cyrilzakka/clinical-trials huggingface dataset:
Compound Glutamine Enteric-Coated Capsules Combined with Thalidomide in Preventing Radiation-induced Oral Mucositis

The goal of this study is to compare Compound Glutamine Enteric-Coated Capsules (CGECC) combined with thalidomide with CGECC in preventing radiation-induced oral mucositis. The aim of this study is to answer whether CGECC plus thalidomide could improve the median incidence time of grade 2 oral mucositis. Participants would be randomly divided into the two groups above mentioned.

Explore the therapeutic efficacy of CGECC combined with Thalidomide as compared to CGECC alone in preventing radiation-induced oral mucositis. The primary research endpoint is the median time to the onset of Grade II oral mucositis, defined as the number of days from the start of radiation therapy to the occurrence of Grade II oral mucositis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years old;
2. Patients with postoperative oral malignant tumors confirmed by pathological histology or cytology and requiring radiotherapy;
3. Patients who have received more than 45Gy of radiation in the oral area;
4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-1;
5. Basic hematological indicators are normal: White blood cell count ≥ 4×10\^9/L; Absolute neutrophil count ≥ 1.5×10\^9/L; Platelets ≥ 100×10\^9/L; Hemoglobin ≥ 90 g/L;
6. Basic renal function is normal: Serum creatinine ≤ 1.5×ULN (Upper Limit of Normal) or Creatinine Clearance Rate (CrCl) \> 60 mL/min (using the Cockcroft-Gault formula):

   For women: CrCl = (140 - age) × weight (kg) × 0.85 / (72 × Scr mg/dl) For men: CrCl = (140 - age) × weight (kg) × 1.00 / (72 × Scr mg/dl)
7. Basic liver function is normal: Serum total bilirubin ≤ 1.5×ULN; AST (Aspartate Aminotransferase) ≤ 2.5×ULN; ALT (Alanine Aminotransferase) ≤ 2.5×ULN.
8. Signed written informed consent.

Exclusion Criteria:

1. Participated in another interventional clinical trial within the last 30 days;
2. Patients with severe underlying oral diseases who cannot tolerate radiation therapy;
3. Patients allergic to glutamine and thalidomide;
4. Patients receiving secondary radiation therapy to the oral area;
5. Pregnant women (confirmed by blood or urine HCG testing) or breastfeeding women, or participants of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female participants) until at least 6 months after the last trial treatment;
6. Patients with underlying peripheral neuropathy;
7. Individuals deemed by the researcher to be inappropriate for participation in this study;
8. Unwilling to participate in this study or unable to sign informed consent.
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.

Bronchopulmonary dysplasia (BPD) is the most common cause of death for premature newborns with low birth weights. In addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive.

It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on.

PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. This is a long term follow-up study of the earlier part of the phase I clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205)

Exclusion Criteria:

* Infants whose parent or legal guardian did not want to participate in the study
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects

This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (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 17.5 to 30.5 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).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Effect of Efpeglenatide on Cardiovascular Outcomes

Primary Objective:

To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.

Secondary Objectives:

To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters:

* 3-point MACE.
* Expanded CV outcome.
* Composite outcome of new or worsening nephropathy.

To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.

The study duration per participant was up to approximately 36 months.

Eligibility Criteria:
Inclusion criteria:

* T2DM with glycosylated hemoglobin (HbA1c) greater than (\>) 7 percentage.
* Age 18 years or older who met at least one of the cardiovascular disease criteria or age 50 years (male), 55 years (female) or older with glomerular filtration rate greater than or equal to 25 and less than 60 milliliters per minute and at least had one cardiovascular risk factor.
* Female participants agreed to follow contraceptive guidance.
* Signed written informed consent.

