cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

The main objective of this study is to evaluate the efficacy of the combination of venetoclax plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).

This study is planned as an adaptive 2-stage design as follows:

Stage 1: Enroll 14 participants with relapsed or refractory (R/R) T-PLL and move to Stage 2 if 4 or more participants meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.

Stage 2: Enroll up to an additional 23 participants.

The study was stopped after Stage 1. Stage 2 was not conducted.

Eligibility Criteria:
Inclusion Criteria:

* Adequate liver, kidney and hematology function per laboratory values as described in the protocol.
* Diagnosis of T-cell prolymphocytic leukemia (T-PLL) that requires treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
* Received prior alemtuzumab (unless unsuitable or unavailable).
* Has no malignancies other than T-PLL that:

  * currently require systemic therapies;
  * were not previously treated with curative intention (unless the malignant disease is in a stable remission due to the discretion of the treating physician); or
  * developed signs of progression after curative treatment.

Exclusion Criteria:

* History of or current decompensated cirrhosis including Child-Pugh class B or C, ascites, hepatic encephalopathy, or variceal bleeding.
* Has human T-cell lymphotropic virus, type 1.
* Prior allogeneic stem cell transplant within 6 months of study drug administration and requirement for graft versus host therapy.
* Has an uncontrolled or active infection including severe acute respiratory syndrome- coronavirus-2 (SARS-COV-2).
* Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.
* Received a prohibited therapy within the specified time frame as described in the protocol.
Hypolipidemic Effect of Adansonia Digitata

Adansonia digitata L. (AD) also known as Baobab is a huge tree that grows in many countries in sub-Saharan Africa. Many studies talking about AD biological activity including hypolipidemic, antioxidant and antimicrobials in animal's but not in human, This study will be undertaken to examine the effect of AD juice consumption against lipid profiles in traditional users and blood samples will be collected form participant's for investigated of lipid profiles pre and post AD juice drinking and the results will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Tradition users (drink AD juice)

Exclusion Criteria:

* Diabetes, hypertension, or chronic illness
Effect of Protein Consumption and Resistance Training on Body Composition, Muscular Strength and Functional Capacity in the Elderly

The increase in life expectancy of the world population is associated with a higher incidence of diseases, leading to functional incapacity and dependence in old age. Aging is usually accompanied by progressive loss of muscle mass, muscular strength and functional capacity, possibly exacerbated by inactivity and low protein and energy consumption of elderly individuals. However, the response to strength training, as well as the daily recommendation of protein and other factors related to sarcopenia in this population seem not to be well understood. Objective: To evaluate the effect of protein intake and resistance training on body composition, muscle strength and functional capacity in the elderly. METHODS: A randomized placebo-controlled clinical trial will be conducted with 38 elderly people, ≥ 60 years old, sedentary, and body mass index between 22 and 30 kg / m2. All those who agree to participate will be randomized into two groups (intervention or placebo) and will undergo an initial assessment consisting of food consumption analysis through the application of the three-day food record, assessment of muscle thickness of the thigh and arm by muscle ultrasonography, evaluation of body composition by dual energy X-ray absorptiometry (DEXA), dynamic maximal strength (1RM) test of knee extension and elbow flexion, peak torque test of knee extension, functional capacity tests and quality of life questionnaire (SF-36). The elderly will participate in resistance training for 12 weeks, two session per week. The intervention group will be supplemented with whey protein isolate (2x / day - 20g for breakfast and 20g for dinner) and the placebo group will receive maltodextrin (2x / day - 20g for breakfast and 20g for dinner). All outcomes will be assessed before and after the 12-week resistance training period.


