cyrilzakka/clinical-trials huggingface dataset:
First-in-Human Study of GM-60106 in Healthy Adults and Otherwise Healthy Adults With an Increased Body Mass Index and Markers of Non-Alcoholic Fatty Liver Disease

This is a Phase 1a/1b, randomised, double-blind, placebo-controlled single- and multiple-ascending dose study to evaluate the safety, tolerability, PK, and PD of GM-60106 in healthy adult male and female participants and otherwise healthy adults who have an increased BMI and markers of NAFLD.

The study consists of 3 parts:

Part A (Single Ascending Dose \[SAD\]): Approximately 56 healthy participants will be enrolled into 7 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).

Part B (Multiple Ascending Dose \[MAD\]): Approximately 24 healthy participants will be enrolled into 3 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo).

Part C (Multiple Ascending Dose \[MAD\]): Approximately 16 participants will be enrolled into 2 cohorts and randomised to receive either GM-60106 or matching placebo at a ratio of 6:2 (GM-60106: placebo). Cohorts will include otherwise healthy participants who have an increased BMI and markers of NAFLD.

Part B and Part C will occur only after the Safety Monitoring Committee (SMC) has reviewed all blinded safety data as well as any available PK and PD data from MAD cohorts that have completed the assessment of doses equal to the proposed starting Part C (MAD) dose and a dose higher (including a minimum safety review interval of 10 days after dosing the sixth participant in the cohort) and recommends initiation.

The study duration for each participant in Part A (SAD) is a maximum of 36 to 43 days, including a Screening period of up to 28 days, 1 day of single dosing, and a follow-up period of 7 days for most cohorts, and food effect assessment with a total treatment and follow-up period of 15 days for one of the SAD cohorts.

The study duration for each participant in Part B (MAD) is a maximum of 49 days, including a Screening period of up to 28 days, 14 consecutive days of once daily dosing, and a follow-up period of 7 days.

The study duration for each participant in Part C (MAD) is a maximum of 63 days, including a Screening period of up to 28 days, 28 consecutive days of once daily dosing, and a follow-up period of 7 days.

Eligibility Criteria:
Key inclusion Criteria:

1. Healthy adult males or females aged 18 to 55 years (inclusive)
2. Body weight ≥ 50 kg for males and ≥ 45 kg for females
3. Negative pregnancy test

Key exclusion criteria:

1. History or presence of clinically significant abnormalities or participants with psychosomatic disorders.
2. Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibody.
3. Dosing in other clinical studies and treatment with a study drug within 3 months prior to IP administration.
4. Females who are pregnant or breastfeeding, or of childbearing potential who are not using effective non-hormonal contraception; men of childbearing potential who are unwilling to use physical methods of contraception during the study
Epidemiological Characteristics of Gastric and Pancreatic Cancers in Latin America

Currently, there is no Brazilian or Latin American epidemiological data, such as clinical-pathological characteristics, standard treatments and outcomes of gastric cancer and pancreatic cancer in the region. The study aims to create a Latin American multicenter database to analyze epidemiological, clinical, and pathological data, treatments, outcomes, and biological information from patients with gastric and pancreatic cancer.

Patients diagnosed with gastric and gastroesophageal junction or pancreatic cancer after January 2019 at participating sites will be included. Data will be collected from medical records in selected centers that comprise different countries from Latin America. Data collection will begin on the time of site activation.

Patients recruited for this study will be identified in the participating sites. Data from clinical, demographic, and socioeconomic variables will be collected. Also, data on treatments performed and outcomes will be abstracted. The patient data sources will be the medical records of the patients. Patients will continue to receive treatment and clinical evaluations for gastric and gastroesophageal junction or pancreatic cancer according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Histological diagnosis of gastric and gastroesophageal junction cancer (Cohort A) or histological diagnosis of pancreatic cancer (Cohort B);
* Advanced disease diagnosis from January 2019: patients can be included prospectively. Advanced disease is defined as metastatic disease or locally advanced disease not amenable to curative therapy;
* Availability of adequate medical data for data collection.

