with early carious lesions.


Eligibility Criteria:
Inclusion Criteria:

* 1. Criteria related to patient:

  * Age's eligible for trial was 18- 30 years.
  * Patient able to read and sign the informed consent form.
  * Cooperative patient who are willing to participate and able to continue the schedule time of wok keep good oral hygiene throughout the study.
  * Healthy volunteers.
  * Patient with moderate and high caries index. 2. Criteria related to tooth:
  * Patient with at least 2 white lesions (WSL) detected clinically on the buccal surface of permanent anterior teeth, one on each side. WSL selected either due to caries or orthodontic treatment (just following deboning).
  * Teeth with score1, 2, 3 according to ICDAS II.
  * Absence of preoperative pain, no mobility \& tenderness on percussion.
  * Radiographically, the pre-operative inclusion criteria were absence of internal or external resorption, no periapical radiolucencies and no widening of periodontal ligament space..

Exclusion Criteria:

* 1. Criteria related to patient:

  * Patient with Rampant uncontrolled caries.
  * Patient with compromised medical history.
  * Pregnant or breast feeding females.
  * Heavy smoker.
  * Patient who currently received extensive fluoride regiments for treatment of WSL.
  * Patients who planned to move within 3 months of enrollment.
  * Patient with evidence of xerostomia. 2. Criteria related to tooth:
  * Teeth with score 4, 5 according to ICDAS II.
  * Teeth with periapical pathology, internal or external resorption or exhibiting any symptoms of pulp pathology.
  * Teeth with questionable vitality or have root canal therapy.
  * Teeth have been pulp capped.
  * Teeth with periodontal pocket and bleeding on probing.
  * Cracked teeth.
Quantifying Lung Tumor Movement Under Deep Inspiration Breath Holds

Radiotherapy is a common treatment for lung cancer. One Challenge of delivering radiation treatment to lung tumors accurately is tumor movement which occurs as a patient breathes. In some situations, tumors move enough during breathing so that some or all of the tumor may be missed by a radiation treatment. One way to decrease the amount a lung tumor moves during radiotherapy treatments is for patients to held their breath briefly during a radiation treatment. By doing this, a patient's lung tumor may not move as much as it would during regular breathing. In this study, the investigators aim to study patients with lung cancers which move during breathing. Patients will be asked to hold their breath after inspiration while a CT scan of their lung tumor is obtained. The purpose of this study is to study how much less patients' lung tumors move when they hold their breath


Eligibility Criteria:
Inclusion Criteria:

* biopsy confirmed primary lung cancer
* undergoing radiotherapy or chemoradiotherapy
* able to perform adequate deep inspiration breath hold
* patients of childbearing potential must practice adequate contraception
* signed study-specific informed consent form

Exclusion Criteria:

* unable to perform adequate deep inspiration breath hold
* prior tumor resection
* prior chest or neck RT
* pregnant
Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery

The addition of adrenaline to the arthroscopic irrigation serum is used during rotator cuff surgery to limit intraoperative bleeding and ensure a clear view. Two concentrations of adrenaline are commonly used in practice: 1mg/L or 0.33 mg/L.

The aim of this study is to determine which of these two doses provides better clarity of the surgical field with less impact on the patient's cardiovascular parameters.

A prospective, randomised, double-blind, multicentre study in two parallel groups of 85 patients comparing two concentrations of adrenaline in the irrigation fluid of an arthroscopy (0.33 mg/L vs. 1 mg/L):

Maximum duration of patient participation in the study = 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age, having read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes)
* Patient with a rotator cuff pathology (subacromial impingement, long biceps tendinopathy or rotator cuff tendinopathy)
* Patient for whom an arthroscopic surgical indication has been given

Exclusion Criteria:

* Allergy to epinephrine
* History of Takotsubo cardiomyopathy
* Coagulation disorder
* Patient under court protection, guardianship or curatorship
* Patient not affiliated to the French social security system
* Patient participating in another therapeutic protocol
* Breastfeeding woman,
* Pregnant woman or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (\> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be post-menopausal unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal condition is defined as the absence of menstruation for 12 months without any other medical cause
* Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
"Outwalk MS" - Benefits of Outdoor Walking in Multiple Sclerosis

Deterioration of walking capacity is a common symptom in persons with multiple sclerosis (pwMS), furthermore having a negative influence on well-being. Studies have nevertheless shown that walking exercise therapy can improve walking capacity in pwMS. This may be particularly potent if occurring outdoors due to the varying stimuli it can provide (different surfaces and terrain etc.), and if the intensity and duration is adequate. Furthermore, outdoor walking is (1) suitable as a group intervention facilitating interaction between pwMS and (2) advantageous due to the health benefits offered through the interaction with nature itself. Both these aspects are also relevant for well-being.