Eligibility Criteria:
Inclusion Criteria:

* Be 60 or older, and in the case of women, they must be postmenopausal (interruption of menstruation for more than one year).
* Have not participated in any systematic exercise program for at least six months prior to the start of this project.
* To have a body mass index (BMI) between 22 and 30 kg / m2.
* Are not cardiopathic, diabetic or have any other metabolic disease.
* Do not present joint problems or any other injury that prevents the proper execution of the exercises of the training routine.
* Non-smoker or have quit smoking for at least five years ago.
* Release of the doctor (medical certificate) to perform the physical exercises.

Exclusion Criteria:

* Do not participate in at least 20 training sessions or miss more than three consecutive training sessions.
Fit Child - Clinical Study on Weight Control

Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted

In this study, children with abnormal weight development of BMI will be recruited and the gut microbiota will be modified using one of there treatment schedules. The subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic Lactobacillus rhamnosus GG or 2) placebo drink and/or 3) drink with Lactobacillus rhamnosus GG.

The children will give a faecal sample in the beginning and at the end and similarly also a blood sample. The faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. Blood samples will be analysed for obesity related biomarkers.

Body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.

Eligibility Criteria:
Inclusion Criteria: 2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development

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Exclusion Criteria:Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics
Effects of a Compliant Arm Support on Post-stroke Upper Extremity Range of Motion

The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness.


Eligibility Criteria:
Inclusion Criteria:

* greater than 6 months post-stroke
* passive abduction to 90 degrees at shoulder
* reduced active (retro)flexion/extension at shoulder when abducted to 90 degrees
* reduced active flexion/extension at elbow

Exclusion Criteria:

* unable to give informed consent
* unable to comprehend and follow instructions
* have a condition (other than stroke) affecting sensorimotor function
* show evidence of unilateral spatial neglect
* unable to sit in a chair without armrests for 2 hours
PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health

The goal of the PROMISE study is to determine how pre-conception lifestyle factors (e.g., sleep, nutrition, physical activity) affect short- and long-term reproductive outcomes.

The overall goal of the PROMISE study is to identify strategies to improve health outcomes for women and their children. The proposed study is important and novel as it aims to capture women before they are pregnant. Current research on maternal and child health often focuses on women who are already pregnant. This time period is likely too late to make a meaningful clinical impact on long term maternal and child health outcomes influenced by social and epidemiologic determinants of health as important epigenetic changes are or have already taken place. Examples of tools that will be used to capture social and epidemiologic data include validated surveys for nutrition, physical activity, sleep, and stress. The importance of these tools is that many of the data points captured are modifiable, and therefore if associations are noted between these data points and health outcomes, actionable interventions may be developed and implemented for women who are preconceptional.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-44 seeking pregnancy at Northwestern Fertility and Reproductive Medicine (FRM) who agree to

  1. Be followed for a period for up to 25 years
  2. Share information regarding their child's health
* No prior IVF cycles

Exclusion Criteria:

* Women using donor oocytes or gestational carriers
* Inability or unwillingness to provide informed consent for any aspects of the study
Promoting Safety Behaviours in Antenatal Care Using a Video

This study investigates the effect of a video which teaches 15 safety behaviours for women subject to intimate partner violence (IPV) during pregnancy. Half of the women screening positive for IPV during pregnancy will view the intervention video. The other half will view a control video.

Intimate partner violence (IPV) poses a risk for the health of the woman during pregnancy also for the health of the unborn child. Pregnancy is time when nearly all women have regular contact with the healthcare system. Pregnancy is also a time during which women consider their situation and are open for change.

Healthcare staff have the opportunity to ask pregnant women if they experience IPV and need to know how to respond to women experiencing IPV. Healthcare staff can refer to other services. If staff are uncertain if referral is needed or wanted they can teach women how to increase their own safety and prepare for leaving through a number of safety promoting behaviours.The safety behaviours were originally developed in the USA to counsel women who attended a family violence unit and qualified for a protection order.

Women do not always disclose the true nature of their IPV to staff. However, they could still benefit from learning about safety promoting behaviours. Using a video for teaching allows for the use of pictures and sound and options for several languages.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women attending antenatal care at the community health center,
* 18 years or older,
* understanding sufficient Norwegian, Urdu, Somali or English to complete the questionnaire and understand the video.