Exclusion criteria:

* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
* History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to screening.
* Personal or family history of medullary thyroid cancer.
* Hypertension (with a systolic blood pressure \>180 millimeters of Mercury \[mmHg\] and/or diastolic blood pressure \>100 mmHg).
* Hospitalization for hypertensive emergency within 3 months prior to randomization.
* Planned coronary procedure or surgery after randomization.
* No documented ophthalmologic exam with fundoscopy within 6 months prior to randomization.
* Retinopathy or maculopathy with treatment, either recent (3 months prior to randomization) or planned during the study.
* Treated with any glucagon-like peptide-1 receptor agonist product alone (eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide) or in combination within 3 months prior to screening.
* Use of any Dipeptidyl peptidase 4 inhibitor within 3 months prior to screening.
* Antihyperglycemic treatment had not been stable within 3 months prior to screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule in Japanese Healthy Males

The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese
* Classified as homo-EM
* Negative for HIV, Hepatitis B, Hepatitis C and syphilis

Exclusion Criteria:

* Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

This study aims to investigate postoperative clinical, cognitive and neurophysiological assessment of patients after open heart surgery among sample of Egyptian patients.

Coronary artery bypass grafting (CABAG) is one of the most common major surgical procedures, as more than 800,000 patients worldwide undergo myocardial revascularization procedures every year. Cardiopulmonary bypass (CPB) is an extracorporeal circulation procedure that assists the operation of cardiac and great vessels and is associated with perioperative morbidity and mortality.

Preoperative neurophysiological status as measured by electroencephalogram (EEG) had a specificity of 94.7% and a sensitivity of 76.9% for predicting 1-week postoperative cognitive status and with specificity of 78.3% and a sensitivity of 77.8% for predicting 3-months postoperative cognitive status.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 60 years.
* Both sexes.
* Patients who are scheduled for on-pump open heart surgery either isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery.

Exclusion Criteria:

* Patients with a past history of CNS disease (e.g. Epilepsy, brain tumors, or Dementia).
* Patients with metabolic disturbance.
* Illiterate patient.
* Patient with sever cognitive impairment on Mini-mental state Examination (MMSE) and/or Montreal Cognitive Assessment (MoCA)
* Patients who cannot undergo DEEG recordings (eg, uncooperative).
* Patients with abnormal brain images except for small vessel disease.
Effect Of Extracorporeal Shockwave Therapy on Tension-Type Headache in Adolescent Females

Chronic headaches in adolescents can have consequences such as absence from school, inability to maintain social activities, and additional disorders such as anxiety, depression, problems sleeping, and reduced quality of life to investigates the efficacy shock wave diathermy on tension headaches in adolescent females

The prevalence of headaches increases with age, with a prevalence of 82% during adolescence. Extracorporeal Shockwave Therapy could reduce the pain of myofascial pain syndrome by pain signal alteration, promoting angiogenesis and increasing perfusion in ischemic tissues induced by sensitization of nociceptors and muscle ischemia

Eligibility Criteria:
Inclusion Criteria:

* Suffering from chronic tension headache (headaches occur 15 or more days a month for at least three months).
* Their age will range from 15 to 18 years.
* Having a sedentary lifestyle (A weekly physical activity of \< 600 MET-minutes/ week in the international physical activity questionnaire)
* Having regular menstruation (28 to 34 days).

Exclusion Criteria:

* Using oral contraceptives or
* any hormonal treatment in the previous six months.
Proximal Row Carpectomy Versus Four Corner Fusion

There are two types of interventions to treat a post-traumatic wrist osteoarthritis: the proximal row carpectomy and the four corner fusion. They are used to reduce pain and to maintain the mobility. In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively, whereas the four corner fusion has lower progression of radiocarpale osteoarthritis.

The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.

Two surgical procedures are used to treat a post-traumatic wrist osteoarthritis, especially after scaphoid non-union advanced collapse (SNAC) and scapholunate advanced collapse (SLAC): the proximal row carpectomy and the four corner fusion. Both surgical procedures are rescue operations. They are used to reduce pain and to maintain the mobility, compared to a complete stiffening of the wrist.