Exclusion Criteria:

* Synchronous invasive tumor or second primary tumor in the last three years (except thyroid tumors or non-melanoma skin);
* Nonepithelial histology in Cohort A: Sarcoma, GIST, lymphoma, and tumors of neuroendocrine origin;
* Nonepithelial histology in Cohort B: Sarcoma, GIST, lymphoma, pancreatoblastoma, and tumors of neuroendocrine origin.
Root Resorption After Maxillary Expansion

The aim of this study will to evaluate the root resorption after RME by hyrax and hybrid hyrax appliances by using of cone beam computed tomography .


Eligibility Criteria:
Inclusion Criteria:

1. skeletal maxillary transvers deficiency
2. unilateral or bilateral posterior crossbite
3. negative buccal corridor
4. patient with good oral hygiene
5. patient with no previous orthodontic treatment
6. no systemic disease

Exclusion Criteria:

1. craniofacial congenital anomalies
2. a history of periodontal disease
3. incomplete treatment records
Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation

The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine for an indefinite period of time. However, the advantage of a long term, calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients. Subjects will receive 2 doses of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®) therapy for approximately 2 weeks (10-20 days).


Eligibility Criteria:
Inclusion Criteria:

* Recipient of cadaver or non HLA identical living donor transplantation (tx), Re-tx recipient (second tx) allowed, but no organ other than a kidney (ie no prev k/p)
* Females of CBP must have neg preg test at the time of study enrollment (SOC) \& agree to practice birth control for duration of the study, or for 6 weeks after the last dose of Myfortic

Exclusion Criteria:

* Subjects who are pregnant or nursing.
* Current malignancy or a malignancy in the past 5 years, except for excised skin CA (BCC or SC)
* Multi-organ tx, ABO incompatible and + CM
* Subjects with a current PRA \>50% within the past 30 days pre tx
* Subjects with active current infection requiring continued use of antibiotics, or the presence of chronic active hepatitis B (surface antigen +) or +HCV.
* Exclude for subjects who have received an investigational drug within 4 weeks of study entry
Transitioning From Cyclosporine to Alefacept in Psoriasis

The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept.

The purpose of this study is to devise a safe and effective method for transitioning patients from cyclosporine to alefacept. Patients in the study are well controlled on cyclosporine and desire to switch to alefacept. The study is done in three phases. In Phase 1 (12 week duration) the two drugs will be overlapped, with cyclosporine slowly tapering. Both drugs will be discontinued after 12 weeks. In Phase 2 (12 weeks duration), patients are off both drugs. In Phase 3 (24 weeks long), patients are on a second course of alefacept alone for 12 weeks and then off for 12 weeks. Topical and UV light treatments are allowed throughout the study. Total length of study is one year.

Eligibility Criteria:
Inclusion Criteria

* Adult psoriasis patients (18 to 80 years old), who are well controlled on cyclosporine (Static PGA score of mild, minimal or clear) and who need or desire to stop cyclosporine and start alefacept.

Exclusion Criteria

* CD4 \<400
* Active infection (other than trivial URI, etc.)
* History of AIDS or Hepatitis B, C
* Inability to understand consent or comply with study requirements
* Pregnancy or Lactation
* History of heart or liver disease
CHM for T2DM & MetS