Exclusion Criteria:

* women who do not speak or understand the languages provided in the study (English, Urdu, Somali and Norwegian)
* women who have never been in an adult intimate relationship
* women who are closely attended by male partner
* women who do not have the mental of physical capacity to answer the questionnaire.
* women who cannot fill out the questionnaire in privacy
DISRUPT PAD III Observational Study

The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions.

Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.


Eligibility Criteria:
Inclusion Criteria:

Subjects were required to meet ALL of the following inclusion criteria in order to be included in this clinical study:

1. Subjects intended to be treated with Shockwave Medical Lithoplasty for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
3. Age of subject is \> 18.
4. Subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
5. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length.

Exclusion Criteria:

Subjects that met ANY of the following exclusion criteria were not included in this clinical study:

1. Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Lithoplasty as per Instructions for Use (IFU) or investigator's opinion.
2. Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Aspirin/Folate Prevention of Large Bowel Polyps

This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.

This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel among subjects with a recent history of these tumors. The study is a randomized, double-blind, placebo-controlled trial with a 2 x 3 factorial design.

Eligibility Criteria:
Inclusion Criteria:

1. One neoplastic polyp removed within three months of study entry or within 16 months of study entry if over 1 cm in size or if subject has had a lifetime history of at least two polyps, with the entire large bowel seen by colonoscopy to be free of further polyps within 3 months of entry.
2. An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
3. Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
4. Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
5. Age between 21 and 80 years at the time of the intake colonoscopy.
6. For women of childbearing potential, agreement to use effective birth control for the duration of the study.
7. Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
8. Not randomized previously or currently in a chemoprevention trial, except for the: "Nutritional Prevention of Large Bowel Polyps" Study (Polyps Prevention Study I); and brief participation in the "VA Cooperative Study" with no continuing involvement.

Exclusion Criteria:

1. Invasive carcinoma in any colonic polyp removed.
2. Familial colonic polyposis syndromes.
3. Ulcerative colitis or Crohn's disease.
4. Malabsorption syndrome (e.g. pancreatic insufficiency).
5. Large bowel resection for any reason.
6. Diagnosed narcotic or alcohol dependence
7. Contraindication to aspirin use, including:

   1. documented peptic ulcer disease in the past 20 years
   2. aspirin sensitivity
   3. bleeding diathesis, including hemorrhagic stroke
8. Likelihood of NSAID use

   1. recurring arthritis or other musculo-skeletal problems
   2. frequent NSAID use in 5 years preceding
   3. history of stroke or TIAs
   4. history of angina or myocardial infarction
   5. desire to take aspirin for the prevention of cardiovascular disease
9. Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
10. Pregnancy or lactation.
Effects of Neuromobilization on Median Nerve Elasticity

Purpose: The aim of this study was to investigate the effect of median nerve neuromobilization on median nerve elasticity using shear wave elastography.

Methods: The study included 36 healthy volunteers (72 upper extremities) aged 18-30 years. Inclusion criteria; no known systemic neuromuscular and metabolic diseases, no nerve impingement syndrome, and no upper extremity bone-tendon-muscle surgery in the last six months. Sociodemographic data of the participants were recorded. Wrist flexion and extension bilaterally with universal goniometer and finger grip strength bilaterally were measured with pinchmeter. Median Nerve Stress Test was performed. Median nerve elasticity was measured by Shear Wave Ultrasound Elastography. The extremity of the dominant side as a study group and the non-dominant side as a control group were measured bilaterally. Median nerve neuromobilization (stretching (n = 18) and shifting (n = 18)) was applied to the upper extremities of the dominant side. The application was carried out as 3 sets in one session. Evaluations were repeated after application.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* Healthy individuals without any known systemic disease

Exclusion Criteria:

* Those who have undergone an upper extremity bone-tendon-muscle operation in the last six months
* People with a systemic disease such as rheumatoid arthritis, diabetes mellitus
* Patients with any neuromuscular disease
Distalization Via Skeletally-anchored Distaljet Appliance With Two Approaches of Micro-osteoperforations

study will be directed to evaluate two approaches of micro-osteoperforations during maxillary molar distalization.