In previous studies are shown that the proximal row carpectomy shows a better mobility of the wrist postoperatively and a lower complication rate, whereas the four corner fusion has a lower progression of radiocarpale osteoarthritis and a better grip strength.

The purpose of this study is to compare the clinical, radiological and subjective outcomes after the treatment with a proximal row carpectomy or a four corner fusion.

Eligibility Criteria:
Inclusion Criteria:

* post-traumatic wrist osteoarthritis
* treated with a proximal row carpectomy or four corner fusion
* signed written informed consent

Exclusion Criteria:

* no knowledge of German
The Effect of Coconut Oil on Alopecia

İn this study will be conducted to evaluate the effect of coconut oil on alopecia in 86 female breast cancer patients treated at Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital between 01.02.2025-31.12.2025.

Cancer is a disease in which the cells in our body multiply uncontrollably and develop by metastasizing, and the symptoms, course and consequences of the disease can show complex qualities in each patient. Cancer treatments have benefits and harms. One of these side effects is alopecia.

Alopecia due to cancer treatments is a condition of hair loss, partial or complete, usually temporary but rarely permanent.

In chemotherapy-induced alopecia, the hair follicle is damaged due to the pause in the anagen phase and causes the hair to break off spontaneously during activities such as washing and brushing the hair.

Various scales are used in the evaluation of alopecia due to cancer treatments, such as the National Cancer Institute Common Terminology Criteria for Side Effects and the Dean Alopecia Scale.

Some applications are made to prevent and treat alopecia. These include strategies and pharmacological applications to physically reduce the amount of medication given to the hair follicle.

Coconut oil helps regrow damaged hair. It provides essential proteins necessary for hair and softens the scalp and hair.

In the literature, it has been observed that studies showing the effects of coconut oil for the prevention and treatment of alopecia are insufficient. This study will be conducted on 86 breast cancer patients to determine the effect of coconut oil on the development of alopecia.

Eligibility Criteria:
Inclusion Criteria:

* • To have been diagnosed with breast cancer.

  * The chemotherapy treatment plan should be planned as the Doxorubicin-Cyclophosphamide protocol.
  * Volunteer to participate in the study.
  * Be 18 years of age or older.
  * Being a woman.

Exclusion Criteria:

* • Having any health problem or disability that prevents communication (vision-hearing problems, neurological, psychiatric diseases).

  * Planning other treatments other than the Doxorubicin-Cyclophosphamide protocol for the treatment of breast cancer.
  * Not volunteering to participate in the study.
  * Having previously experienced any disease/skin problem that causes hair loss.
  * Having received chemotherapy before.
A Study of Experimental Medication BMS-986235 in Healthy Subjects

This is a study of experimental medication BMS-986235 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
* Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive

Exclusion Criteria:

* Patients that are pregnant
* Patient with any significant acute or chronic medical illness
* Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
* Patient with any surgery within 12 weeks of study treatment administration
* Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
* Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
* Patient who received a blood transfusion within 12 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria apply
The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU

This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.


Eligibility Criteria:
Inclusion Criteria:

* Non- intubated patient diagnosed with moderate to severe pneumonia (confirmed by chest x-ray and officially reported) as secondary to COVID-19 with one more symptom such as:

  1. Respiratory rate at ≥ 20 breath.min-1.
  2. Oxygen saturation (SatO2) ≤ 90% at rest on room air.
  3. Arterial partial pressure of oxygen (PaO2) ≤ 80 mmHg at resting.
  4. PaO2/FiO2 ratio or P/F (is the ratio between the arterial partial pressure of oxygen and the percentage of oxygen supplied) \< 300mmHg.