This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. The primary outcome measure will be fasting plasma glucose and blood pressure. Secondary outcome measures including changes of anthropometric data (body mass index, waist-to-hip ratio), lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), HbA1C, Framingham Stroke Risk Score (FSRS), Audit of diabetes-dependent quality of Life (ADDQoL), International Physical Activity Questionnaire Short Form (IPAQ-SF), daily step count and physiological parameters from wearable watch, dietary record, retinal and sublingual vein imaging, concurrent medications and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Age between 30-75y.
* Diagnosed with Type 2 diabetes no more than 5 years.
* Having current prehypertension (systolic blood pressure 130-139 mmHg or diastolic blood pressure 85-89mmHg), or with a history of hypertension (systolic blood pressure 140-159mmHg or diastolic blood pressure 90-99mmHg).
* Diagnosed with Metabolic Syndrome according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) from Chinese Diabetes Society. People who meet 3 of the following diagnostic criteria or more can be diagnosed as Metabolic Syndrome: (a)Abdominal obesity: waist circumference ≥ 90cm for male and ≥ 85cm for female; (b) Hyperglycemia: Fasting blood glucose ≥ 6.1mmol/L or 2-hour postprandial glucose ≥ 7.8mmol/L and/or those who have been diagnosed with hyperglycemia and in treatment; (c) Hypertension: blood pressure ≥ 130/85mmHg and/or those who have been diagnosed with hypertension and in treatment; (d) Fasting triglyceride ≥ 1.70mmol/L; (e) Fasting HDL-C \< 1.04mmol/L.
* Diagnosed with Accumulation of phlegm and dampness pattern or Intertwined phlegm and blood stasis pattern based on Traditional Chinese Medicine (TCM) theory.
* Stable vital signs and with sufficient sensorimotor and language competency for completing assessments.

Exclusion Criteria:

* Allergic history to Chinese herbal drugs or a known allergy to the ingredients of the CHM.
* Diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes.
* Diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc.
* Secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.).
* Secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.).
* Secondary hyperlipidemia (e.g., hypothyroidism, nephrotic syndrome, etc.).
* Experienced at least one day of diarrhea in the past 7 days.
* With previous stroke history.
* With unconsciousness, aphasia, and cognitive dysfunction.
* With severe heart, liver, or kidney disease or bleeding disorders, or with other serious diseases (e.g. cancer, dementia, etc.).
* Pregnancy or lactation female.
* Had joined other clinical trial within past 4 weeks.
Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients

The aim of this study is to evaluate the impact of gluten-free diets on symptoms and inflammatory markers in individuals with previous diagnosis of fibromyalgia (FM), as well as to identify the presence of non-celiac gluten sensitivity (NCSG) in individuals with FM. Patients with FM diagnosis will be kept on a gluten-free diet for a 10 weeks. In the 7th week, they will receive placebo capsules for 7 days and after washout, capsules containing gluten for another 7 days. A questionnaire based on Salerno protocol will be applied to evaluate the presence of NCGS in the beginning, 8th week and 10 week.

Fibromyalgia (FM) is a chronic and widespread pain condition, usually accompanied by several associated symptoms such as fatigue, sleep disorder, headache, irritable bowel syndrome and mood disorders. Recent studies point to the possibility of gluten protein having a role in the development of FM symptoms in a subgroup of patients. Fourteen patients with FM diagnosis will be kept on a diet restrict in gluten-free foods for a period 10 weeks. At the 7th week they received rice protein isolate capsules (placebo) for 7 days, followed by a 3-day wash-out and a new challenge with capsules containing 8 g/day of gluten (corresponding to 6,3g gluten protein) for another 7 days. In the initial period, at 8th week (final of placebo period) and after challenge with gluten (10th week), blood will be collected for analysis of inflammatory markers. Questionnaires will be carried out to evaluate the quantity and severity of FM symptoms and the impact of FM on daily routine. Inflammatory markers (IL-1bera, IL-6 and IL-10) will be evaluated in the blood. In the challenger period (gluten or placebo) questionnaires will be carried out to evaluate the quantity and severity of symptoms related to fibromyalgia and the impact of fibromyalgia on a daily basis. In addition, a questionnaire based on Salerno protocol was applied to evaluate the presence of NCGS.

Eligibility Criteria:
Inclusion Criteria:

• Women between 18 and 65 years of age with prior clinical diagnosis of FM, according to the American College of Rheumatology criteria of 2010

Exclusion Criteria:

* Subjects diagnosed with positive serology for celiac disease or allergy to wheat
* Subjects diagnosed with autoimmune diseases
* Subjects with diseases that are not part of the comorbidities associated with FM and t hat could influence the results of the study
* Pregnant or lactating women
Evaluating the Effect of Senna in Uremic Pruritus

Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients
* Suffering from pruritus for at least 6 weeks
* Have not responded to other drugs

Exclusion Criteria:

* Dermatological disease
* Liver disease
* Metabolic disease
Patient Satisfaction and Dimensional Accuracy of Bre Flex and Peek for Removable Partial Dentures

Evaluation the patient satisfaction and dimensional stability of upper removable partial denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).