Maxillary molar distalization via skeletally anchored distal jet appliance randomly divided into two equal groups

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

All patients should satisfy the following criteria:-

1. Age range from 13-17 years.
2. Bilateral Class II molar relationship.
3. Skeletal Class I or mild Class II relationship.
4. Normodivergent skeletal pattern
5. No posterior crowding or diastemas.
6. Fully erupted maxillary first and second molars.
7. Congenitally missing or extracted third molars.
8. Good oral and general health.
9. No systemic disease/medication that could interfere with OTM.
10. No previous orthodontic treatment.

Exclusion Criteria:

* Exclusion criteria:

  1. Patient diagnosed to have an indication for non-extraction approach.
  2. Poor oral hygiene or periodontally compromised patient.
  3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
  4. Previous orthodontic treatment
Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes

This study is a multi-center, prospective, observational clinical trial study. 528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the cesarean section group, full term pregnant women with prelabor rupture of membrane (PROM) who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the non-cesarean section group, pregnant women after 37 weeks of gestation with PROM but without vaginal labor contraindications will be enrolled. Whether in the cesarean section group or non-cesarean section group, if spontaneous labor does not occur, and they all will be induced by oxytocin. After 24 hours, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers sign the informed consent;
2. Age: 20-40 years;
3. Singleton, a cephalic presentation;
4. No contradiction to vaginal delivery;
5. gestation: 37\~42 weeks;
6. With prelabor rupture of membrane.

Exclusion criteria:

1. Konwn contraindication to vaginal delivery or severe complications;
2. Multiple gestation;
3. Uterine malformation;
4. Severe psychiatric disorder;
5. Without family's support.
Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section

Cesarean delivery rates are rising globally, and effective postoperative analgesia is crucial for maternal recovery and newborn care. While intrathecal morphine offers strong analgesia, it may cause side effects such as nausea, pruritus, or respiratory depression. The transversus abdominis plane (TAP) block provides somatic pain relief but is often insufficient alone. The transversalis fascia plane block (TFPB) has been shown to enhance lower abdominal analgesia. This study aims to evaluate whether combining TAP and TFP blocks can provide analgesic efficacy comparable to intrathecal morphine in cesarean section patients who are unable to receive opioids or are at high risk of side effects.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* American Society of Anesthesiologists physical score I or II
* caesarean section with a Pfannenstiel incision

Exclusion Criteria:

* additional surgical intervention, or received general anaesthesia,
* hypersensitivity to the agents to be used
* BMI greater than 35 kg m-2
* coagulopathy,
* local infection,
* opioid addiction,
* pregnancy-related hypertension
* diabetes mellitus
Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects

High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually applied to neonatal intensive care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after conventional mechanical treatment fails. ventilation. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a research hotspot in this field. Recommended to avoid intubation after failure of conventional non-invasive ventilation therapy. There is a lack of large-scale clinical trials systematically exploring its efficacy for intubation therapy. The increasing clinical application of nHFOV has also enriched its application in the treatment of other diseases. Human-machine asynchrony during non-invasive ventilation will seriously affect its efficacy, but no one has reported on the research related to nHFOV human-machine asynchrony.


Eligibility Criteria:
Inclusion Criteria:

1. Age 25-40, males and females;
2. Pulmonary function test found that the subject's lung function was normal;
3. Pulmonary disease not related to the results of the experiment;
4. Willing to participate in the study;
5. Able to provide informed consent.

Exclusion Criteria:

1. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
2. Intolerant with NIV