cyrilzakka/clinical-trials huggingface dataset:
To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)

Type-I diabetes mellitus (T1DM) is an autoimmune condition, in which the pancreas reduces/stops insulin production. Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation. In India, approximately 8.6 lakh people suffer from T1DM, and one in six young patients dies without a diagnosis.

Significant advancements are being made in the field of T1DM research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. However, so far, there is no known permanent cure for T1DM. Thus, treatment of T1DM aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise.

Dietary constituents play an important role in the management of T1DM. Studies have shown that the fruits of Phyllanthus emblica Linn, colloquially known as Indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. Amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. However, clinical trial data with human subjects are limited and preliminary.

Numerous studies also report that turmeric (Curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. The hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion.

In Ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for Prameha (Diabetes mellitus).


Eligibility Criteria:
Inclusion Criteria:

1. K/C/O type-I DM for more than 1 year
2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
3. Parents provide consent and children providing assent for the study

Exclusion Criteria:

1. K/C/O type-I DM for more than 1 year
2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
3. Parents provide consent and children providing assent for the study
A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening

Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score \<6) increases the risk of cesarean section. This risk may be reduced by ripening or softening the cervix before the induction of labor. This protocol outlines a randomized trial of 200 women evaluating the placement and use of Cervidil to the post vaginal fornix to soften the cervix in preparation for induction.

This trial is looking at inpatient vs outpatient pre-induction cervical ripening using Cervidil and the effects on (1) maternal and newborn outcomes including time of admission to delivery, (2) system healthcare cost, (3) cost to patient, and (4) patient satisfaction.

The investigators hypothesize when compared to patients admitted to the hospital for cervical ripening:

1. From the time of admission, patients in the outpatient cervical ripening arm will progress to complete cervical dilation in less time.
2. The total overall cost of care for the encounter will be reduced for the group in the outpatient cervical ripening arm.
3. Patients in the outpatient cervical ripening arm will have more overall satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Accurate gestational age dating by Intermountain dating criteria placing the patient between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening
* Planning to undergo cervical ripening for induction of labor
* Participants must live \<20 minutes away from the enrolling facility, or must stay \< 20 minutes away.
* Pregnant women between the ages of 18 and 41 at the time of enrollment.
* Fetus in vertex position

Exclusion Criteria:

* Gestational age \< 39 weeks or \> 41 weeks and 6 days
* Hypertension (chronic, transitional, gestational, preeclampsia)
* Multiple gestation
* Intrauterine Growth Restriction
* Anticoagulant therapy or at high risk for thromboembolism
* Cardiac disease other than class I per American Heart Association (AHA)
* Prior incision in the contractile portion of the uterus
* Placenta previa
* Oligohydramnios per American College of Obstetricians and Gynecologists (ACOG) criteria: AFI \< 5 or deepest vertical pocket \<= 2
* Polyhydramnios per ACOG criteria: Amniotic Fluid Index (AFI) \>= 24
* Cervical dilation \>= 3cm
* Known fetal anomaly that would require advanced neonatal care
* Pitocin-induction of labor is otherwise contraindicated
* Patient is receiving other uterotonics (e.g. oxytocin, Cytotec, etc.)
* Fetal distress
* Unexplained vaginal bleeding during the pregnancy
* Sensitivity to prostaglandin
* Evidence of or suspicion of marked cephalo-pelvic disproportion (per the Cervidil package insert revision 02/2016, Ferring Pharmaceuticals Inc. Parsippany, NJ)
Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft

A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory loss which can result in functional disability. This article reports the treatment of the thumb PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN. Fourteen patients with the thumb PDN defect underwent a new surgical procedure in which the pedicled nerve graft was used to bridge nerve defect. For comparison, the investigators also collected a consecutive series of 21 patients with thumb PDN defects treated using a nonvascularized sural nerve graft. This study was designed to evaluate the efficacy of pedicled nerve grafting for PDN defects in the thumb.

At final follow-up, the investigators measured the sensibility of the thumb pulps and the donor sites using the Semmes-Weinstein monofilament test and static 2-point discrimination (2PD) test. The test points were at the centers of the radial and ulnar portions of the thumb pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.

Eligibility Criteria:
Inclusion Criteria:

1. thumb PDN defects between the middle of the distal phalanx and the metacarpophalangeal joint;
2. PDN defects of single or both sides;
3. PDN defects 1-4 cm in length.

Exclusion Criteria:

1. injury to the course of the pedicle or the donor sites;
2. PDN defects less than 1 cm or longer than 4 cm;
3. no Doppler sound at the location of the second dorsal metacarpal artery (SDMA).
Dual Source CT Angiography for Detection of Coronary Artery Stenoses

The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.