The assessor is responsible for all clinical procedure that will be conducted in this study during all the visits:

Panoramic radiograph and periapical radiographs will be made on the prospected abutment teeth to evaluate the crown-root ratio, the apical condition of the abutment and their alveolar bone support.

The preliminary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts. Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the interarch distance and occlusal plane.

Special trays will be constructed and Mouth preparation will be performed by preparing guiding planes and rests seats will be prepared opposing to the edentulous area. Final impression will be taken by elastomeric impression material. The impression will be poured into type IV dental stone in order to obtain master cast. The master cast will be surveyed. The proposed design will be as follows: metal framework base saddle for edentulous areas on both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention. The denture base will be tried in with acrylic teeth in patient's mouth. After that, the denture base of the partial denture will be processed incorporation with the metal framework into the two different materials to be evaluated. The first group will receive the partial denture in which the metal framework incorporated with the denture base fabricated from PEEK material. The second group will receive the partial denture in which the metal framework incorporated with the denture base material fabricated from BRE-FLEX.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have Kennedy class III modification I upper partially edentulous ridges.
* The remaining teeth have good periodontal condition, with no signs of attrition or gingival recession.
* Male or female patient with age range (45-55) and in good medical condition
* All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
* Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
* Free from any tempro-mandibular joint disorder.
* The patients have good oral hygiene and low caries index.

Exclusion Criteria:

* Patients having abnormal habits as bruxism or clenching
* Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
* Teeth with compromised bone support.
* Patient with xerostomia or excessive salivation.
* Patient with abnormal tongue behavior and/or size.
Pocket Colposcopy Using CARE Algorithm

The Pocket colposcope has 510k FDA clearance and has been successfully used in \~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at 4-6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.

Women undergo Pocket-Assisted VIA (PA-VIA) and green light imaging using the Pocket Colposcope. Women will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure. Once we have obtained enough images to develop the CARE algorithm, it will also be used to assist the provider in diagnosis.

This record reflects Phase 1 of Aim 3 of the grant. Phase 2 of Aim 3 will be added once approved. Phase 1 of Aim 3 was previously included within NCT04998318.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 25 years old and \< 65 years old
2. Sex: Female
3. Positive HPV test within past 6 months

Exclusion Criteria:

1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
2. Women with a negative HPV test
3. Patients incapable of giving informed consent
4. Women with a history of cervical cancer
5. Pelvic exam concerning for cervical cancer or cervical infection
Return To Sport Activities in Patients Surgically Treated For Flat Foot in Paeditric Age

The SURGERY of arthrosis of the subtalar joint, carried out between 9 and 12 years of age, the aim is to restore and maintain the physiological alignment between the talus and the calcaneus during bone maturation.

There are few articles in the literature that talk about the return to sport of pediatric patients after surgery. The aim of the study is to review patients operated on remotely kick heel and describe how they return in their sports (resilience, type of activities carried out, recovery times). The aim of this study is to evaluate the clinical and functional results of patients of age Pediatric treated in the investigator's SC Orthopedics Pediatric Traumatology department for flat feet with "calcaneostop" surgery. The study aims to describe the method of resuming sports activities, analyzing the timing and difficulties declared by patients after surgery, with the help of specific questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Flatfoot;
* Surgical treatment with arthrorisis of subtalar joint;
* Follow-up\> 48 months
* Completeness of the clinical-radiographic documentation.

Exclusion Criteria:

* Diagnosis of secondary flat valgus foot;
* Flat foot treated with other techniques;
* Incomplete clinical documentation;
* Patients who refuse to undergo the study