Few studies have nevertheless examined the effects of outdoor walking exercise therapy in pwMS. The purpose of the present study is therefore to examine the effects of 7 weeks of moderate-to-high intensity outdoor walking exercise therapy on walking capacity (primary outcome: 6-minute walk test) and well-being in pwMS.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* self-reported clinical MS diagnosis
* PDDS ≤ 4 (corresponding to preserved walking capacity without assistive devices of at least 10 m)
* able to independently attend the testing

Exclusion Criteria:

* self-reported comorbidities excluding participation in the intervention
* recent (6 months retrospective) fractures, amputation or other critical physical impairments that eliminates participation in the described training study
* participation in structured exercise therapy (including walking) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)
Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers

This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 65 years of age.
* Weight\> 50 kg and \<95 kg inclusive
* For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1.
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant during the full duration of the study.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

* Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
* Pregnant or breast-feeding women.
* Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
* Hospitalization for any reason within 60 days of screening.
* Known history of Human Immunodeficiency Virus (HIV) antibody; and/or positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit.
* Previous exposure to any therapeutic or investigational biological agent.
* History of alcohol or substance abuse within previous 5 years.
Intestinal Flora Sequencing for Nasopharyngeal Carcinoma

This study investigated the correlation between the changes in the intestinal flora and NPC by an examination of the intestinal flora and multiple clinical indicators of the blood of 8 carefully screened patients of familial NPC, 24 patients of sporadic NPC and 27 healthy controls and a comparison of the differences in their intestinal flora structures and biological functions. By analyzing the function of the intestinal floras of NPC patients, we aimed to provide a better biological marker for patients with familial and sporadic NPC and constructed a disease prediction model for high-risk populations.

Nasopharyngeal carcinoma (NPC) is a malignant nasopharyngeal disease with a complicated etiology that occurs mostly in southern China. Intestinal flora imbalance is believed to be associated with a variety of organ malignancies. Currently, the relationship between intestinal flora and NPC is not clear, although many studies have shown that intestinal flora can be used as a biomarker for many cancers and to predict cancer.

To compare the differences in intestinal flora compositions and biological functions among patients with familial NPC (NPC_F), patients with sporadic NPC (NPC_S) and healthy controls (NOR), we compared the intestinal flora DNA sequencing and hematological testing results between every two groups using bioinformatic methods.

Eligibility Criteria:
Inclusion Criteria:

* NPC patients with a first degree family history of NPC
* NPC patients without any kind of tumor family history

Exclusion Criteria:

* Informed refusal.
* Lack of necessary tests and patient test information is not detailed
A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)

The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment period (Up to 18 months). The primary hypothesis of the study was that administration of dalotuzumab as an every other week infusion in participants with relapsed or refractory locally advanced or metastatic cancers associated with a high frequency of insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and well tolerated to permit further study and achieve a constant clearance and a minimum trough concentration of 3 µg/mL.

The study consisted of 3 parts. In Part 1 the loading dose was escalated while the maintenance dose was kept constant. In Part 2 the loading dose was kept constant while the maintenance dose was escalated. In Part 3 the recommended phase 2 loading and maintenance doses and schedule were administered to an expanded cohort to explore safety and efficacy of dalotuzumab.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function

Exclusion Criteria:

* Participant is using growth hormones or growth hormone inhibitors
* Participant is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin G
* Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks of entering the study or has not recovered from previous therapy
* Participant is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug
* Participant has an active Central Nervous System metastases and/or carcinomatous meningitis. However, a participant who has completed a course of therapy and is clinically stable may be able to participate
* Participant is pregnant or breastfeeding
* Participant is human immunodeficiency virus (HIV) positive
* Participant has a history of Hepatitis B or C
* Participant has symptomatic ascites or pleural effusion. However, if the participant has received treatment and is stable, they may be able to participate
* Female participant plans to become pregnant or a male participant who plans to impregnate their partner during the time the study is ongoing
Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure

To assess the ability of KEFPEP® to reduce blood pressure

Primary objective-

• To assess the ability of KEFPEP® to reduce blood pressure.

Secondary objective-

1. To access the effect of KEFPEP® on vascular inflammation or damage.
2. To access the effect of KEFPEP® on cardiovascular diseases prevention.
3. To assess the safety of KEFPEP® .

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient ages 20 years or older.
2. Belong to either one of the following categories based on the Seventh Report of the Joint National Committee (JNC 7) as measured by office BP at Screening visit:

   * Prehypertension (SBP 120 - 139 mmHg or DBP 80 - 89 mmHg)
   * Stage I hypertension (SBP 140 - 159 mmHg or DBP 90 - 99 mmHg)
3. Body weight≤90 kg, and BMI≥18.5 kg/m2 or \< 30 kg/m2.
4. NOT on any antihypertensive treatment at the time of entry into the study.
5. Willing to comply with the study procedures and follow-ups.
6. Understand the nature of the study, and have signed informed consent forms.

Exclusion Criteria:

1. Patients with any of the following conditions within 6 months prior to study participation:

   * Secondary hypertension
   * Uncontrolled diabetes mellitus
   * Renal disease based on the investigator's judgment
   * Severe hepatic disease with Child-Pugh class C
   * Severe anaemia
   * Any malignant disease or serious disease
2. Patients with clinically significant abnormalities in the following laboratory parameters within 2 weeks prior to Screening visit or during the screening period:

   * HbA1c \> 9%
   * AST or ALT ≥ 3 x upper limit of normal (ULN)
   * Estimated glomerular filtration rate (eGFR) \< 50 ml/min/1.73 m2
   * Serum creatinine ≥ 3 x ULN
   * Hemoglobin \< 10 g/dL
3. History of milk allergy and/or lactose intolerance.
4. History of alcohol abuse.
5. Constant use of oral medication or supplements affecting blood pressure.
6. Female patients who are pregnant, planning to become pregnant, or lactating.
7. Male or female patients of child-bearing potential do not agree to use an effective method of contraception during the study period.
8. Currently participating in any other interventional clinical study within 30 days
9. Patients who are considered not suitable for the study according to the investigator's judgment for the patient's best interest.