Eligibility Criteria:
Inclusion Criteria:

* suspected coronary artery disease
* chest Pain
* intermediate likelihood of coronary stenoses
* planned invasive coronary angiography
* age 30 to 80 years

Exclusion Criteria:

* non sinus rhythm
* contrast allergy
* renal failure
* unstable clinical condition
* previous coronary revascularization
* calcium score exceeding 800
* inability to perform 10 second breathhold
* possible pregnancy
* metformin medication that cannot be interrupted
* inability to establish antecubital iv access
Fructose-Induced Palmitate Synthesis in Overweight Subjects

Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride palmitate made by the liver from each single oral dose of fructose (0.5 g/kg), fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose and 2) show a dose-response. The lipogenic responses will be compared and correlated with markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results will serve as a guide to the development of a new outpatient probe of the de novo lipogenic pathway in subjects who vary in their lipogenic response to oral fructose. These studies should ultimately yield valuable new information about the mechanisms linking dietary carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-75 years of age
* Body mass index (BMI) 25-35 and within 10% of maximum weight
* Willing and able to stop fish oil, psyllium, other non-prescribed vitamins/supplements for 1 week prior to study until completion of study
* Willing to not drink alcohol for 24 h before each day of blood sampling

Exclusion Criteria:

* Diabetes or other endocrine disorder, hepatitis or other liver disorder, HIV, or autoimmune disease
* Medication(s) known to affect lipids, including hormonal contraceptives
* Recent acute illness
* Gastrointestinal disease resulting in significant GI dysfunction or malabsorption
* History of fasting TG \>800 mg/dl
* History of ethanol abuse (current intake \>2 drinks/d) or illicit drugs
* History of severe psychiatric illness
* If female, pregnant or breastfeeding
* Participation in an investigational drug study within one month of screening
* Unusual diet or extreme level of physical activity
* Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
DMT210 Topical Gel in the Treatment of Atopic Dermatitis

The objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female 12 years or older
* Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement
* Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline
A Study of GZR18 Injection in Obese/Overweight Patients

This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.


Eligibility Criteria:
* Inclusion Criteria:

  1. Male or female aged 18-65 years (inclusive).
  2. Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI\<28 kg/m2) with at least one comorbidity.
  3. Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
* Exclusion Criteria:

  1. Limb deformities or defects affecting height and body weight measurement.
  2. Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.
  3. History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
  4. Alcohol abuse history within 6 months prior to screening.
  5. Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
  6. Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.
@ctiveHip Tele-rehabilitation System

The purpose of this study is to determine if the @ctivehip tele-rehabilitation system improves the functional level and quality of life of hip fracture patients and reduce the caregiver burden.

Background: The best option for rehabilitation after a hip fracture is still unclear. The home rehabilitation is one of the options and the use of tele-rehabilitation programs at home could be the option for some patients in the future. The main objective of this study is to improve the functional level and quality of life of hip fracture patients and reduce the caregiver burden using the @ctivehip tele-rehabilitation system.

Methods: This project will include hip fracture patients who met the following inclusion criteria: having a high pre-fracture functional level, not having severe cognitive impairment, absence of terminal disease, absence of post-surgery complications, going to live to their home or a relative home at hospital discharge, and signing an informed consent. The criteria to be part of this experimental group will be: having internet at home and a main caregiver with the ability to use the internet (@ctiveHip system). Patients without the internet at home will be part of the no intervention group, and they will receive the usual care, in addition to a triptych with information on recommendations and exercises to do at home. Caregivers of patients of both groups will receive a training session on patient management. Patients will be assessed at 4-weeks and 12 weeks after beginning to use the @ctiveHip system. The primary outcome will be the Functional level, measured by the Functional Independence Measure. The secondary outcomes: quality of life (Euro-qol), physical function (Timed Up and Go, Short Physical Performance Battery, International Fitness Scale), emotional status ( The Hospital Anxiety and Depression Scale ), health status (American Society of Anesthesiologists Score), cognitive status (Mini-mental Test ), fear of falling (Short Falls efficacy scale), pain (visual analogue scale), and caregiver burden of care (Zarit Burden Interview).

Discussion: This study has been designed to provide a tele-rehabilitation system which includes a rehabilitation protocol created by a multidisciplinary team of surgeons, occupational therapist, physiotherapist, and sport scientist, to improve the functional level of patients after hip fracture surgery. The @ctiveHip system could be a new low cost treatment option for some hip fracture patients.

Eligibility Criteria:
Inclusion Criteria:

Patients who had hip fracture surgery

Having a high pre-fracture functional level

Having Internet at home

Hospital discharge to their homes or a relative home.

A main caregiver who has the ability to use the internet (@ctivehip system)

Have signed an informed consent

Exclusion Criteria:

Presence of severe cognitive impairment

Presence of terminal disease

Presence of post-surgery complications
Trial to Compare the SherpaPak™ Device vs Cold Storage

The Investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated hearts.

There are two methods of organ preservation. The first method is the use of cold storage. With this method, the donor heart is stored in preservation fluid within bags that are then placed on ice and transported in a cooler. This is the usual method for transporting donor hearts. This is also known as "standard of care."