Exclusion Criteria:

1. Patient that has received upper abdominal or thoracic surgery recently (≤ 3 months).
2. Cancer patients.
3. Pregnant patients.
4. Patient mentally unstable.
5. Patient with unstable cardiovascular or neurological functions.
6. Patients refusing to participate in this clinical trial.
7. Patient less the 21 years old (According to Kuwaiti Law).
8. Patients who have a language barrier who cannot understand Arabic or English.
A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo

An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of nonsegmental vitiligo with genital involvement
* At least ≥ 0.25% BSA of nonsegmental vitiligo in the genital area.
* Pigmented hair within some of the genital vitiligo areas.
* At least 1 genital target lesion that is ≥ 0.1% BSA that has a pigmented hair within it.
* Vitiligo on areas of the body besides the genitals.
* Total body vitiligo area not exceeding 10% BSA.
* Willing to have genital photography conducted.
* Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

* Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.
* Prior or current use of depigmentation treatments (eg, monobenzone).
* Active or recurrent genital warts or herpes.
* Male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia.
* An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum).
* Had ≥ 3 laser hair removal treatments in an area to be treated for vitiligo.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study or interpretation of study data.
* Clinical laboratory test results outside of protocol defined ranges
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
CentriMag RVAS U.S. Post-approval Study Protocol

The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause

Objectives of this study are to evaluate:

1. Duration of right ventricular support
2. Incidence of adverse effects
3. Evaluation of end-organ function
4. Evaluation of hemodynamics
5. Survival at 30 days post RVAD removal

The primary endpoints include:

1. In patients who recover and do not go on to transplantation or a long-term device:

   a. Survival to 30 days post-support or to hospital discharge (whichever is longer)
2. In patients who do not recover and are bridged to transplant or a long-term system:

   1. Survival to induction of anesthesia for implantation of a long-term mechanical support device or heart transplant

Secondary endpoints include:

1. On Pump Hemodynamics

   1. A clearly observable trend toward reduction of mean right atrial pressure / central venous pressure is demonstrated while the patient is on support compared to baseline.
   2. A clearly observable trend toward an increase in mean arterial pressure is demonstrated while the patient is on support compared to baseline
   3. A clearly observable trend toward an increase in mean cardiac index is demonstrated while the patient is on support compared to baseline
2. Post Pump Hemodynamics (must meet at least two of the following criteria)

   1. Based on plotting of the data, success will be achieved if a clearly observable trend toward reduction of mean right atrial pressure/central venous pressure is demonstrated after device removal compared to baseline
   2. Based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean arterial pressure is demonstrated after device removal compared to baseline
   3. Based on plotting of the data, success will be achieved if a clearly observable trend toward increase in mean cardiac index is demonstrated after device removal compared to baseline
3. A clearly observable trend toward a reduction in creatinine and/or BUN while on support and after device removal compared to baseline
4. A clearly observable trend toward a reduction in total bilirubin while on support and after device removal compared to baseline
5. An acceptable incidence of adverse effects observed

Patient Population

This study includes data from 25 consecutive patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.

Eligibility Criteria:
Inclusion Criteria:

* Right ventricular failure from any cause

Exclusion Criteria:

* Primary coagulopathy or platelet disorders
* Allergy or sensitivity to heparin and all alternative anticoagulants
Mobile Phone Text for Optimizing Asthma Treatment

The study aims at providing information on how the Short Message Service (SMS) tool influences self-management in asthma patients and to assess the resulting health related effect. A wide range of models and theories exist in the compliance area, such as technical models, communication models, cognitive models and self-management models and theories. The use of some of these theories and models will serve as theoretical and explanatory tools for studying how and why the SMS tool influences the patient's self-management.

Objective:

The objective of this study is to assess the health-related effects of a SMS compliance and monitoring system for optimized asthma treatment in a controlled trial setting.


Eligibility Criteria:
Inclusion Criteria:

* asthmatics

Exclusion Criteria:

* below 18 and above 45
* COPD patients
* no mobile phone
* not using the prescribed asthma inhalation medication