The second method is the use of the SherpaPak™ Cardiac Transport System. With this method, the donor heart is kept at a steady, consistent temperature throughout transportation. This method is not typically used for transporting donor hearts.

The study will include up to 20 people in total.

This is a randomized study and has 2 study groups. Participants will be randomly assigned to a group in a 1:1 ratio.

* 50% chance of receiving a donor heart using the SherpaPak™ method, or
* 50% chance of receiving a donor heart using the cold storage method.

The research team will analyze data from the medical records from the heart transplant and clinic visits up to 30 days after the heart transplant. Participants will be in the study for about 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Any sex/gender, 18 years of age or older listed for primary heart transplant.
* Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research.
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
* Subjects must receive and accept a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies)

Exclusion Criteria:

* Re-do heart transplant
* Multi-organ transplant
A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-OA when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. The study is divided into two parts; a dose escalation (Part A) and an optional dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) may be further expanded in Part B.


Eligibility Criteria:
Major inclusion criteria:

* Aged ≥40 and ≤75 years at Screening
* Radiological evidence of predominantly medial osteoarthritis in the knee, uni- or bilateral, of KL grade II to III
* Moderate to severe pain associated with osteoarthritis in the knee as measured by a VAS pain score of ≥35 and ≤90 mm

Major exclusion criteria:

* Body mass index (BMI) of ≥35 at Screening
* Ongoing signs or symptoms of systemic or local infection
* Known knee infection in the study knee within 6 months of Screening
* History of clinically relevant concomitant joint disease, clinically-relevant knee deformities, or any clinically significant medical history of the ligament, or realignment surgery or joint replacement surgery
* Medical history of any autoimmune disease
* History of surgery in the study knee that occured within 6 months of Screening
* Treatment with immunosuppressive therapy (systemic or local) or any medication affecting the bone or cartilage metabolism within 6 months of Screening
* Patients who are immunocompromised as caused by a disease
Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma

Positron emission tomography (PET) with \[18F\]fluorodeoxyglucose (FDG-PET) evaluates cancer cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this study is that early changes in FDG-PET signal can predict sorafenib response in hepatocellular carcinoma (HCC).

Hepatocellular carcinoma (HCC) is a major health issue worldwide, particularly in Asia and Africa, and a disease that has increased in incidence in the Western world over the past 20 years primarily as a result of the prevalence of hepatitis C virus infection, which predisposes patients to HCC.

Sorafenib (a new oral potent multikinase inhibitor directed against both tumour proliferation and angiogenesis) can be considered standard of care for patients with advanced and metastatic HCC who are not candidates for curative or locoregional therapies. Clinical benefit has been shown in 75% of patients with advanced HCC.

PET is a noninvasive imaging technique which might be an effective tool for evaluating sorafenib treatment in HCC. The aim of this study is to evaluate this new treatment with PET with fluorodeoxyglucose (FDG), since the use of only computed tomography (CT) measurements can be questioned. Our hypothesis is that early effects of sorafenib treatment in advanced HCC can be detected and quantified by PET-CT after one month of treatment. We try to reveal a decrease in tumour glucose uptake at one month and correlate it with other radiologic findings (measured by CT and diffusion-weighted nuclear resonance imaging) and the more clinically relevant endpoints clinical benefit and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* advanced hepatocellular carcinoma: diagnostic assessment by biopsy/cytology; in cirrhotic patients conventional radiologic criteria are also accepted
* more than 18 years of age.
* life expectancy greater than three months
* candidate to sorafenib therapy
* informed consent required

Exclusion Criteria:

* hepatocellular carcinoma patients candidate to local/curative therapies(surgery/radiofrequency/TACE/other local therapy
* another active cancer than primary liver cancer
Safety and Efficacy of Different Intervals of Pulsed Dye Laser Sessions on Improvement of Surgical Scars

The appearance of skin after surgery plays an important role in patient's self confidence and life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. Among different kind of lasers, used to improve the appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture, and elasticity of scars. Also, treatment with this technique is noninvasive, minimally uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of different intervals of pulsed dye laser sessions on improvement of surgical scars.


Eligibility Criteria:
Inclusion Criteria:

* Surgical scar with minimum length of 6 cm

Exclusion Criteria:

* History of light sensitivity or photodermatoses
* History of adverse reactions to laser treatment
Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis

Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis.

The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.

Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol).

Improvement is expected in voice and breathing, without aspiration.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before.
* Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing).
* Patient with passive mobile arytenoid at least on one side
* Tracheostomized or not
* Age \> 18 years old
* Good general situation

Exclusion Criteria:

* Long term vocal fold paralysis (more than 3 years with strong denervation)
* Ary-cricoid ankylosis or synechiae
* Age \>75 years
* Anaesthesiologist contra indication
* Strong respiratory disease history
* Severe coagulation troubles
* Ongoing neoplasia disease
* Cardiac pace maker
* Pregnant woman or without contraception
* Impairment of the freedom